VAERS DATA 2021: PEOPLE WHO DIED AFTER TAKING A COVID-19 VACCINE (UNDER THE AGE OF 50)

The great majority of the reports to the VAERS (Vaccine Adverse Events Reporting System) involving deaths after a COVID-19 vaccination involve older patients with underlying health conditions. But what about people under the age of 50? How many people have died after being vaccinated. We wanted to look at the data reported to find out.

The table below is data downloaded directly from the VAERS website. It includes all reports where someone died after taking the vaccine. It’s important to note that this does not mean they died because of the vaccine. At the same time, death caused by the vaccine cannot simply be ruled out.

Can someone die from taking a COVID-19 vaccine?

Of course there is a chance, just like when taking any other drug or vaccine, of serious injury or death. Anyone that says otherwise is uninformed or is simply not being honest. However, the statistical probability of dying from taking a COVID-19 vaccine is incredibly low, especially for healthy individuals. The majority of people who died had multiple underlying conditions and/or were on multiple other medications.

In total, from January 1 2021 to July 30 2021, there have been 472 total vaccine deaths reported for people under the age of 50. That includes a number of people who committed suicide. Considering there have been hundreds of millions of vaccinations administered in the U.S. in 2021, the numbers are very small.

There is a lot of information included in each report which doesn’t make for optimal viewing on the web, but below you can scroll through the table to see each event below.

VAERS_ID

RECVDATE

STATE

AGE_YRS

SEX

VAX_TYPE

VAX_MANU

DATEDIED

VAX_DATE

ONSET_DATE

NUMDAYS

LAB_DATA

OTHER_MEDS

CUR_ILL

HISTORY

ALLERGIES

VAX_DOSE_SERIES

SYMPTOM_TEXT

921667

1/5/21

COVID19

PFIZER\BIONTECH

1/3/21

12/29/20

1/3/21

LTCF Pfizer Vaccine clinic conducted 12/29/2020 Vaccine lead received a call indicating that a staff member deceased somewhere between 1/3/2021 and 1/4/2021. Cause of death is unknown, and an autopsy is being performed.

933578

1/11/21

COVID19

MODERNA

1/8/21

metform, atorvastin

Diabetes, Hypertension, Sleep Apnea, Obese

Hx smoking

NKA

Pronounced dead 1/9/2021 at 12:42. Received first dose of vaccine 1/8/2021

936805

1/12/21

COVID19

MODERNA

1/11/21

12/22/20

1/11/21

None associated.

See Continuation Field

Whiplash injury to neck. Sprain of ligaments of cervical spine

Septal defect (heart), chronic sinusitis

Ceftriaxone

Patient received the vaccine on 12/22/20 without complication. It was reported today that the patient was found unresponsive and subsequently expired at home on 1/11/21.

937527

1/12/21

COVID19

PFIZER\BIONTECH

1/4/21

12/23/20

1/4/21

unknown, not reported

unknown

unsure if related to vaccine, but was notified by her next of kin that she died on 1/4/2021. No reports of side effects or hospitalization were reported to the facility prior to the notification of death.

939050

1/12/21

COVID19

MODERNA

1/4/21

12/28/20

12/29/20

Unknown

Morbid obesity and hypothyroidism

Unknown

Patient vaccinated on 12/28. Approximately one day later, develops cough and on azithromycin x 1 week. On 1/3, patient develops left-sided weakness and aphasia. Taken to the hospital, tested COVID+, required intubation — acute hypoxic respiratory failure secondary to COVID – on H&P. Patient died on 1/4/21 at 7:20am.

943397

1/14/21

COVID19

PFIZER\BIONTECH

1/11/21

12/23/20

1/11/21

No labs or tests.

None

Ceclor, Penicillin, Sulfa

UNK

On day due for 2nd dose, Patient was found unresponsive at work in the hospital. Patient pupils were fixed and dilated. Full ACLS was initiated for 55 minutes with multiple rounds of bicarb, calcium chloride, magnesium, and epinephrine. Patient was intubated. Patient continued into V. Fib arrest and was shocked multiple times.

948418

1/15/21

COVID19

PFIZER\BIONTECH

1/12/21

1/7/21

1/12/21

Autopsy pending;

Unknown

Received 1st Covid vaccine 12/18/2020; 2nd 1/7/2021. This patient is now deceased 1/12/2021.

Per patient health history: hearing loss, asthma, bronchiolitis, chronic cough, anemia, depression

No known

UNK

Expired on 1/12/2021; unknown cause of death

950057

1/16/21

COVID19

MODERNA

1/15/21

Hydrocephalus with ventricular shunting Prior history of leukemia

UNK

Patient suffered a cardiac arrest and was unable to give details about her symptoms. Per husband, patient did not complain of any symptoms after vaccine administration. She began seizing without warning which was complicated by cardiac arrest of uncertain etiology

960841

1/21/21

COVID19

PFIZER\BIONTECH

1/21/21

1/17/21

1/19/21

Amantadine, clonazepam, clobazam, lovenox, dextroamphetamine-amphetamine , famotidine, gabapentin, keppra, robinul, polyethylene glycol, propanolol, sertaline, senna, valproic acid, vimpat, cefepime

none

ventilator dependent, anoxic encephalopathy, seizure disorder

none

Patient developed 104.4 temp approximately 48 hours after being given the vaccine. I treated him with antibiotics, IV fluids, cooling methods. CXR does show a new right perihilar infiltrate. However, his fever came down within the next 24-48 hours. Unfortunately, he suffered a cardiac arrest on 1/21/21 in the early morning and expired.

961339

1/21/21

COVID19

MODERNA

1/19/21

1/18/21

1/19/21

Wellbutrin, Ambien

COPD, Sleep apnea

contrast die

UNK

possibly got it at clinic, possibly who administered shot. Pts. daughter said the pts boyfriend denied any symptoms the whole day but that in the middle of the night the pt passed away.

965256

1/22/21

COVID19

MODERNA

1/19/21

12/23/20

1/19/21

Atorvastatin calcium 20mg daily

Hypertension Hyperlipidemia Obstructive Sleep Apnea Obese Hearing loss Degenerative Disc Lumbar

NKDA

Found deceased, presumed while exercising

967240

1/22/21

COVID19

PFIZER\BIONTECH

1/6/21

12/29/20

1/6/21

Patient unexpectedly died on o1/6/2020. No known signs or symptoms.

977319

1/27/21

COVID19

MODERNA

1/25/21

12/29/20

1/25/21

Unknown

Notified by patient’s sister on 1/26/2021 that patient died in his sleep on 1/25/2021. She did not know cause of death.

981407

1/28/21

COVID19

PFIZER\BIONTECH

1/24/21

1/6/21

1/24/21

Expired in sleep on 1/24/21

982826

1/28/21

COVID19

PFIZER\BIONTECH

1/26/21

1/21/21

1/26/21

not available

unknown

immunocompromised with reportable conditions

immunocompromised with reportable conditions, positive for COVID-19 September 2020

unknown

Was at work on 1/26/21 and collapsed, no known complaints a the time. CRP was initiated immediately, transported to ER and pronounced dead

986901

1/29/21

COVID19

PFIZER\BIONTECH

1/29/21

1/28/21

Autopsy pending

Copaxone

Optic neuritis; asthma

None

Patient received vaccine uneventfully with no acute concerns. Left clinic and by report went out with friends. Spoke to father on phone at or around 9:00 pm. Failed to show up to work and was found dead at home. Other details pending

992237

2/1/21

COVID19

PFIZER\BIONTECH

1/29/21

1/25/21

1/29/21

Bag valve mask and intubation prior to arrival to ED. Epi x3 and defibrillation x2.

Nebivolol 5mg; Pantoprazole 40 mg; Levocetirizine dehydrochloride 10 mg

Hypertension; Hyperlipidemia; decreased GFR. Family history of CAD

None

UNK

1/28/2021- Seen by FNP for indigestion, chest pressure and palpitations. EKG reviewed and referral made to Cardiology. 1/29/2021-1800 Presented to ED in cardiac arrest-onset PTA. Patient was found unresponsive by his wife at their home. The last known well was at 1530 when she called him on the phone. The patient was pronounced at ~1850.

994913

2/2/21

COVID19

MODERNA

2/1/21

1/30/21

1/31/21

UNK

patient passed away 2 days after vaccine. patient had temperature, nausea, and vomiting after vaccine.

1000228

2/4/21

COVID19

PFIZER\BIONTECH

1/26/21

1/21/21

Medical History/Concurrent Conditions: COVID-19; Immunocompromised

dead; Collapsed; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; This is a spontaneous report from a contactable nurse. A 40-year-old male patient receive first dose of bnt162b2 (Lot number: EK9231, Brand: Pfizer), intramuscular in left arm on 21Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included immunocompromised w/ reportable conditions from an unknown date and unknown if ongoing, positive for Covid in September from Sep2020 to an unknown date. The patient’s concomitant medications were not reported. The patient experienced dead, collapsed on 26Jan2021. Therapeutic measures were taken as a result of collapsed. The outcome of collapsed was unknown. The patient died on 26Jan2021. It was not reported if an autopsy was performed. Received Covid vaccine here on 21Jan2021, was at work on 26Jan2021 and collapsed, no known complaints at the time, CPR (cardiopulmonary resuscitation) was initiated immediately, transported to ER (Emergency room) and pronounced dead. Unknown if other vaccine in four weeks. The patient had COVID prior vaccination. Unknown If COVID tested post vaccination.; Sender’s Comments: Based on the information currently provided, the patient was immunocompromised and had prior COVID infection. The death and syncope more likely are associated with the patient underlying medical conditions. More information such medical history, concomitant medications, treatment indication and event term details especially death cause and autopsy results are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Dead

1006640

2/5/21

COVID19

PFIZER\BIONTECH

2/5/21

2/3/21

2/4/21

UR COLOR Yellow [3873] 02/05/21 01:16 UR CLARITY HAZY [3873] 02/05/21 01:16 UR SPECIFIC GRAVITY 1.010 1.001 – 1.035 [3873] 02/05/21 01:16 URINE PH 7.0 UNITS 5.0 – 9.0 [3873] 02/05/21 01:16 UR PROTEIN 100 mg/dL “Neg ” [3873] 02/05/21 01:16 UR GLUCOSE 150 mg/dl “Neg ” [3873] 02/05/21 01:16 UR KETONES NEG mg/dL “Neg ” [3873] 02/05/21 01:16 UR BILIRUBIN NEG mg/dL “Neg ” [3873] 02/05/21 01:16 UR BLOOD MOD mg/dl “Neg ” [3873] 02/05/21 01:16 UR NITRITE NEG mg/dL “Neg ” [3873] 02/05/21 01:16 UR UROBILINGEN NEG L mg/dL “<2.0” [3873] 02/05/21 01:16 UR L.ESTERASE NEG “NEG” [3873] 02/05/21 01:16 RBC/HPF 262 /HPF [3873] 02/05/21 01:16 WBC/HPF 5 /HPF [3873] 02/05/21 01:16 UR EPITHELIAL CELLS [none] /HPF [3873] 02/05/21 01:16 UR-BACTERIA [none] /HPF [3873] 02/05/21 01:16 WBC CLUMPS [none] /HPF [3873] 02/05/21 01:16 UR-TRIPLE PHOS CRYSTALS [none] [3873] 02/05/21 01:16 UR-CA+OXALATE CRYSTALS [none] [3873] 02/05/21 01:16 UR-URIC ACID CRYSTALS [none] [3873] 02/05/21 01:16 UR-AMORPHOUS SEDIMENT RARE [3873] 02/05/21 01:16 UR-BUDDING YEAST [none] [3873] 02/05/21 01:16 URINE HCG Neg [3873] 02/05/21 01:16 Internal QC Hcg PASS [3873] 02/05/21 01:16 Comment: rare MUCOUS Urine sent for culture. Res Site Test name Result Flg Units Ref. range Code Result Dt/Time Cannabinoids UR NEG “NEG” – [3873] 02/05/21 01:32 “Positive at 50 ng/mL” Methadone, UR NEG “NEG” – [3873] 02/05/21 01:32 “Positive at 200 ng/mL” Cocaine Screen, UR NEG “NEG” – [3873] 02/05/21 01:32 “Positive at 150 ng/mL” Buprenorphine Screen, UR NEG “NEG” – [3873] 02/05/21 01:32 “Positive at 10 ng/mL” Internal QC Ur Tox Screen PASS [3873] 02/05/21 01:32 Amphetamines, UR NEG “NEG” – [3873] 02/05/21 01:32 “Positive at 500 ng/dL” Barbiturates, UR NEG “Neg” – [3873] 02/05/21 01:32 “Positive at 200 ng/mL” Benzodiazepines, UR NEG “Neg” – [3873] 02/05/21 01:32 “Positive at 150 ng/mL” Methamphetamine, UR NEG “Neg” – [3873] 02/05/21 01:32 “Positive at 500 ng/mL” Opiates, UR NEG “Neg” – [3873] 02/05/21 01:32 “Positive at 100 ng/mL” Oxycodone, UR NEG “Neg” – [3873] 02/05/21 01:32 “Positive at 100 ng/mL” Phencyclidine Screen, UR NEG “Neg” – [3873] 02/05/21 01:32 “Positive at 25 ng/mL” Tricyclic Antidepressants,UR NEG “Neg” – [3873] 02/05/21 01:32 “Positive at 300 ng/mL” Propoxyphene, UR NEG “NEG” – [3873] 02/05/21 01:32 “Positive at Res Site Test name Result Flg Units Ref. range Code Result Dt/Time _SARS-CoV-2 NEGATIVE [3873] 02/04/21 23:49 Eval: Positive – The 2019 novel coronavirus (SARS-CoV-2) target nucleic acids are detected. Eval: Eval: Presumptive Positive – The 2019 novel coronavirus (SARS-CoV-2) target nucleic Eval: acids may be present. Sample is retested. For samples Eval: with repeated presumptive positive result, additional Eval: confirmatory testing may be conducted to differentiate Eval: between SARS-CoV-2 and SARS-CoV-1 or other Sarbecovirus Eval: currently unknown to infect humans, for epidemiological Eval: purposes or clinical management. Eval: Eval: Negative – The 2019 novel coronavirus (SARS-CoV-2) target nucleic acids are not detected. Internal QC SARSCOV2 Valid [3873] 02/04/21 23:49 Test name Result Flg Units Ref. range Code Result Dt/Time SO2 88.8 L % 90.0 – 100.0 [3873] 02/04/21 21:58 PH, BLOOD 7.16 L* 7.35 – 7.45 [3873] 02/04/21 21:58 PCO2 34.7 mmHg 30 – 40 [3873] 02/04/21 21:58 PO2 68 mmHg 58 – 70 [3873] 02/04/21 21:58 HCO3 12.6 L mmol/L 18.0 – 24.0 [3873] 02/04/21 21:58 Base Excess -16.8 L mmol/L <3.0 [3873] 02/04/21 21:58 TCO2 34.7 H mmol/L 19.0 – 25.0 [3873] 02/04/21 21:58 SAT 88.8 L % 90 – 99 [3873] 02/04/21 21:58 Oxy Hgb 87.0 % [3873] 02/04/21 21:58 Patient Temperature 92.0 Deg Far [3873] 02/04/21 21:58 COHB% 0.6 % 0.0 – 10.0 [3873] 02/04/21 21:58 METHB 1.5 H % <0.5 [3873] 02/04/21 21:58 Comment: AC RR 28 VT 400 FIO2 100 PEEP +5 Test name Result Flg Units Ref. range Code Result Dt/Time MAGNESIUM-09 0.9 L mg/dL 1.6 – 2.6 [3873] 02/04/21 22:20 Test name Result Flg Units Ref. range Code Result Dt/Time SALICYLATE-09 <1 mg/dL [3873] 02/04/21 22:20 ACETAMINOPHEN-09 <5 L mcg/mL 5 – 200 [3873] 02/04/21 22:20 Res Site Test name Result Flg Units Ref. range Code Result Dt/Time TROPONIN I-09 2.6 H* ng/mL 0.0 – 0.3 [3873] 02/04/21 22:19 Res Site Test name Result Flg Units Ref. range Code Result Dt/Time D-DIMER (TOP) >5250 H ng/mL 0 – 230 [3873] 02/05/21 00:10 Eval: The HemosIL D Dimer assay is cleared by the FDA for 100% negative predictive value Eval: for results <230 ng/mL DDU, when used in conjunction with clinical pre-test Eval: assessment for the purpose of ruling out Deep Vein Trombosis (DVT) and/or Eval: Pulmonary Embolism (PE). Res Site Test name Result Flg Units Ref. range Code Result Dt/Time _PT (TOP) 29.4 H sec 9.8 – 12.8 [3873] 02/04/21 22:20 _INR (TOP) 2.58 H 0.85 – 1.11 [3873] 02/04/21 22:20 name Result Flg Units Ref. range Code Result Dt/Time WBC-XE 5.70 10*3/uL 4.74 – 10.94 [3873] 02/05/21 00:30 RBC-XE 1.83 L M/uL 4.32 – 5.85 [3873] 02/05/21 00:30 HGB-XE 5.1 L* g/dL 12.6 – 17.3 [3873] 02/05/21 00:30 HCT-XE 18.6 L* % 38.2 – 52.4 [3873] 02/05/21 00:30 MCV-XE 101.6 H fL 81.7 – 96.6 [3873] 02/05/21 00:30 MCH-XE 27.9 pg 26.7 – 32.2 [3873] 02/05/21 00:30 MCHC-XE 27.4 L g/dL 31.4 – 34.7 [3873] 02/05/21 00:30 PLT-XE 37 L 10*3/uL 125 – 400 [3873] 02/05/21 00:30 MPV-XE 10.6 fL 8.7 – 11.8 [3873] 02/05/21 00:30 NEUT% 74.2 % 47.2 – 74.4 [3873] 02/05/21 00:30 LYMPH% 20.0 % 17.9 – 42.6 [3873] 02/05/21 00:30 MONO% 1.2 L % 3.0 – 9.0 [3873] 02/05/21 00:30 EO% 0.7 % 0.0 – 4.6 [3873] 02/05/21 00:30 BASO% 0.2 % 0.0 – 1.1 [3873] 02/05/21 00:30 NRBC 0.5 /100WBC 0.0 – 1.0 [3873] 02/05/21 00:30 IM GRAN% 3.7 H % 0.0 – 1.0 [3873] 02/05/21 00:30 RDW-XE 14.9 % 12.2 – 15.1 [3873] 02/05/21 00:30 NEUT# 4.24 10*3/uL 1.56 – 6.13 [3873] 02/05/21 00:30 LYMPH# 1.14 L 10*3/uL 1.18 – 3.74 [3873] 02/05/21 00:30 MONO# 0.07 L 10*3/uL 0.24 – 0.86 [3873] 02/05/21 00:30 EO# 0.04 10*3/uL 0.04 – 0.36 [3873] 02/05/21 00:30 BASO# 0.01 10*3/uL 0.01 – 0.08 [3873] 02/05/21 00:30 IG# 0.21 10*3/uL [3873] 02/05/21 00:30 NRBC# 0.03 H 10*3/uL 0.00 – 0.01 [3873] 02/05/21 00:30 SEGS 72 % 55 – 75 [3873] 02/05/21 00:30 BANDS 9 H % 0 – 3 [3873] 02/05/21 00:30 LYMPHS 14 L % 20 – 35 [3873] 02/05/21 00:30 MONOS 1 L % 2 – 8 [3873] 02/05/21 00:30 EOS 1.0 % 1.0 – 4.0 [3873] 02/05/21 00:30 META 3.0 H % <0.0 [3873] 02/05/21 00:30 Reactive Lymphs 3 #/100 WBC [3873] 02/05/21 00:30 NUCLEATED RBC/100WBC 1 #/100 WBC [3873] 02/05/21 00:30 MICROCYTOSIS 1+ [3873] 02/05/21 00:30 HYPOCHROMIA 1+ [3873] 02/05/21 00:30 PLT SMEAR EST Reduced [3873] 02/05/21 00:30 RBC COLOR/SIZE ABNORMAL [3873] 02/05/21 00:30 Comment: Notified/Readback Rec’d: PHARM/ED/2.4.21@2159/DD Verified by Repeat Analysis. NO Platelet Clumps Present NO Cells Resembling Immunoblasts Are Present PLATELET ESTIMATE= 36,000 Res Site Test name Result Flg Units Ref. range Code Result Dt/Time _CALCULATED OSMOLALITY 306 H mOsm/kg 275 – 295 [3873] 02/04/21 22:19 Eval: Neonatal: may be as low as 266 Eval: >60 yrs old: 280 – 301 ALCOHOL-09 <10 L mg/dL “<10” [3873] 02/04/21 22:19 LIPASE-09 26 U/L 13 – 60 [3873] 02/04/21 22:19 T BILI-19 0.3 mg/dL 0.1 – 1.2 [3873] 02/04/21 22:19 Eval: Per manufactures instructions, intereferance substance of IgG >28 gm/L Eval: may affect Total Bilirubin results. Clincal judgement is recommended. No Eval: significant interference was shown in the bilirubin concentration Eval: ranges >5.9 mg/dL, medical risk for the newborn population is most Eval: unlikely. GLUCOSE-RANDOM-09 101.0 mg/dL 74.0 – 106.0 [3873] 02/04/21 22:19 Eval: NEONATES: 40 – 60 mg/dL Eval: CHILDREN: 60 – 100 mg/dL BUN-09 3.0 L mg/dl 6.0 – 20.0 [3873] 02/04/21 22:19 Eval: 18 – 60 year old = 6-20 mg/dL Eval: 60 – 90 year old = 8-23 mg/dL CREATININE <0.5 L mg/dL 0.5 – 1.5 [3873] 02/04/21 22:19 SODIUM-09 148.0 H mEQ/L 136.0 – 145.0 [3873] 02/04/21 22:19 POTASSIUM-09 1.5 L* mEQ/L 3.5 – 5.1 [3873] 02/04/21 22:19 Eval: PLASMA reference range: 3.4 – 4.5 mmol/L CHLORIDE-09 134.3 H mEQ/L 98.0 – 107.0 [3873] 02/04/21 22:19 CO2-09 5.0 L* mEQ/L 22.0 – 29.0 [3873] 02/04/21 22:19 ANION GAP-09 9.00 0.00 – 14.00 [3873] 02/04/21 22:19 CALCIUM-09 2.8 L* mg/dL 8.6 – 10.2 [3873] 02/04/21 22:19 T PROTEIN-09 1.5 L gm/dL 6.6 – 8.7 [3873] 02/04/21 22:19 ALBUMIN-09 0.7 L gm/dL 3.5 – 5.2 [3873] 02/04/21 22:19 ALK PHOS-09 43.0 IU/L 37.0 – 108.0 [3873] 02/04/21 22:19 Eval: CHILDREN: Eval: <1 day old: <260 U/L Eval: 6 days-6 months: <467 U/L Eval: 1-3 yrs: <292 U/L Eval: 1-12 years: <312 U/L Eval: 13-17 yrs(f): <195 U/L Eval: 13-17 yrs(m): <406 U/L AST-09 463.0 H IU/L 10.0 – 32.0 [3873] 02/04/21 22:19 ALT-09 89.0 H IU/L 10.0 – 33.0 [3873] 02/04/21 22:19 ESTIMATED GFR N/A mL/min [3873] 02/04/21 22:19 Res Site Test name Result Flg Units Ref. range Code Result Dt/Time LACTATE-09 70.7 H* mg/dL 4.5 – 19.8 [3873] 02/04/21 22:02 Res Site Test name Result Flg Units Ref. range Code Result Dt/Time _ABO Group A [3873] 02/04/21 22:39 _Rh Positive [3873] 02/04/21 22:39 Antibody Screen Negative [3873] 02/04/21 22:39

Naltrexone 25mg PO daily, chlordiazepoxide 25mg was 2/4 at 1:25pm for CIWA 9

Alcohol use disorder, facial laceration, alcohol intoxication, secondary syphillis

Alcohol use disorder

NKDA

In discussion with Dr., medical director at Detox, she arrived night of 2/3/21 was quite intoxicated so was not going through any withdrawal. She was getting vitals and CIW checked regularly. First dose of chlordiazepoxide 25mg was 2/4 at 1:25pm for CIWA 9. She had repeat vitals at 5:50pm, CIWA 1, vitals: P 67, 118/79, 94% on RA, T 98.3. she had complained of some “pressure in her head” and feeling anxious, but otherwise denied other complaints. she was talking with others in the group, then other patients report she suddenly started having seizure like activity around 6:45pm, med techs came to help and found her stiff, gurgling. they tried to get vitals on her, called 911, noticed that at 6:54pm she had lost a pulse and they started CPR. paramedics arrived at 7:08pm and she was brought to ED. Pt BIBA in cardiac arrest. Pt was at Detox Center when she was reported to have seizure-like activity followed by collapse. She was found to be pulseless and CPR initiated by staff members. EMS arrived and performed approx 15 min of CPR and gave pt epi x 3 and bicarb. No shocks administered but they did not report a rhythm. In the emergency room the patient arrived and was found to be pulseless with PEA arrest, CPR was initiated, patient was intubated. ROSC ultimately achieved, patient remained very acidotic despite ventilator adjustment, head CT revealed cerebral edema. Pt also found to be profoundly anemic with a hemoglobin of 5 and platelets of 37, she was thought to be GI bleeding so medications for this were initiated. Patient then became more hypoxemic with bradycardia, consultation with neurosurgery and critical care medicine at tertiary care center deemed ongoing CPR futile. Patient arrested at 2:30AM on 2/5, pronounced dead at 2:48AM.

1020702

2/10/21

COVID19

MODERNA

2/9/21

1/20/21

2/9/21

Hydrochlorothiazide, Hydroxyzine, Mirena, Ocrevus, Prednisone, triamcinolone acetonide, valacyclovir, vitamin D 3

calcaneal spur displacement of intervertebral disc without myelopathy female stress incontinence foot pain hand joint pain herpes simplex low back pain menorrhagia multiple sclerosis neck pain numbness of lower limb peripheral edema polyneuropathy

No known allergies.

Passed away the morning of 2/9/21.

1021040

2/10/21

COVID19

PFIZER\BIONTECH

1/17/21

1/6/21

1/17/21

Unknown

Unknown – LTCF will also be reporting

Obesity, others unknown

Unknown – LTCF will also be reporting

Pfizer-BioNTech COVID-19 Vaccine Hospital Emergency Room Provider reported cause of death as COVID vaccine administered 11 days prior to death. Additional information being reported from LTCF.

1026362

2/12/21

COVID19

PFIZER\BIONTECH

2/6/21

1/1/21

2/4/21

Autopsy 2/11 Medical Center

Duchenne muscular dystrophy

UNK

Patient stated he had a migraine after the vaccine. We were advised of a change in appetite on Thursday February 4th. Patient died on February 6th.

1027619

2/13/21

COVID19

PFIZER\BIONTECH

2/11/21

2/10/21

2/11/21

no acute

Anemia, unspecified Congenital malformation syndromes predominantly associated with short stature Constipation, unspecified Dysphagia, unspecified Gastro-esophageal reflux disease without esophagitis Illness, unspecified Intermittent explosive disorder Moderate intellectual disabilities Neuromuscular dysfunction of bladder, unspecified Other iron deficiency anemias Other specified eating disorder Pica of infancy and childhood Thrombocytopenia,

NKA

UNK

Swollen leg/pain- taken to urgent care- became unresponsive – CPR initiated- expired

1028778

2/14/21

COVID19

PFIZER\BIONTECH

1/13/21

1/7/21

1/10/21

COVID-19 test after paramedics arrived which came back negative.

Anxiety and depression medication

Arrhythmia 20 years ago

On December 17, 2020, my husband, received his first BioNTech BNT162b2 COVID-19 vaccination. On Thursday January 7, 2021, he received this second COVID-19 vaccination. The following three days after his second vaccination, he felt fine. The fourth day, on Sunday January 10, my husband felt extremely fatigued. On Monday the 11th and Tuesday the 12th, he worked a full shift but complained of extreme fatigue and extreme chills to the point that his teeth were chattering while on the phone with me. He decided to work through it. When he got home on Monday night, he started vomiting. On Wednesday January 13, he woke up and had swollen eyes. Once again, he felt extremely fatigued, even after a full nights rest. He had the day off but had an early meeting. After his meeting, he was still tired so he went back to sleep. I left to get lunch, and drop off our kids, and upon my return, I found him on the walk in closet floor, face up, having passed away. He felt as cold as ice. The rapid test done after they called the paramedics resulted in a negative COVID-19 test for him.

1033873

2/16/21

COVID19

PFIZER\BIONTECH

2/1/21

1/20/21

2/1/21

UNKNOWN

VENLAFAXINE, LOSARTAN, TRAZODONE. THERE MAY BE OTHERS. SHE WAS PARTICIPATING IN A CLINICAL TRIAL

CHRONIC KIDNEY DISEASE

UNKNOWN

PATIENT PASSED AWAY ON 2-1-2021

1034146

2/16/21

COVID19

MODERNA

2/1/21

2/13/21

2/14/21

WAS NOT REPORTED AT TIME OF VACCINATION

UNKNOWN

ARRIVED AT EVENT, CONSENT FORM COMPLETED, DID NOT REPORT HE HAD BEEN ILL, DID NOT REPORT THAT HE TOOK ANY FEVER REDUCING MEDICATIONS

1035597

2/17/21

COVID19

PFIZER\BIONTECH

1/17/21

12/30/20

1/17/21

unknown

Unknown. Patient died on 01/17/2021. Related to vaccine? I do not know but am reporting because I sent an email to VAERS and never received an answer whether it should be reported or not. So, erring on the side of caution, I am reporting.

NKA

Death on 1/17/2021. Found at home deceased.

1035641

2/17/21

COVID19

PFIZER\BIONTECH

2/9/21

1/24/21

2/9/21

Azathioprine 50mg po qd Bupropion XL 300mg po qam Furosemide 40mg po qd Nadolol 20mg po qd Omeprazole 20mg po qd Prednisone 20po qd Spironolactone 25mg po qd

Tobacco Use – 0.5 pack per day cigarette use Autoimmune Hepatitis – flare in 2020, improved with increased immunosuppressants per GI note 12/15/20 Bilateral leg swelling 1/21/21 – Primary care office visit

Tobacco Use – 0.5 pack per day cigarette use Autoimmune hepatitis Essential Hypertension Migraine Mood disorder Allergic Rhinitis

None

Healthcare was advised that this patient expired approximately two weeks after receiving her initial COVID vaccination

1037207

2/17/21

COVID19

MODERNA

2/5/21

2/1/21

2/2/21

contact shock trauma center and the medical examiner

birth control, and she did do botox

none,

trigeminal neuralgia – has been in remission since she started doing botox

sulfa drugs

She had pain in the injection site Tuesday night and then during Tuesday she got worse with nausea and some fever. By Wednesday she was complaining that she could not pee even though she was drinking a lot of fluids. She continued to complain it was the worst she ever felt and then at 0600 Thursday morning she woke us up and said she needed to go to the hospital. We arrived at the hospital just before 0700 and she immediately threw up in the trash can. We went into a treatment room and they took blood and started fluids as she became incoherent. She said she had taken Tylenol so they started a drug to counter that but her liver function was all wrong and they started to look for a hospital that could transplant a liver. She was air evade about 0930 to Medical center and just over 30 hours latter she was dead. There is a pending autopsy. She was a healthy 39 year old mother who got the shots because she worked as a surgical tech and she was the single mother of a 9 year old little girl.

1040170

2/18/21

COVID19

MODERNA

2/13/21

2/6/21

2/13/21

labs from ER on 2/13/2021 – trop 2.49; WBC 55, lactate 21.5, creat 1.29, postassium 6.2, mag 3.4, glucose 57, AST 3024, ALT 3088, acetaminophen < 10, salicylate < 1.

Tylenol, calcium citrate, antifungal cream to stoma, Bisacodyl suppository as needed, calcium citrate, tube feeds, lansoprazole, reglan, centrum multivitamin, polyethylene glycol every other day, norgestimate-estradiol daily, trazodone, tiz

none. she had been very stable on her medication regimen and in her living arrangement for years. No issues whatsoever. Caregivers had been caring for her for as long as 19 years.

cerebral palsy, spastic quadriplegia, dysphagia with g-tube in place, developmental delay – minimally verbal, tube feed dependency, intrathecal baclofen pump, osteoporosis, white coat hypertension, candidiasis of skin..

reclast – caused fever in 2014, leading to hospitalization, seizure from the fever.. tegretol (no reaction noted)

Received vaccine on 2/6/2021. was a bit off all week per caregivers – low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 – got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don’t think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation.

1044420

2/21/21

COVID19

PFIZER\BIONTECH

2/8/21

1/9/21

1/31/21

Sodium 131, creatinine 1.2 on admission, transaminases initially normal, lactic acid 2.6, white blood count 11.0, platelets 110, coronavirus nucleocapsid IgG positive, troponin 18, ferritin 1435, fibrinogen 642, D-dimer 5.22, CRP 284

none

Please reference separately submitted MIS-A form. He had sore throat, high fever, diarrhea, deteriorating in to multisystem failure and apparent acute myocarditis, notably with relative initial sparing of the lungs. He suffered cardiac arrest in radiology after developing aphasia and was transferred to Hospital after cannulation for VA ECMO; he died there 2/8/21.

1046179

2/22/21

COVID19

PFIZER\BIONTECH

2/18/21

2/15/21

2/16/21

unknown

MRDD

NKMA

patient was not vaccinated at hospital. Caregiver reports that patient was vaccinated with second dose on Monday 2/15/21. Tuesday patient experienced n/v/d. Went to an ED on Wednesday and was cleared and sent home. Thursday reported shortness of breath to her caregiver and then collapsed. Patient was brought to as PEA arrest and ultimately died.

1046447

2/22/21

COVID19

PFIZER\BIONTECH

2/18/21

2/12/21

2/13/21

2/17/2021 Labs show pancytopenia with WBCs of 1.4, RBCs 2.18, hemoglobin 6.8, hematocrit 23, platelets 63. PT/INR elevated at 20.4/1.71. PTT elevated at 42. Fibrinogen level low at 147. CO2 level low at 20. Anion gap elevated at 19. Creatinine elevated at 1.63. BUN elevated at 32. Albumin low 1.7. Total bilirubin elevated at 4.5. Alk phos elevated at 154. ALT evaded at 72. Magnesium dated at 2.7. Is low at 48. Lactic acid elevated at 2.9. Urine is negative for infection. COVID-19 test is negative. Cultures x2 obtained. Chest x-ray was done and shows CVP line is in the right atrium. Left lower lobe pneumonia and left pleural effusion. Urine and blood cultures from 2/17/2021 grew Escherichia coli.

Vitamin D3 2000 U daily, Calcium carbonate 500 mg daily, Cyanocobalamin/folic acid/pyridoxine 200mcg-500 mcg-5mg daily, Vitamin B12 1000 mcg daily, Echinacea 450 mg twice daily, St. John’s Wort 300 mg daily, Fish oil 1000mg daily, Vitamin

1/17/2021 Fell while drunk, right distal humerus fracture, right facial bruising

Metabolic disorder, anemia

Penicillin

2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM

1051803

2/24/21

COVID19

MODERNA

1/15/21

1/8/21

1/15/21

unknown

unknown- not the facility that administered the vaccine

unknown

unknown- not the facility that administered the vaccine

unknown, was informed by Health Director that person had passed away

1054160

2/25/21

COVID19

MODERNA

2/15/21

2/11/21

2/12/21

unknown

not applicable

Right VP shunt at birth.

Latex and Ceclor

2/12/2021 woke up with sore arm and back. 2/13/2021 woke up with headache around 1am. Headache and nausea all morning. Mid-late afternoon started having seizures. Admitted to Hospital 2/15/2021 expired. Reported per wife on 2/25/2021.

1055070

2/25/21

COVID19

MODERNA

2/21/21

2/19/21

2/21/21

Post pending

Cetirizine, ferrous gluconate, atorvastatin, acetaminophen, aspirin EC, sertraline, clozapine, risperidone, clozapine, polyethylene glycol, sennosides, glipizide, levothyroxine,

Morbid obesity, hypothyroidism, Diabetes, Iron deficiency anemia, QT prolongation, hyperlipidemia, chronic hypoxia, psychosis, luteal phase dysphoria, anxiety, early onset schizophrenia, moderate intellectual disability, left ankle ORIF.

Same as item 11, remove left ankle ORIF

No known allergies

Client died on 02/21/2021 and had received the second dose of the vaccine series on 02/19/2021.

1058447

2/26/21

COVID19

MODERNA

2/23/21

2/24/21

Urine toxicology on 2/24/21: positive for cocaine and fentanyl

Albuterol, abilify, mirtazapine, buprenorphine/naloxone,

None known

Opioid use disorder, cocaine use disorder, hypertension, asthma, hepatitis C (treated), tobacco use, bipolar

Lamotrigine

Moderna COVID- 19 Vaccine EUA Patient was found deceased in the community near his home address on 2/24/21. The Medical Examiner’s cause of death is currently listed as “Drug Intoxication – Accidental Overdose.” Per the MEO, post mortem urine toxicology was positive for cocaine and fentanyl. His death is believed to be related to a cocaine product that was adulterated with fentanyl and is not believed to be related in any way to the Moderna COVID-19 vaccine. This was explicitly stated by the Medical Examiner’s Office.

1061911

3/1/21

COVID19

MODERNA

2/13/21

1/28/21

Anxiety depression; Blood pressure high; Thyroid disorder

Died at home; Gasping for air/difficulty breathing; Soreness; A spontaneous report was received from a physician concerning a 45 years-old, female patient who experienced soreness/MedDRA PT: pain, gasping for air/difficulty breathing/MedDRA PT: dyspnoea and subsequently died/MedDRA PT: death. The patient’s medical history included blood pressure (disorder not specified), thyroid disorder, depression and anxiety. Concomitant product use included blood pressure medication, thyroid medication and possibly depression and anxiety medication. On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot #007M20A) (route of administration and injection site not provided) for prophylaxis of COVID-19 infection. On 28 Jan 2021, following the vaccination, the patient was fine but had experienced some soreness. Per patient’s coworker, the patient did not take any medication as it made the patient sick. The physician was not aware of any complaints from the vaccine. On 13 Feb 2021 at 3:31am, the patient called 911. Per the 911 call, the patient was gasping for air on the call and having difficulty breathing. The patient subsequently died on 13 Feb 2021 at home. The physician inquired whether Moderna gets involved with the autopsy and logistics of the death of patients and wanted to know the time frame for reporting a death of a patient who received the vaccine. The physician did not know who administered the patient’s vaccine. Action taken with mRNA-1273 in response to the events was not applicable as the patient deceased. The event died was fatal. The outcome for the events soreness and gasping for air/difficulty breathing was unknown. The patient died on 13 Feb 2021. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter’s Comments: Very limited information regarding the event of dyspnea and death has been provided at this time. Further information has been requested. Patient’s medical history of blood pressure is considered a risk factor. Based on the current available information and temporal association between the use of the product and the onset of the pain, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Died at home

1065434

3/2/21

COVID19

PFIZER\BIONTECH

2/18/21

2/13/21

2/18/21

UNK

Patient died; This is a spontaneous report from a contactable consumer (parent’s patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route on 13Feb2021 (at the age of 47-year-old) at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 18Feb2021 the patient died. The cause of death was unknown. An autopsy was not performed. No COVID prior vaccination. The patient had not been tested for COVID post vaccination. Information about lot/batch number has been requested.; Reported Cause(s) of Death: Patient died

1066118

3/2/21

COVID19

PFIZER\BIONTECH

2/17/21

2/16/21

2/17/21

Atorvastatin Dulaglutide Glipizide Loratadine Losartan Metformin

None

Type 2 Diabetes Hypertriglyceridemia Hypertension Recurrent pancreatitis Obesity Nicotine dependence

Apple, cherry, pear, pollen – throat swelling and itching

UNK

Patient had an unwitnessed cardiac arrest while outside walking his dog. AED in the field initially advised shock and was shocked 3 times without effect. At the time EMS ALS arrived, patient was in PEA arrest. He was transferred to Hospital with CPR in progress. Time of death called at 1857.

1066274

3/2/21

COVID19

PFIZER\BIONTECH

1/23/21

1/21/21

1/23/21

death

1068993

3/3/21

COVID19

MODERNA

2/20/21

1/23/21

2/20/21

Autopsy performed 3/1/2021

Unknown

Hypertension, morbid obesity

Unknown

Spontaneous intracerebral hemorrhage and death on 2/20/2021

1069728

3/3/21

COVID19

MODERNA

3/3/21

3/2/21

3/3/21

Everything was done in ED in the hospital on early morning of 3/3/2021

None

Patient Started having dizziness, feeling faint at around midnight on 3/3/2021. He then lost consciousness, had seizure-like activity and was taken to hospital via EMS. In the hospital patient was unresponsive and received resuscitation attempts unsuccessfully. Per family, after about 45 minutes, code was called and patient expired.

1071935

3/4/21

COVID19

PFIZER\BIONTECH

3/3/21

Wt = 201 kg (443 lbs), No specific labs were drawn when he presented to ED coding.

Metoprolol ER 50 mg qHS, Trazodone 50 mg qHS, Lisinopril 40 mg daily, HCTZ 25 mg daily, Topiramate 25 mg qHS, Melatonin 1 tab qHS, Bupropion 300 mg daily

HTN, sleep apnea

HTN, sleep apnea, hx of MRSA wound infection in groin

Penicillin

Patient received the vaccine around 11 am. He hadn’t been feeling well (headache, dizziness) per report and initially called in to work. He then decided to come to work and was found down in a patient bathroom during his shift on our Facility while taking care of a patient (he was a nurse aid). Patient was coded and the team and was transferred to our Facility ED. He expired 3/3 2112

1072113

3/4/21

COVID19

PFIZER\BIONTECH

2/16/21

2/12/21

2/14/21

UNK

Death

1073092

3/4/21

COVID19

UNKNOWN MANUFACTURER

3/3/21

2/11/21

3/3/21

Autopsy examination performed on 3/4/2021: Examination revealed diffuse subarachnoid hemorrhage. The case is pending additional studies at this time for definitive cause and manner of death.

Omeprazole, citalopram, aspirin

Anxiety, GERD, Asthma, Obesity, Head Aches

Unknown

The decedent reported a continuous headache since receiving the vaccination. On March 3rd he suffered a cardiac arrest and was pronounced deceased.

1074788

3/5/21

COVID19

PFIZER\BIONTECH

2/1/21

3/4/21

UNK

At 8 weeks pregnancy (2 weeks after first shot) started bleeding and had a subchorionic hematoma. By 10 week subchorionic hematoma resolved. Received second shot and of Feb. 1 week later, at 12 weeks pregnancy , fetus had no heart beat! It measured normal size (as expected) and limited normal first trimester anatomy by ultrasound. But NO heart beat. Something insulted this placenta to lead to fetal demise.

1076949

3/5/21

COVID19

PFIZER\BIONTECH

2/22/21

1/29/21

2/22/21

Patient admitted on 2/21/21 and died in hospital on 2/22/2021. Patient had a significant, lifelong underlying medical condition.

1078352

3/6/21

COVID19

MODERNA

3/5/21

3/2/21

3/5/21

Medical examiner report is pending.

Developed fatigue, body aches, headache 1 day after vaccination on 3/3. The morning of 3/5 complained of chest pain. Took Tylenol at 8:30 am. At 10:30 am his family found him unresponsive. EMS was called and he was pronounced dead in the home.

1079976

3/7/21

COVID19

MODERNA

2/2/21

12/23/20

After 1st vaccination (12/23/20): Triamterene/HCTZ, Losinopril, DayQuil, Mucinex, prescribed Augmentin 12/25/20 After 2nd (1/25/21): Addition of Zinc, Quercetin, Vitamin C, Augmentin rx’d 2/1/21

HTN

None

12/23/20 (Moderna #1) – Malaise, cough on 12/24, went to walk-in on 12/25 c/o cough, malaise, rx’d Augmentin x14d, Rapid covid negative (and PCR resulted negative). 12/27 slept all day, 12/28 back to work. 1/12/21 metallic taste in mouth, severe GI sx, malaise, aches, headache. 1/14 seen at walk-in and covid swabbed Negative. 1/21/21 exposed to parents who found out they were covid + on 1/22/21. 1/25/21 (Moderna #2) – Continued with persistent cough and GI sx. Then also developed urinary frequency and urgency. Seen at urgent care 2/1 c/o cough, dx URI, rx’d augmenting. Woke up morning of 2/2/21 abruptly, stood up, said something was wrong, and collapsed. CPR attempted immediately, EMS brought him to ER where he was pronounced dead.

1079976

3/7/21

COVID19

MODERNA

2/2/21

12/23/20

After 1st vaccination (12/23/20): Triamterene/HCTZ, Losinopril, DayQuil, Mucinex, prescribed Augmentin 12/25/20 After 2nd (1/25/21): Addition of Zinc, Quercetin, Vitamin C, Augmentin rx’d 2/1/21

HTN

None

1082804

3/8/21

COVID19

PFIZER\BIONTECH

3/2/21

2/18/21

3/2/21

not known

anxiety/depression

none known

not known

UNK

Patient committed suicide the morning of March 2, 2021. He stepped in front of a truck on a highway. I consulted with pharmacy and they said that I should report even if the 2 most likely have nothing to do with each other.

1085413

3/9/21

COVID19

PFIZER\BIONTECH

3/4/21

3/2/21

3/4/21

Autopsy requested by wife pending

None

none

Hyperlipidemia, hypertension, Severe Obesity, Prediabetes, Gout of left big toe

None

patient was on treadmill at home on 3/4/21 and became shortness of breath, collaspsed, hitting head on floor. Family started CPR, Downtime prior to ED arrival 30 minutes. Arrived at ER at 8:48AM. Intubated by EMS. initially shocked 1x but otherwise was in asystole. Eventually after about 70 minutes of CPR at ER patient had no ROSC, pupils dialted and fixed and at this point pronounced dead.

1085478

3/9/21

COVID19

MODERNA

3/13/21

2/24/21

3/8/21

Multiple CT’s, labs

None

PCN

Patient has been feeling fatigued since the vaccine. On 3/8 he went to play Hockey, first time since pandemic started. He reported feeling to his friends that he felt unwell and left the ice. He was found dead, CPR started, EMS called-> had shockable rhythm (VF), shocked 10 times pre-hospital. Brought to Hospital ER and placed on VA ECMO. He is currently in the ICU setting; echo suggests possible MI but formal cath pending. Has anoxic brain injury, splenic laceration, pulmonary hemorrhage/contusions, rib fractures all related to CPR (received over an hour prior to ECMO placement). Patient may ultimately expire, he is critically ill.

1085783

3/9/21

COVID19

PFIZER\BIONTECH

3/5/21

2/24/21

3/5/21

Currently with Coroner.

Lactose Intolerant

Sudden Unexpected Death – No signs or symptoms

1085783

3/9/21

COVID19

PFIZER\BIONTECH

3/5/21

2/24/21

3/5/21

Currently with Coroner.

Lactose Intolerant

Sudden Unexpected Death – No signs or symptoms

1088723

3/10/21

COVID19

PFIZER\BIONTECH

3/1/21

2/21/21

2/24/21

Multiple tests were done that I no longer can access. Multiple COVID tests which were all negative, Chest x-rays, blood work, CT scan

Levothyroxin, Depakote, Sertraline, Trazodone, Risperidone, Vit D3

Down Syndrome, Autism, CKD, ITP

Augmentin

Patient had 2nd COVID vaccine on 2/21/2021. He started having a temperature on 2/24/2021. Patient then started having trouble breathing. We took him to hospital. He was admitted on 2/25/2021. He steadily declined and was sent to ICU and died on March 1, 2021.

1093986

3/12/21

COVID19

MODERNA

3/11/21

3/10/21

3/11/21

UNK

Received a phone call stating that the patient complained of not feeling well on 3/11/21 while at work and that the patient died that night while at home.

1095327

3/12/21

COVID19

PFIZER\BIONTECH

2/23/21

I was alerted on 3.11.21 by the patient’s wife that patient had passed away the night after having received the vaccine. The wife informed me that she did not wake up the next morning.

1096497

3/13/21

COVID19

MODERNA

3/12/21

3/11/21

3/12/21

None

Setraline, Methocarbamol, Pantoprazole, Gabepentin, Benztropine, Hydroxyzine, Zyrtec, Ferrous Sulfate, Memantine, Donepezil, Lamotrigine, Fluticasone, Propranolol

Bipolar Disorder, Hypertension, Allergic Rhinitis

Bipolar Disorder Hypertension Chronic Back Pain

None

UNK

Notified by police department that patient was found dead at his home on 3/12/21. Per the officer, the family reports patient reported diarrhea on 3/11/21 and fatigue on 3/12/21. The family found him in his home deceased later in the day on 3/12/21

1098028

3/14/21

COVID19

JANSSEN

3/14/21

3/13/21

3/14/21

levothyroxine

Hypothyroidism, MVP, valve repair

UNK

Cardiac arrest, death approx 12 hours later

1101884

3/15/21

COVID19

PFIZER\BIONTECH

3/10/21

2/17/21

Rapid COVID-19 Negative Test UA, Blood Glucose, CMP, CBC, Urine Drug Screening

Unknown

None

History, patient received 1st COVID-19 Pfizer vaccine on 1/28/21 and 2nd Pfizer COVID-19 vaccine on 2/17/21 Unsure if any relation but patient was treated in our urgent care on 3/8/2021 18 day post receipt of 2nd COVID-19 vaccine unresponsive. Patient received ACLS support for unknown cause with suspected neurological/respiratory/cardiac complications. Patient was transferred to higher level of care.

1104175

3/16/21

COVID19

PFIZER\BIONTECH

3/11/21

3/9/21

3/11/21

Norethindrone .35MG Daily – Birth Control 10 MG Zyrtec Allergy Daily – Allergies 5000 mcg Biotin Gummy Daily – Hari, Skin & Nails Vitamin 50 mcg D3 Gummy Daily – Bone & Immune System Vitamin 45 mg Iron plus Vitamin C Soft Chew Daily – Vitam

None

Myotonic Dystrophy DM 1 – Congenital : characterized by progressive muscle wasting and weakness. Physical and Intellectual Disability

None to Date

She received the 2nd Dose on 3/9/2021. On 3/10/2021 She complained of a headache. On the morning of 3/11/2021 she complained of abdominal pain and had no appetite. We then found her unresponsive, called 911 and the medics pronounced her at around 1300.

1104175

3/16/21

COVID19

PFIZER\BIONTECH

3/11/21

3/9/21

3/11/21

None

Myotonic Dystrophy DM 1 – Congenital : characterized by progressive muscle wasting and weakness. Physical and Intellectual Disability

None to Date

1104671

3/16/21

COVID19

JANSSEN

3/13/21

3/12/21

3/13/21

None

CoQ-10 200 mg twice a day, diazepam 10mg one as needed for seizures, Dilantin Infatabs 50mg 1 tab every morning. lamictal 150mg 2 tabs twice a day, midodrine 2.5mg 1 tab twice a day, vitamin D3 400IU daily.

Seizure disorder, severe mitochondrial myopathy, gastroesophageal reflux disease

Seizure disorder, severe mitochondrial myopathy

IV lactated ringers, midazolam, morphine, vancomycin

Patient has a long history of seizures. He has seizures on a daily basis. He lives with his family, who are his primary caregivers, they family provides all of his activities of daily living. Patient received vaccine on Friday morning, feeling well throughout the day according to the father. Went to bed, during the night in bed he had seizures which is typical for him, and during the episode the father noticed that he had stopped breathing. called 911 who came to the house and the patient died in the house. I do not believe he went to the hospital.

1105115

3/16/21

COVID19

MODERNA

2/28/21

2/14/21

2/18/21

None

Keppra 1000 mg, Lamictal , Vimpat, Quetiapina, Lorazepam, Zyprexa, Motrin, Vitamina K, Acido Folico, Sultato Ferroso, Multivitamínico 365

None

Portal hypertension (secondary to portal vein thrombosis), Leukopenia, Thrombocytopenia, Epilepsy, Splenomegaly, Esophageal Varices, Asthma, Pancytopenia and Severe mental retardation.

Dilantin and aspirin

Resident did not express having any symptoms, the only thing that the POC observed abscesses in the arm, groin, thigh and knees after the first vaccination. After the second dose, he was hypoactive. On 2/27 at about 3:30 am he asked him to turn on his side, between 4 am and 5 am POC went to the room I notice it strange, because his head was wrapped in the sheet. When the POC removed the sheet, she observed that her mouth and nose were full of secretions. So he turned it and he himself did not react. He called the emergency who certifies that he had no vital signs. (emergency arrives within 5:45 am to 6:00 am)

1105146

3/16/21

COVID19

MODERNA

2/2/21

1/30/21

None

Keppra 1000 mg, Flexeril, Vitamins

None

Epilepsy, Hydrocephalus, and Multiple Sclerosis

Not reported

1/19 began vomiting and was hospitalized. On 1/30 he was discharged and later received the vaccine. It begins with weakness and a lack of appetite. He started coughing up foul-smelling secretions. He makes the arrangements to take him to the emergency room again, he called 911 to be transported, when they are taking the information from the POC, he is under oxygenation to 44. They take him in the ambulance, he receives CPR, they transport him to the facility where he arrives lifeless.

1112122

3/18/21

COVID19

JANSSEN

3/15/21

3/13/21

3/15/21

None. Patient was being discharged. I suspected a massive PE however pt was on DVT prophylaxis. The coroner refused to do an autopsy so cause of death was not known but it was a highly unusual and unexpected outcome.

Macrobid 100 mg po BID Cefepime 2g daily (3/12-3/19) Dilaudid 2 mg po PRN pain gabapentin 600 mg BID Methotrexate qFriday Metoprolol 25 mg BID Odefsey (HAART) Mirtazipine daily Glipizide, insulin for DM2

Complicated lower UTI (hospitalized for this- received vaccine in house) – MDR bacteria

Neurosarcoidosis Transverse myelitis with lower paraplegia HIV positive (on HAART) DM2 MDD

PCN Cipro Ertapenem Fosfomycin

Patient was admitted for Multi drug resistant UTI (for which he has been admitted many times before). Was hospitalized for 3 days while awaiting cultures, hemodynamically stable, with no lab abnormalities. On the day of discharge (sensitivities to UTI came back, pt to be discharged on cefepime, had PICC line) pt got up from bed, sat on the edge of the bed and was being given belongings by the nurse, alert and oriented and in a pleasant mood, when suddenly pt grabbed at his chest and stated “I can’t breathe” and became combative and altered when O2 was attempted to be placed on pt’s face; then pt had PEA arrest x3 and unable to achieve ROSC.

1112164

3/18/21

COVID19

MODERNA

3/7/21

3/4/21

3/6/21

Unknown

Individual was a number of medications. His Psyciatrist wants Clozapine Emphasized CARBAMAZEPINE 200 MG TABLET Carbamazaepine 100mg ER Tab 12h Clozapine FLUTICASONE PROP 50 MCG SPRAY FOLIC ACID 1 MG TABLET Gabapentin 300mg caps Gabapentin

Had COVID November

299.00 – Autistic disorder, current or active state 307.50 – Eating disorder, unspecified PICA 318.0 – Moderate mental retardation 493.9 – Asthma, unspecified 780.39 – Other convulsions

Amoxicillan Lactose

lndividual Suddenly passed away on 3/7/21…..His Psychiartrist stated that there could be an adverse effect with COVID, the COVID Vaccination and medications, with an emphasis on Clozapine

1114806

3/19/21

COVID19

JANSSEN

3/18/21

3/6/21

3/12/21

CT Angiogram of the head 3/17/21: “The supraclinoid ICAs are patent bilaterally. The right MCA is elevated by the large right hemispheric hematoma. There is no occlusion or significant stenosis involving the right MCA. The left MCA and bilateral ACAs are within normal limits. The intracranial vertebral arteries, left PICA, basilar artery and both PCAs are patent. There is no aneurysm or AVM. The evaluation of the venous structures is limited on this CTA but there is no opacification of the right transverse and sigmoid sinuses, suggestive of dural sinus thrombosis. Large right hemispheric hematoma is demonstrated with significant right-to-left midline shift measuring approximately 16 mm. Effacement of the right lateral ventricle and dilation of the left lateral ventricle. Right-sided transtentorial herniation is noted. IMPRESSION: 1. Suspect right transverse and sigmoid sinus dural sinus thrombosis. This can be confirmed with CTV if clinically necessary 2. No evidence of aneurysm or AVM to account for the right hemispheric intraparenchymal hematoma. Significant right-to-left midline shift and downward transtentorial herniation is noted.”

Fluoxetine

Depression

NKMA, No allergies

Diagnosis: Cortical vein thrombosis, massive intracerebral hemorrhage with tentorial herniation, thrombocytopenia. Clinical Presentation and Course: 1 week after receiving Janssen COVID19 vaccination, patient developed gradually worsening headache. On March 17th, patient presented to Hospital with dry heaving, sudden worsening of headache and L sided weakness. Evaluation with head CT revealed a large R temporoparietal intraparenchymal hemorrhage with 1.3cm midline shift. She ended up getting intubated for worsening mental status. On evaluation at arrival in Medical Center, she was noted to have extensor posturing. Repeat imaging revealed worsening midline shift to 1.6cm. CTA showed cortical vein thrombosis involving the right transverse and sigmoid sigmoid sinus with tentorial herniation. Patient developed brain herniation and brain death was pronounced on March 18th, 2021.

1116808

3/19/21

COVID19

PFIZER\BIONTECH

3/13/21

No symptoms reported. Found dead seated on couch the day after vaccination (3/14/2021). Autopsy performed on 3/15/2021 showed no evidence of anaphylaxis. Cause of death = Cardiomyopathy of Obesity.

1121695

3/22/21

COVID19

PFIZER\BIONTECH

3/1/21

3/10/21

03/17/2021 Initial ABG pH 6.94, pCO2 20, pO2 101 Serum glucose 1,041, bicarb <5 Beta hydroxybuterate 7.7 HbA1C 5.7 Urine drug screen negative EtOH, acetaminophen, aspirin negative Lipase 675– >1001

None

UNK

The patient, who has no significant past medical history including diabetes, presented with very severe diabetic ketoacidosis one week after receiving the vaccine. He developed severe metabolic encephalopathy, aspiration pneumonia, and was placed on mechanical ventilation. At the time of this reporting, he is brain death (awaiting apnea test confirmation). He is expected not to survive.

1121847

3/22/21

COVID19

MODERNA

Medical History/Concurrent Conditions: No adverse event (no relevant medical history reported)

Kidneys and liver shutting down; Kidneys and liver shutting down; Heart started racing 3 days later; Vomiting; A spontaneous report was received from a consumer concerning a 39-year-old, female patient, who received Moderna’s COVID-19 vaccine (mRNA-1273) and experienced heart racing, kidney failure, liver failure,vomiting and death. The patient’s medical history included Sjogren’s syndrome, Hashimoto’s, inflammatory joint disease, osteoporosis, osteoarthritis. She has history of fractured tail bone and leg in three places. Concomitant medications included D3 2 pills a day, folic acid, B12, and calcium citrate. She was allergic to 15 different antibiotics two of which she had anaphylaxis; had huge autoimmune issues; had had reaction to Pneumovax vaccine. On an unown date ,prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. Approximately after three days of receiving second dose vaccine patient experienced heart racing and went to the emergency room .The patient started vomiting and developed a kidney and liver failure. And on the next day she died.Autopsy is doing and the results are not available at the time of report. Action taken with mRNA-1273 in response to the events was reported as not applicable. The events heart racing, kidney failure, liver failure and death were considered serious and medically significant. The outcome of the events renal failure,hepatic failure,palpitations and vomiting was considered as Fatal.; Reporter’s Comments: This is a case of death in a 39year-old female subject with unknown medical history of anaphylactic reactions, allergic reactions to pneumovax vaccine, Sjogren’s syndrome, Hashimoto’s, inflammatory joint disease, osteoporosis, osteoarthritis, who died 4 days after receiving second dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Renal failure; Hepatic failure

1122080

3/22/21

COVID19

MODERNA

3/21/21

3/12/21

3/19/21

As above.

Xulane birth control patch Prescribed prednisone the day prior to presentation

None

Augmentin-itching

UNK

Patient’s received 2nd dose of Moderna vaccine Friday 3/12. Her husband reported she had not unexpected fatigue, malaise, and fever for 1 day but better after that. On Monday she began complaining of shortness of breath. This progressively worsened and she started having presyncopal episodes. On Saturday she was unable to come down the stairs in the house so husband planned to take her to the hospital but she stood up and passed out and woke up quickly. He decided to call EMS. By the time she presented to our hospital she was cyanotic and agonal breathing. On moving her from EMS stretcher to ED bed she had PEA cardiac arrest. She underwent mechanical device CPR with only brief (<1 min) ROSC x1. She at some point did have a shockable rhythm. Cath lab was notified and she was taken emergently to the cath lab with ongoing mechanical device CPR. Peripheral VA ECMO was placed after about 1.5 hours. Pulmonary angiogram was done which showed massive saddle PE with near complete obliteration of the right pulmonary tree and some filling defects in the left tree as well. At that time she had severe mixed respiratory and metabolic acidosis with a lactate of 24. She also had no gag or corneal reflex, minimally responsive pupils, and no response to noxious stimuli. Mechanical thrombectomy was attempted with some result. She was transferred to the SICU with increasing pressor requirement, and DIC. Ultimately, the venous catheter of the ECMO circuit malfunctioned thought to be secondary propagating IVC thrombosis. Family decided to withdraw care and she passed away.

1124794

3/22/21

COVID19

PFIZER\BIONTECH

3/20/21

3/17/21

none known

Ipratropium Bromide, (0.5mg/2.5ml) (Atrovent) Budesonide, (0.5mg/2ml) (Pulmicort) Tobi neb, (28 days on/28 Days off) Glycopyrolate, (2mg) (Robinol) Aspirin, (81 mg) Omeprazole, (20 mg) (Prilosec) Cimetidine, (300 mg) Azithromycin, (250

Pulmonary inflammation

MEDICAL SUMMARY: VATER?S SYNDROME ? Tetralogy of Fallot with LPA Atresia s/p repair (last conduit replacement 2/96) ? TE Fistula s/p repair 10/89 (Medical Center) ? Abnormal Ear Canals ? Absent right kidney ? Absent Corpus Colossus ? Abnormal Vertebrae (fissured) ? 7th Nerve Palsy ? Developmental Delays ? Nissen Fundoplication 11/89 (AMC), failed ? G-Tube placement 9/89 (AMC) ? J-Tube placement 3/95 (BCH) (complicated with fistulas) ? ? CVA 0-3mo. ? Reglan Reaction 12/90 (fever – 108.1F) ? Upper Right Lobectomy 10/93 (BCH) ? Poor Venous Access ? Seizure Disorder, controlled, out grown ? Growth on back of tongue (looks like ordinary tissue-benign-prone to bleeding if irritated) ? Enlarged Adenoids ? 6th digit left hand (ligated 9/89) ? Prone to Candida ? Pseudomonas Picetti lung infection 2/98, colonized ? History of bleeding duodenal ulcer ? MRSA 05/07, lungs, colonized ? Power Port placed 2/15 ? Power Port removed due to bacterial infection 6/15 ? Cardiac Cath, LPA Stent dilated, 20mm/100%, Melody valve placed, RV, 8/27/2015, (BCH)

Medication Allergies: REGLAN, Morphine, Droperidol, Intal, Keflex, Erythromycin, Augmentin, Latex FOOD ALLERGIES: Milk, NUTS ENVIRONMENTAL ALLERGIES: Evergreens, Dust, Mold, Dog and Cat dander, Spiders, ?Bugs?

Extreme head ache, chest pain, fever 101 F. Gave 1000 mg Tylenol, albuterol via nebulizer Q4hr. Died 3/20/2021 approx 11:00 am from Cardiac Arrest.

1126015

3/23/21

COVID19

MODERNA

3/16/21

3/9/21

3/13/21

Unknown

baclofen, citracal with D, Multivitamin, coumadin, folic acid, trazadone, Vitamin B 12 injection, SMX/TMP 800/160 mg, Tylenol, Tums prn, albuterol inhaler prn, Triamcinolone topical prn, a & d ointment prn,

Cellulits with ruled out DVT

Multiple sclerosis, neurogenic bladder, depression, B12 anemia deficiency, anticoagulant therapy

Amoxicillin, oxybutynin, amandadine

Unknown adverse event from vaccination. 3/14/21 Informed by caregiver that client was sent by ambulance to ER and diagnosed with bilat pneumonia. She developed difficulty breathing on 3/13/21. She was seen at Walk In on 3/12/21 for toenail eviscerated and INR, and had been giving tylenol for pain control for toe. 3/15/21 Informed by caregiver client was in ICU, septic, bilat pneumonia, and low oxygen levels. 3/16/21 Informed by caregiver client not doing well authorized indwelling cath due to low blood pressure and ventilator. Client transfered by med flight to ICU. 3/17/21 Informed by caregiver client death last night.

1129860

3/24/21

COVID19

MODERNA

1/21/21

1/19/21

1/21/21

Medical History/Concurrent Conditions: No adverse event (No reported medical history.)

UNK

Died January 21 after she received an mRNA shot; A spontaneous report was received from a consumer via social media concerning a 28-year-old, female patient who received Moderna’s COVID-19 vaccine (mRNA-1273) and died two days later (death). The patient’s medical history was not provided. No relevant concomitant medications were reported. On 19 Jan 2021, per social media post, the patient received one of their two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. The reporter stated that the patient was dead on 21 Jan 2021. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on 21 Jan 2021. The cause of death was reported as unknown. An autopsy was done. The reporter stated that the autopsy showed no other red flags, otherwise, no additional autopsy results were reported.; Reporter’s Comments: Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death

1130616

3/24/21

COVID19

MODERNA

3/17/21

3/16/21

3/17/21

Unknown

Community partner reported that they found her unresponsive on the 17th (so she may have died on the 16th) from what they believe was a heart attack. The family has requested an autopsy.

1133712

3/25/21

COVID19

MODERNA

3/24/21

3/22/21

3/24/21

unknown

only reported allergy was to black walnuts

UNK

reported bad headaches on the day following the vaccine–did not see the doctor–later died. the coroner reported that the preliminary autopsy showed an enlarged heart and liver

1135730

3/26/21

COVID19

MODERNA

3/13/21

3/11/21

3/13/21

IRON SULFATE; FLUTICASONE; GABAPENTIN; LAMOTRIGINE; METHOCARBAMOL; PROPRANOLOL HYDROCHLORIDE

Bipolar disorder; Hypertension; Polyps; Tremor

Patient found dead two days after vaccination; A spontaneous report was received from a healthcare provider concerning 48-year-old, male patient who received Moderna’s COVID-19 vaccine (mrna-1273) and died. The patient’s medical history includes bipolar disorder, colon polyps, hypertension, benign tremors & other Comorbidities. Concomitant product like iron sulfate, Fluticasone, Gabapentin, Lamotrigine, Methocarbamol, Propranolol hydrochloride was reported by the reporter . On 11 mar 2021, approximately 2 days prior to the event, the patient received their first dose of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 13 Mar 2021, the patient died. No other details were reported. Treatment information was unknown. The patient died on 13 Mar 2021. The cause of death was not provided. Plans for an autopsy were unknown.; Reporter’s Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

1140258

3/27/21

COVID19

PFIZER\BIONTECH

3/27/21

3/26/21

3/27/21

unknown

Obesity, and other co-morbidities

Obesity

unknown

Patient contacted 911 complaining of not feeling well and difficulty breathing. Upon arrival patient was found by EMS in cardiac arrest. EMS was unable to get return of spontaneous circulation.

1144826

3/29/21

COVID19

PFIZER\BIONTECH

3/5/21

2/17/21

3/5/21

none

unknown

none listed in our medical record

NKA

received word that the patient passed away on 3/5/2021. Do not know the cause of death, nor where he passed away. He does not have any significant medical history at Health Care Corporation, but did get his first vaccination here on 2/17/2021.

1145054

3/29/21

COVID19

MODERNA

3/14/21

3/13/21

3/14/21

none available

unknown

pleural effusion glaucoma of R eye depression Type 2 diabetes with peripheral artery disease hypertension hyperlipidemia end stage renal disease on dialysis

NSAIDs – unknown reaction aspart insulin – unknown reaction

patient received 2nd dose of Moderna on 3/13/2021; reported by Police Department as having passed away on 3/14/2021. No other details available.

1145526

3/29/21

COVID19

MODERNA

3/23/21

3/13/21

3/14/21

None

Unknown

3/13- First shot of Moderna vaccine received. 3/14- Sore arm, chills and a headache. 3/15- Shortness of breath and rapid heartbeat. 3/16- Went to ER because of more severe shortness of breath and rapid heartbeat. 3/17- COVID test with negative result. 3/19- Patient messaged her PCP explaining persisted symptoms. 3/23- Chest pain and shortness of breath developed and she died at ER in PEA. 3/25- Autopsy showed pulmonary embolism with no evidence of peripheral vascular disease. Double check COVID test with negative result.

1145918

3/29/21

COVID19

MODERNA

1/21/21

1/19/21

1/20/21

Diabetes Mellitus Type I

No reported allergies

As reported by the patient’s mother, the patient received the vaccine on 1/19/21, “got sick” on 1/20/21, and died in the early morning hours of 1/21/21. No further information was offered.

1152759

3/31/21

COVID19

MODERNA

3/17/21

3/25/21

Events on 3/25/2021: -AP Chest X-Ray, CT angiography proved bilateral pulmonary emboli, TTE showed severely dilated right ventricle with reduced EF at 60-65%. Arterial line and IJ central line placed for pressor support. Intubated on a vent. -Labs collected on this date: D_Dimer elevated at 5000, Potassium at 2.7, elevated LFT’s – AST = 439, ALT = 331. -Vasc doppler venous bilateral lower extremities showed no evidence of DVT in either leg. Venous flows in bilateral lower legs showed high pressure indicating right sided heart failure. -CT of head w/o contrast negative for intracranial hemorrhage, hydrocephalus, mass, or midline shift. Calvarium is intact. -MRI Brain w/o contrast negative for acute intracranial abnormalities. Event on 3/26/2021: EEG concerning for myoclonic seizures related to anoxic brain injury Event on 3/28/2021: MRI Brain w/o contrast showed new changes suggesting hypoxic/anoxic injury

unknown at this time

7 AM 3/25/2021 – Patient called out to husband from the bathroom where she experienced a syncopal event, then passed out. An ambulance was called and she was revived for a short period of time. She was taken to Hospital where she coded 3 times. She was then life-flighted to second Hospital. According to the hospital records, tests conducted over the course of several days determined that she had no neurological activity. Initial reports in the records indicate pulmonary embolism, cardiac and respiratory arrest. She was on life support for the remainder of her time. Organ donation is being pursued at present and results of this are pending at time of this report submission. Date of death is unknown until organ retrieval is accomplished. Family will be contacted in the next few days to ask further questions about any other kinds of vaccine-related reactions that may have happened more immediately to days after the vaccination on 3/17/2021. A co-worker thought that she had shortness of breath for 3-4 days before this critical event occurred on 3/25/2021.

1154639

3/31/21

COVID19

JANSSEN

3/27/21

Unknown

Penicillin

Patient began having seizures about four hours post vaccine while at a friends house and passed away

1154856

3/31/21

COVID19

MODERNA

3/29/21

Currently awaiting coronary results they took tissue sample

My sister died due to allergic reaction 45min after taking the Moderna Vaccine

1154126

4/1/21

COVID19

PFIZER\BIONTECH

3/21/21

Medical History/Concurrent Conditions: Gastroparesis (Verbatim: Gastroparesis); Type I diabetes mellitus (Verbatim: Type 1 Diabetes); Ulcer (Verbatim: Ulcer)

UNK

Diabetic ketoacidosis; This is a spontaneous report from a contactable consumer. A contactable consumer reported for her nephew. A 33-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (at the age of 33-years-old) at single dose for covid-19 immunisation. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing, impaired gastric emptying from an unknown date and unknown if ongoing, ulcer from an unknown date and unknown if ongoing. The patient’s concomitant medications were not reported. The patient experienced diabetic ketoacidosis on an unspecified date. The patient died on 21Mar2021 due to diabetic ketoacidosis. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Diabetic ketoacidosis

1156266

4/1/21

COVID19

MODERNA

3/27/21

3/4/21

3/17/21

3/17/21 sCr 1.48 GFR 41 WBC 4.5 (ER) 3/19/21 sCr 1.55 GFR 66.16 (CLINIC) 3/26/21 sCr 2.29 GFR 25 WBC 10.9 (CLINIC) 3/27/21 sCr 4.01 GFR 13 WBC 12.0 (ER)

spironolactone 25 mg po bid, bispirone 10 mg po daily, contin, trazodone 300 mg po hs, gabapentin 800 mg po bid, ultram 50 mg po q4-6 hours prn, tizanidine 4 mg po bid prn, Metformin 500 daily, hctz 25 mg po daily, breo ellipta daily, hydro

UTI With back pain

Type 2 diabetes, hepatitis C, hypertension, hyperlipidemia, osteoarthritis, COPD, BMI 43.4

morphine, lithium

pt presented in ER 3/17/21 with SOB and back pain; felt bad since vaccine given; UTI diagnosis-given keflex 500 tid and rocephin shot pt presented to clinic 3/19/21 with continuing back pain dx low back pain and candidia given methocarbamol, diflucan, and ibuprofen pt presented to clinic 3/26/21 with continuing back pain, difficulty urination. given ceftin and rocephin shot pt presented to ER 3/27/21 renal failure and expired within 10 min of arrival no fever documented at any visit

1156620

4/1/21

COVID19

PFIZER\BIONTECH

2/10/21

1/12/21

APAP, amlodipine, albuterol, Symbicort, clonazepam, famotidine, enoxaparin, gabapentin, milk of mag, methocarbamol, oxycodone, prednisone, spiriva

chronic COPD/respiratory failure, DVT, hypertension

nkda

Mandatory EUA Reporting – Patient received COVID-19 vaccine on 1/12/21 and then tested positive for Covid the same day. Was admitted to hospital from rehab (resides in rehab for chronic respiratory failure). Patient deteriorated throughout hospitalization, was transitioned to comfort care, and expired on 2/10/21.

1159535

4/2/21

COVID19

PFIZER\BIONTECH

4/1/21

3/31/21

All tests are from 4/1/21. CBC, CMP, lactate, blood gases, UA, U tox, apap and asa levels, troponin, cpk, lipase, amylase, CTs of head, chest abdomen and pelvis., ekg, chest x-ray leukocytosis, markedly elevated LFTS, elevated coag studies, renal failure,

none

unknown

none

Patient described myalgias, headache and dyspnea at ER visit on 4/1/21 at 2:37 am. Patient was discharged. Patient returned the same day at 15:40 cyanotic, altered, hypoxic and hypotensive. The patient was found to have profound metabolic acidosis, liver failure, renal failure. She went into cardiopulmonary arrest, was revived, rearrested and died. Patient was treated for possible sepsis, shock, liver failure.

1160526

4/2/21

COVID19

PFIZER\BIONTECH

4/1/21

Autopsy Performed. Histology, Toxicology, and Cultures Pending

Zoloft, Lexapro, Vit B, Folic Acid, Hydroxychloroquine, Synthr

Unk

Multicentric Reticulohistiocytosis, Hypothyroidism

Unk

Death 5 hours after second shot. Decedent contacted her mother around 3:30 c/o difficulty breathing. Died on 4/1/20

1161106

4/2/21

COVID19

MODERNA

3/23/21

3/11/21

3/17/21

CONTRACTED COVID, CONFIRMED 3/17/21, PATIENT DIED ON 3/23/21

1165154

4/3/21

COVID19

JANSSEN

3/30/21

3/12/21

3/30/21

Yes

Heart meds, blood thinners, and blood pressure meds.

Heart disease

Penacilan

My husband died 18 days after the shot

1168104

4/3/21

COVID19

PFIZER\BIONTECH

3/18/21

3/2/21

3/18/21

Pregnant 39 weeks, 3 days on 3/16/2021, Gestational Diabetes on insulin, Hemochromatosis, Low lying placenta, endometriosis, Sleep Apnea

UNK

Pfizer COVID Vaccine treatment under Emergency Use Authorization(EUA): Vaccination received 3/2/2021. On 3/16/2021, maternal cardiac arrest, terminal fetal bradycardia, emergent C-section. Likely amniotic fluid embolism and DIC.

1166062

4/4/21

0.42

COVID19

PFIZER\BIONTECH

3/20/21

3/17/21

3/18/21

Patient received second dose of Pfizer vaccine on March 17, 2020 while at work. March 18, 2020 her 5 month old breastfed infant developed a rash and within 24 hours was inconsolable, refusing to eat, and developed a fever. Patient brought baby to local ER where assessments were performed, blood analysis revealed elevated liver enzymes. Infant was hospitalized but continued to decline and passed away. Diagnosis of TTP. No known allergies. No new exposures aside from the mother’s vaccination the previous day.

1168641

4/5/21

COVID19

PFIZER\BIONTECH

2/26/21

2/25/21

2/26/21

Vyvanse, Adderall, Trazodone, Clonazepam

None

ADHD

Tdap vaccine

Death.

1169650

4/5/21

COVID19

PFIZER\BIONTECH

3/16/21

3/13/21

3/13/2021 ECG

INSULIN

NONE

TYPE 1 DIABETES

NONE

DIFFICULTY BREATHING, SEVERE CHEST PAIN, STOMACH ACHE, HEADACHE, JOINT PAIN WENT TO EMERGENCY ROOM THAT EVENING ON 3/15/2021 WENT TO BED WITH CHEST PAIN AND DID NOT WAKE UP THE NEXT MORNING PARAMEDICS WERE UNABLE TO REVIVE HIM, PRONOUNCED HIM DEAD AT THE SCENE.

1170822

4/6/21

COVID19

PFIZER\BIONTECH

3/18/21

3/4/21

3/18/21

Atorvastatin 40mg Lisinopril

No known illnesses

Patient was unfamiliar to this clinic and provider however upon review of medications in room patient was on both atorvastatin and lisinopril

NKDA

Patient was found deceased on arrival in his living quarters after not showing up for work. This was approximately 14 days after his second pfizer vaccination. We have no reports of previous signs or symptoms in the days preceding his death. Patient had not visited the clinic since receiving his second shot in the series

1171191

4/6/21

COVID19

MODERNA

4/1/21

3/31/21

4/2/21

Unknown

Olanzapine, metformin, albuterol, atorvastatin, omeprazole

Diabetes, schizophrenia, GERD

None

Patient was found dead in his apartment. I’m not clear on details, but he was having some issues the week prior to being vaccinated. He was in acute distress when his attendant care worker came to give him his medications the day before.

1171601

4/6/21

COVID19

PFIZER\BIONTECH

4/2/21

3/19/21

3/20/21

Unknown

Suboxone

Unknown

Ibuprofen, aspirin

Loss of appetite, malaise, nausea, falls, mental fog, death.

1172648

4/6/21

COVID19

MODERNA

3/23/21

3/16/21

3/23/21

DDimer 55, 000 thouand

unk

NIDDM, HTN, CKD, obesity, lymphedema, chronic non pressure ulcer

Erythromycin

UNK

Cardiopulmonary arrest, D-Dimer 55,000, TNKase administered, ACLS, needle thoracostomy, persistent PEA arrest, decompensated into asystole , pronounced

1174338

4/7/21

COVID19

PFIZER\BIONTECH

3/26/21

3/25/21

3/26/21

SUBOXONE

Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None

Patient died 12-15hrs after vaccination.; This is a spontaneous report from a contactable Consumer. A 40-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 25Mar2021 12:45 (Batch/Lot Number: ER8727) at the age of 40-year-old as single dose for covid-19 immunisation. Medical history reported as none. Concomitant medication included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient patient died 12-15 hours after vaccination. The patient died on 26Mar2021. An autopsy was not performed. No treatment received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19.; Reported Cause(s) of Death: Patient died 12-15hrs after vaccination.

1175952

4/7/21

COVID19

MODERNA

3/25/21

2/4/21

3/25/21

Patient death within 60 days of receiving the COVID vaccine series

1176010

4/7/21

COVID19

MODERNA

3/21/21

3/10/21

3/18/21

None.

Two different insulin’s.

None.

Diabetes, type I.

None.

He got his vaccine, and mother had talked to his girlfriend said that he felt fine other than a sore arm. He called his mother and told her that he was sick to his stomach with cramps and that he was throwing up blood. The girlfriend found him on the floor on the 21st dead on the floor in his hotel room at 8:00 AM. The girlfriend said she had spoken with him around 10:00 PM and that he said he was going to sleep on the floor in the bathroom as he was throwing up and the floor was cool. She subsequently found out that he was throwing up blood, and autopsy report showed that his stomach was full of blood and further testing is being done to see what has caused the bleeding.

1176274

4/7/21

COVID19

MODERNA

4/5/21

3/25/21

4/5/21

Glipizide 5mg 1 BID, Simvistatin 20 mg qhs, Lisinopril 20 mg qhs, Isosorbide MN ER 30 mg qd, Carvediol 6.25 mg BID, Phoslo 667 mg 3 with meals TID, Renavite 1 QD, Lemimir 30 units BID, Aspirin 81 mg qd.

NONE

ESRD, Diabetes Type 2, Hypertension, Aortic Valve Stenosis Chronic Diastolic Heart Failure Anemia

NKDA

Patient became SOB 911 called patient arrested in ambulance and died

1177058

4/7/21

COVID19

UNKNOWN MANUFACTURER

4/6/21

4/1/21

4/2/21

refer to medical record if needed

unknown

One week history of increasing shortness of breath, chest tightness and wheezing and allergy type symptoms Evening of 4/1 started to have some GI symptoms and some diarrhea

asthma nasal polyps

allergy to aspirin

Family reports that patient had her 2nd dose of COVID-19 vaccine on 4/1, approximately 3 weeks after her first dose. Patient had one week history of “allergy type” symptoms. Evening of 4/1 developed “GI symptoms and diarrhea”. Morning of 4/2 her “neighbor came by to check on her and she stated that she was not feeling very well last night but thought she just needed some Gatorade of something…He stated that as he gave her the alka-Seltzer he told her that there was aspirin in it which apparently she has an allergy to. He stated that her response was I should be fine I do not think I’m that allergic to aspirin…5 to 10 minutes later she started to have some issues…Patient stated to her neighbor that she was having a hard time breathing and thought she needed to go to the hospital, and that maybe she was more allergic to the aspirin than she had thought…Over the 15 miles between her house and the hospital patient condition deteriorated to the point where they arrived at the hospital she is in full cardiac arrest…given ACLS protocol including epinephrine and was intubated.” “They achieved ROSC after approximately 10 minutes.” Patient was then flown, MT emergency department to Hospital. Patient was cared for in the ICU. Patient herniated her brain the night of 4/5-4/6. “After meeting the clinical and imaging criteria at 1605 on 4/6/2021 she was declared brain dead. Medical team suggests that patient had Samter’s Triad/Triad Asthma with history of asthma, nasal polyps and allergy to aspirin. Anaphylaxis secondary to ingestion of aspirin via Alka-Seltzer.

1177548

4/7/21

COVID19

PFIZER\BIONTECH

4/3/21

attempt at CPR by responding EMS

symbicort 150/4.5, singulair 10mg, pepcid 10mg, amlodipine

PTSD

BMI 95, HTN, OSA, RAD, GERD, hypothyroidism

NKA

On the evening of 4/3/2021 the patient was at home, prone in bed, gasped suddenly and became unresponsive. EMS was called and unable to resuscitate. She expired.

1178531

4/7/21

COVID19

MODERNA

4/4/21

Death within 12 hours

1178887

4/7/21

COVID19

MODERNA

4/7/21

4/6/21

4/7/21

UNK

Death

1180895

4/8/21

COVID19

JANSSEN

4/3/21

3/14/21

4/3/21

death Narrative: Pt with hx substance use disorder (on suboxone), depression, PTSD, SI and grief following her son’s suicide. Pt received COVID vaccine 3/14/21. Clinic notified of pt’s death on 4/6, for which it HAS NOT BEEN VERIFIED but reported death date of 4/3. Pt was scheduled for MH f/u appt 4/5, but no-showed it. Unclear report or cause of death, however, suspected via suicide or drug overdose given risk factors and worsening of mental illnesses. Was pt previously covid positive? No Are there any predisposing factors (i.e. PMH, HPI, allergy history etc) for patient experiencing adverse drug event? No Any occurrence of an ADR at time of administration or during time of observation? No Did patient recover from event? N/A – pt died but does not appear related to vaccine Was there an ADR between observation period and date of death? No Was patient hospitalized prior to vaccination? No Was patient hospitalized between vaccination and date of death? No Was patient hospitalized prior to death No What are the possible cause of death? Suicide, illicit drug overdose

1186348

4/9/21

COVID19

MODERNA

4/8/21

3/17/21

3/24/21

Too many to list

budesonide-formoteroL (SYMBICORT) 160-4.5 mcg/actuation inhaler; eucalyptus oil/menthol/camphor (VICKS VAPORUB); fluticasone (FLONASE) 50 mcg/actuation nasal spray; guaiFENesin (MUCINEX FAST-MAX CHEST-CONGEST) 100 mg/5 mL liquid;

Asthma, lupus

Penicillin G, Hydroxychloroquine

Copied from MD discharge note – Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21

1186348

4/9/21

COVID19

MODERNA

4/8/21

3/17/21

3/24/21

Too many to list

Asthma, lupus

Penicillin G, Hydroxychloroquine

1186471

4/9/21

COVID19

JANSSEN

4/9/21

4/7/21

4/9/21

Resulted on 3/31/2021 FT4 – (NF) FT4 – FT4 L <0.25 (<0.25) 0.78-2.19 ng/dL T3 TOTAL – (NF) T3 TOTAL – T3 TOTAL LL 0.355 (0.355) 0.970-1.69 NG/ML TSH-HIGH SENSITIVITY – (NF) TSH-HIGH SENSITIVITY – TSH-HIGH SENSITIVITY HH 170.783 (171.219) 0.465-4.68 uU/mL

AMLODIPINE 10MG TABLET — [TAKE 1 TABLET(S) ORALLY ONCE DAILY] — 2021-02-23–2021-09-20 ATORVASTATIN 40MG TABLET — [TAKE 1 TABLET(S) ORALLY ONCE DAILY] — 2021-02-23–2021-09-20 LACTULOSE 10GM/15ML SOL — [TAKE 30 MILLILITER(S) ORALLY TWI

D-4 – POST-OPERATIVE ANALGESIA, MILD-TO-MODERATE – 2020-09-03 E78.5 – HYPERLIPIDEMIA, UNSPECIFIED – 2021-02-23 I10 – HYPERTENSION, UNSPEC. – 2019-02-04 F10.20 – **[F10.20A]** ALCOHOL USE DISORDER, MODERATE – 2019-02-11 F14.20 – **[F14.20A]** COCAINE USE DISORDER, MODERATE – 2019-02-11 D-19 – FRACTURED TOOTH – 2020-08-24

VANCOMYCIN RELATED

Complaints of diarrhea, sweating, weakness suffered sudden cardiac arrest. CPR, AED, Lucas device applied ACLS protocol initiated by EMS. Efforts terminated. Patient pronounced deceased at 1003am.

1187918

4/9/21

COVID19

MODERNA

4/6/21

4/5/21

levothyroxine

Trisomey 21, Atrioventricular canal s/p repair, hypothyroidism, asthma, obstructive sleep apnea, cervical spine instability, hypotonia, scoliosis, feeding difficulties, renal dysplasia, autism, chronic constipation, bronchopulmonary dysplasia, mixed conductive and sensorineural hearing loss, binocular vision disorder, gastroesophgeal reflux,

Cefdinir, Sulfa, Ex-Lax, NSAIDS

UNK

I do not know the exact date of the first or second Moderna Vaccine. I am the PICU attending who cared for the patient after her cardiac arrest which we believe was about 3-4 days after her second Moderna Vaccine

1189015

4/10/21

COVID19

JANSSEN

4/9/21

medication for hypertension

hypertension

Patient was given the vaccine without incident at or near 0924a. He previously was diagnosed, through PCR test to have COVID-19 back in December 2019. Outside of supportive therapy at home, he was not treated and was not hospitalized and he recovered within a few weeks. At or near 930-10p, on April 9th, approximately 12 hours after the vaccine was given, while out at a restaurant with family, the patient experienced a medical event, (what appears to be an acute coronary event) and died.

1196666

4/12/21

COVID19

MODERNA

3/15/21

3/14/21

3/15/21

Pt. Expired

1198157

4/12/21

COVID19

MODERNA

4/7/21

2/27/21

4/7/21

Hospice patient death within 60 days of receiving the COVID vaccine series

1198162

4/12/21

COVID19

JANSSEN

3/27/21

3/13/21

3/20/21

My sister received the Janssen vaccine on March 13, 2021. One week later, March 20, 2021, she started complaining of severe headaches, dizziness and vomiting. This continued so she visited the ER on Wednesday, March 24, 2021, where she suffered a cerebral venous sinus thrombosis. She was pronounced brain dead on March 27, 2021, which is also the same day she was pronounced dead.

1198211

4/12/21

COVID19

MODERNA

2/11/21

2/10/21

2/10/21: WBC 15.1, CRP 32. COVID19 negative. Viral respiratory panel negative.

Fluoxetine, methenamine, gabapentin, baclofen, clonazepam, seroquel

Bilateral community acquired pneumonia

quadriplegic spinal cord paralysis secondary to remote MVA autonomic dysreflexia depression/anxiety neurogenic bladder

None

The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70’s) at 8 PM that day. He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI’s and pneumonia with associated sepsis. CT negative for pulmonary embolism and showed bilateral infiltrates. Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin. He was initially stable in the hospital on 1-2 LPM 02. The following evening he became febrile and acutely developed asystole without any pre-existing arrhythmia. Resuscitation was attempted for 45 minutes but unsuccessful. Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination.

1198540

4/12/21

COVID19

JANSSEN

4/11/21

4/1/21

4/11/21

unknown what was done at hospital.

none known

reported none on medical screening

Unknown if the vaccine has any correlation to event. Patient was found unresponsive and not breathing on 4/11/21 @ approximately 3:45 PM outside on the grounds of the campus. A rented scoter was next to him. There was no sign of trauma. 9-1-1 was called and CPR initiated by passerby (there were no witnesses). He remained unresponsive and was intubated when the paramedics arrived. He was transported to hospital where he was pronounced dead.

1198967

4/12/21

COVID19

MODERNA

4/7/21

3/31/21

4/7/21

Cerebral palsy, seizure disorder

Cardiac arrest, death

1199455

4/12/21

COVID19

PFIZER\BIONTECH

4/10/21

4/2/21

4/10/21

fluoxetine, fesoterodine, ortho-tricyclen, oxybutynin

spina bifida, spinal meningocele, VP shunt, scoliosis, neurogenic bladder, constipation

bananas, cephalexin, kiwi, mango, pineapple, latex

UNK

Patient reported difficulty breathing and chest pain; suffered cardiac arrest and death

1199575

4/12/21

COVID19

PFIZER\BIONTECH

4/9/21

4/7/21

4/9/21

Patient died 36 hours after his second dose of Pfizer vaccine

Alogliptin 25 mg tab, aspirin 81 mg DR tab, atorvastatin 80 mg tab, BD Ultr-fine Nano Pen Needle 32 gauge x 5/32 Ndle, benztropine 0.5 mg tab, carvedioloL 25 mg tab, fenofibrate nanocrystallized 145 mg tab, HumaLOG KwikPen Insulin 200unit/m

–

Diabetes, high blood pressure, schizophrenia, heart attack two years ago

None

Death

1199594

4/12/21

COVID19

PFIZER\BIONTECH

4/8/21

4/7/21

4/8/21

unknown

obesity, hypertension

none known

There were no noted adverse signs or symptoms at the time of vaccination. Fiance of patient called Public Health on 4/12/21 to report the patient died in her sleep overnight on 4/7 or 4/8. Autopsy not performed, body embalmed prior to Public Health’s knowledge of client death. Pfizer BioNTech COVID-19 Vaccine EUA

1200939

4/13/21

COVID19

PFIZER\BIONTECH

4/6/21

3/19/21

4/6/21

D-dimer 5.2. Trop 0.17. COVID neg. PTT 18.7. BNP 204.

pepcid

none.

No PMH, was healthy prior to vaccine.

none.

UNK

Massive PE, patient died. No history of DVT, we did a COVID test here and it was negative. She had no PMH, we suspect the vaccine made her hypercoagulable. Had pleuritic CP, tachycardia, tachypnea.

1200959

4/13/21

COVID19

PFIZER\BIONTECH

4/5/21

death

1201114

4/13/21

COVID19

MODERNA

4/10/21

4/2/21

4/10/21

Autopsy is pending at this time

Due date 4/18/2021. Pt presented in labor on 4/10/21. Her labor was uncomplicated and progressing appropriately. She had sudden onset of coughing following by loss of consciousness. Code blue was called. Emergency bedside C/S was performed. Despite resuscitative efforts of 1 hour and 15 minutes, the patient expired.

1201543

4/13/21

COVID19

JANSSEN

4/6/21

3/3/21

3/12/21

CT of Head=Subacute left MCA territory infarct, Chest CT=Acute pulmonary embolism, right kidney and splenic infarcts, Upper extremity U/S=occlusive & nonocclusive deep vein thrombosis in the bilateral upper extremities, occlusive superficial venous thrombosis within the bilateral cephalic veins

Diamox Unsure of other meications

unknown

Hypertension, Type2 DM, Idopathic Intercranial Hypertension, Obesity, Chronic back pain

Unknown

Death

1202257

4/13/21

COVID19

MODERNA

3/24/21

3/5/21

3/19/21

Unknown

Unknown. Brother mentioned gene mutation under review/

See above.

No known allergies to medication reported Other allergies unknown

Brother called pharmacy on 04.13.2021 at approximately 10am and informed pharmacist that his sister had passed away due to a pulmonary embolism about 2 weeks after receiving her first dose of the Moderna COVID vaccination at our pharmacy. He mentioned that healthcare provider was looking at possible gene mutation in family that may have contributed.

1202482

4/13/21

COVID19

JANSSEN

4/12/21

4/6/21

4/12/21

unknown

nka

blood clots

1203510

4/13/21

COVID19

PFIZER\BIONTECH

4/11/21

4/9/21

Gabapentine, Olanzaprine

Unknown on any adverse events or symptoms

1203510

4/13/21

COVID19

PFIZER\BIONTECH

4/11/21

4/9/21

Gabapentine, Olanzaprine

Unknown on any adverse events or symptoms

1204016

4/13/21

COVID19

JANSSEN

4/13/21

4/9/21

4/13/21

None

UNK

HE DIED SUDDENLY !!!!! JUST COLLAPSED !!!!

1205423

4/13/21

COVID19

PFIZER\BIONTECH

4/11/21

4/9/21

4/10/21

Unknown

Patient’s physician reported this adverse event by phone to Medical Center administration on 4/13/2021. Per the physician, the patient received his 2nd Pfizer COVID19 vaccination dose on Friday 4/9/2021 at the drive through vaccination clinic. On Saturday 4/10/2021 the patient told to his wife that he felt ill, continuing through Sunday. On Sunday, 4/11/2021, at his home, the patient told his wife that he felt ill and went to sleep. The patients wife found him not breathing, called 911 and started CPR. The patient was pronounced deceased at his home and was not transported to hospital.

1205518

4/13/21

COVID19

MODERNA

4/12/21

4/9/21

4/10/21

none known

Resident was inoculated on 04/09. According to family members, he began to feel unwell that evening, cold sweats, high fever, dehydration. According to family members, he refused to get medical attention. After not hearing from him for a few days, family members called for a wellfare check on 04/12 at which time he was found deceased.

1206323

4/14/21

COVID19

JANSSEN

4/10/21

4/11/21

per coroner

Pt received vaccine at 1130 on 4/10. Per report of others reported feeling fine at 2300 4/10. Went to bed. Awoke at approx 0100 4/11, reported not feeling well, vomited, returned to bed. Found by housemate at appox 2100 4/11 unresponsive. Declared deceased with rigor mortis by EMS. Pt in custody of the coroner for autopsy.

1206330

4/14/21

COVID19

MODERNA

4/12/21

4/11/21

4/12/21

Autopsy

Cardiomegaly

Death

1208419

4/14/21

COVID19

JANSSEN

4/12/21

3/13/21

4/12/21

Pending Coroner’s results

Unknown, pt was diabetic

Diabetic

Diabetes

none

UNK

Patient described throwing up, pale in skin, sweating prior to passing away.

1209498

4/14/21

COVID19

JANSSEN

4/12/21

3/24/21

4/12/21

Covid swab on the date of expired NEGATIVE

Lorsatan 100mg daily Lipitor toprol XL 50mg daily nifedipine 60mg daily chlorthalidone 25mg daily

DVT (not on anticoagulation) Brain Aneurysm CVA HTN HLD CKD

Pt received the vaccine on 3/24/21. On 4/12/21 pt died of cardiac arrest

1209903

4/14/21

COVID19

PFIZER\BIONTECH

3/13/21

3/6/21

3/13/21

PLEASE CONTACT THE MEGA SITE FOR THIS INFORMATION

UNKNOWN

UNKNOWN, CHECK WITH THE MEDICAL EXAMNINER’S OFFICE, OR PRIMARY PHYSICIAN

UNKNOWN

I DON’T KNOW THE EXACT EVENTS FOR THE CASE, BUT WAS ASKED TO FILL IN THE INFORMATION THE BEST I COULD WITH THE INFORMATION I HAD ON HAND. THIS YOUNG LADY, RECEIVED A COVID-19 VACCINE ON 3/6/2021 AND EXPIRED ON MARCH 13, 2021. THIS IS MOST OF THE INFORMATION THAT I HAVE. YOU WOULD NEED TO CONTACT THE MEDICAL EXAMINER’S OFFICE, THAT WILL BE ABEL TO PROVIDE YOU WITH MOST DETAIL FOR THIS CASE.

1212567

4/15/21

COVID19

PFIZER\BIONTECH

4/11/21

4/10/21

4/11/21

autopsy 4-14-2021

clonidine; gabapentin; beet powder

none

ibuprofen

UNK

he died while on his routine daily run; medical examiner agreed he should have an autopsy which showed coronary artery disease/likely an acute cardiac event

1212820

4/15/21

COVID19

PFIZER\BIONTECH

4/13/21

4/10/21

4/13/21

Postmortem COVID test is positive.

None known

COVID

Drug abuse, unknown type

None known

Unexpected death 3 days after vaccination

1213431

4/15/21

COVID19

PFIZER\BIONTECH

4/6/21

3/1/21

3/16/21

albuterol HFA (PROVENTIL HFA) 108 (90 Base) MCG/ACT Aerosol Solution inhaler Ammonium Lactate (LAC-HYDRIN) 12 % Lotion ibuprofen 600 MG Tablet

Mild intermittent asthma without complication

Ciprofloxacin-ciproflox Hcl ErNausea/GI Upset Peanut

UNK

Patient admitted with massive portal vein thrombosis and low plt in setting of infection. Symptoms started one week prior

1214500

4/15/21

COVID19

PFIZER\BIONTECH

4/15/21

4/2/21

4/14/21

Yes, 4/14 bloodwork at clinic 4/15 labs at hospital

None reported.

Patient at 27 weeks of pregnancy, reported to midwife at regular visit on 4/14/21 that she was experiencing SOB but all blood work normal – assumed normal SOB with pregnancy. Night/morning of 4/15 started seizures, transported to ED. Diagnosed with massive pulmonary embolism. Emergency C-section prerformed by Dr. Pt. did not survive.

1214640

4/15/21

COVID19

JANSSEN

4/12/21

4/11/21

4/12/21

Emergency Room

None

After receiving the J&J vaccine on Sunday afternoon, when my husband got up on Monday morning he passed out in the bathroom and was unresponsive. The EMTs arrived and were able to revive him in the ambulance. When they reached the hospital he was put on life support. After he coded again in the Emergency room they told me he was without oxygen for too long and was taken off the respirator. He passed away at 4:10 PM.

1215403

4/15/21

COVID19

JANSSEN

4/14/21

4/7/21

4/14/21

None

Oxycodone, Amlodipine/atorvastatin, metformin, losartan, atorvastatin, gabapentin, metoprolol tartrate, clonidine, duloxetine, spiriva resp, advair diskus, fluticasone, bupropion xl, lamotrigine, albuterol hfa, monteleukast, furosemide, pot

None

HTN, low back pain, T2DM, bilat primary osteoarthritis of hip, anxiety, severe persistent asthma, depression, CVA Hx.

Lisinopril

1 week post vaccination – patient, not responding to albuterol HFA, called 911, he passed out, was unresponsive, pronounced dead.

1216091

4/15/21

COVID19

JANSSEN

4/13/21

3/23/21

4/13/21

unknown

Unknown

Unkown

NKA

UNK

Patient at gym working out and had a seizure, when 9-1-1 crews arrived patient was post-ictal, while treating the patient he had another seizure, during transport patient went into cardiac arrest, crews provided ACLS care and transported patient to hospital for treatment. Resuscitation efforts were terminated by physician in emergency room.

1220590

4/16/21

COVID19

PFIZER\BIONTECH

5/12/21

4/13/21

4/14/21

4/15 CXR with pulmonary edema 4/15 Transthoracic echocardiogram with LVEF < 25%, apical mural thrombus 4/15 Cr 1.95 increased from baseline Cr 1.20 on 2/27/21 4/16 Heart cath with 100% occluded LAD

albuterol, fluticasone, cetirizine, pioglitazone, lisinopril, glipizide

DM2, HTN, HLD, obesity

metformin (GI symptoms)

– In the early morning of 4/14/21 Pt called Kaiser help line complaining of cold hands/ feet, restlessness, pallor, R arm pain. – Telephone visit 4/14/21 complained of chills, nausea, vomiting, abdominal cramping, diarrhea. Fluids and rest recommended. – 4/15/21 presented to Kaiser with chest pain, shortness of breath, abdominal pain. Diagnosed with late presentation of acute coronary syndrome / anterior ST elevation MI. Echo with low EF < 25%, LV apical thrombus – 4/16/21 heart catheterization showed 100% occlusion of LAD treated with PCI / DES x 2, IABP. Endotracheal intubation for respiratory failure.

1220723

4/16/21

COVID19

JANSSEN

4/16/21

4/6/21

4/14/21

please see hospitalization record for details.

amlodipine aspirin, albuterol inhaler, HCTZ

hypertension, schizophrenia, asthma, morbid obesity, diabetes

hypertension, diabetes, morbid obesity , schizophrenia

bactrim, clindamycin

36 year old male with hx of hypertension , asthma, schizophrenia . he recieved Janssen vaccine on 4/6/2021. he started to fell unwell on 4/14 and on 4/15 he was found by his father unresponsive then sent to the hospital. Pt was diagnosed with massive pulmonary embolism, severe shock, acute renal failure ,Diabetic ketoacidosis , hyperglycemic hyperosmolar nonketotic coma, acute respiratory failure, patient expried from massive pulmonary embolism within 48 hours after admission.

1221166

4/16/21

COVID19

MODERNA

Medical History/Concurrent Conditions: No adverse event (No reported medical history)

needed kidney and/or bladder transplant; within 30 hs after second shot, she died; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (within 30 hs after second shot, she died) and TRANSPLANT (needed kidney and/or bladder transplant) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient’s past medical history included No adverse event (No reported medical history). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEATH (within 30 hs after second shot, she died) (seriousness criterion death) and TRANSPLANT (needed kidney and/or bladder transplant) (seriousness criteria death, hospitalization and medically significant). The cause of death was not reported. It is unknown if an autopsy was performed. The reporter does not remember if this was from Pfizer or Moderna. Concomitant product us e was not provided. Treatment information was unknown. This case concerns death of a 30 year old female 30 minutes after the administration of the mRNA-1273 vaccine. Patient is reported to have no underlying issue. Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded. Reporter did not allow further contact; Reporter’s Comments: Th; Sender’s Comments: This case concerns death of a 30 year old female 30 minutes after the administration of the mRNA-1273 vaccine. Patient is reported to have no underlying issue. Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death

1221176

4/16/21

COVID19

MODERNA

4/3/21

3/30/21

4/3/21

Medical History/Concurrent Conditions: No adverse event (No reported medical history)

he died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (he died) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient’s past medical history included No adverse event (No reported medical history). On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 03-Apr-2021 The patient died on 03-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medications were reported. No treatment medications were reported. Action taken with mRNA-1273 in response to the event was not applicable. Very limited information regarding this event has been provided at this time. Further information has been requested; Sender’s Comments: Very limited information regarding this event has been provided at this time. Further information has been requested; Reported Cause(s) of Death: Unknown cause of death

1228010

4/16/21

COVID19

MODERNA

3/17/21

3/8/21

3/17/21

Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient died of a drug overdose and had a UDS positive for fentanyl and alcohol on 3/8/21 patient tested positive for Chlamydia due to high risk sexual behavior and substance use disorder. Patient was admitted to facility on 2/26/21 to detox from alcohol.

1236415

4/16/21

COVID19

MODERNA

3/30/21

3/25/21

3/30/21

death Narrative: Patient received Moderna covid vaccine #1 on 3/25/21. No notes entered after this time and date of death is recorded as 3/30/21. No scanned records. No autopsy results available. 5 days from date of vaccine to date of death.

1223650

4/17/21

COVID19

PFIZER\BIONTECH

3/15/21

3/12/21

3/15/21

Dialysis 3x per week for kidney disease

Kidney disease

Kidney disease, heart disease, type 2 diabetes

In the evening on March 15th, she began having shortness of breath and chest pain. She asked her boyfriend for her blood pressure cuff so she could take her blood pressure. As he was getting it she told him to call 911 and then her eyes rolled back in her head and she stopped breathing. Paramedics attempted to revive her but were unsuccessful. She was taken to the hospital and pronounced dead. Cause of death listed as heart disease.

1223683

4/17/21

COVID19

PFIZER\BIONTECH

2/22/21

1/27/21

2/12/21

platelet count on admission was 212k; autopsy report is pending

aimovig, vit d, calcium, sumatriptan prn

none

migraines, osteoporosis

none known

Patient reported severe headache on 2/12/21 at approximately 3:30 pm followed by vertigo, nausea, vomiting. Patient became unconscious and EMS was called, found patient on floor and she was brought to ED where CT revealed intracranial hemorrhage. Patient was admitted and supportive care given. She had worsening status on 2/17/21 with pupillary reflexes no longer present and withdrawal of care was performed on 2/21/21. Patient expired on 2/22/21.

1223714

4/17/21

COVID19

JANSSEN

4/17/21

3/20/21

4/17/21

Unknown- This report came second hand. I know that this patient has an extensive medical history, he uses a wheelchair.

This information is second hand, I have not been in contact with next of kin- I am reporting this because I don’t know if anyone else including a medical examiner or his PCP would know that he was recently vaccinated. I was told that this patient was feeling sick for a couple of weeks. A friend visited him within the last couple days and he had a migraine headache. When they went to check on him today they found him deceased in his chair. Further investigation would be needed.

1223941

4/17/21

COVID19

JANSSEN

4/17/21

4/9/21

4/17/21

UNK

Death 4/17/21

1224177

4/18/21

COVID19

PFIZER\BIONTECH

3/19/21

2/24/21

3/12/21

Blood clot blocking blood flow to brain – 1st episode: ( 3/12/21) stabilized, minor limited movement left side – 2nd episode: (3/24/21) no blood flow to brain, death (maintained on life support for organ donation)

1225942

4/18/21

COVID19

PFIZER\BIONTECH

3/30/21

3/19/21

3/28/21

Reported to be on Drospirenone-Ethinyl Estradiol 3-0.02 MG per tab

Patient was a 16yr female who received Pfizer vaccine 3/19/21 at vaccine clinic and presented with ongoing CPR to the ED 3/28/21 after cardiac arrest at home. Patient placed on ECMO and imaging revealed bilateral large pulmonary embolism as likely etiology of arrest. Risk factors included oral contraceptive use. Labs have since confirmed absence of Factor V leiden or prothrombin gene mutation. Patient declared dead by neurologic criteria 3/30/21.

1228351

4/19/21

COVID19

PFIZER\BIONTECH

3/8/21

3/4/21

3/8/21

Inhaler for mild asthma

None

Asthma

None that he was aware of

He died unexpectedly early in the morning. He woke up suddenly, said he needed help, and then was gone.

1230371

4/19/21

COVID19

PFIZER\BIONTECH

4/13/21

4/10/21

4/13/21

? Buproprion-XL 300 mg extended release tablet daily ? Folic acid 1 mg tablet daily ? Docusate 100mg twice daily ? Gabapentin 300mg twice daily ? Hydrocodone-APAP 10-325 mg 1 tablet every 6 hours as needed. ? Hydromorphone 8 mg table by mo

? Hypertension ? Hemoglobin s/beta thalassemia ? Dysthymic disorder ? Sickle cell pain crisis Low Testosterone

Penicillin

Patient passed away on 4/13 after presenting to local hospital with near syncope and AKI. Records from local hospital are unavailable, unclear regarding cause of death and circumstances thereforth.

1232541

4/20/21

COVID19

MODERNA

4/11/21

4/10/21

4/11/21

Unknown, patient unknow to us and received vaccine as part of clinic.

Unknown

Patient denies allergies during verbal interview.

Patient found unresponsive at approximately 12:00 am 10/11. EMS called and patient was pronounced dead at scene.

1233510

4/20/21

COVID19

JANSSEN

4/19/21

4/8/21

4/19/21

Morbid obesity

UNK

Death. Multiple pulmonary thrombi.

1234064

4/20/21

COVID19

MODERNA

5/5/21

4/14/21

4/19/21

Husband stated wife had a severe stroke on 4/19

1234152

4/20/21

COVID19

JANSSEN

3/28/21

3/12/21

3/18/21

unable to get medical records from hospital

SEE PAGE 2

NONE

UNK

Pt. had (what we think) a small seizure on Thursday, March 18th and then again on Saturday, March 20th. On Sunday, March 21st, 911 had to be called as his seizure did not end. He had a grand male. He was seizing for several hours. At the time this was all occurring he has been on anti seizure meds for a few years Divalproex 1000 mg am and 1000 mgs pm daily). He passed 1 week later, March 28 at approx 6:45pm at the Clinic. I am unable to get any information on his medical report for that week. Statement from his Nurologists is on second page. Additional information for Item 18: Statement: 47 year old gentleman who passed away on March 28 from aspiration pneumonia secondary to status epilepticus and on a history of multiple sclerosis / additional leukoencephalopathy of unknown etiology (both treated with rituximab), prior seizures (on valproic acid) and pulmonary embolism (on apixaban). The key reason for reaching out is in light of the announcement about the side effects of the Johnson & Johnson vaccine specifically cerebral venous sinus thrombosis. While he had a known history of seizures, he had no clear trigger for these seizures; including that his valproic acid level was therapeutic (83.0 mcg/mL) at time of presentation. He had, however, received the Johnson & Johnson vaccine on March 12 before having what in hindsight appeared to be repeated seizures between March 18-21; he had a more significant one on March 21 that hospitalized him. This time frame appears consistent with the reported cases of central venous sinus thrombosis associated with the Johnson & Johnson vaccine. Equally, he was taking apixaban at that point in time and his PLT (173) / INR (1.1) / PTT (36.6) at time of presentation were all normal and stable. He did have an elevated ProBNP (552.0) at presentation; nasopharyngeal swab was negative for COVID / Influenza A/B / RSV and non-contrast head CT did not show any clear new abnormalities. His only D-dimer was obtained on March 23 and was 226. He did not have a CT angiogram or venogram. Overall the link between the vaccine and pt. seizures is not definite. At the same time, the similarity with the reported cases has led to me wanting to report it in case of the possible link. If you require further information then please don’t hesitate to email me Pt. med list at the time of this incident Modifinil – 100 mg/1per day/AM Sertraline – 100 mg/1per day/AM Vitamin D3 – 50 mg/1per day/AM Divalproex – 500 mg/2per day/AM Eliquis – 5 mg/1per day/AM Furoseminde – 20 mg/1per day/AM Metroprolol – 100 mg/1per day/AM Lisinopril – 10 mg/1per day/AM Divalproex – 500 mg/2per day/PM Eliquis – 5 mg/1per day/PM Metroprolol – 100 mg/1per day/PM Melatonin – 5 mg/1per day/PM Quetiapine – 50 mg/3per day/PM

1235191

4/20/21

COVID19

MODERNA

3/29/21

2/11/21

3/25/21

CT head and MRI of her brain on 3/25/2021

none

my sister had a ruptured brain aneurysm on 3/25/2021

1235191

4/20/21

COVID19

MODERNA

3/29/21

2/11/21

3/25/21

CT head and MRI of her brain on 3/25/2021

none

my sister had a ruptured brain aneurysm on 3/25/2021

1235822

4/21/21

COVID19

PFIZER\BIONTECH

4/9/21

3/29/21

3/1/21

Test Date: 20210405; Test Name: Work-up; Result Unstructured Data: Test Result:like thrombotic microangiopathy; Comments: revealed like thrombotic microangiopathy although etiology unclear. ADAMTS13 level 29 with no inhibitor not suggestive of TTP; Test Date: 20210405; Test Name: Nasal Swab; Test Result: Negative

Medical History/Concurrent Conditions: Metastatic breast cancer

microangiopathic hemolytic anemia; thrombocytopenia; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with coagulopathy; thrombotic microangiopathy; jaundice; nausea; vomiting; diarrhea; This is a spontaneous report from a contactable physician. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 29Mar2021 13:45 (Batch/Lot Number: ER8733) as single dose for covid-19 immunisation. Patient was not pregnant. The COVID-19 vaccine was administered at Doctor’s office/urgent care. Medical history included Metastatic breast cancer. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant Therapy included Clinical trial oral drug – ARV-471 on 22Mar2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient presented to the hospital on 05Apr2021 complaint of (c/o) 1 week of jaundice, nausea, vomiting, and diarrhea, which started on an unknown date in Mar2021, and on 05Apr2021 found to have evidence of microangiopathic hemolytic anemia, thrombocytopenia, and severe hyperbilirubinemia/cholestasis with coagulopathy. Work-up revealed like thrombotic microangiopathy although etiology unclear. ADAMTS13 level 29 with no inhibitor not suggestive of Thrombotic thrombocytopenic purpura (TTP). Patient eventually died of this acute presentation. She also had a history of metastatic breast cancer and had also just started taking a phase 1/2 oral clinical trial drug ARV-471 on 22Mar2021. Unclear if the drug, COVID vaccine, or breast cancer may have contributed to current illness. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Patient died. Patient hospitalized for 5 days. Date of Death was on 09Apr2021. Death cause: Death certificate stated metastatic breast cancer. No autopsy performed. Therapeutic measures were taken as a result of events included plasmapheresis, steroids, antibiotics. The patient underwent lab tests and procedures which included Nasal Swab: negative on 05Apr2021. The outcome of the events was fatal.; Sender’s Comments: Based on temporal association and the limited information available, the causal association between BNT162B2 vaccine and the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: severe hyperbilirubinemia/cholestasis with coagulopathy; jaundice; nausea; vomiting; diarrhea; microangiopathic hemolytic anemia; thrombocytopenia; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with co

1237092

4/21/21

COVID19

JANSSEN

4/19/21

4/10/21

4/14/21

unknown

UNK

Massive pulmonary thromboemboli

1237709

4/21/21

COVID19

PFIZER\BIONTECH

4/20/21

4/19/21

4/20/21

Patient deceased

1238566

4/21/21

COVID19

MODERNA

4/18/21

4/9/21

4/18/21

On April 18, 2021, nine days after the person got his second dose of Moderna vaccine, he committed suicide using a gun in the presence of his family.

1238566

4/21/21

COVID19

MODERNA

4/18/21

4/9/21

4/18/21

On April 18, 2021, nine days after the person got his second dose of Moderna vaccine, he committed suicide using a gun in the presence of his family.

1240207

4/22/21

COVID19

JANSSEN

3/30/21

3/18/21

3/29/21

None

none

None

None known

Symptoms of tiredness and head sinus pressure came on throughout the day monday 3-29-21. Symptoms were unchanged tues morning 3-30-21. She died Tuesday 3-30-21 between 10:34 am and 12:00 pm. She was found unresponsive at 12:07 pm when husband returned home for lunch. Autopsy results still pending.

1241805

4/22/21

COVID19

PFIZER\BIONTECH

4/18/21

4/17/21

Body examined by medical examiner, Case Number #2021-04116

none

Patient experienced a headache within 4 hours of vaccination. Took recommended dose of Tylenol. 4 hours after that (8 hours after vaccination) he was still experiencing extreme headache and also vomiting and took another dose of Tylenol. Was still feeling poor at 1am but coherent and talking, not thinking that it was serious enough to warrant going to hospital, as he believed it was just a bad headache and the vomiting was from the headache. At 6am, he was found blue/dead in his bed.

1242117

4/22/21

COVID19

PFIZER\BIONTECH

4/16/21

4/9/21

4/16/21

Hypertension

Healthy male, no substance use, no symptoms reported made plans to go hiking with a friend the following Sunday (4/18/21) on 4/16/2021 in afternoon. This was last known contact, patient stopped responding to phone after text and was found deceased in home on 4/22/2021, appearing to have passed away in sleep, likely 4/16/2021 in evening.

1242520

4/22/21

COVID19

MODERNA

4/19/21

3/10/21

4/17/21

Acetaminophen 650 mg up to 2x daily Alvesco 80mcg/actuation – 1 puff 2 times every day Claritin 10mg daily Ferrous Sulfate 325mg two times daily Folic Acid 1mg two times every day Levothyroxine 100mcg tablet daily Methotrexate Sodium 2.5mg

35 y/o with asthma (on alvesco and singulair), GERD, morbid obesity (BMI 45) and RA (on prednisone and MTX, SZA.) Vaccinated for COVID 2.12. and 3.10 Recent lab 3/17- normal, including negative CRP. Code continued for 50 minutes, no shock advised. PEA, gave Epi X 4. Normal BS. Considered narcan. Over the weekend- 4/17/21 Chest pain that started with eating. Labile blood pressure. EKG showed NSR rate 64. Treated with ASA 325, clear liquid diet and rest. Treated with toradol and Zofran. Improved. At f/u on Monday, discussed chronic knee pain was overall better. Normal for her exam. BP 136/79. Felt dizzy and then passed out, hitting her head, became pulseless an apneic and was coded for over an hour.

Asthma, RA, constipation, Hypothyroidism, Anemia

Morphine Sulfate

35 y/o with asthma (on alvesco and singulair), GERD, morbid obesity (BMI 45) and RA (on prednisone and MTX, SZA.) Vaccinated for COVID 2.12. and 3.10 Recent lab 3/17- normal, including negative CRP. Code continued for 50 minutes, no shock advised. PEA, gave Epi X 4. Normal BS. Considered narcan. Over the weekend- 4/17 Chest pain that started with eating. Labile blood pressure. EKG showed NSR rate 64. Treated with ASA 325, clear liquid diet and rest. Treated with toradol and Zofran. Improved. At f/u on Monday, discussed chronic knee pain was overall better. Normal for her exam. BP 136/79. Felt dizzy and then passed out, hitting her head, became pulseless an apneic and was coded for over an hour.

1242573

4/22/21

COVID19

PFIZER\BIONTECH

4/20/21

4/18/21

4/19/21

Vaccinated with Pfizer/Biontech, died 04/20/2021, 2 days after vaccination

Nothing

Heart failure

1242906

4/22/21

COVID19

PFIZER\BIONTECH

4/19/21

4/14/21

4/19/21

Unknown

None inidicated

Pharmacy was contacted by an aunt, who is also a healthcare provider. This contact was requested by the family. Per nurse practitionar who is the aunt of the deceased), patient passed away on Monday, 4/19/2021. He was found unresponsive on a jogging trail, where he had been jogging, by a third party person. They had called an ambulance and could not revive him. Family requested a VAERS report due to the proximity in time to his 2nd Pfizer vaccination. He had received his vaccination at 9:56am on 4/14/21 (lot ER8730) and per father the only side effect he indicated was a sore arm. Autopsy pending per family.

1243487

4/22/21

COVID19

PFIZER\BIONTECH

4/21/21

4/13/21

4/21/21

None

Unknown, History of Mental Illness

Mental Illness,

Mental Illness

None Reported

Patient Committed Suicide with a firearm.

1243648

4/22/21

COVID19

JANSSEN

4/11/21

4/7/21

4/8/21

Aripiprazole, apixaban, basaglar, gabapentin, fluoxetine, metoprolol, furosemide, famotidine, farxiga, albuterol, mametasone, admelog, atorvastatin

none

HF, Bipolar, OSA, DMs, HLD, HTN, PE, morbid obesity, COPD/Asthma

no known allergies

headache on 4/8/21, sudden death 4/11/2021

1243650

4/22/21

COVID19

MODERNA

4/20/21

4/19/21

4/20/21

County Medical Examiner Case

Amlodipine Naproxen

Hypertension Osteoarthritis of knee

NKA

Unexpected death; found unresponsive 04/20/21 morning and pronounced dead after unsuccessful resuscitative efforts

1243791

4/22/21

COVID19

MODERNA

4/12/21

4/10/21

4/12/21

None known at this time.

Per family, Xarelto

None communicated at this time to this office

History of clotting disorder at age 16 with Xarelto treatment and hospitalization

None communicated to this office

UNK

Per the father, the deceased received his first shot of Moderna vaccine on Saturday, 4/10/2021 at a local church. He did not work on 4/11/2021. Worked on 4/12/2021. The deceased was found dead at 6:43 p.m. at his home.

1243832

4/22/21

COVID19

MODERNA

3/23/21

3/8/21

Unknown

None reported

Anorexia, 2nd Degree Type II heart block, pacemaker

NKA

4.21.2021- I spoke with (patient’s husband) related to spouse. Husband stated the patient has a history of 2nd Degree Type 2 heart block, pacemaker placed at the age of 14, and she currently has issues with an eating disorder dx with anorexia. Patient is reported to be approximately 68-70 pounds at the time of vaccination. March 8.2021- Husband states he and his wife came to receive the vaccine around 1630. After, receiving the vaccine the patient stated to her Husband “my arm really hurts.” She begin experiencing s/s at approximately 1900 including: fever, chills, runny nose, fatigued and tired – reportedly temperature was 100.0 and the patient began to drink Gatorade and take Tylenol. Monday, 3.15.2021 patient continued to have symptoms therefore, (husband) contacted Moderna Representatives from the safety team, to determine if it would be safe for the patient to get the 2nd vaccine dose – advised everyone that does not have contraindications should be vaccinated-advised to reach out to PCP. Husband stated that the patient did not want to go to her PCP because of her eating disorder. The patient worked from bed during the week per the husband and spent 90-95% of her time in the bed after receiving the vaccine. Husband states on Saturday 3.20.2021 the patients fever had subsided however, she continued to feel poorly and remained bedbound most of the time. Husband is an Pilot 3.23.2021 stated once, he had landed he began trying to contact wife but she was not answering the phone, after several attempts to contact wife – Husband called a neighbor to check on wife. Upon, entering the residence the neighbor found wife lying on the floor unconscious and not breathing. The neighbor notified Husband and called 911. EMS arrived at the scene and pronounced the patient as a DOA. Husband states that the death certification list cardiac arrest, electrolyte imbalance, and heart block, as causes for death. Husband is concerned that the vaccine may have contributed in some way demise of his wife as he stated “she was never the same after the vaccination.”

1244990

4/22/21

COVID19

MODERNA

4/15/21

3/19/21

He had lab work, cardiac cath and an echo

None

After receiving the second dose of the vaccine, my husband experienced left arm pain which he thought was from the injection. About a week later, the pain got worse and moved toward his chest. It got so bad, he had to be taken by ambulance to the hospital to find out he had been having a heart attack. He spent nearly three weeks in the hospital before he died on 4/15/21

1246534

4/23/21

COVID19

MODERNA

4/10/21

4/9/21

Dr. from the Office of Chief Medical Examiners is currently conducting an autopsy report but shared some initial findings such as: an enlarged heart and patches on her kidney (4/10/21)

Acetaminophen at approximately 5:00pm.

No.

Asthma, stomach ulcers.

No.

Patient felt initially well, but later in that afternoon her arm started hurting and she felt increasingly nauseous and started vomiting at 10:49pm, two hours later she was pronounced dead at approximately 12:30am.

1246604

4/23/21

COVID19

PFIZER\BIONTECH

4/18/21

4/6/21

4/18/21

POCT COVID 19: Negative POCT glucose: 165

Carvedilol, ASA 81mg, gabapentin, spironolactone, albuterol, famotidine

Dyspnea with exertion, cholelithiasis, 2nd degree heart block, RBBB

Tetralogy of Fallot with repair COVID 19 with residual symptoms History of pulmonary embolism History of DVT

NKDA

Patient presented to ED on 04/18/2021 with cardiopulmonary arrest, per ED “He was receiving CPR with EMS for arrival to the emergency. Two rounds epi. Asystole and then went into V-tach. Got shocked once. Then after that has been strip PA asystole.” ED called time of death on patient 04/18/2021 at 05:14AM.

1247401

4/23/21

COVID19

MODERNA

4/16/21

Abdominal Ascites, recent shock liver peri-arrest, recent subdural hematoma, recent cardiac arrest

ESRD, AFib, HTN, Anemia, Migraine headaches, Bipolar disorder, Hx of polysubstance use on methadone, Gout, COVID-19 infection 3/27/2020

Morphine, Phenergan, Unasyn

Patient received Moderna Vaccine on Friday 4/16/2021 12:00pm in dialysis clinic. Over the weekend family called and left a message stating that patient CTB on Friday 4/16/2021 around 8pm.

1247816

4/23/21

COVID19

JANSSEN

4/23/21

4/8/21

4/23/21

none

folic acid hydroxyurea Lisinopril MS contin Camila oxycodone xarelto voxeletor

sickle cell anemia (hgb SS) , obesity avascular necrosis, proteinuria history of Pulmonary embolism on anticoagulation

penicillin- rash

patient called EMS with pain crisis and noted that she had lost vision in both eyes. was transported to Emergency room by EMS and had cardiac arrest and died.

1247997

4/23/21

COVID19

PFIZER\BIONTECH

4/20/21

4/16/21

An autopsy is going to be done. See above for coroner information. I?m indicating below that he died, but I don?t know if the vaccine caused it or played a role. I?m filling this out as a concerned citizen wanting more investigation into this. Please speak to coroner for further information.

Per his parents, patient started feeling nauseous an hour or two after the vaccine and at night around 10pm it worsened where he felt nauseous, had shivers and he vomited in the middle of the night. He then vomited again the next day and continued to not feel well the next couple of days. On 4/20/2021 at around 4:20pm he called his mother, his girlfriend and his mentor that he was not feeling well, was nauseous and dizzy and had shivers and was going to pull over on his car to get something to drink. He then stopped answering his phone and was found dead in his car later on that day. Police is investigating the case.

1248086

4/23/21

COVID19

MODERNA

4/20/21

2/5/21

4/6/21

Heparin-induced thrombocytopenia antibody: negative (three days after surgery) Heparin induced IGG antibody, IA: positive (thirteen days after surgery) Prior to surgery: platelets 307 10*9/L, hemoglobin 13.3 g/dL, hematocrit 41.7% Intraoperative: Platelet: 89 10*9/L Fibribnogen: 223 mg/dL INR: 1.2 Immediately after surgery: Platelets: 5 10*9/L, hemoglobin: 3.2 g/dL, hematocrit: 10.1%

amoxicillin, apple cider vinegar, Excedrin migraine, atorvastatin, chlorthalidone, vitamin D3, cyclobenzaprine, doxycycline, escitalopram, ferrous sulfate, gabapentin, ginseng, ibuprofen, lisinopril, loratadine, potassium, teriparatide, Tob

progressive lower extremity paresthesias/myelopathies and gait/balance abnormalities, severe T11-12 stenosis (thoracic decompression 3/30/21)

anemia, osteoporosis, hyperlipidemia, hypertesnion, low testosterone, sleep apnea, spondylosis of lumbar region, hepatitis, obesity, history of spinal osteomyelitis, deep vein thrombosis

lamotrigine, rifampin, tramadol

Moderna COVID-19 Vaccine EUA: patient underwent L1-2 corpectomy, pedicle subtraction osteotomy, and extension of fusion from T4 to the pelvis two months after vaccination. During surgery patient became thrombocytopenic and required massive transfusion. Thirteen days after surgery found to have bilateral pulmonary embolisms and deep vein thromboses and placed on anticoagulation. Patient subsequently suffered cardiac arrest and was unable to be resuscitated.

1251028

4/24/21

COVID19

PFIZER\BIONTECH

4/22/21

4/14/21

4/22/21

None that we know of

Depression

None

Death by suicide sometime between late evening Wednesday, April 21st, 2021 and early morning April 22nd, 2021. He was found at about 8am that morning.

1251028

4/24/21

COVID19

PFIZER\BIONTECH

4/22/21

4/14/21

4/22/21

None that we know of

Depression

None

Death by suicide sometime between late evening Wednesday, April 21st, 2021 and early morning April 22nd, 2021. He was found at about 8am that morning.

1255612

4/25/21

COVID19

PFIZER\BIONTECH

4/6/21

12/18/20

4/6/21

109

Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None

Heart attack and death; This is a spontaneous report from a contactable Nurse. A 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Ej1685) intramuscular in left arm on 18Dec2020 at 11:00 AM at single dose for COVID-19 immunisation. Medical history was none, no known allergies. No other concomitant medications in two weeks. No other vaccine in four weeks. The patient experienced heart attack at 05:30 pm on 06Apr2021 and the event caused patient death. No treatment for the event. Autopsy results was available. Autopsy remarks: heart attack. No COVID prior vaccination, no COVID tested post vaccination. The patient died on 06Apr2021. An autopsy was performed and the reported cause of death was heart attack.; Sender’s Comments: Myocardial infarction occurred 3 months and 19 days after BNT162B2 vaccine administration. The event is considered unrelated to suspect drug being rather an incidental occurrence. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Heart attack and death; Autopsy-determined Cause(s) of Death: Heart attack

1256112

4/25/21

COVID19

PFIZER\BIONTECH

4/24/21

4/22/21

4/24/21

Equate one daily multivitamin, turkey tail mushroom, coq10, magnesium, glucosamine, fish oil/flax, holy basil, 6-mushroom blend (piping rock brand)

Emphysema, Peripheral Arterial Disease, High BP

My husband received the shot on the 22nd. He died in his sleep on the 24th. He was complaining how the second shot really was giving him a lot of trouble, but nothing that would indicate life-threatening symptoms

1257062

4/25/21

COVID19

MODERNA

4/23/21

4/16/21

4/17/21

Ferritin: >15000 CD25: 9908 CT Abdomen/Pelvis with hepatosplenomegaly Triglycerides 326 AST 54

Prednisone 10 mg, mycophenolate 360 mg BID, betalacept, sodium bicarbonate 1300 mg BID, magnesium oxide 400 mg daily, carvedilol 25 mg BID, atorvastatin, clindamycin 150 mg daily

ESRD s/p renal transplant, hypertension, relapsing cellulitis

The patient developed high fevers, profound watery diarrhea up to 13L/day, requiring IV administration of replacement fluids. He ultimately developed ARDS and succumbed to this illness.

1257204

4/25/21

COVID19

MODERNA

3/25/21

3/3/21

3/23/21

Birth Control pills

obesity

UNK

Patient began experiencing pain and difficulty walking on Tuesday, March 23. Later that afternoon she was taken to an Urgent care, who sent her to the ER for evaluation. She was diagnosed with a very large blood clot in her leg, spanning from just above the knee to her groin area. They admitted her and began treating her with blood thinners. While undergoing that treatment, her heart stopped 3 times and she had to be resuscitated. They discovered a pulmonary embolism. While removing a large clot from her lungs, the doctor found that her lungs were riddled with hundreds of tiny blood clots. They also said that she was bleeding internally, very heavily, from an unknown location. In all, they gave her 20 units of blood, and none of it stayed in her veins. The doctor said it seemed to just disintegrate. At that point, her brain and organs had begun shutting down and family made the decision to remove her from life support. She passed away Thursday evening, March 25, 2021.

1258614

4/26/21

COVID19

JANSSEN

4/26/21

4/1/21

4/25/21

Vienva

Appendicitis, fall from 12 foot ladder resulting in fracture of olecranon process of left ulna requiring admission to skilled nursing facility

UNK

Patient presented to ED for 2 syncopal episodes and went into cardiac arrest 5 minutes prior to ED arrival in ambulance. She received ACLS measures and alteplase was mixed and administered for pulmonary embolism concern.

1259763

4/26/21

COVID19

MODERNA

4/2/21

3/29/21

4/2/21

I don’t have anything

none

High cholesterol

none

Fever, chills, headache, and tiredness (2nd day of receiving the 2nd dose) Feeling good on the 3rd day Headache, stomach burn, throwing up, and heart attack (4th day of receiving the 2nd dose) Passed away on April 2, 2021

1261201

4/27/21

COVID19

JANSSEN

Comments: Unknown

UNK

DEATH; This spontaneous report received from a patient concerned a 36 year old male. The patient’s weight, height, and medical history were not reported. As per reporter patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for this case. No concomitant medications were reported. The reported stated that presence of antibodies should be tested before taking the vaccine and taking the vaccine with covid antibodies present can kill. The patient died on an unspecified date with unknown cause of death after vaccination. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender’s Comments: V0: 20210428954 -covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

1261766

4/27/21

COVID19

MODERNA

4/10/21

4/8/21

4/10/21

increased body temperature, seizure, death

1264618

4/27/21

COVID19

MODERNA

4/26/21

4/21/21

4/26/21

Autopsy results pending

Insulin, Levemir, robinirole seroquel, xanax, gabapentin, oxycodone

Diabetes mellitus, hypertensive and atherosclerotic cardiovascular disease.

103 fever 2 days after the vaccine. Then became afebrile. Then found deceased on 4-26-2021

1266821

4/28/21

COVID19

MODERNA

4/24/21

4/23/21

4/24/21

Past medical history: Vestibular schwannoma. Cerebellopontine angle tumor. Multiple meningioma. Neurofibromatosis. Cancer of the Breast [Z85.3], left breast-diagnosed 8/2018. Compression of brain stem. Anxiety disorder, generalized [F41.1]. Anemia [D64.9]. Depression. Arthritis [Z87.39],

Pollen Extracts- confusion. Sulfamethoxazole- confusion. Cephalexin- hives. Ciprofloxacin- nausea and vomiting. Clindamycin- nausea and vomiting. Grass Pollen. Iron- nausea and vomiting. Latex- rash. Tape Adhesive- rash. Sulfonamide Antibiotics- nausea and vomiting.

Pt was seen in Family Medicine on 4/23/2021. Was given her first Moderna vaccine that day. On-call doctor received phone call on 4/24/2021 that pt had expired. Death certificate states cause of death: seizure due to possible complication of COVID 19 vaccine. Conditions if any, leading to immediate cause: cerebellopontine angle tumor of brain

1267074

4/28/21

COVID19

MODERNA

4/27/21

2/3/21

4/26/21

4-26-21 CXR – no acute process 4-26-21 CTAP no contrast: no acute process 4-26-21 CT chest no contrast: bibasilar atelectasis and 8mm upper lobe nodule in R lung ECG 4-26-21 ST elevation in v2, with t wave inversion on v5 and v6 4-26-21 – rapid sarscov2 test – detected 4-26-21 sars covd 2-igg negative 4-26-21 – ddimer 2190

none

none stated

no significant past medical history / no home meds

intolerance to percocet – nausea / vomiting

#1 = 011J20A on 1-6-21 #2 = 028L20A on 2-3-21 patient presented after sudden onset of chest pain early in morning and found to be covid +. ECG demonstrated diffuse ST elevation, troponins negative. CT without contrast didn’t have much in it. He was found to be COVID rapid test+ and IGG negative. He was admitted into isolation, no oxygen needs. DDIMER was over 2000 and friction rub noted on physical exam. Cardiology ruled out STEMI, thought maybe viral pericarditis – but wanted echo done after out of isolation. CTA was planned for AM on 4-28-21, but patient died 4-27-21 PM after being found down in room. ROSC was not able to be achieved despite aggressive resuscitation efforts

1267278

4/28/21

COVID19

MODERNA

4/12/21

4/10/21

4/11/21

None

Insulin Lispro (HUMALOG KWIKPEN INSULIN) 100 unit/mL SubQ Insulin Pen, INJECT 14 UNITS SUBCUTANEOUSLY TEN MINUTES BEFORE EACH MEAL. USE INSULIN SENSITIVITY RATIO OF 2/50 TO TARGET BLOOD SUGAR OF 150 IF NEEDED. DISCARD USED PENS AFTER 28 DAY

LONG TERM INSULIN THERAPY HTN (HYPERTENSION) DM 2 MAJOR DEPRESSIVE DISORDER, RECURRENT EPISODE DM 2 W BILAT PROLIFERATIVE RETINOPATHY HX OF VITRECTOMY HX OF PANRETINAL PHOTOCOAGULATION LEGAL BLINDNESS USA DM 2 W MICROALBUMINURIA HX OF MRSA HYPOTHYROIDISM DIASTOLIC HEART FAILURE, CHRONIC HX OF MULTIPLE DRUG RESISTANT ORGANISM HX OF FOURNIER GANGRENE, MALE DM 2 W HYPERGLYCEMIA HX OF PULMONARY EMBOLUS IRON DEFICIENCY ANEMIA ANEMIA OF CHRONIC DISEASE HYPERLIPIDEMIA ANEMIA CHRONIC RESPIRATORY FAILURE HX OF CORONAVIRUS COVID-19 DISEASE DM 2 W ULCER OF LEFT FOOT DM 2 W CKD STAGE 4 (GFR 15-29) MODERATE PROTEIN CALORIE MALNUTRITION DM 2 W CKD STAGE 4 (GFR 15-29) W HTN SECONDARY HYPERPARATHYROIDISM, RENAL ORIGIN SEVERE OBESITY GERD (GASTROESOPHAGEAL REFLUX DISEASE) MOOD DISORDER, UNSPECIFIED TYPE

norco

UNK

Patient passed away 4/12/2021 suddenly, found by family on couch. Was having shortness of breath day before. Per mom, patient had been laughing and talking the morning before patient passed away.

1267487

4/28/21

COVID19

PFIZER\BIONTECH

4/26/21

4/24/21

4/26/21

Coroner autopsy, case 2021-05544

None know

Kidney stones

None known

Cough and diarrhea the day after receiving vaccine. The next day, had difficulty breathing and collapsed.

1267794

4/28/21

COVID19

MODERNA

3/5/21

2/5/21

2/24/21

Extensive over the course of approximately 1 week at Hospital and Medical Center – please contact them for details.

unknown

none known

hypertension

none known

Approximately 3 weeks after Moderna Covid-19 vaccine administration, patient began to experience dizziness, transferred to Hospital, diagnosed with ischemic stroke, discharged, returned within days with worsening, diagnosed with new ischemic stroke (contralateral side), transferred to Medical Center, patient’s condition worsened, presumably additional new ischemic stroke, patient ultimately died on 3/5/2021. Diagnosis was acute infarction of the brainstem/pons as well as acute bilateral cerebellar/occipital infarctions.

1268424

4/28/21

COVID19

PFIZER\BIONTECH

4/26/21

4/24/21

4/26/21

Swabbed for COVID by medical examiner, no results available.

History of blood clots

The decedent was found in her bedroom by her daughter. Medical history only includes previous blood clots. Decedent has been complaining of coughing and shortness of breath the past few days. There is no history of drug use. The decedent had a foam cone when found.

1269763

4/29/21

COVID19

PFIZER\BIONTECH

4/14/21

4/2/21

SYNTHROID; SUMATRIPTAN; CLONAZEPAM

Migraine

Medical History/Concurrent Conditions: Anxiety; Hypothyroidism

died on 14Apr2021 01:30 pm of a sudden death; first dose of BNT16B2 on 15Mar2021 09:00 am/ second dose via an unspecified route of administration on 02Apr2021; first dose of BNT16B2 on 15Mar2021 09:00 am/ second dose via an unspecified route of administration on 02Apr2021; This is a spontaneous report from a contactable healthcare professional (patient’s spouse, nurse practitioner). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 02Apr2021 (lot number: EW0150) as single dose (at the age of 47-years-old) for COVID-19 immunisation, vaccinated at a hospital. Medical history included hypothyroidism, anxiety, and chronic migraine (ongoing). The patient had no known food and drug allergies. Concomitant medications included levothyroxine sodium (SYNTHROID); sumatriptan for migraines; and clonazepam for anxiety. The patient received the first dose of BNT16B2 on 15Mar2021 09:00 am (lot number: EN6708) (at the age of 47-years-old) for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient died on 14Apr2021 01:30 pm of a sudden death. She was found at home unresponsive and pulseless. Efforts at resuscitation were unsuccessful. Her medical history of hypothyroidism, anxiety and chronic migraines do not appear to be contributory. The patient did not receive treatment (as reported). The reporter considered the event to be a serious adverse effect (SAE). A full autopsy has been performed; the results were pending.; Reported Cause(s) of Death: died on 14Apr2021 01:30 pm of a sudden death

1270366

4/29/21

COVID19

MODERNA

4/28/21

4/19/21

4/24/21

Wellbutrin

Anxiety and depression

NKA

cardiac arrest 5 days post vaccination.

1271212

4/29/21

COVID19

MODERNA

4/12/21

4/22/21

ECHO-CARDIOGRAM BLOOD TEST

Clonazepam, Ambien, Transene

Asma , Anxietyy

On admission time was found with ejection fraction of 16%

NONE

UNK

PATIENT DEVELOP CARDIOGENIC SHOCK AFTER RECEIVED FIRST DOSE OF MODERNA VACCINE ON THURSDAY 29 2021 PATIENT DIED

1273475

4/30/21

COVID19

MODERNA

4/29/21

4/28/21

4/29/21

Isosource Continuous feeding, Tylenol 650mg PRN; Ibuprofen 400mg PRN; Metoprolol 50mg BID

Anoxic Brain Injury, History of MI, Uterine rupture, dysphagia, PEG TUBE, Tracheostomy

Anoxic Brain Injury

NKA

on 04/29/2021 Resident was checked at 1830 and found to be at baseline status. At approximately 1855, resident was found pulses and apneic. CPR initiated and resident transferred to medical center. Resident expired 1939.

1273940

4/30/21

COVID19

JANSSEN

4/11/21

4/9/21

4/11/21

CCU, Stent Inserted,

None

Heart Attack at 7:10 am( 4/9/21), CPR, CCU, CPR, Death(4/11/21) 9:15pm

1273988

4/30/21

COVID19

JANSSEN

5/2/21

4/7/21

4/26/21

Topiramate 50 mg dly Lisinopril 20 mg dly Humolog 150 u via pump dly phentermine 37.5 mg dly glycopryrrolate 1 tab po TID Q8hours

diabetes asthma

vicodin

UNK

Patient had vaccination 4/7/2021 and started having symptoms 04/25/2021 arrived at the ER today with hypoxia

1274722

4/30/21

COVID19

PFIZER\BIONTECH

4/30/21

4/20/21

4/28/21

none

Pt presented to the hospital after a cardiac arrest. Work up showed renal artery thrombosis b/l causing renal failure and hyperkalemia. ROSC was achieved and pt coded multiple times after. We were unable to obtain CT A 2/2 to pt being unstable so only U/S imaging with doppler was used for diagnosis. Pt was treated with heparin gtt., hematology work up was sent but cause not identified. ECHO did not show thrombosis in the heart. CCRT was attempted but pt expired.

1276530

5/1/21

COVID19

JANSSEN

Comments: Unknown

UNK

DEATH; BLOOD CLOT; This spontaneous report received from a consumer news/social media platform concerned a 5 decade old female. The patient’s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient developed a rare blood clot and died within two weeks of getting the Janssen covid vaccine. On an unspecified date, the patient died from unknown cause of death. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to.; Sender’s Comments: V0-covid-19 vaccine ad26.cov2.s-This case concerns with 5 decade old female. Death, Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

1276773

5/1/21

COVID19

MODERNA

4/5/21

Stroke; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion death). The patient died on 05-Apr-2021. The reported cause of death was Stroke. It is unknown if an autopsy was performed. Concomitant medications were not reported. The patient was not hospitalized prior to or during the stroke. The reporter mentioned that the organs were donated as the patient was on a ventilator.; Reported Cause(s) of Death: Stroke

1277679

5/1/21

COVID19

JANSSEN

4/30/21

4/9/21

4/30/21

Protonix, Folic Acid, K-Dur,

Cardiac, lung problems, history of blood clots, back and leg pain

Death on 04/30/2021

1278030

5/1/21

COVID19

PFIZER\BIONTECH

5/1/21

4/27/21

4/30/21

COVID 19 not detected (4/30/21 at 21:40) D-dimer > 20 (5/1/21 at 03:38) AST 7730 (5/1/21 at 03:38) ALT 7128 (5/1/21 at 03:38) Ferritin >30,000 (5/1/21 at 03:38) Lactate > 20 (5/1/21) PTH 680 (5/1/21) pH 7.26 (5/1/21 Troponin > 50 (5/1/21 at 05:13) CK 2889 (5/1/21 at 05:13) Bedside ECHO 5/1/21 demonstrated good ejection (EF not reported).

None

Down’s Syndrome

No known food or medication allergies

27 year old male with Down’s Syndrome and no other past medical history received second COVID-19 vaccine on 4/27/2021. On 4/30/2021 began “feeling poorly” with nausea/vomiting and possible chest discomfort. Originally presented to ED on morning of 4/30 – EKG completed demonstrated diffused ST elevation. Patient was transferred to Medical Center for heart catheterization. Left heart catheterization demonstrated normal coronary arteries and LVEDP of 25. Stat ECHO demonstrated pericardial effusion and concern raised for myopericarditis. Patient subsequently transferred to a different Medical Center for higher level of care. Upon arrival to Medical Center plan was to intubate and take to cath lab for heart biopsy and PA catheter placement. However, upon intubation patient began to decompensate and subsequently developed cardiac arrest. During ACLS, VA ECMO was placed and therapeutic hypothermia was initiated. Following VA ECMO placement patient received IVIG, high dose methylprednisolone (1000 mg), anakinra 100 mg, and broad spectrum antibiotics (vancomycin and Zosyn). Despite these efforts the patient continued to have hemodynamic instability and was on high dose vasopressors (epinephrine, norepinephrine, dopamine, angiotensin II, vasopressin). Patient subsequently suffered another cardiac arrest, briefly regained pulse with high dose vasopressors, but subsequently lost pulse despite best efforts and died on 5/1/2021 at approximately 13:00.

1278349

5/1/21

COVID19

PFIZER\BIONTECH

4/29/21

4/24/21

4/29/21

None

UNK

Patient suffered a seizure and pulmonary edema four days after receiving second Pfizer shot. He was pronounced dead several hours later. Patient had no health issues and was 45 years old.

1279801

5/2/21

COVID19

MODERNA

4/22/21

3/22/21

4/22/21

UNK

Death. Autopsy was done. Awaiting results

1281531

5/3/21

COVID19

MODERNA

4/24/21

4/5/21

4/12/21

None

Nothing than seasonal allergies

None

UNK

Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling. He had severe headache afterwards, dizzy and blurred vision. 04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to. Wife called 911 and was talking and walking. Was awake and talking in ambulance, oxygen level was low. Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age – 35 and no pre-existing illnesses – was determined he died of Pulmonary Thrumbo Embolism

1283686

5/3/21

COVID19

MODERNA

4/24/21

4/23/21

4/24/21

Lamotrigine 100mg Levetiracetam 1000mg Senna-Docusate Vimpat 200mg Lorazepam 1 mg Lamotrigine 200mg Metamucil Baclofen 10mg Primidone 250mg

Dental Abscess

Rhett Syndrome Epilepsy/Seizure Disorder Intellectual Disability

No known

Patient discovered by caregiver to have passed away on the morning of 4/24/21

1286144

5/4/21

COVID19

PFIZER\BIONTECH

4/23/21

4/21/21

4/23/21

Autopsy confirmed presence of bilateral pulmonary emboli

Doxepin, Gabapentin, Lamotragine, Methocardimal, Resperidone

Bipolar, HTN, PTSD, Polysubstance abuse

Shortness of breath followed by sudden collapse followed by death.

1286275

5/4/21

COVID19

JANSSEN

4/21/21

4/12/21

4/1/21

Obesity

Death due to a Subarachnoid hemorrhage

1288450

5/5/21

COVID19

PFIZER\BIONTECH

4/13/21

4/11/21

4/12/21

Test Date: 20210405; Test Name: COVID-19 PCR test; Test Result: Negative

NAPROSYN [NAPROXEN SODIUM]; BENZONATATE

Feeling Tired; Headaches; Passed away; found dead in her bed; Was not feeling well; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 11Apr2021 (lot number: ER8729) at the age of 49 years old, as single dose for COVID-19 immunisation. The patient’s medical history was not reported. Concomitant medications included naproxen sodium (NAPROSYN) taken for an unspecified indication from 05Apr2021 to an unspecified stop date; and benzonatate taken for an unspecified indication from 05Apr2021 to an unspecified stop date. The patient previously received first dose of BNT162b2 on 21Mar2021 (lot number: EP6955) at the age of 49 years old, for COVID-19 immunization and experienced fatigue, legs were hurting, dry cough, and really bad headaches. No other vaccines received in four weeks. The caller’s friend (patient) got her second dose on a Sunday (11Apr2021). Monday, (12Apr2021), the patient went to work, but left because she wasn’t feeling well. The reporter stated that the reporter did not speak to her friend (patient) directly on this day but was told that her friend (the patient) was feeling tired and having headaches. The reporter stated that her friend died early Tuesday morning 13Apr2021. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 05Apr2021. The patient died on 13Apr2021. An autopsy was performed, and results were not provided. Outcome of events ‘was not feeling well’, ‘feeling tired’, and ‘headaches’ was unknown.; Reported Cause(s) of Death: Passed away; found dead in her bed

1288833

5/5/21

COVID19

PFIZER\BIONTECH

4/14/21

4/2/21

4/14/21

n/a; My wife was declared dead at the home. Toxicology is pending.

L-Thyroxine (Synthroid) 50 mcg PO, daily Lexapro 20 mg PO, daily Sumatriptan 100 mg PO, PRN (may take a 2nd dose after 2 hours if needed), PRN Clonazepam 0.5 – 1.0 mg PO, PRN as needed for anxiety

Occasional migraines

Anxiety

NKDA No food allergies

My wife (age 47) died on 14Apr2021 of a sudden death. She was found at home unresponsive and pulseless. Her medical history is non-contributory for a sudden cardiac death. A full autopsy is pending.

1288833

5/5/21

COVID19

PFIZER\BIONTECH

4/14/21

4/2/21

4/14/21

n/a; My wife was declared dead at the home. Toxicology is pending.

L-Thyroxine (Synthroid) 50 mcg PO, daily Lexapro 20 mg PO, daily Sumatriptan 100 mg PO, PRN (may take a 2nd dose after 2 hours if needed), PRN Clonazepam 0.5 – 1.0 mg PO, PRN as needed for anxiety

Occasional migraines

Anxiety

NKDA No food allergies

My wife (age 47) died on 14Apr2021 of a sudden death. She was found at home unresponsive and pulseless. Her medical history is non-contributory for a sudden cardiac death. A full autopsy is pending.

1289723

5/5/21

COVID19

MODERNA

5/4/21

5/3/21

5/4/21

UNK

Death. Approximately 12 hours after administering the vaccination shot, patient experienced a medical emergency and lost her pulse. Paramedics attempted to resuscitate her for about 80 minutes. Her heart was unable to be restarted. She was declared deceased at 3:00 AM locally.

1290128

5/5/21

COVID19

PFIZER\BIONTECH

4/23/21

4/1/21

Labs were within normal limit with the exception of a potassium of 3.3, glucose of 157 and lactic acid of 6.9.

None

Shortness of breath for 1 week. Starting after pfizer vaccination and continuing until patient expired.

None

UNK

Patient collapsed at home with cardiopulmonary arrest. He had been complaining of shortness of breath 1 week prior to the event, starting when he received his covid vaccination. The differential diganosis was pulmonary embolism, myocardial infarction or arrythmia. CPR was started immediately and patient received tPA during ACLS without return of spontaneous circulation.

1293657

5/6/21

COVID19

PFIZER\BIONTECH

5/6/21

5/5/21

5/6/21

generic cetirizine, tylenol

None

UNK

34 y/o male with no PMHx presenting in cardiac arrest from home. Per pt’s wife, he received 2nd dose of the Pfizer vaccine roughly 24 hours prior. He complained of arm soreness yesterday afternoon and some chills this morning, took Tylenol for these symptoms. She found him unresponsive in bed after speaking to him roughly 2 hours earlier. Per EMS, patient was in asystole upon their arrival. He received ~ 30 minutes of prehospital ACLS and an additional 20 minutes in the ED and remained in asystole throughout.

1293909

5/6/21

COVID19

MODERNA

5/1/21

4/20/21

4/23/21

unknown

Uncontrolled DM, HTN

Uncontrolled DM, uncontrolled HTN

UNK

Per family, pt reported fatigue and elevated glucose, nausea and diarrhea 3-4 days after immunization. She was seen by her PCP following week and again was experiencing elevated blood glucose.

1295555

5/7/21

COVID19

JANSSEN

5/1/21

4/30/21

5/1/21

Autopsy preformed

ADVAIR DISKUS 500-50 mcg/dose inhalation Disk with Device Last dose: — Start: 3/16/21 End: — 1 Inhalation by inhalation route twice daily. albuterol sulfate 2.5 mg /3 mL (0.083 %) inhalation Solution for Nebulization Last dose:

Ibuprofen, Naproxen, Onion

UNK

Patient found dead

1296030

5/7/21

COVID19

PFIZER\BIONTECH

5/1/21

4/25/21

MRIs, brain scans, blood work, organ biopsies, and I’m sure more.

Unknown cardiac event. Found on sidewalk down. Revived but resulted in extensive neurological damage. Was put in life support. Never came to. Passed away 05/05/2021.

1297262

5/7/21

COVID19

PFIZER\BIONTECH

5/7/21

5/3/21

5/5/21

None

Unknown

Heavy tobacco and alcohol use

Unknown

The patient had developed a rash, fatigue, difficulty breathing, stomach pain, possible fever and began to cough up blood. He took Tylenol and a Chinese herbal medication called Lianhua Qingwen Jiaonang on 5/5/21. It is unclear when his symptoms began, as he did not share that information with his wife until 5/5/21.

1301355

5/9/21

COVID19

PFIZER\BIONTECH

5/9/21

5/6/21

none per parents

Thyroidectomy

She began having shortness of breath after getting her second shot. He parents found her dead in her bed this afternoon. No other known comorbidities.

1301965

5/10/21

COVID19

JANSSEN

4/27/21

Comments: The patient had no known drug allergies.

UNK

DEATH; This spontaneous report received from a company representative concerned a 49 year old female. The patient’s height, and weight were not reported. The patient’s pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-APR-2021, the patient died from unknown cause of death after 4 weeks of Johnson and Johnson vaccination. An autopsy was performed on an unspecified date and there was no sign of high blood pressure, heart disease, or diabetes to patient as per report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender’s Comments: V0. 20210505962-covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH; Autopsy-determined Cause(s) of Death: UNKNOWN CAUSE OF DEATH

1302383

5/10/21

COVID19

PFIZER\BIONTECH

5/4/21

4/27/21

5/4/21

On May 4, office call me in the afternoon. They told me their autopsy indicated he had an enlarged heart and a defective valve.

Not known of

No known of

He felt very bad the night he received the 2nd shot of Pfizer covid-19 vaccine on April 27. He even joked he probably would die that night. He also complained that despite his protest, the person who administered the shot insisted to inject on his shoulder joint. He developed a bigger-than-quarter-size bruise on his right inner arm the next day. He was feeling tired the following days. On May 4 around 3:30, I heard he was making loud noises. I came to his side immediately. At the time I thought he was making louder than usual snores. I nudged him gently but he didn’t respond. After about 15 seconds, the sound stopped, and he had no breath. I then called 911 within 10 seconds, tried to do CPR on him. It took EMS 6 minutes to arrive even though we live very close to a fire station in a well-accessed urban area. EMS worked on him for about 30 minutes before transported him to hospital. They continued to work on him for a while. He never regained breath.

1302428

5/10/21

COVID19

MODERNA

5/5/21

UNK

The patient was last seen well at 3:30 PM. He was found unresponsive, face down in his own vomit, cyanotic, apneic by family. Patient was unable to be resusitated. He was pronounced dead at 6:51 PM.

1302705

5/10/21

COVID19

PFIZER\BIONTECH

5/5/21

4/6/21

5/5/21

This 49 year old female received the Covid shot on 4/6 /21 and went to the ED on 5/5 /21 with the following diagnoses listed below and died on 5/5/21.

1302844

5/10/21

COVID19

MODERNA

5/9/21

5/6/21

5/7/21

Autopsy on May 10, 2021. Results pending.

Hydroxyzine pamoate

Hypertension, non-insulin dependent diabetes

None

Lethargy began the day of vaccine and shortness of breath along with abdominal and chest pain followed the next day. Decedent was found deceased the next evening.

1304434

5/10/21

COVID19

MODERNA

3/30/21

None yet

unknown

williams syndrome one functioning kidney faulty aorta asthma when young hyperlipidemia

unknown

Patient found dead after receiving vaccine. At 11:44 on 3-30-2021 Medical Investigator was able to return call after leaving scene where there was no phone service. Police were on the scene requesting Medical Investigator Contact was made between Medical Investigator and member of the police force. Narrative was that the patient, who is handicap with considerable health issues which he was born with, and his parents had been to healthcare facility to receive COVID vaccination. Returning they had traveled in order to arrive at their residence. The decedent had asked to be dropped off close to parents home. The parents arrived at the residence and after waiting ten to fifteen minutes walked searching for the decedent. He was located unresponsive and 911 was initiated.

1304956

5/11/21

COVID19

JANSSEN

Comments: Unknown

UNK

BLOOD CLOT; This spontaneous report received from a company representative concerned a 42 year old male. The patient’s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry were unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, between three to ten days later after vaccination the patient died due to blood clots. It was unknown, whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender’s Comments: V0;20210510772-covid-19 vaccine ad26.cov2.s-Thrombosis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOT

1306318

5/11/21

COVID19

MODERNA

4/23/21

Allergy NOS (unspecified allergy); Blindness (All blind in left eye); Feeding tube user; Neurofibromatosis, type 2 (acoustic neurofibromatosis) (Diagnosed at age 11, had tumor on nerves and all over body.); Walker user

Went back to sleep and never woke up; Arm soreness; Feeling bad; very flushed/looked red; very tired/fatigue/nappy women taking a lot of naps; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Went back to sleep and never woke up) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C2117) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Neurofibromatosis, type 2 (acoustic neurofibromatosis) (Diagnosed at age 11, had tumor on nerves and all over body.), Blindness (All blind in left eye), Allergy NOS (unspecified allergy), Walker user and Feeding tube user. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced DEATH (Went back to sleep and never woke up) (seriousness criterion death), PAIN IN EXTREMITY (Arm soreness), VACCINATION COMPLICATION (Feeling bad), FLUSHING (very flushed/looked red) and FATIGUE (very tired/fatigue/nappy women taking a lot of naps). The patient died on 23-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PAIN IN EXTREMITY (Arm soreness), VACCINATION COMPLICATION (Feeling bad), FLUSHING (very flushed/looked red) and FATIGUE (very tired/fatigue/nappy women taking a lot of naps) outcome was unknown. The patient was on a feeding tube, lived independently but had a caretaker who came in every day. The patient had long list of medications for her conditions but concomitant medications were not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. Regarding the events of Pain in extremity, Fatigue, Flushing, Vaccination related malaise, based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, regarding the event of Death,Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender’s Comments: Regarding the events of Pain in extremity, Fatigue, Flushing, Vaccination related malaise, based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, regarding the event of Death,Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

1306986

5/11/21

COVID19

MODERNA

5/10/21

5/7/21

5/10/21

Patient expired of probable aneurysm at Hospital on 5/10/2021

1307384

5/11/21

COVID19

MODERNA

3/11/21

5/8/21

Schizophrenia, type 2 diabetes, Sleep Apnea, hypertension, Gerd, Hyperlipidemia

Was feeling fine the day before, went to sleep around midnight and passed away during the night while sleeping.

1307657

5/11/21

COVID19

PFIZER\BIONTECH

4/23/21

4/19/21

4/23/21

None

none

Death by suicide.

1308207

5/11/21

COVID19

MODERNA

5/7/21

4/20/21

5/7/21

unknown whether autopsy was obtained

Paxil 20mg and Trazodone 100mg

Depression / anxiety

unknown

nka

#2 Moderna Vaccine given on 4/20/21 On 5/7/21 patient became SOB before syncope to cardiac arrest, event was witnessed and CPR started immediately. Patient expired 45 min later at Medical Center.

1310174

5/12/21

COVID19

PFIZER\BIONTECH

5/4/21

4/24/21

5/2/21

Death on 2 May 2021

1310622

5/12/21

COVID19

MODERNA

4/27/21

1/6/21

4/26/21

110

Will need to request.

Unknown

None

None known

Unknown

Developed symptoms around 4/25, presented to ED with complaints of chest pain and something being stuck in his throat. Subsequently died on 4/27.

1310622

5/12/21

COVID19

MODERNA

4/27/21

1/6/21

4/26/21

110

Will need to request.

Unknown

None

None known

Unknown

Developed symptoms around 4/25, presented to ED with complaints of chest pain and something being stuck in his throat. Subsequently died on 4/27.

1312456

5/12/21

COVID19

MODERNA

5/4/21

5/3/21

5/4/21

Body was taken to Hospital for autopsy.

None

Death. While driving patient passed out and was found by County Sheriffs Office. EMT was called and could not save patient. M.E. Declared patient dead at 7:20 PM on May 4, 2021

1313803

5/13/21

COVID19

JANSSEN

5/9/21

5/6/21

5/8/21

Coroner autopsy 2021-05968.

Fluoxetine, montelukast, trazodone

None known

Asthma

None known

Received vaccine on 5-6-21. On 5-8-21, complained of headache, bloating, fever, and constipation. Last seen alive at 9 PM on 5-8. Found dead at home at 7 PM on 5-9.

1313922

5/13/21

COVID19

MODERNA

4/15/21

4/13/21

4/15/21

Influenza A RNA NOT DETECTED Influenza BRNA NOT DETECTED SARS-CoV-2 RNA DETECTED

HX SUBSTANCE ABUSE

PT NO SHOW FOR APPT 5/11 FOR 2ND DOSE -CHECK OF agency system SHOWS PT REPORTED DECEASED 5/14- CHECK OF database SHOWS PT FOUND DECEASED AT HOMEN 5/14/21- AUTOPSY Completed

1314069

5/13/21

COVID19

JANSSEN

5/13/21

5/12/21

5/13/21

UNKNOWN

UNKNOWN-NOTHING MARKED ON REGISTRATION FORM

UNKOWN

DEATH

1314342

5/13/21

COVID19

PFIZER\BIONTECH

4/14/21

4/13/21

4/14/21

Paramedics pronounced him DEAD.

Lisinopril, levothyroxine, suboxone, Xanax,

None

High blood pressure, low thyroid, obesity, drug addiction

None

He died. He got the shot then several hours later he was found DEAD in his sleep. We are still awaiting coroners reports.

1314542

5/13/21

COVID19

PFIZER\BIONTECH

5/10/21

5/7/21

5/8/21

unknown

Past medical HX of TIA’s

Mitral valve prolapse, CHF, 44%EF,

unreviewed

UNK

Death

1314846

5/13/21

COVID19

MODERNA

5/13/21

5/6/21

5/7/21

Unknown

Lisinopril; metformin

none

HTN; DMII

none

5/07 general ill feeling; runny nose, watery eyes. continued until 5/10. Wife denied fever or cough. continued until 5/10. 5/11 at work, patient collapsed. Was awake but non-responsive, breathing on his own, vomited shortly before EMS arrived. EMS arrived, patient stopped breathing, was bagged until arrival at hospital where he was intubated. 5/12 Patient was extubated and died in early AM 5/13. Medical records state cerebral brain hemorrhage.

1317203

5/14/21

COVID19

MODERNA

4/16/21

4/14/21

4/15/21

AntibDepressants, yes dietary supplements

None

Started having lain in right home on 4/15/2021. On 4/16/2021 complained more about right hip, said feels like he got hit by a truck, and that he felt like he was starting to get a cold. Then he died the night of 4/16/2021.

1321517

5/16/21

COVID19

PFIZER\BIONTECH

5/1/21

4/30/21

5/1/21

He used to take Tylenol for headaches and melatonin ocassionally to sleep. Dont know if he had it the day of vaccine or the day he died.

He did not told me about any symptoms. He just died the next day of the vaccine. Still today doesn?t know why he died. He appeared to be in good health.

1321832

5/16/21

COVID19

MODERNA

4/30/21

5/2/21

Venlafaxine ER 150mg qAM, Venlafaxine ER 75mg QD, Divigel 0.75mg gel packet QD, Pantoprazole 20mg QD, Adderall 30mg BID PRN – OTC unknown

NKDA

Per her father on 5/2/21 she had kidney and liver failure and was admitted to the hospital. Was notified on 5/15/21 by her mother that she passed away. They are performing an autopsy to determine the cause.

1322176

5/16/21

COVID19

JANSSEN

5/14/21

5/13/21

5/14/21

none

unknown

severe nausea and vomiting for one week prior to vaccination (unknow to immunizer at time of vaccination)

unknown

NKDA

patient passed away ~24-48 hours after time of vaccination

1322310

5/16/21

COVID19

PFIZER\BIONTECH

4/1/21

4/7/21

Autopsy performed. Awaiting final report and toxicology report.

Not sure. Believe he died that evening. He did not make it to his 2 pm dental appt that he had been waiting awhile to get an appt. He never answered his cellphone nor made any phone calls on day of Covid injection, nor ever again.

Yes, hepatic steatosis. Smoker, high blood pressure.

High blood pressure – monitored with cuff.

Death. Coroner said collapsed of unknown cause. Autopsy performed. Awaiting final report and toxicology report.

1322484

5/17/21

COVID19

MODERNA

5/10/21

5/5/21

5/6/21

Still waiting on autopsy results.

About a week after his first dose he developed a skin reaction at the injection site. Redness, swelling, itching. The affected area was about 10 inches by 6 inches. The day following the second dose of the vaccine he developed chills, sweats, aches, and a low grade fever. He also developed the same skin reaction. He had these symptoms for 2 days (Thurs and fri). By Saturday his condition was improving. Sunday was even better, Monday evening he died. He was 37 with no known medical issues. He just died out of nowhere.

1323392

5/17/21

COVID19

PFIZER\BIONTECH

5/15/21

5/13/21

5/15/21

None

Labetalol 100 mg, Biktarvy 50/200/50mg, Amlodipine 5mg, Losart

Unknown

Hypertension, HIV, Chronic alcohol abuse

Unknown

None reported

1323719

5/17/21

COVID19

MODERNA

3/25/21

3/11/21

3/25/21

3/8/2021: Patient Visit to ED: Patient presents to ED with complaints of asthma exacerbation with shortness of breath. O2 saturations are initially 85% on room air but increased to 94% when at rest. States has been dealing with her asthma for about a week, using her nebulizer every 4 hours and her inhalers every 1-2 hours. 3/11/2021: Patient Visit to PCP – Regular Follow Up (Asthma, Edema, Hypertension, Pain)

Hypertension, Obesity, Asthma, Edema, Anxiety, Depression

Patient is a 41 y.o. female, reported history of asthma, obesity, polysubstance use, is transferred to the hospital via EMS in cardiac arrest. Per EMS report, the patient was found in an apartment complex by a neighbor unconscious. The initial report was that she was breathing however EMS was called back and then told that she was not breathing and not responsive. Estimated downtime was between 5 and 8 minutes before paramedics arrived and initiated CPR. Due to the patient’s body habitus, it did take approximately 15 minutes to get the patient transported to the hospital. 3 rounds of epinephrine were given in the field. Her rhythm has been asystole prior to getting to the emergency department. Intraosseous access is obtained. There is an OPA in place.

1327397

5/18/21

COVID19

MODERNA

5/4/21

4/1/21

None

Pacemaker/Thyroid issues

None

Pneumonia that put her in the Hospital. Followed by brain,lung,kidney. & Death after over a month in the Hospital.

1327755

5/18/21

COVID19

PFIZER\BIONTECH

5/17/21

3/21/21

4/23/21

Acetaminophen, Atorvastatin, Carvedilol, Docusate Sodium, Ergocalciferol, Hydralazine, Insulin Lispro, Lantus Solostar U-100 Insulin, levothyroxine, magnesium chloride, mycophenolate, Nifedipine, Norethindrone, Prednisone, Zoloft, Sodium Bi

Kidney transplant December 4th, 2020

Iron deficiency, benign essential hypertension, type 2 diabetes, severe obesity, focal segmental glomerulosclerosis, diabetic nephropathy, hypothyroidism, secondary hyperparathyroidism of renal origin, ESRD on peritoneal dialysis, obstructive sleep apnea syndrome, mixed hyperlipidemia, metabolic acidosis, end stage renal disease

Nsaids, penicillin, lactose

Hospitalized for COVID-19 pneumonia on 4/23, ICU on 5/3, passed on 5/17 of 2021

1328720

5/18/21

COVID19

JANSSEN

5/18/21

4/1/21

5/18/21

Patient was admitted to the hospital on 04/15/2021. He was in the ICU and on a ventilator for majority of the time.

1328722

5/18/21

COVID19

PFIZER\BIONTECH

2/7/21

12/20/20

2/7/21

UNK

Was told she died in her sleep. This is one of 3 nurses in the medical center that passed away suddenly. Vaccine roll out was December 2020, unknown exact date or type

1328751

5/18/21

COVID19

PFIZER\BIONTECH

3/20/21

12/20/20

3/20/21

UNK

He is a co worker and he passed away in his sleep I heard. One of 3 nurses that died in the medical center since the vaccine roll out

1329078

5/19/21

COVID19

JANSSEN

OPSUMIT; WARFARIN

Primary pulmonary hypertension

Comments: Unknown

UNK

REACTION TO COVID VACCINE; This spontaneous report received from a patient concerned a 45 year old female of unspecified race and ethnicity. The patient’s weight was 88.2 kilograms, and height was not reported. The patient’s concurrent conditions included primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. The patient received epoprostenol sodium (form of admin unknown, intravenous, batch number: MM248M0101 expiry: 30-JUN-2022) 1.5 mg, frequency, and therapy dates were not reported for drug used for unknown indication. Concomitant medications included macitentan and warfarin for drug used for unknown indication. On an unspecified date, the patient experienced reaction to covid vaccine, and was hospitalized on 07-MAY-2021. On an unspecified date, the patient died from reaction to covid vaccine. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of epoprostenol sodium was not changed. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender’s Comments: V0. 20210521894-COVID-19 VACCINE AD26.COV2.S-REACTION TO COVID VACCINE. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: REACTION TO COVID VACCINE

1330411

5/19/21

COVID19

PFIZER\BIONTECH

5/15/21

5/10/21

5/11/21

hypo- and hypercoagulopathic state due to worsening liver disease

AKI, worsening liver disease

ETOH cirrhosis; previously diagnosed acute hepatitis

Within 12-24 hours, patient noted to have altered mental status – transferred to ICU where it was later discovered that patient had an intracranial hemorrhage

1330552

5/19/21

COVID19

PFIZER\BIONTECH

2/21/21

1/11/21

1/29/21

Labs done from01/29-02/19

Insulin

Diabetes

UNK

Blood clot in brain causing stroke then death

1332849

5/20/21

COVID19

PFIZER\BIONTECH

5/9/21

3/20/21

4/24/21

Test Date: 20210424; Test Name: covid-19; Test Result: Positive

Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None

passed away from COVID (positive test on 24Apr2021); passed away from COVID (positive test on 24Apr2021); This is a spontaneous report from a contactable physician. A 37-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 37-years-old, via an unspecified route of administration on 20Mar2021 (Lot Number: EP7534, also reported as EPT534) as single dose for covid-19 immunisation. Medical history was none. The patient’s concomitant medications were not reported. Patient received first dose of bnt162b2 at the age of 37-years-old on 27Feb2021 (Lot Number: EN6205) for covid-19 immunisation. Patient with no comorbidities passed away from COVID (positive test on 24Apr2021) in the ICU on 09May2021. Autopsy is still pending. Patient’s family members provided vaccination card and she would like to verify if the lot numbers are from Pfizer Covid-19 vaccine. Added that it is freighting as the patient developed fatal Covid a month after being fully vaccinated. Additionally, she would like to verify if it is possible to know where the vaccines were shipped or any other distribution or facility information she could get from these lots. Stated that the vaccination card has something written on a box from the right hand side. Reporter seriousness for Tested Positive for Covid was Hospitalization, Death. Cause of death: Autopsy Pending, they assume Covid. Autopsy performed, Autopsy details not available. Events outcome was fatal. The patient died on 09May2021.; Sender’s Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded in a context of LOE. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ; Reported Cause(s) of Death: passed away from COVID (positive test on 24Apr2021)

1334174

5/20/21

COVID19

MODERNA

5/13/21

4/30/21

5/13/21

None reported on prescreen.

Health department received notification that patient expired unexpectedly while operating a vehicle. No known link to vaccination at this time, but reported as it occurred on day 13 post-vaccination.

1334527

5/20/21

COVID19

PFIZER\BIONTECH

5/15/21

5/4/21

5/10/21

Yes, blood work, ECHO, CAT, and Covid test that was negative, potassium was low, HR was elevated to 200bpm Blood work showed infection.

may be high blood pressure

Seasonal allergies only

My brother got the Pfizer 5/4 and started getting sick with a cough on the 7th and by the 10th he was getting more and more sick and ye was taken to the ER on the 14th and he started coughing up blood, he was out of it and pale and not able to move much. On 5/15 in the hospital he was having a hard time breathing and they were trying to give him meds to make him better, they gave him antibiotics because his blood work showed infection, and Precedex to help him rest, and he passed away the same day, he was in good health before. They also said his heart rate was 201/123 and the doctors said pulmonary anema. It escalated so quickly.

1336767

5/21/21

COVID19

MODERNA

4/3/21

4/30/21

Cetirizine

None

Patient presented 5/16/2021 with 1 week dizziness, fever and sore throat, found to have acute myopericarditis c/b cardiogenic shock and bradycardic arrest.

1337198

5/21/21

COVID19

PFIZER\BIONTECH

5/11/21

4/1/21

5/7/21

Tamsulosin, hydrocodone-APAP, ibuprofen , ondansetron .

Left sided renal stone and mild hydronephrosis week prior to admission for ITP. (went to ED on 4/30). No other PMH prior to this.

None.

NKA

UNK

Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechiae, blood in stool and urine, and platelets . Prior to this, patient presented to the ED on 4/30 with kidney stone, no other significant PMH and prescribed medications mentioned on prior page. Suspected ITP, patient received IVIG x 3 days and prednisone x 4 days while admitted. On morning of 5/11, patient had AMS, became unresponsive and was evaluated for stroke. Patient had large intra-axial hemorrhage with significant midline shift, transferred to the Hospital and died the same day.

1337439

5/21/21

COVID19

PFIZER\BIONTECH

5/20/21

4/28/21

5/11/21

NONE

NONE PER DAD

NONE

UNK

ACCORDING TO DAD, HE GOT THE VACCINE ON 4/28/21. ON MAY 11 HE WAS COMPLAINING OF N/V, LATER HEADACHE AND ALTERED VISION, ENCEPHALOPATHY, CARDIAC ARREST AND DEATH…. AFTER MULTIPLE LOCAL ER VISITS. HE NEVER HAD FEVER. I WAS CALLED ON HIS CASE DUE TO CONCERN FOR CNS INFECTION. HE WAS ADMITTED ON 5/18 AND DIED ON 5/20 THIS MAY OR MAY NOT BE RELATED TO THE COVID VACCINE, BUT IT IS IMPORTANT IT IS REPORTED JUST INCASE IT IS AND MAY HELP SOMEONE.

1337723

5/21/21

COVID19

PFIZER\BIONTECH

5/18/21

5/13/21

5/18/21

UNKNOWN

05/13-DISCUSSED WITH PHARMACIST A TOPICAL ALLERGIC REACTION HE HAD BEEN HAVING FROM A NEW BODY SOAP. PHARMACIST RECOMMENDED TOPICAL HYDROCORTISONE CREAM AND ORAL BENADRYL TO HELP MANAGE SYMPTOMS.

UNKNOWN

PATIENT WAS IMMUNIZED 5/13. PATIENT WAS FOUND DECEASED IN THEIR APARTMENT ON 5/18. FAMILY LAST SAW HIM ON 5/16 WHEN THEY DROPPED HIM OFF AT HIS APARTMENT. MEDICAL EXAMINER HAS NOT YET DETERMINED CAUSE OF DEATH OR EXACT DATE OF DEATH.

1337951

5/21/21

COVID19

MODERNA

5/13/21

5/12/21

5/13/21

Hydromorphone 2 mg 1 tablet q 4 hours as needed ASA 81 mg daily Calcium Acetate 667mg ( 2 capsules TID ) Coreg tablets 25 mg ( 1 tab BID ) Entresto tablets 49-51 mg ( 1 tab BID ) Folic acid tablet 1 mg ( 1 tab OD ) B Complex tablet ( t

UNKNOWN

CHF Essential HTN NON Ischemic cardiomyopathy Cardiac LV EJECTION FRACTION 21-40% COVID-19 Virus infection ( march 2020

NKDA

patient expired 1 day after receiving 2nd dose of Moderna vaccine

1338394

5/21/21

COVID19

PFIZER\BIONTECH

5/10/21

4/7/21

5/7/21

Death N17.9 – Acute kidney failure, unspecified FATIGUE CHEST PAIN NAUSEA

1338394

5/21/21

COVID19

PFIZER\BIONTECH

5/10/21

4/7/21

5/7/21

Death N17.9 – Acute kidney failure, unspecified FATIGUE CHEST PAIN NAUSEA

1338625

5/21/21

COVID19

MODERNA

5/21/21

5/20/21

5/21/21

Office of Medical Investigator will perform

Acetaminophen

none known

Had positive COVID test Nov 28, 2020 at Hospital. Was followed with daily phone calls from Health Nursing throughout isolation period. Cough, fever, body aches for first several days. Released from isolation Dec 11. Suffered assault Feb 11 with blunt trauma to head and face. Seen in ER 2/14 with facial bruising and swelling. Head CT showed no intracranial injury. Required operative drainage of forehead hematoma 2/23

none known

Outcome: unexpected/unexplained death Had first dose Moderna Vaccine 3/31/21. She described body aches and mild fever ? ?like I had COVID again for a day? ? lasting about 36 hours, and then felt fine. Had dose # 2 Moderna vaccine about 6:50 PM at Community vaccination site. She was driver, received left deltoid injection from Doctor. During observation period reported no symptoms, was happy and talkative with family and staff. Family reports later that evening she did not feel well ? ?just not hungry? and wanting to lie down. Slept well, then woke up feeling better except for left arm achiness at injection site. Did not report redness, rash, or any difficulty breathing. Was talkative, walking around, took a shower, and was planning to drive to the grocery store later that day. Mid morning ? maybe beginning about 11 AM, family said she went in and out of bathroom several times. She told them she had vomited three times and was feeling shaky. Her oral temperature was 101.3. About 1:30 PM, she was in her room and called out for her mother. When family went into the room, she was shaking ?like she was having a seizure? and then her eyes rolled back and she fell to her side and stopped breathing. Family called 911 and started CPR. CPR was continued by EMT?s once they arrived, but they were not able to resuscitate her.

1343571

5/24/21

COVID19

JANSSEN

4/28/21

4/7/21

4/28/21

Diabetes Type II, obesity, Hypertension, Lipidemia,

Patient received their J&J vaccination on 4/7/2021. The patient’s wife tested positive on 4/12/2021. The patient tested positive on 4/23/2021. The patient presented to the ER with a severe progressive cough (starting one week prior), worsening shortness of breath, a high fever, chills, myalgias, and malaise. The patient was diagnosed with COVID pneumonia and ARDS with hypoxia and given Lovenox, remdesivir, and dexamethasone, tessalon, and Brovana. The patient was admitted on the 23rd and continued to decline until their eventual passing on 4/28/2021.

1343614

5/24/21

COVID19

JANSSEN

5/24/21

5/18/21

5/20/21

xarelto, methadone, morphine, prochlorperazine, lorazepam, ondansetron, protonix

fibrolamellar hepatic carcinoma with metastatic disease

NKDA

UNK

presented to ED dept confused, incr n/v, weakness. Received palliative carex4 days. deceased 05/24

1346657

5/25/21

COVID19

MODERNA

2/19/21

2/18/21

2/19/21

Autopsy with histology, toxicology, postmortem Covid-19 PCR test negative, post mortem Tryptase normal and elevated elevated IgE, cause and manner of death undetermined, Covid-19 not suspected cause, suspected cause heart arrhythmia (family history, history of chest pain, and medications) or seizure.

Clonidine, Vyvanse, Vraylor

none

Autism and ADHD

Found deceased in bed, no known symptoms, undetermined cause and manner of death

1347105

5/25/21

COVID19

MODERNA

5/1/21

4/20/21

5/1/21

Lamictal, zestoretic

Had seizure 3.5 years prior, had “night time seizure in mid march.

elevated BP, seizures

Found dead on May 3, 2021. Question day of death 05/01/2021. Medical examiners case. Cause pending, possible SUDEP.

1347160

5/25/21

COVID19

MODERNA

5/24/21

2/2/21

5/19/21

106

CT Imaging shows a very large right MCA stroke with small areas of hemorrhage. He does have 6 mm of shift and small petechiae. CT angiogram shows clot at the bifurcation with complete opacification. He is Covid positive, and chest x-ray shows significant Covid pneumonia. He has a history of CHF, and his BNP is 25,000, up from his baseline of 7000. His troponin is also positive at 0.18. I assume that this is from a type II NSTEMI.

Carvedidol 3.125 bid; lisinopril 5 mg; furosemide 20 mg daily; spironolactone 12.5 mg daily

DM – diet controlled; systolic heart failure; Rheumatoid arthritis; meth and alcohol abuse

cephalexin

fall on May 19 and admitted to ER May 22 with subacute R MCA stroke resulting in obtundation and left sided hemiparalysis. Complicating his presentation is acute COVID 19 infection with pneumonia along with acute on chronic systolic congestive heart failure.

1347547

5/25/21

COVID19

PFIZER\BIONTECH

4/21/21

4/15/21

4/16/21

unknown

Beta Thalassemia

? Bean ? Peanuts ? Shrimp ? Soy ? Sweet Potato ? Tree Nuts ? Kiwi ? Mango ? Penicillins

The injury that led to the death occurred within 1 day of the decedent receiving the vaccine

1347808

5/25/21

COVID19

MODERNA

5/3/21

4/20/21

4/28/21

see above

Moderna 044B21A given

none

Migraine Head aches Depression

started with c/o “feels weird in my chest like a pulled muscle”, few days later slight short of breath with fatigue, May 2 11:45 cardiac arrest when paramedics placed O2, rounds of CPR and med’s, pronounced dead at hospital after attempts of CPR. Out come on death certificate Bilateral Pulmonary Thromboemboli. Coroner stated there were multiple PE’s in bilateral lungs. Positive for Covid 19 (Had in Feb, vaccine in April 20)

1349104

5/26/21

COVID19

MODERNA

UNK

Died; irregular heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died) and HEART RATE IRREGULAR (irregular heartbeat) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Died) (seriousness criteria death and medically significant) and HEART RATE IRREGULAR (irregular heartbeat) (seriousness criterion medically significant). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HEART RATE IRREGULAR (irregular heartbeat) outcome was unknown. Concomitant medication and treatment information were not reported. Action taken with mRNA-1273 in response to the event was Not Applicable. Company comment:Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not reported.; Sender’s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not reported.; Reported Cause(s) of Death: Died

1349127

5/26/21

COVID19

MODERNA

4/4/21

3/19/21

4/4/21

CLONAZEPAM; TRILEPTAL; GABAPENTIN

Movement disorder; Seizures (since she was a baby at 11 months old); Speech loss; Traumatic brain injury

found dead; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (found dead) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032m20a) for COVID-19 vaccination. Concurrent medical conditions included Traumatic brain injury, Movement disorder, Seizures (since she was a baby at 11 months old) and Speech loss. Concomitant products included CLONAZEPAM, OXCARBAZEPINE (TRILEPTAL) and GABAPENTIN for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 04-Apr-2021 The patient died on 04-Apr-2021. The cause of death was not reported. An autopsy was not performed. Reporter stated that death certificate said the cause of death was natural causes. She did have her yearly physical exam after her first dose with her physician prior to her death and no other health issues were noted at the time of the exam. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender’s Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Natural causes

1350670

5/26/21

COVID19

PFIZER\BIONTECH

3/24/21

2/25/21

Ametriptolin, eliquis, seizure medicine

Kidney disease

Penicillin, msg

After first dose her mental status become slightly altered and she leaned to the left a bit when standing up and walking.. From the day of second dose my sisters appetite decreased. She started sleeping more, got weaker to the point I had to bathe her, she had to start using a wheelchair. Mental status much more altered. She was to weak to go to dialysis on Monday March 22 2021 hospice was called in Tuesday March 23 2021 and she passed away at approximately 4:00 P.M. March 24th 2021.

1351172

5/26/21

COVID19

UNKNOWN MANUFACTURER

2/18/21

1/1/21

2/18/21

Renal Mass (malignancy status unknown at time of writing this)

Diabetes Mellitus II (non-insulin dependent)

Death on 2/18/21. Pulmonary embolism found on autopsy.

1354898

5/27/21

COVID19

PFIZER\BIONTECH

5/7/21

4/30/21

5/1/21

None

My brother had his second vaccine shot on 4/30. When I talked to him on 5/5 he told me he’d had a lot of joint pain and fatigue but thought he would go into work the next day. Thursday he left work feeling sick with a lot of ‘rib pain’. At some point that night he passed away. We still do not have an autopsy report, but the timing seems odd.

1355039

5/27/21

COVID19

PFIZER\BIONTECH

5/25/21

5/22/21

5/23/21

UNK

Cardiac Arrest

1356045

5/27/21

COVID19

PFIZER\BIONTECH

5/3/21

5/1/21

5/3/21

Unknown

Hypertension

Unknown

Death. Patient died on 5/3/2021; two days after receiving vaccine.

1357362

5/28/21

COVID19

PFIZER\BIONTECH

5/20/21

UNK

Patient went to sleep and died within 12 hours of vaccination; feeling sick; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 45-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at the age of 45-year-old on 20May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient’s medical history and concomitant medications were not reported. It was reported that 45-year-old healthy male patient received Pfizer Covid vaccine in the morning, reported feeling sick by the evening on 20May2021. Patient went to sleep and died within 12 hours of vaccination on 20May2021. Event took place after use of product. The patient died on 20May2021. It was not reported if an autopsy was performed. The outcome of event feeling sick was unknown. The outcome of event ‘Patient went to sleep and died within 12 hours of vaccination’ was fatal. Information on lot number/batch number has been requested.; Reported Cause(s) of Death: Patient went to sleep and died within 12 hours of vaccination

1357369

5/28/21

COVID19

PFIZER\BIONTECH

3/15/21

3/11/21

3/15/21

Wolff-Parkinson-White syndrome

Passed away from a Pulmonary Embolism; This is a spontaneous report from a contactable consumer. A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 39 years old, on 11Mar2021 (Lot Number: EN6208) as single dose for covid-19 immunisation. Medical history included wolff-parkinson-white syndrome from an unknown date to 15Mar2021. The patient was diagnosed with this later in life, but was told he probably had it his entire life it just hadn’t caused any issues for him. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient’s concomitant medications were not reported. The patient previously got the flu vaccine for immunization every year with no issues. The patient passed away from a pulmonary embolism on 15Mar2021. The patient was not hospitalized prior to his death. He died from the pulmonary embolism in his sleep. The reporter denied any medications, labs, testing, or treatments for her husband relevant to these events. The patient died on 15Mar2021. There was a private autopsy performed and they said that the Pfizer Covid Vaccine was one of the contributing factors to the patient’s death. The autopsy said the vaccine was a contributing factor. The reporter stated she told them since they said it was the pulmonary embolism that killed him, then that’s what it should say. The Medical Examiner was saying that the science for the vaccine is so new, they just don’t have the data that they need.; Reported Cause(s) of Death: Pulmonary embolism

1357679

5/28/21

COVID19

MODERNA

5/15/21

5/12/21

5/15/21

nml bmp/cbc

apixaban metoprolol

none

paroxysmal a-fib

pcn

UNK

3 days after 2nd dose of moderna patient presented to our er in cardiac arrest; lacking extensive cardiac history other than a-fib; he had reported anginal like symptoms to his wofe during the day and then collapsed in v-fub and was unrecusitatble; no autopsy or further information; unclear if vaccine is contributory but within 3 days i agreed with patient’s wife in that the temporal relation should be reported

1358491

5/28/21

COVID19

PFIZER\BIONTECH

5/24/21

5/23/21

5/24/21

ibuprofen PRN foot pain

fracture of 5th metatarsal noted ~10 days prior – patient was utilizing crutches at that encounter

history of previous clots (unclear when these were but not in our electronic health record or nearby facilities as far back as 2015) – he was not on medication for them at time of event

nkda

UNK

patient called 911 with shortness of breath and chest pain. When squad arrived, he was still oriented and awake and told squad he had Pfizer vaccine the previous day. Thought was a pulmonary embolism had occurred. Then he lost consciousness and pulses. EMS started CPR. Despite aggressive ACLS maneuvers, the patient ultimately died.

1360114

5/29/21

COVID19

MODERNA

4/17/21

4/11/21

4/13/21

None

UNK

Soarness, low blood pressure and then death.

1362539

5/31/21

COVID19

MODERNA

5/31/21

5/13/21

5/28/21

May 28 – Platelet 100, Hgb 10.5 CT of Chest : no PE, bilateral infiltrates and mediastinal lymphadenopathy Fibrinogen 34 D Dimer greater than 5000 CT of abdomen : retroperitoneal LN

none

UNK

Pt presented to the hospital with abdominal pain and shortness of breath May 28, 2021 Noted to be thrombocytopenic – had normal platelet 20 days prior Had bruising, melena

1362566

5/31/21

COVID19

JANSSEN

5/27/21

5/26/21

5/27/21

unknown

mostly unknown, but partner said patient was unresponsive the next morning the day after receiving her Covid vaccine

1364631

6/1/21

COVID19

PFIZER\BIONTECH

5/9/21

5/1/21

See above.

Seroquel, Zosyn, Quetiapine, Escitalopram, OTC heartburn meds.

None.

Had hemorrhagic stroke in 2014.

None.

This is reported by his mother. Around 10:00 AM he got his vaccine. Mother met him at 12:30 and went to lunch, said he felt OK. She stayed with him a couple of hours, went home and apparently he went to sleep. The next day he texted his mother and said that he felt yucky. She told him to give it a couple of days, and he went to work all week, but said that after he ate he felt “funny”. Then on Sunday, Mother’s day on 5/9/21 and they face timed and was supposed to meet him at 5:30. At 12:45 he had finished eating, ate some enchilladas and said that he felt weird. He said that he was going to be ok to meet him at 5:30. At 4:37 PM she texted him to say that she was on her way to meet him. She got at the meeting place at 5:30 and he was usually there before her, this is a normal weekend ritual to exchange his dog. She waited 9 minutes and she tried to facetime him thinking he was in traffic, and he didn’t answer. She thought he was just not answering. She then waited 9 more minutes and then called his phone and local Hospital answered the phone and asked who she was, and she answered the questions, and she told her to get to the hospital. She went to the hospital and the doctor came in and told her that he had the car running and he went to the gas pump to get gas and he stepped out of the car and collapsed. The person who saw him told the attended that he had collapsed and they called 9-1-1 and he was pronounced dead. He worked in a warehouse and was doing well and about to be certified to be a forklift driving. They said that they worked on him and that they could not get his heart started again. They had to do an autopsy which is against her religion and she will not find out those results for 3-6 months. She said that he was healthy and looking forward to get tested at work. They told her that he had an enlarged heart and an enlarged spleen, and had never had any heart issues in the past. He walked 20,000 steps a day in the warehouse. He was living in a sober man’s facility, he has been clean for 18 months. He had an addiction to pain pills and Xanax. She feels that there was something in the vaccine that had something to do with it as he was perfectly healthy before the vaccine.

1364855

6/1/21

COVID19

JANSSEN

5/25/21

4/29/21

4/30/21

Vertigo test

None

High blood pressure

High blood pressure, high cholesterol, CAD

None

Dizziness, blurred vision, headache, nausea

1365007

6/1/21

COVID19

MODERNA

1/25/21

1/18/21

1/23/21

unknown

unk

weakened immune system

I do not know the individuals medical hx or illness/complications. Due to new information circulating related to mRNA vaccines and myocarditis/pericarditis and being made aware that this person had suffered cardiac arrest after being admit to the hospital following complications with their health it warrants being reported regardless of prior health conditions.

1365075

6/1/21

COVID19

PFIZER\BIONTECH

3/19/21

3/10/21

3/12/21

CT scan of shunt at ER visit lab tests at ER visit

Kepra-for seizures

none

Cerebral Palsy legally blind Epileptic Seizures deteriorating bones in hips Hydrocephalus Shunt in head

none

Patients father said his son began throwing up 2 days after injection. They took him to the ER and patient was given some medication to stop emesis. Two days later patient was still throwing up and the ER told him to give the medication a couple more days to work. The father said the throwing up was not constant and patient was able to eat and keep it down. The emesis was reported as dark brown mucous with no food particles in it. Patient was reported to throw up everyday until his death on day 9.

1365222

6/1/21

COVID19

PFIZER\BIONTECH

5/15/21

5/1/21

5/15/21

Edarbi

Obesity, high blood pressure

Received the shot 5/6 and very unexpectedly died 5/15, autopsy was not performed because foul play was not suspected and family could not pay to have it done

1365485

6/1/21

COVID19

MODERNA

5/28/21

5/26/21

5/27/21

Coroner’s autopsy

None

On 05/27/2021 the decedent began complaining of shortness of breath, cough, fever, chills, and pain at the injection site. On 05/28/2021 the decedent complained of the same symptoms.

1365485

6/1/21

COVID19

MODERNA

5/28/21

5/26/21

5/27/21

Coroner’s autopsy

None

On 05/27/2021 the decedent began complaining of shortness of breath, cough, fever, chills, and pain at the injection site. On 05/28/2021 the decedent complained of the same symptoms.

1365932

6/1/21

COVID19

MODERNA

4/27/21

4/13/21

4/27/21

Carvedilol 12.5 Mg Tab; Lisinopril 5 Mg tablet; K-Tab Cr 10 Tab; Furosemide 40 Mg Tab; Fluocinonide 0.05% Ointment; Sarna 0.5-0.5 % Lot Glax;

Heart murmur Congestive heart failure Hypertension Obesity

Patient passed away on April 27, 2021, which was two weeks after receiving second dose of Moderna Covid-19 vaccine.

1366320

6/1/21

COVID19

PFIZER\BIONTECH

5/6/21

3/10/21

3/11/21

None

He died

1366333

6/1/21

COVID19

JANSSEN

5/4/21

4/21/21

5/4/21

Call the Coroners office

None

Death

1368271

6/2/21

COVID19

MODERNA

4/15/21

3/30/21

4/2/21

MRI, LP, intubation, medically induced coma, shunt, craniotomy

Hx of positive Covid 19 test and illness in November 2020 with full recovery

On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin’s daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months.

1368779

6/2/21

COVID19

MODERNA

6/1/21

5/17/21

Los Angeles County Coroner’s case 2021-06655

None

Asthma

None

After receiving second dose of vaccine, complained of stomach pain and feeling “bloated.” Later had muscle pain, insomnia, and nausea. Found dead at home on 6/1.

1368779

6/2/21

COVID19

MODERNA

6/1/21

5/17/21

Los Angeles County Coroner’s case 2021-06655

None

Asthma

None

After receiving second dose of vaccine, complained of stomach pain and feeling “bloated.” Later had muscle pain, insomnia, and nausea. Found dead at home on 6/1.

1369287

6/2/21

COVID19

MODERNA

4/3/21

3/31/21

4/3/21

Autopsy showed no anatomic cause of death; toxicology non-contributory. Suspect possible undiagnosed underlying genetic arrhythmia syndrome. Parents suspect a vaccine-related death.

None.

None known.

Sudden cardiac death. After vaccine patient experienced headache, chills, fatigue, chest pain and did not seek medical care. He had a witnessed cardiac arrest less than 3 days after vaccine #2.

1371338

6/3/21

COVID19

PFIZER\BIONTECH

6/3/21

4/9/21

5/31/21

Autopsy pending

Prenatal vitamins

asymptomatic Factor V Leiden, anxiety, insomnia

No drug allergies

32 year old female received vaccines while pregnant with her 3rd child. Pt has asymptomatic Factor V Leiden. She delivered on 5/27/2021 and passed away on 5/31/2021.

1371338

6/3/21

COVID19

PFIZER\BIONTECH

6/3/21

4/9/21

5/31/21

Autopsy pending

Prenatal vitamins

asymptomatic Factor V Leiden, anxiety, insomnia

No drug allergies

32 year old female received vaccines while pregnant with her 3rd child. Pt has asymptomatic Factor V Leiden. She delivered on 5/27/2021 and passed away on 5/31/2021.

1372096

6/3/21

COVID19

PFIZER\BIONTECH

4/29/21

In progress – have not received final pathology notes/results

melatonin, clobazam (10mg), gabapentin (800mg), omeprazole (40mg), levetiracetam (1000mg), divalproex (500mg), hydroxyzine (25mg) , fluticasone nasal spray (60mg), emtricitabine (200-300mg), lidocaine 5%

none known

Epilepsy and Neurofibroma

none known

Patient died abruptly 2-3 hours after receiving shot.

1372112

6/3/21

COVID19

MODERNA

4/23/21

4/5/21

4/23/21

Autopsy revealed massive pontine hemorrhage

lisinopril, protonix, bystolic

HTN, GERD

obesity

none

Pt died of massive pontine hemorrhage and then cardiac arrest two weeks after vaccination.

1372120

6/3/21

COVID19

JANSSEN

6/1/21

5/1/21

6/1/21

unknown

None

hx anemia

Unknown

Pt called 911 for shortness of breath The following is the paramedic narrative patient found at home, sitting on floor. alert, speaking. Patient with sob, saying she can not breath , states it came on suddenly about a half hour ago and pt has not been feeling ill prior to this. No trauma, no pains or other complaints. pt went unconscious then into pea cardiac arrest, witnessed. Laid pt down and check for heart beat and breathing, became pulseless and apneic Initial treatment CPR, IV, BVM. Family states no medical history other than anemia. no drug use, no respiratory or cardiac issues. Pt was given J and J covid 19 vaccine recently. Pt also just returned from a trip and noted to not have gone diving. 2 epinephrine IV given on scene with no change to heart rhythm. Pt loaded into the ambulance and cpr continued while transporting. pt with copious amounts of vomit, suction enroute to ed. Pt w/o shockable rhythm throughout transport. Continue cpr and bvm via king airway , cap at 9. unable to get capnography higher. no change in heart rhythm. while enroute to er. At ED pt did get pulses back however it was reported that pt loss pulses and was pronounced

1372338

6/3/21

COVID19

PFIZER\BIONTECH

5/22/21

5/21/21

Asthma

Asthma Anxiety/Depression/Panic

Death

1374169

6/4/21

COVID19

PFIZER\BIONTECH

3/8/21

3/4/21

3/6/21

3/06/21 to 3/10/21

None

became unresponsive, intubated in the field with CT images revealing a diffuse SAH, IVH, cerebral edema, brain compression, possible aspiration pneumonia o Admit to NICU s/o Doctor o Consult Doctor for CC o Neuro checks q1h o SBP < 110 o Mannitol 50g IV x1 stat than 3% HTS for NA goal 145-155 o EVD placement ASAP o Amicar 5g stat o COVID PCR negative o Labs/ medications as ordered o SAH protocol o Plan for cerebral angiogram and possible coiling in am with Doctor.

1374720

6/4/21

COVID19

JANSSEN

6/1/21

4/8/21

6/1/21

Coroner’s report states cause of death as: Pulmonary thromboembolism, bilateral, massive

none

phenothiazines

Pt. was in his dorm, stood up and stated he could breathe, then went unresponsive. A medical response was called and staff arrived to the dorm within 2 minutes. Pt. took a couple of agonal breaths and stopped breathing, no pulse was found and CPR was initiated. Staff and EMTs administered 45 minutes of CPR, narcan and cardiac medications. He was pronounced dead by EMT at 10:45 am.

1375603

6/4/21

COVID19

MODERNA

6/1/21

5/24/21

5/26/21

Patient had a significant number of medical and lab tests to list.

Seen at ED on 6/25/2020 for Essential hypertension, Benign Paroxysmal positional vertigo. No follow up found in record.

No known allergies

Received vaccine at on 5/24/2021. Patient is a 40 y/o male with no significant PMH who initially presented to the hospital after being found down at a restaurant. Was found to have ST segment changes on EKG, somnolent, and hypotensive requiring pressors. Taken to the cath lab where he had equalization of diastolic pressures and subsequently received pericardiocentesis due to concern for tamponade from pericardial effusion. 350 ccs of fluid was drained and his hemodynamics immediately improved and he came off vasopressors. Pericardial drain was placed. Over the next several days he had ongoing workup for the etiology of his pericardial effusion. His pericardial drain output dropped off, was clamped 5/31 and repeat echocardiogram 6/1 did not show significant effusion. Unfortunately, patient went into PEA arrest in the afternoon and was coded for ~40 minutes without return of ROSC. Unclear etiology at this time, no evidence of significant effusion on echocardiogram

1376795

6/6/21

COVID19

MODERNA

6/4/21

5/14/21

6/3/21

An autopsy is being preformed

None

On June 3 he developed a sore throat. His voice sounded like he had a frog in it. Early on June 4 he had to urinate about 10 – 15 times overnight in about a 6 hour timeframe. Later on Friday he left home and a short time later called 911 saying he couldn?t breath. When the paramedics arrived they couldn?t revive him and he died.

1377302

6/7/21

COVID19

JANSSEN

5/11/21

5/8/21

5/11/21

CLONAZEPAM, OXYCODONE, MIDODRINE, MORPHINE

BACTRIM, CODEINE, CYMBALTA, LYRICA, REGLAN, VANCOMYCIN

PATIENT WAS FOUND DECEASED 3 DAYS AFTER THE SHOT WAS GIVEN.

1378118

6/7/21

COVID19

PFIZER\BIONTECH

6/5/21

6/2/21

6/5/21

metoprolol, topiramate, meloxicam, acetaminophen codeine, clonazepam

unknown

anxiety, hip issues, Type I diabetes – maybe

unknown

Decedent passed 06/05/2021 at 1042 hours. Exam showed bilateral pulmonary emboli.

1380716

6/8/21

COVID19

UNKNOWN MANUFACTURER

5/16/21

4/21/21

5/1/21

Muscular dystrophy

Medical History/Concurrent Conditions: Flu

Missed second dose; Heart attack; heart was racing; stomach bothering him; 101.4 degrees fever; chills; some headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 22-year-old male patient who received mRNA-1273 (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient’s past medical history included Flu in February 2020. Concurrent medical conditions included Muscular dystrophy. On 21-Apr-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 01-May-2021, the patient experienced TACHYCARDIA (heart was racing), ABDOMINAL DISCOMFORT (stomach bothering him), PYREXIA (101.4 degrees fever), CHILLS (chills) and HEADACHE (some headaches). On 16-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. The patient died on 16-May-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, PRODUCT DOSE OMISSION ISSUE (Missed second dose), TACHYCARDIA (heart was racing), ABDOMINAL DISCOMFORT (stomach bothering him), PYREXIA (101.4 degrees fever), CHILLS (chills) and HEADACHE (some headaches) outcome was unknown. No Concomitant product use was provided This is a case of product dose omission issue. Very limited information regarding this patient’s death has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Significant follow up received :- Patient died, Reporter email and phone number added, patient’s medical history added,events updated; Sender’s Comments: This is a case of product dose omission issue. Very limited information regarding this patient’s death has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Heart Attack

1381355

6/8/21

COVID19

JANSSEN

Comments: Patient was healthy.

UNK

DEATH; This spontaneous report received from a consumer concerned a 39 year old male. The patient’s height, and weight were not reported. No past medical history or concurrent conditions were reported. Patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Reporter stated that the patient took the vaccine and then died 3 days later (date unspecified). Reporter did not have any further information to provide. On an unspecified date, the patient died from unknown cause of death. It was unknown whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender’s Comments: V0: 20210611846-COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

1381705

6/8/21

COVID19

PFIZER\BIONTECH

5/18/21

5/1/21

5/18/21

Medical examiner. Also had autopsy.

First shot Lot# ER 8732 administered 04/03/2021 Death

1382906

6/8/21

COVID19

PFIZER\BIONTECH

6/7/21

5/15/21

6/7/21

None known

none noted

Acne, no other conditions noted

None noted

Unexplained death within 48 hours

1383413

6/8/21

COVID19

PFIZER\BIONTECH

4/8/21

3/29/21

4/8/21

antihistamine

Sudden death in sleep

1384860

6/9/21

COVID19

PFIZER\BIONTECH

6/8/21

5/8/21

6/8/21

06/08/21: SARS2 PCR and resp path pcr neg BCx x2 prelim grp A strep Tpn 1.9, BNP 30,000 WBC 9/hct 35/plt 18 Na 129/K6.2 (subsequently lower)., BUN 53/Cr 5.1 Phos 23.7 (not a typo), iCa 1.06, Mg wnl Glucose “LO” in field peri-arrest, 74 after glucose 74gm lactate 27, SCvO2 40-50 on epi/dobut/vaso ABG 6.87/57/167/10 on FiO2 100%+8 CTHead noncon (done >90mins after arrest onset) sulcal effacement, no ICH/SAH. CTA chest L base consolidation, no PE, no pericardial effusion CT A/P no significant abnl. No sig ascites, abscess, pancreatic stranding; no tampon/foreign body (except IUD) Echo EF 20%, global LV HK, no RV strain ECGs intermittent diffuse ST elevation, transient.

None.

Alcohol dependence (not long term). Otherwise none.

None.

Bee stings – anaphylaxis. No medication/food allergies.

UNK

Pt rec’d 2 doses Pfizer/BioNTech, 2nd dose May 9,2021 at outside facility. Presented to hospital on 06/08/21 after cardiac arrest, sudden collapse at home, refractory PEA with ongoing CPR >4hrs, cardiogenic shock (EF20%), refractory DIC, MOSF and coma. Uncertain antecedent history, pt had tolerated vaccine well w/o untoward reactions, was possibly “sick” in the 2 days prior to admission 06/08, but limited history available. SARS2 PCR and resp path PCR panels negative, no clear bacterial source of shock/collapse initially identified, thus concern for primary myocarditis resulting in refractory shock (perhaps also with ischemic CVA); Tpn not c/w type I ACS/MI. Workup negative for PE, hemorrhagic stroke, PTX/tamponade, etc. 6hrs after death (in evening 06/08/21) BCx x2 resulted Grp A strep, thus pt may have had TSS at home then collapsed in PEA, however source of TSS is uncertain. Notably patient usually healthy, active, no medications, favorable lipid panel, no illicits; + EtOH binge-drinking last several months but no cirrhosis/ESLD previously doubt primarily Etoh-related process. Pt had ongoing PEA arrests with brief ROSC for approx 7 hrs in field -> ED > ICU until death declared.

1386054

6/9/21

COVID19

MODERNA

6/6/21

5/14/21

6/6/21

AUTOPSY 6/8/21

VANAFLAXINE BUSPIRONE ABILIFY SPRINTEC

CHLAMYDIA

DEATH FROM BLOOD CLOT

1386841

6/9/21

COVID19

PFIZER\BIONTECH

6/7/21

6/3/21

6/7/21

Autopsy pending

Adderall

Headache, upset stomach

ADHD

NKDA

UNK

Prodrome of headache and gastric upset over 2 days following second dose. Then felt fine. Found the following day dead in bed. Autopsy pending

1388042

6/10/21

COVID19

PFIZER\BIONTECH

5/23/21

6/7/21

CT scans 6/7 and 6/8

None

Headache started around 3 weeks prior to event that delayed dose of second vaccine. Headache was very severe and she saw PCP for it twice and it lasted a week. It then resolved and she got her second vaccine.

None except obesity with BMI 39

None

Patient had massive acute intracranial hemorrhage. Was found down in bathroom. In ED CT scan showed large intraventricular hemorrhage, EVD placed, patient progressed to massive brain swelling and infarctions, decompressive craniectomy, unable to control intracranial pressure, parents agreed to DNR status and patient is not expected to survive.

1389518

6/10/21

COVID19

PFIZER\BIONTECH

6/8/21

5/15/21

5/16/21

None

Pro Air Inhaler

None

Asthma

None known

Flu like symptoms with vomiting and nausea for 2 weeks following the second shot

1389518

6/10/21

COVID19

PFIZER\BIONTECH

6/8/21

5/15/21

5/16/21

None

Pro Air Inhaler

None

Asthma

None known

Flu like symptoms with vomiting and nausea for 2 weeks following the second shot

1390027

6/10/21

COVID19

MODERNA

5/24/21

5/21/21

5/24/21

Autopsy conducted by the local Medical Examiner, as of the date of this report cause of death is still undetermined pending results of tissue samples taken during the autopsy. Tox screens were negative.

Up until the vaccination has been on Augmentin Oral Tablet for an ear infection that was changed on the day of vaccination to Cefurozime Axetil 500MG

Ear infection

High function autism

No known

The day after the vaccine, reported typical reactions including aches and pains, which improved the following day. The Monday after noted snoring, which was atypical but consistent with the ear infection and seasonal allergies. Sometime on midday Monday 5/24 Pt died. Was found in his bed at approximately 6pm with rigor already set.

1391006

6/11/21

COVID19

PFIZER\BIONTECH

4/30/21

4/14/21

4/26/21

Ruptured aneurysm with in 12 days of vaccine with no previous symptoms and patient deceased due to brain dead after the surgery due to rupturing.; Ruptured aneurysm with in 12 days of vaccine with no previous symptoms and patient deceased due to brain dead after the surgery due to rupturing.; This is a spontaneous report from a contactable reporter consumer wife reporting on behalf of her 35-year-old husband (patient) received the second dose of BNT162B2 (lot number: ER 8731) at single dose for COVID-19 immunisation on 14Apr2021 at 05:15 PM. Relevant history included was unknown. Relevant concomitant drug was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: ER 8727) at single dose for COVID-19 immunisation on 22Mar2021 at 04:45 PM. The patient experienced ruptured aneurysm on 26Apr2021 at 09:00 PM, within 12 days of vaccine with no previous symptoms and patient deceased due to braindead after the surgery due to rupturing. The event was assessed as serious due to Hospitalization (7 days), Life threatening illness (immediate risk of death from the event), Patient died on 30Apr2021 due to brian anuerysm. No autopsy was performed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Reported Cause(s) of Death: brain dead; Brian Anuerysm

1391226

6/11/21

COVID19

PFIZER\BIONTECH

6/4/21

5/26/21

5/1/21

5/31-6/4 several tests were performed

Unknown

My brother started with some swelling in the legs/feet, followed by chest pains that led him into a heart attack, followed by cardiac arrest. He was shocked back to life where he lay in a coma. His kidneys stopped functioning followed by his lungs and liver?he was kept alive on life support and dialysis, he died after having 4 more heart attacks back to back on June 4, 2021.

1391864

6/11/21

COVID19

PFIZER\BIONTECH

5/13/21

4/23/21

5/13/21

Final autopsy report is pending but preliminary report showed a thoracic aortic dissection. The heart and coronaries are reported as normal

none

About 14 days after the first vaccine dose ( Pfizer) patient presented to the ER with severe chest pain. He was sent home after labs, EKG and CT chest were reported as normal. He was told that he had a hiatal hernia. One week later he was found by his wife expired in his bedroom late morning. Patient had no medical problems such as hypertension and never smoked. He was very active and played sports such as pickle ball.

1394845

6/13/21

COVID19

MODERNA

6/11/21

unknown

none listed

Patient received 2nd Moderna shot on 6/11/21 at 10:32am. Went home after the shot and didn’t feel well, so he laid down to rest. His wife checked on him and he was unconscious, so she called 911. Patient was taken to local hospital and died of Cardiac Arrest sometime between his vaccine and 7pm on 6/11/21.

1396032

6/14/21

COVID19

PFIZER\BIONTECH

6/11/21

Enalapril-HCTZ, prednisone, Albuterol nebulizer

states that asthma has been doing well lately

Asthma, Hypertension, MR

No known drug allergies

Patient had no reaction at time of vaccination; was monitored for 15 minutes prior to leaving clinic. This nurse was notified today by ER Physician that the patient came into the ER around 8pm (on the night of the same day that he received his vaccine in the early morning hours) with c/o shortness of breath. It was reported that the patient had taken nebulizer treatments at home with no relief. Symptoms began around 5:30pm. Patient ambulated into ER at time of visit but during the visit became unresponsive. Patient was intubated and coded with time of death called at 9:52pm. Patient has history of asthma.

1396581

6/14/21

COVID19

JANSSEN

3/14/21

4/2/21

HIV+, hypertension, and BMI=43

Patient is a COVID-19 vaccine breakthrough case who is deceased. Patient was admitted to the hospital on 4/5/2021. He was then admitted to the ICU and placed on a ventilator before passing.

1397246

6/14/21

COVID19

MODERNA

6/5/21

5/14/21

6/3/21

LABORATORY DATA: Reviewed by me in ED. WBC 9.9, hemoglobin 14.4, hematocrit 41.8, platelets 177. CPK 114. Chemistry, sodium 139, potassium 4.3, chloride 108, carbon dioxide 25, blood glucose 114,BUN 7, creatinine 0.72, calcium 8.9, protein 7.9, albumin 3.8, A/G ratio 0.9, AST 72, ALT 74, alkaline phosphatase 42, bilirubin 0.5. Lactic acid 2. COVID-19 negative. EKG reviewed by me, sinus rhythm with premature atrial complexes.

UNK

HISTORY OF PRESENT ILLNESS: This is a 20-year-old male with past medical history of asthma, who was brought to ED by ambulance for nausea, vomiting, generalized weakness, and fever. The patient received his second dose of Moderna vaccine 10 days ago. The patient is experiencing symptoms of nausea, vomiting, fatigue, poor p.o. intake for the last few days. He was at ED 4 days ago and had a negative workup. The patient had a fever with T-max of 103 at home. He also had 2 episodes of emesis in the last few days. He denies any diarrhea, chest pain, abdominal pain. He complains of headache. He denies any blurred vision or neck stiffness. At hospital, the patient was given 4 L of fluid and had multiple blood tests. Even echocardiograms were unremarkable. The patient is unable to ambulate because of generalized weakness and dizziness.

1398802

6/15/21

COVID19

PFIZER\BIONTECH

4/17/21

4/16/21

4/17/21

Autopsy

Blood pressure med don?t know name

Psriosis

Psriosis had short history of blood pressure

None

UNK

Patient went into cardiac arrest about 14 hours after receiving vaccine and passed

1399375

6/15/21

COVID19

MODERNA

6/3/21

5/18/21

6/3/21

NONE

Heart Murmur

NONE

Coroner stated that 3 weeks after patient received 2nd dose of COVID-19 Moderna vaccine, patient collapsed from cardiac arrest, which lead to death.

1399375

6/15/21

COVID19

MODERNA

6/3/21

5/18/21

6/3/21

NONE

Heart Murmur

NONE

Coroner stated that 3 weeks after patient received 2nd dose of COVID-19 Moderna vaccine, patient collapsed from cardiac arrest, which lead to death.

1399413

6/15/21

COVID19

PFIZER\BIONTECH

5/29/21

5/13/21

5/28/21

Multiple test were ran at facility

No Perscriptions

None

No Allergies

began with a fever, and slowly starting having nausea and diarrhea. we could not bring down fever with antibiotics

1399516

6/15/21

COVID19

MODERNA

5/14/21

3/21/21

5/12/21

5/12/2021 blood clot

Metformin, otc allergy meds

None

High blood pressure

Sweating, soreness, vomiting

1400337

6/15/21

COVID19

PFIZER\BIONTECH

5/18/21

4/27/21

5/18/21

An autopsy was completed. The final report is pending.

Over the counter Ibuprofen

None

No known allergies to food or other products

On May 18, 2021, Patient said he was experiencing severe back pain and that both of his arms had gone numb and he had vomited. Patient called his mother to come help him with the baby because he wasn’t feeling well. When she got there 30 minutes later he was not breathing. They were not able to revive him. He died of a blood clot in the front of his heart.

1400337

6/15/21

COVID19

PFIZER\BIONTECH

5/18/21

4/27/21

5/18/21

An autopsy was completed. The final report is pending.

Over the counter Ibuprofen

None

No known allergies to food or other products

1403396

6/16/21

COVID19

PFIZER\BIONTECH

4/19/21

4/11/21

4/16/21

None

Irinotecan and Avastin for colon cancer

None

Colon cancer. At the last visit to infushion center for chemo on April 9, 2021 , blood counts indicated no imminent organ failure and he was not jaundice.

None

UNK

On Friday night, April 16,2021, after working all day for his job, Pt told his roomates that he wasn’t feeling well, was throwing up, had the chills and was going to lay down. When the roomates didn’t see him Monday morning, April 19, 2021, they went into his room and found him unresponsive. The medical examiner ruled death due to cancer which appears incorrect considering the evidence.

1403766

6/16/21

COVID19

JANSSEN

5/12/21

5/10/21

5/12/21

Autopsy performed and death determined to be result of hypertrophic cardiomyopathy. Death determined to be not the result of adverse reaction to above stated vaccine.

ibuprofen

Unknown

Hypertrophic cardiomyopathy and obestiy

unknown

Individual passed away within 48 hours of receiving vaccine.

1404484

6/16/21

COVID19

PFIZER\BIONTECH

2/17/21

2/16/21

2/17/21

The ER refused to undertake a medical exam to determine cause of death due to COVID policies. A private autopsy would have been required which I was unable to pay for.

Atorvastatin 40 mg Glipizide 10 mg Losartan Potassium 100 mg Metformin HCL 1000 mg Trulicity

Diabetes, hypertension

hayfever allergies, allergic to stone fruits

Pt passed out unconscious with no pulse. A neighbor who is an ER doctor performed CPR for 5 minutes, then paramedics tried to resusitate Pt and took him to local Hospital ER, less than a mile away. He was not resusitated. No cause of death was found – doctor said it was likely a heart attack.

1406840

6/17/21

COVID19

PFIZER\BIONTECH

6/13/21

6/14/21

UNK

Flu like symptoms for 2 days then was found deceased

1407804

6/17/21

COVID19

MODERNA

4/21/21

4/12/21

4/21/21

As per wife’s account, patient died approximately 9 days after receiving vaccine on 4/21 of massive, unknown (suspected cardiac) event. Wife explained that patient was diagnosed with Wolff-Parkinson-White (WPW) syndrome prior to being vaccinated. PCP unaware of diagnosis, and patient did not disclose that on vaccine consent form. Patient reported to his wife that he was feeling unwell after receiving vaccine including unable to move legs well. Patient later diagnosed with thrush and supposedly treated by physician. Patient did not discuss concerns regarding vaccine or WPW with physician. Patient called his wife the day of death and asked her to bring him to the doctor the following day. Wife reported that patient experienced seizures but not concerned as it was similar to childhood seizure. Wife was done at work and drove home after phone call, arriving at house approximately 10-15 minutes after call. Patient supposedly dead when wife arrived. Wife performed CPR for ~15 minutes until EMS arrived, and EMS attempted for another 40 minutes for any electrical activity. Wife declined full autopsy from ME, suspecting that it was massive MI or clot. Wife and patient unaware that WCW could place patient at risk of clots and wondering if the vaccine was partially responsible.

1407929

6/17/21

COVID19

MODERNA

5/29/21

5/21/21

5/29/21

Blood and vitreous toxicology

unknown

diabetes mellitus type I, inactive TB

unknown

Decedent passed away from causes not yet determined

1407967

6/17/21

COVID19

MODERNA

4/23/21

6/8/21

unknown

Patient was vaccinated with the Moderna Covid-19 vaccine on 3-26-21 and 4-23-21. He was admitted to Hospital on 06-08-2021. He tested positive for Covid-19 on 06-11-2021. He passed away on 06-12-2021. It is unknown whether or not Covid-19 contributed to the case’s illness, hospitalization, possible adverse vaccine reaction or death.

1407967

6/17/21

COVID19

MODERNA

4/23/21

6/8/21

unknown

1408027

6/17/21

COVID19

MODERNA

6/8/21

6/15/21

AKI with severe hyperkalemia, mildly elevated troponin, elevated LFT, leukocytosis, lactic acidosis, presence of EtOH. ECG indicates markedly reduced systolic function of Left ventricle, estimated EF of 15 – 20%. Right ventricle shows moderately reduced systolic function. Mitral and Tricuspid valves show mild mitral regurgitation.

Naltrexone, Trazodone, Fioricet

Unknown

Von Willebrand’s Disease, nerve damage (unspecified), Opioid addiction

NKDA

UNK

Per family, patient reported to have been experiencing fatigue for several days after receiving Covid vaccine. On 6/15/21, patient’s significant other discovered patient in bed, not breathing, with ashen appearance, uncertain how long it had been since patient was last breathing. EMS was contacted, CPR was given and patient was transferred to Emergency Department at the hospital. Diagnosis of Cardiologist is cardiac arrest, NSTEMI (suspects type 2). Per cardiologist, patient appears to exhibit cardiomyopathy, etiology difficult to ascertain (patient’s family/acquaintances have endorsed periodic use by patient of anabolic steroids in the past, making it more difficult to rule out source of cardiomyopathy. ). Physicians involved are reporting this case in the event that this may be a case of vaccine-induced myocarditis, although no diagnosis as such has been made.

1410110

6/18/21

COVID19

PFIZER\BIONTECH

6/16/21

6/13/21

6/14/21

death

1410676

6/18/21

COVID19

MODERNA

4/13/21

1/29/21

birth control

With her first vaccine on 12-31-2020, she experienced a runny nose, sniffles, and cough. Felt a little tired.

After her second vaccine, she became weaker and very fatigued. She just kept saying she felt funny that something wasn’t right. On April 12, 2020 she had a hypoglycemic attack at work and they gave her a glucose tablet along with a soda and snack but her sugar came up to normal. After getting home from work, she laid down for a while because she was tired and said she just needed a nap. after a while, she got up and cooked. afterwards she was going to hunt for mushrooms but came back after about half an hour and tired and not feeling right once again. Her fiancé called me at 11:33 p.m. saying that I needed to get over here right away that patient was in bad shape. Once I got over there I checked her blood sugar level and it was good. As she began to tell me by motioning that she was hurting from her color bone and over chest she then proceeded to tell us that her right arm and thumb felt weird. She then went into a seizure. We called 911 and reported her that she had a hypoglycemic attack earlier in the day and that she had just seized and now was having a heart attack and CPR was being performed. The ambulance came 40 minutes later telling us that dispatch messed up the call. They pronounced our daughters’ death at 0121 on April 13, 2021 due to ischemic heart disease due to coronary artery atherosclerosis.

none

UNK

ACHE, RUNNY NOSE, COUGH, LETHARGIC

1411734

6/18/21

COVID19

PFIZER\BIONTECH

6/12/21

5/7/21

5/8/21

multiple blood levels were taken in the 24 hours she was hospitalized, chest xray 1 showed bilateral infiltrate, congestion, and cardiomegaly. The 2nd chest xray showed increased bilateral pulmonary infiltrates and placement of an IV catheter in the superior vena cava.

Benzoyl Peroxide, Ibuprofen 600mg, SalonPas patches

none

Obesity, History of Asthma

none

Symptoms started with tightness of muscles and body aches, tightness of chest, increased blood pressure, herpes simplex A mouth sores – saw PMD received muscle relaxer, and antibiotic cream… in the 30 days prior to last event she had been having dizzy spells, chills, hot flashes, shortness of breqth, tightness of chest, darkened urine, muscle cramping and knotting, pitting edema, halo discoloration lower right extremity (she wasnt one to complain and thought her symptoms were from use of muscle relaxer) – woke AM 6/11/2021 with severe shortness of breath and was taken to ER – diagnosed with obesity, cardiomegaly, renal failure, severe anemia, hypoxia, and hypokalemia, she went into respiratory distress AM 6/12/2021 and then went into cardiac arrest. She died as a result.

1413325

6/20/21

COVID19

MODERNA

4/8/21

4/5/21

4/8/21

UNK

He said he felt bad and fell over and died.

1414536

6/21/21

COVID19

MODERNA

6/13/21

6/10/21

6/12/21

Patient was homeless. Self-reported history of seizures; self-report of not walking well or being able to stand for more than 15 minutes at a time; shortness of breath

This patient was homeless. Partner was with patient on the night of 6/12 when patient complained of not feeling well and attributed it to side effects of his COVID vaccine, which he received two days prior. Patient declined to go to the hospital. When partner woke up the morning of 6/13, the patient was found dead. A coroner’s report is expected sometime within the next 4-6 weeks.

1415237

6/21/21

COVID19

JANSSEN

6/13/21

5/4/21

6/1/21

He had an appointment set but died before going in.

Unknown, bipolar medications

Bipolar disorder

My dad died after he had symptoms of sweating without doing anything to increase his heart rate. He had stated his heart had been racing recently. He died suddenly and unexpectedly.

1416816

6/22/21

COVID19

PFIZER\BIONTECH

5/3/21

2/17/21

5/3/21

Death certificate states cardiomyopathy

None

unknown

Woke that morning very lethargic and hard to arouse. Mom states had been doing very well, exercising and losing weight. States he felt good up until that day. DEATH

1416816

6/22/21

COVID19

PFIZER\BIONTECH

5/3/21

2/17/21

5/3/21

Death certificate states cardiomyopathy

None

unknown

Woke that morning very lethargic and hard to arouse. Mom states had been doing very well, exercising and losing weight. States he felt good up until that day. DEATH

1417142

6/22/21

COVID19

JANSSEN

6/4/21

5/22/21

5/25/21

ondansetron

IBS

UNK

19-year-old male presenting for evaluation due to ongoing nausea and vomiting. Patient says he has had vomiting for approximately 4 days. Admits to daily marijuana use secondary to IBS. He states that he was in the emergency department yesterday and told that he has a acute viral infection. States that he struggled to keep food or liquid down even after discharge home. Patient denies other illicit substance abuse. Patient discharged with ondansetron. Of note, patient Qtc >600ms before discharge.

1417642

6/22/21

COVID19

MODERNA

6/8/21

5/24/21

6/7/21

vimpat Depakote dr

epilepsy learning disabilities

clindamycin topamax

Patient father reported he passed away in his sleep the night of 06-07-21 and was pronounced diseased on 6-8-21

1417790

6/22/21

COVID19

PFIZER\BIONTECH

6/20/21

6/18/21

6/20/21

Autopsy on 6/21/21 was essentially unremarkable. Death is likely due to epilepsy in the setting of noncompliance with anticonvulsants, but I thought I would make this report to cover all the bases.

Unknown – reportedly non-compliant with prescribed medications.

Nothing acute. Reportedly had a seizure after her first COVID vaccine dose 3 weeks prior.

Epilepsy, Obesity

Unknown.

37 yo woman with a history of epilepsy and medical noncompliance found dead in her bed less than two days after receiving 2nd COVID vaccine (believed to be Pfizer). Reportedly experienced a seizure following the 1st dose approximately 3 weeks prior.

1418055

6/22/21

COVID19

JANSSEN

6/21/21

4/1/21

6/20/21

Oral contraceptives

anxiety

anxiety; herpes simplex

clarithromycin; penicillins

UNK

Pulmonary Embolism

1419805

6/23/21

COVID19

MODERNA

3/23/21

3/20/21

Diabetes (was on anti-diabetic medicine.)

Died due to heart attack; Lot of blood was on the floor; He fell on bathroom tiles; Feeling weakness/Could not coming out of bed; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Died due to heart attack) and HAEMORRHAGE (Lot of blood was on the floor) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes (was on anti-diabetic medicine.). On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ASTHENIA (Feeling weakness/Could not coming out of bed), PYREXIA (Fever) and CHILLS (Chills). On 23-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Died due to heart attack) (seriousness criteria death and medically significant), HAEMORRHAGE (Lot of blood was on the floor) (seriousness criterion medically significant) and FALL (He fell on bathroom tiles). The patient died on 23-Mar-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGE (Lot of blood was on the floor), FALL (He fell on bathroom tiles), ASTHENIA (Feeling weakness/Could not coming out of bed), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Concomitant medication included was anti-diabetic medicine. The treatment information was not provided. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender’s Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: heart attack

1420257

6/23/21

COVID19

JANSSEN

6/22/21

3/12/21

6/22/21

102

PCR positive SARs CoV2

asthma, depression, hypothyroid

hospitalized with respiratory distress and death

1420630

6/23/21

COVID19

PFIZER\BIONTECH

6/15/21

3/13/21

4/3/21

Artane, azithromycin, calcium carbonate, dicyclomine, doxycycline, escitalopram, flovent, gabapentin, lansoprazole, melatonin, ondansetron, tedizolid,

disseminated mycobacterium chelonae infection

ataxia telangiectasia; EBV-associated lymphoma

none

~4 weeks after the 2nd dose of Pfizer, patient presented to the hospital with chest pain; had pericardial effusion. Initially improved but then had decompensation, prolonged hospitalization. Diagnosed with hemophagocytic lymphohistocytosis (HLH) and ultimately died.

1420762

6/23/21

COVID19

PFIZER\BIONTECH

6/23/21

6/17/21

6/23/21

Vienva 0.1-20 mg-mcg per tablet

No.

Obesity, Family history of clotting disorder (her workup with negative), and depression.

NKDA

UNK

Cardiac arrest without resuscitation. Unknown cause of cardiac arrest. Awaiting autopsy report.

1421533

6/23/21

COVID19

MODERNA

6/22/21

6/21/21

6/22/21

Unclear, patient was hospitalized when she died. I am reporting as her PCP and the location that gave the vaccine. Per her husband, he has not been given a cause of death, and was not offered an autopsy.

amlodipine, lisinopril, metoprolol, eliquis, sertraline, pregabalin, hydrocodone, trazodone, clonazepam, on an insulin pump

Left fore-foot amputation with open wound, improving and undergoing appropriate care

diabetes mellitus – most recent check A1c 7.3 (well controlled) with complications (nephropathy, neuropathy, gastroparesis); history of SVT and HTN well controlled; history of venous thromboembolism on eliquis life-long; carotid artery stenosis , severe; obstructive sleep apnea

NSAID (rash and throat swelling), latex, penicillin

Per report from patient’s husband, the patient developed a fever to 103 on the evening of 6/21/21. She awoke in the morning and was “not herself”. He describes her as having difficulty breathing and not being lucid. He took her to the hospital where she was hospitalized and then he got a call from the hospital in the evening reporting that she had walked to the restroom and then collapsed. Per his report, she had CPR performed for 30 minutes prior to being declared deceased. His phone number is the one included in this report.

1423308

6/24/21

COVID19

MODERNA

6/8/21

4/7/21

6/7/21

Xanax 1mg, chlorthalidone 25mg, celexa 40mg

Bipolar 1, HTN, Obesity

clavulanic acid, sulfa

patient complained of intermittent fevers since the first administration of the Moderna vaccine on 4/7/21. fevers continued intermittently until second moderna dose on 5/5/21. Patient developed lymphadenopathy and eventually was hospitalized on 6/6/21 for sepsis symptoms. Patient was intubated and found to have an acute lymphoproliferative disorder that caused cardiac arrest and the patient expired on 6/8/21. She has no lab abnormalities suggesting a lymphoproliferative disorder prior to these events.

1423631

6/24/21

COVID19

MODERNA

6/12/21

5/19/21

6/12/21

albuterol sulfate simvastatin prazosin amLODIPine

cardiac pacemaker in situ essential hypertension

Sulfa (Sulfonamide Antibiotics)

FAMILY PRACTICE was notified by a County coroner that the patient died on 12 June 2021. It is unknown to us if this is related to the Moderna vaccine received 19 May 2021. Dr. had seen this patient one time as a new patient of FAMILY PRACTICE to establish a primary care provider 25 May 2021 FAMILY PRACTICE provided the 1st dose Moderna vaccination 19 May 2021

1424021

6/24/21

COVID19

PFIZER\BIONTECH

5/30/21

3/24/21

4/15/21

furesomide carvedilol spironolactone

chf

unknown

UNK

Patient had an acute MI died after within 8 weeks of last vaccine patient had been complaining of dizziness and feeling different since second vaccine

1425204

6/24/21

COVID19

PFIZER\BIONTECH

6/11/21

6/4/21

6/11/21

Fluoxetine Clonidine Atorvastatin Risperidone Buspirone Metformin Carvedilol

Death 7 days after vaccination, deceased on June 11th

Congestive heart failure disease stage 3 Diabetes type 2 Atherosclerotic cardiovascular disease

Unknown

UNK

Experienced shortness of breathe resulting in death cardiac arrest.

1425926

6/25/21

COVID19

MODERNA

5/7/21

3/30/21

4/16/21

RT-PCR or other NAAT test

COVID-19 sepsis

Sarcoidosis End stage renal disease Hypertension Congestive heart failure

Death: 5/7/2021 Causes of death listed on death certificate: 1) COVID-19 2) Sepsis 3) Sarcoidosis 4) End stage renal disease Other: Hypertension, Congestive heart failure

1427367

6/25/21

COVID19

MODERNA

6/5/21

4/30/21

6/5/21

unknown

A friend of the patient called us today to inform us that the patient had recently passed away from a brain aneurysm. The friend asked it it were possible that this occurrence was somehow related to patient receiving his covid vaccination. The friend did not have a lot of information about the occurrence; he only stated that the patient’s brain aneurysm was about 6 weeks after his 2nd dose of the covid vaccine. Patient was not a regular patient of ours so we have no additional medical history for him. We administered his first Moderna vaccine on 4-2-2021, and he returned for his second dose on 4-30-2021. I assured the friend I would report this to VAERS and thanked him for reaching out to us on behalf of patient.

1427448

6/25/21

COVID19

MODERNA

6/15/21

5/17/21

6/15/21

n/a sudden death

listed in chart are OTC tylenol as needed and meclizine for vertigo

Dizzyness and vertigo

not listed in chart

Not listed in medical chart or history

Notified on 6/16 /2021 patient died. Death by PE 1 month after prime dose of Moderna-since unexpected- reported to VAERS

1427855

6/25/21

COVID19

JANSSEN

5/30/21

5/24/21

5/30/21

UNKNOWN

UNK

PATIENT’S MOTHER REPORTED TO PHARMACY THAT PATIENT DIED 6 DAYS AFTER RECEIVING THE JANSSEN COVID 19 VACCINE.

1427998

6/25/21

COVID19

MODERNA

5/21/21

The final autopsy has not yet been completed, and I don’t know if they’re even checking for Covid-19 vaccine reaction.

insulin, lipitor, not sure what else

Type 1 Diabetes; hospitalized May 16-18 acute ketoacidosis

Type 1 Diabetes

don’t know of any

UNK

Patients appointment was either 2:15 or 2:30. His Apple watch recorded it’s last heart beat reading at 3:15 pm, 05/21/2021, within an hour after receiving his second Moderna Covid-19. His heart rate increased rapidly from 3:00 to 3:15, reading 104 – 106 – 108 – 116 bpm. I can provide a photo of these last four readings if you need them. I don’t know other symptoms. His body was found by police who were called for a well-check three days later, 05/24/2021. Patient died unattended, at home, alone. I only know for sure the vaccine was administered at a Target store near his home. Patient texted me at 2:48pm saying that Target gave him a $5 coupon for getting his vaccine, and he was going to use it to buy Tylenol.

1428029

6/25/21

COVID19

MODERNA

6/23/21

Flagyl, Quinolones

N/A — patient was perfectly fine during wait time

1429713

6/26/21

COVID19

MODERNA

6/19/21

6/13/21

6/18/21

June 18 + 19 2021

Ulcerative colitis, bipolar, advanced degenerative arthr

My son had been complaining of racing heart and became a week after the first dose of Moderna then started vomiting once or twice a week thereafter I tried to get him to go the doctor but he kept saying he was ok. He said he feels like something was wrong but didn?t know what. He received his second dose of moderna 6/13/2021, 5 days later on 6/18/2021 he didn?t feel well laid down around 9 pm was checked on at 9:21 he was unresponsive no heart beat no breathing 911 was called. They resuscitated him after 45 minutes then he was transported to hospital then to medical center. he was in ICU on a ventilator unresponsive brain swollen , totally unresponsive and organs shutting down. He passed away 9:45 pm June 19

1430291

6/27/21

COVID19

PFIZER\BIONTECH

5/11/21

3/31/21

4/1/21

Multiple Lab blood tests done 5-6 to 5-10-21 TTE 5-7-21 Chest X-rays 5-9-21 Echocardiogram 5-6-21 Nuclear medicine ventilation perfusion lung 5-7-21 US lower extremity veins 5-7-21 ECG 12 lead 5-9-21 CT

Omeprazole before vaccine Albuterol after 1st vaccine

Gastritis

None

NKDA

Started with body aches, joint pain and weakness, followed by SOB that was aggravated over time- especially after the 2nd dose- Then, she started having increase heart palpitations and chest pressure. Eventually noted ischemic changes with purplish discoloration face, hands and feet. At this time it became great effort to walk due to lack of air- SOB was severe. She was taken to ER at hospital where she was admitted with possible PE, MI or heart failure. After few days no improvement was achieved and patient trans ported to another Hospital to receive more advance care but she was pronounced death in the morning of 5-11-21. The death certificate heart failure as immediate cause of death, preceded by PE and pulmonary hypertension.

1430291

6/27/21

COVID19

PFIZER\BIONTECH

5/11/21

3/31/21

4/1/21

Omeprazole before vaccine Albuterol after 1st vaccine

Gastritis

None

NKDA

1430452

6/27/21

COVID19

MODERNA

6/11/21

5/27/21

5/28/21

Check patient medical records from hospital. Multitude of blood, urine, and other tests performed.

none

None known

none known

Penicillin

Fever, pain in thigh, vomiting, diarrhea, sepsis, eventually died two weeks later. Time of death 6-11-21 1am

1430978

6/28/21

COVID19

MODERNA

4/4/21

3/31/21

4/4/21

01/28/2021 COVID-19 PCR test positive

Received COVID-19 monoclonal antibodies 02/2021

tested positive for COVID-19 on 01/28/2021 via PCR testing

Obesity

03/31/2021 received 1st dose of Moderna COVID-19 vaccine 04/01/2021 104 F fever, dizziness, nausea 04/03/2021 symptoms subsided 04/04/2021 case expired as a result of undetermined natural causes per medical examiner final report

1431067

6/28/21

COVID19

PFIZER\BIONTECH

6/24/21

5/10/21

6/24/21

UNK

Pt died during child birth on 06/24/2021

1431289

6/28/21

COVID19

PFIZER\BIONTECH

6/20/21

6/2/21

6/19/21

see above. Was covid positive on admission 6/19. Family gave a history of previous covid infection earlier this year.

none

Date of Admission: 6/19/2021 Date of Death: 6/20/2021 Primary Care Physician: No primary care provider on file. REASON FOR ADMISSION: Patient is a 13-year-old previously healthy male who was admitted after out-of-hospital cardiac arrest with ROSC after CPR for 15 minutes in the field, found to be in the context of large cerebellar hemorrhage secondary to brain lesion (AVM vs tumor). BRIEF SUMMARY OF HOSPITALIZATION: Patient was intubated prior to arrival to the ED. Upon arrival he was started on epinephrine and norepinephrine drips to maintain perfusion and was administered bicarbonate x2. Head CTA was obtained and was notable for midbrain hemorrhage and tonsillar herniation, and no contrast enhanced blood flow in the brain. Brain death exams were completed at 09:59 and 14:20. APNEA test was performed at 13:30, which is the official time of brain death. Official cause of death was brainstem herniation from intracranial hemorrhage. Mechanical ventilation was continued to allow family time to grieve and perform last rites. Time of cardiac death after mechanical ventilation withdrawal was 18:36. HOSPITAL COURSE BY PROBLEM: FEN/Renal/Endo: #Central DI He received 1.5 L of normal saline bolus in the ED and an additional 3 L of ringers lactate bolus overnight in the ICU to maintain perfusion and decrease heart rate. His sodium was 141 upon presentation but reached a maximum of 160 due to central diabetes insipidus. He was started on 0.45% normal saline at 100 mL/hr to improve hypernatremia, which was monitored Q1h until normonatremic. He additionally required vasopressin drip to be started due to central DI, which was increased to a maximum of 20 mU/kg/hr. CV: At time of admission, epinephrine was running at 0.1 mcg/kg/min and norepinephrine was 0.1 mcg/kg/hr. Norepinephrine was increased shortly thereafter to 0.12 mcg/kg/min. In the morning after admission, he had tachycardia to the 190s, which appeared to be narrow complex. Epinephrine and norepinephrine were discontinued. Two doses of adenosine were administered (6 mg first dose, 12 mg second dose) due to suspected SVT. The rate decreased for ~4 seconds after the second dose however returned to ~180. EKG arrived which showed sinus tachycardia so no further medications or cardiac interventions were done. Fluid rates were increased to 2x MIVF rate and additional 500 mL bolus of LR was administered. Norepinephrine and epinephrine were restarted and escalated due to low blood pressures in the early afternoon.to allow family time with patient. Both titrated to effect. Pulm: Patient was mechanically ventilated to achieve normal pH, normocarbia, and high arterial oxygen tension per brain death protocol. He had no primary pulmonary disease during this admission. Neuro: #Intraparenchymal hemorrhage #Tonsillar herniation Neurosurgery was consulted. Mannitol x1 and hypertonic saline 23% x1 were administered to decrease intracranial pressures. Keppra 2g was administered for seizure prophylaxis. No sedation was needed during patient’s hospitalization. PERTINENT STUDIES & CONSULTS: Pediatric neurology Neurosurgery PENDING TESTS RESULTS: None RECOMMENDATIONS AND FOLLOWUP: None No future appointments. PHYSICAL EXAMINATION: BP 108/78 | Pulse (!) 144 | Temp 36.5 °C (97.7 °F) | Resp (!) 15 | Ht 1.65 m (5′ 4.96″) | Wt 46.5 kg (102 lb 8.2 oz) | SpO2 99% | BMI 17.08 kg/m² Estimated body mass index is 17.08 kg/m² as calculated from the following: Height as of this encounter: 1.65 m (5′ 4.96″). Weight as of this encounter: 46.5 kg (102 lb 8.2 oz). ALLERGIES No Known Drug Allergies

1431372

6/28/21

COVID19

PFIZER\BIONTECH

5/12/21

5/11/21

5/12/21

The cause of death is unknown. An autopsy was performed. I believe it is likely a coincidence that she died only hours after her vaccination.

breathing difficulties. Sometimes needed oxygen.

UNK

13 hours after the patient had had her 2nd covid-19 shot, she was found dead. She had indicated that she had no side effects after her shot.

1433459

6/29/21

COVID19

PFIZER\BIONTECH

1/14/21

3/7/21

EXPIRED 3/7/21

1433459

6/29/21

COVID19

PFIZER\BIONTECH

1/14/21

3/7/21

EXPIRED 3/7/21

1437378

6/30/21

COVID19

MODERNA

5/5/21

3/12/21

5/5/21

Positive COVID-19 Antigen test on 04/23/2021

Unknown

Chronic Kidney Disease

Unknown

Died of COVID-19 illness on 05/05/2021

1437378

6/30/21

COVID19

MODERNA

5/5/21

3/12/21

5/5/21

Positive COVID-19 Antigen test on 04/23/2021

Unknown

Chronic Kidney Disease

Unknown

Died of COVID-19 illness on 05/05/2021

1438057

6/30/21

COVID19

MODERNA

3/27/21

3/13/21

3/27/21

Inhaler, Wellbutrin, Trintellex, Daily Vitamin

Asthma, Sleep Apnea

seasonal allergies

UNK

Patient died on March 27, 2021. Coroner ruled it Acute Asthma Exacerbation. Because it was only a short time after his shot, his family wants to rule that out as a possible cause of death.

1440493

7/1/21

COVID19

PFIZER\BIONTECH

4/29/21

4/19/21

4/20/21

We are waiting for waiting for results from the Medical Examiner and do not know what tests they are running.

UNK

Pt became severely sick with flu-like symptoms and could not work on April 20-22. He worked on April 23. He told people he was sick again on April 24. He was very anxious and committed suicide some time between April 27-28.

1440769

7/1/21

COVID19

PFIZER\BIONTECH

5/28/21

5/13/21

5/28/21

None.

Any medications ending with -ox or -oxin.

Patient was gone out for a run on 28th May. While running, he collapsed suddenly. Onlookers called 911 and they tried to revive him but he died on the spot. his autopsy result is still pending. He had no history of any illness and had been a healthy individual. He used to exercise regularly. He had received his second dose of vaccine that month on 13th May and had faced expected symptoms like fever and chills that only lasted for 2 days.

1443056

7/2/21

COVID19

PFIZER\BIONTECH

5/23/21

5/21/21

5/23/21

Unknown

HTN, electrolyte disorder, renal disease

Unknown

49yom with PMH HTN presents with CP and SOB. Ddx includes but is not limited to: ACS, PE, PNA, aortic dissection, pericarditis, myocarditis. On arrival, patient appeared critically ill with cool, clammy skin, diaphoretic, complaining of chest pain. Patient initially able to answer simple questions, however quickly became unconscious, witnessed having tonic colonic seizure activity. Patient given 2 mg of lorazepam which aborted the seizure, however he remained unresponsive. IV fluids were started, and patient remained hypotensive after 3 L of fluids. Bedside cardiac ultrasound was performed which showed a large pericardial effusion with tamponade physiology. We continued fluid resuscitation and patient was intubated, while stat Cardiology consult was called. Patient suffered a cardiac arrest shortly after intubation. Cardiology performed emergent pericardiocentesis at the bedside which showed hemopericardium with output of greater than 500 mL of blood. ROSC was achieved following pericardiocentesis, and we continued resuscitative measures. Emergent arterial line and central venous lines were placed. Patient began to have profuse bleeding from all orifices, and massive transfusion protocol was initiated. Patient was stabilized enough to be taken to CT scanner which showed an extensive aortic dissection extending into the RCA, abdominal aorta, brachiocephalic artery, common carotids, and into the abdominopelvic vasculature. Cardiac and vascular surgery were consulted stat, and the decision was made to take the patient emergently to the OR. We were informed shortly after that the patient had expired en route to the operating room and they were unable to obtain ROSC. Final impression: type A aortic dissection, cardiac tamponade. Second dose of mRNA vaccine (unknown if Pfizer or Moderna) received two days prior to event.

1443056

7/2/21

COVID19

PFIZER\BIONTECH

5/23/21

5/21/21

5/23/21

Unknown

HTN, electrolyte disorder, renal disease

Unknown

1443143

7/2/21

COVID19

PFIZER\BIONTECH

6/25/21

6/21/21

6/25/21

ECT the morning of arrest.

Amlodipine, baby aspirin, albuterol, aripiprazple, benztropine,clonidine, gabapentin, haldol, iron, lithium, metporolol, prazocin, norethindrone, tramadol and vicodin prn.

Uncontrolled Hypertension, severe bipolar 1 disorder, asthma, Leukocytosis

see 11

penicillins

48 y/o female with pmh of HTN, HLD, DM2 and bipolar disorder, transferred to ICU from the psychiatric until after cardiac arrest. The patient was originally admitted on 5/22 for evaluation of bizarre behavior. She was noted to have flight of ideas, emotional instability and multiple attempts to leave the room naked. She was admitted to the floor there with behavioral health consulted for evaluation. She was then transferred to another unit on 5/27/21 for additional management, with a plan for a 90 day inpatient hold. While in the unit she was managed with a medication regimen including Thorazine, Lithium and Abilify. Medicine was consulted for management of hypertension, and Ob-Gyn was following for abnormal vaginal bleeding with work-up unable to be completed due to her mental status. ECT treatments were also started this week on 6/23, with the patient receiving her second ECT treatment this afternoon. From review of the pre-procedure note, the planned induction was with etomidate, succinylcholine, glycopyrrolate, and Brevitol (methohexital, barbiturate class); the actual MAR is not up to date with her procedural medications at the time of admission. Post treatment, the patient was noted to be conversive and in her normal state of health. This evening, nursing staff heard a loud noise from the patient’s room around 1630. Upon arrival, they found her down, unresponsive and without a pulse. An ACT was called and CPR was initiated for a duration of approximately 30 minutes. Reportedly the AED display showed asystole, followed by PEA. She received a reported five rounds of epinephrine, one dose of bicarbonate, and one dose of calcium during the event. The patient was intubated during the code with a large amount of gastric contents present, concerning for aspiration. A right ankle IO was placed due to significant difficulty securing access elsewhere. ROSC was obtained with a junctional rhythm, and the patient was transferred for further management. On arrival the patient is non-responsive without any sedation running. She became hypotensive by arrival to the ICU requiring norepinephrine. On later inspection of her IO, there was suspicion for infiltration of fluids and medications around her right ankle. She has had significant secretions into her ETT since transfer. HPI as noted above. ICU course notable for hypoxic respiratory failure with ARDS likely from lung injury from cardiac arrest. She subsequently developed shock and required vasopressors. Initially the patient was noted to have brainstem reflexes, however on 6/25 the patient had an exam change with no spontaneous breaths and pupils fixed and dilated. The initial head CT following arrest was performed which showed diffuse cerebral edema with effacement of the sulci and gray and white matter differentiation consistent with severe anoxic brain injury. There was diminished ventricular size with complete effacement of the fourth ventricle and tonsillar herniation from mass effect. Neurology was consulted. The patient remained on vasopressor and mechanical ventilator support. A NM scan was performed to evaluate cerebral blood flow showed absence of effective cerebral perfusion. Neurology performed an exam and the patient was pronounced deceased at 1802 on 6/27/21 a doctor. The family was informed of the results. After discussion with family, the patient was removed from mechanical ventilator support and vasoactive medications discontinued with the family at beside.

1443187

7/2/21

COVID19

MODERNA

3/26/21

3/24/21

3/26/21

Below are the medications he was on but he was not always consistent about taking them, so I can’t be sure what all he took in the days and weeks leading up to his death. clonazepam amitriptyline buspirone hydrochlorothiazide metoprolol pr

Hypertension Hypercholesterolemia Depression Anxiety Alcohol abuse

Unexpected death. Coroner reported enlarged heart, enlarged liver.

1446849

7/5/21

COVID19

PFIZER\BIONTECH

7/4/21

7/2/21

7/4/21

none

None

Holcomb’s disease; hypertrophic cardiomyopathy

None

death

1450252

7/6/21

COVID19

PFIZER\BIONTECH

6/24/21

6/1/21

6/6/21

UNK

my wife died of a hart attack 4 days after her shot she was only 30 years old,. with no previous symtoms. please explain to me how this could happen.

1458126

7/8/21

COVID19

MODERNA

6/18/21

6/13/21

6/18/21

No medications taken at the time and no medication profile given by patient.

Patient recorded no illnesses or chronic conditions at the time of receiving his vaccination.

No chronic history or medical condition was documented on his paperwork.

No allergies to medication, food or other products.

Father of patient came to store pharmacy to inform us of his son’s passing. He stated patient died 5 days after receiving his Moderna vaccine on 6/13/2021 due to blood in the lungs. He stated the autopsy has not been done yet to confirm his death, however he was curious of the possibility. I contacted Moderna on July 8th at 4:30pm and spoke to a pharmaceutical representative of Moderna regarding possible side effects of the vaccine.

1458628

7/9/21

COVID19

PFIZER\BIONTECH

5/2/21

4/17/21

4/21/21

Yes a lot of test and lab were done, but like I said previously they have not given me his medical records so I don’t know all the exact dates to everything yet.

None

My previously healthy brother received the Pfizer vaccine (1st dose) and 4 days after he was hospitalized with shortness of breath, heart failure, blood clots in his arm, lungs and leg along with a stroke and many medical conditions kept arising as he was hospitalized. He was in the CICU for a week and a half. Unfortunately, my brother passed away from the Pfizer vaccine. Until his last day the doctors still “didn’t know” what was wrong with him. A lot happened during his hospital stay, but this is just a brief statement. They have been keeping his medical records from me. They tested him repeatedly there from covid and he wa salways negative. They had no other explanation to what was happening and all along they wanted it to be COVID-19 and were so quick to say it was not the vaccine.

1460255

7/9/21

COVID19

MODERNA

7/7/21

6/30/21

7/7/21

Labs obtained 7/6/21 with elevated WBC 16,000. Hgb 16.0. Platelets normal. Complete metabolic panel normal aside from elevated alkaline phosphatase of 205. Hemoglobin A1c 6.5.

Sertraline ProAir inhaler Oxycodone/acetaminophen Omeprazole Hydroxyzine Gabapentin

Lower extremity edema, increasing shortness of breath prior to vaccination

COPD fibromyalgia deconditioning tobacco use

Azithromycin Bee allergy (anaphylaxis) Zolpidem

Patient received COVID vaccine on 6/30/21. She had been experiencing chronic dyspnea, lower extremity edema. On 7/7 had some nausea, vomiting at home. Found unconscious by her spouse a few hours later and subsequently died.

1461829

7/10/21

COVID19

JANSSEN

7/10/21

7/1/21

7/2/21

UNK

Dead

1461898

7/10/21

COVID19

PFIZER\BIONTECH

3/14/21

3/12/21

3/14/21

Autopsy

Unknown

None

Unknown

UNK

Had 2nd vaccine a few days earlier and died of cardiac arrest. Was healthy and active prior to vaccine with no known health problems.

1463061

7/11/21

COVID19

MODERNA

UNK

Died three days after vaccine; 13 year old boy dies three days after the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died three days after vaccine) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old boy dies three days after the Moderna vaccine). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old boy dies three days after the Moderna vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter. Treatment information was unknown. Company comment: This is a case of death in a 13-year-old male subject with unknown medical history, who died one day after receiving the vaccine. Very limited information has been provided at this time. Further information has been requested.; Sender’s Comments: This is a case of death in a 13-year-old male subject with unknown medical history, who died one day after receiving the vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

1463962

7/12/21

COVID19

MODERNA

3/31/21

3/23/21

3/31/21

Full autopsy with histology, toxicology, and SARS-CoV-2 testing (negative) The autopsy demonstrated systemic inflammatory reaction, which affected primarily the small blood vessels of the brain with leptomeninges (soft coverings of the brain), heart, lungs, and liver. Generalized systemic tissue inflammation has caused diffuse intravascular inflammatory microthrombi and hemorrhagic myocarditis.

Butalbital Omeprazole Prednisone

None

Well controlled rheumatoid arthritis

Sulfa antibiotics

Found unresponsive on the floor of her residence; DOA in the ER

1464157

7/12/21

COVID19

PFIZER\BIONTECH

5/31/21

5/24/21

5/30/21

Levemir 46 units twice daily Novolog 10 units three times daily before meals Ozempic 1 mg weekly Lisinopril 5 mg daily simvastatin 40 mg daily Tums 500 mg daily in the morning Omeprazole 20 mg daily Docusate 100 mg twice daily Albut

uncontrolled Type 2 diabetes acute hyponatremia

Hypertension CKD stage 3 Hyperlipidemia GERD History of small bowel obstruction Constipation Chronic Hepatitis C Bipolar affective disorder Fragile X syndrome ADHD Tardive dyskinesia generalized anxiety disorder tobacco abuse Seizure disorder COPD Neuropathy/pain Allergic Rhinitis Hypothyroidism Vitamin D deficiency

copper (dermatitis) Nickel Olanzapine (nausea and vomiting) staples zinc Zyprexa

Cardiac arrest, followed by seizure and death. Pt was hospitalized, undetermined cause of death, case send to a medical examiner. Case was noted upon chart review by reporter.

1464157

7/12/21

COVID19

PFIZER\BIONTECH

5/31/21

5/24/21

5/30/21

uncontrolled Type 2 diabetes acute hyponatremia

copper (dermatitis) Nickel Olanzapine (nausea and vomiting) staples zinc Zyprexa

Cardiac arrest, followed by seizure and death. Pt was hospitalized, undetermined cause of death, case send to a medical examiner. Case was noted upon chart review by reporter.

1464651

7/12/21

COVID19

JANSSEN

6/5/21

5/26/21

autopsy pending

antibiotics

dry socket from tooth removal

UNK

This was a J&J vaccine but I didn’t see that as a choice in the drop down. My son passed away on June 5 2021. He had severe nausea

1465112

7/12/21

COVID19

PFIZER\BIONTECH

3/28/21

3/25/21

3/27/21

autopsy performed by local Medical Examiner

hypertension cardiac

ceolor

UNK

Patient died we think on March 27th although he wasn’t found until March 28th. We are waiting for the histology report on his cardiac tissue samples. We are suspecting myocarditis.

1465762

7/12/21

COVID19

MODERNA

3/31/21

3/28/21

3/29/21

Autopsy findings along with histology, toxicology and other ancillary tests; SARS-CoV-2 negative in the nasopharyngeal and pulmonary swabs.

None

Hypertension and obesity

Not known

Fever, chills, malaise, progressive shortness of breath and sudden collapse

1466009

7/13/21

COVID19

PFIZER\BIONTECH

4/30/21

4/3/21

4/30/21

He had no previous symptoms. I was with him one hour before and my assistant saw him 20 minutes prior and he did not show any irregularities.

None

My son died, while taking his math class on Zoom. We are waiting for the autopsy because the doctors did not find anything. He was a healthy boy, he had a good academic index, he wanted to be a civil engineer. He was the best thing in my life.

1466685

7/13/21

COVID19

PFIZER\BIONTECH

7/12/21

6/23/21

6/24/21

NONE

ELIQUIS 5MG CARVEDILOL 3.125 MG BENZONATATE 200MG

SUPRAVENTRICULAR TACHYCARDIA

NONE

ARM PAIN, COUGHING, LETHARGIC, CHEST PAIN, CLAMMY,

1470249

7/14/21

COVID19

PFIZER\BIONTECH

5/30/21

5/27/21

None

Zoloft

None

Diabetes, Hypoglycemia

None

The first dose of vaccine (lot number EW0176) was taken on 05/06/2021, and the second dose of vaccine (lot number EW0186) was taken on 05/27/2021. within 12 hours of second does she had gotten severe headache, she couldn’t eat for severe vomiting, she said she felt like she was hit by a truck, and had the chills. she would go from really cold to really hot. She couldn’t keep anything down even water. On the third day after the vaccine she was very sick and we ( the family) thought she was sleeping but when we went to try and wake her up we discovered her dead.

1474054

7/15/21

COVID19

JANSSEN

6/9/21

3/1/21

6/9/21

100

Heart attack 06/10/2020 widow maker stints put in and at age of 21 had a brain aneurysm. He died 6/9/2021. They didn?t ask if he had the vaccine. So how are they to know the correct numbers if they aren?t asking if he had the vaccine or not. He had the Johnson and Johnson vaccine in March and then died 3 months later. People with underlying health issues shouldn?t be getting them!

UNK

None stated.

1475006

7/15/21

COVID19

PFIZER\BIONTECH

6/30/21

5/27/21

6/22/21

Divalproex, Vyvanse, Risperidone, multivitamin, vitamin D3

None

ADHD, Epilepsy, Anxiety, Microcephalus, Autism, urinary incontinence, incontinence of feces

NKA

Pt. started coughing Tuesday, June 22, 2021, in the afternoon and it worsened through the rest of day. She also was beginning to be drowsy. Wednesday, June 23, 2021, coughing continued, she became drowsier, she felt warm to the touch (forehead, face, arms, back) and was not acting like herself. Thursday, June 24, 2021, 9am she was at the clinic. The doctor ordered an x-ray and blood work. After results arrived, we were advised to go to the emergency room. There the doctor ordered CT scan. The results showed an abscess and fluid in her left lung and pneumonia. Her lung was drained, was not able to get all of it out. They discussed surgery but needed to send pt. to ER. The discussion for surgery was a daily thing but never happened. They tried multiple procedures, CT scans, etc. On Tuesday, June 29, 2021 there was a meeting called with her doctor to discuss palliative care. The risk of surgery and all the complications following were high risk. Pt. did not understand that she needed to leave the IV and drainage tube in as well as leaving the oxygen on. Based on the complications and pts. quality of life after surgery and the fact that the fluid and pneumonia spread quickly throughout her body – the doctors were leaning towards end-of-life comfort. It all happened so fast! The evening of the 29th, pt. was transported home to end her life on hospice. On Wednesday, June 30, 2021 pt. passed away in the afternoon. Pt. was rarely ever sick. Once in a great while she would get a runny nose or little cough. Everyone around her would catch a virus and she simply would not. We had a member of our family test positive for COVID-19 in November 2020, and pt. never showed any symptoms of being ill. This was all before she received the COVID-19 Vaccine. About a week or two after she received the second vaccine, on May 27,2021. she had increased behaviors with eating and daily ADLs. But the behaviors were her ?normal? behaviors that would occasionally come and go. Nothing was ever persistent. Then on Tuesday June 22, 2021 when sick like symptoms started to appear it was less then four weeks after the second vaccine.

1475006

7/15/21

COVID19

PFIZER\BIONTECH

6/30/21

5/27/21

6/22/21

Divalproex, Vyvanse, Risperidone, multivitamin, vitamin D3

None

ADHD, Epilepsy, Anxiety, Microcephalus, Autism, urinary incontinence, incontinence of feces

NKA

1475434

7/15/21

COVID19

PFIZER\BIONTECH

7/13/21

7/7/21

7/13/21

unknown

enlarged heart

unknown

The patient died 6 days after receiving dose #2

1478327

7/16/21

COVID19

JANSSEN

7/4/21

5/27/21

6/11/21

colace and famotidine

ilieus , GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS, BENIGN PROSTATIC HYPERPLASIA WITH LOWER URINARY TRACT SYMPTOMS, PARKINSON’S DISEASE, QUADRIPLEGIA, NONTRAUMATIC INTRACEREBRAL HEMORRHAGE

morphine

PE diagnosed 6/11/21 death 7/4/21

1478393

7/16/21

COVID19

PFIZER\BIONTECH

6/20/21

6/15/21

6/20/21

None

UNK

PT was found on floor in dining room expired by wife on 6/20/21 at approximately 7:30. Body was hard and cold. Called EMS immediately , EMS provided treatment. Declared dead. Body taken to coroner for autopsy.

1478430

7/16/21

COVID19

PFIZER\BIONTECH

5/20/21

4/25/21

4/29/21

None

medication for PTSD,

None

PTSD, bipolar

None

The lot number for the first dose of vaccine was taken on 04/06/2021is: EW0153, and the lot number for the second dose of vaccine that was taken on 04/25/2021 is: EW0162. He started swelling really bad, and the mortician said all of his organs were very swollen. He was in terrible mental condition, he couldn’t think. He had so much swelling that his feet were blue. He was so swollen in his brain he couldn’t make basic cognitive decisions. His chest was so swollen his chest was up to almost double his normal size. He was under severe mental strain to the point that it took him 14 hours to make a 10 hour drive. He was dealing with maratil strain and shot himself on 05/20/2021.

1481758

7/18/21

COVID19

MODERNA

6/18/21

6/13/21

6/18/21

passed away; blood in lungs; This spontaneous case was reported by a pharmacist and describes the occurrence of DEATH (passed away) and PULMONARY HAEMORRHAGE (blood in lungs) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced DEATH (passed away) (seriousness criteria death and medically significant) and PULMONARY HAEMORRHAGE (blood in lungs) (seriousness criteria death and medically significant). The patient died on 18-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. Company Comment: Very limited information regarding the events has been provided at this time. Further information is expected.; Sender’s Comments: Very limited information regarding the events has been provided at this time. Further information is expected.; Reported Cause(s) of Death: unknown cause of death

1481796

7/18/21

COVID19

MODERNA

UNK

Toxic effects of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TOXICITY TO VARIOUS AGENTS (Toxic effects of Moderna vaccine) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOXICITY TO VARIOUS AGENTS (Toxic effects of Moderna vaccine) (seriousness criterion death). The reported cause of death was toxic effects of moderna vaccine. It is unknown if an autopsy was performed. No relevant concomitant medications were reported. No treatment information was provided. Company comment: Very limited information regarding this event has been provided at this time. Critical details including medical history, concomitant medication, date of vaccine administration and the event term, and cause of death is required for further assessment.; Sender’s Comments: Very limited information regarding this event has been provided at this time. Critical details including medical history, concomitant medication, date of vaccine administration and the event term, and cause of death is required for further assessment.; Reported Cause(s) of Death: Toxic effects of Moderna vaccine

1483122

7/18/21

COVID19

PFIZER\BIONTECH

6/28/21

6/10/21

6/1/21

Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No

Received first dose on 27May2021/ received second dose on 10Jun2021; he had a massive heart attack; This is a spontaneous report from a contactable consumer (patient parent). A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EW0176, on 10Jun2021 at single dose (at the age of 36-year-old) for COVID-19 immunization. Medical history and concomitant medication were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number : EW0176, on 27May2021 and experienced chest pain. Reporter stated Pfizer drug kill the patient yesterday (28Jun2021). He had a massive heart attack in Jun2021. The outcome of massive heart attack was fatal. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: he had a massive heart attack

1484524

7/19/21

COVID19

PFIZER\BIONTECH

7/18/21

6/9/21

6/30/21

a second COVID swab was done post-mortem, those results are pending

Potassium Chloride

acute kidney failure, acute respiratory failure, anemia, blepharitis, acidosis, encephalopathy, hyperkalemia, sepsis, and a previous COVID-19 diagnosis

developmentally delayed, seizures

unknown

death 18 days after vaccine

1484736

7/19/21

COVID19

PFIZER\BIONTECH

5/26/21

5/6/21

5/26/21

Anxiety, Depression

Pt.’s mother states that after receiving the 2nd dose of Phizer vaccine the Pt. collapsed 05/26/2021 and passed away. Currently waiting for Autopsy results.

1485423

7/19/21

COVID19

MODERNA

7/15/21

7/13/21

7/14/21

Mycophenolate mofetil, rituximab (last administered 4/2021), losartan, furosemide, metoclopramide, cyclobenzaprine, gabapentin, calcium carbonate

He had an ED visit for headaches (which resolved after administration of migraine cocktail), with normal head imaging.

Mixed connective tissue disease complicated by ILD (which was stable on most recent imaging and PFTs), pulmonary hypertension (with normal RVSP on recent echocardiogram), Raynaud’s , and sensory >> motor polyneuropathy.

NKDA

After his office visit with me on Tuesday 7/13, the patient went to get the Moderna COVID vaccine. He received the vaccine on Tuesday evening. On Wednesday, he developed new fevers as high as 104F (measured at home). Fevers improved with Tylenol. He did not report his symptoms, as per his wife, he assumed this was related to the COVID vaccine. By the following morning, his fevers had resolved. He took a nap midday, and shortly after waking, he reported to his wife that he was feeling short of breath. According to his wife, he appeared in respiratory distress and she heard wheezing. He asked to be helped to the ground, and she immediately called EMS. Unfortunately, before they could get him to a hospital, he died. At the hospital, his wife was told that because his death was outside the hospital, it was presumed to be due to “natural causes”. She was told an autopsy would cost $5000, which she could not afford.

1486071

7/20/21

COVID19

PFIZER\BIONTECH

7/19/21

7/9/21

none

None

General complaints of feeling unwell, no specific symptoms

DM 2

None

daily fever of 103.3, cough, diarrhea, chest pain, SOB, sore throat

1486784

7/20/21

COVID19

JANSSEN

6/11/21

4/8/21

4/9/21

None

Developmental delay since birth with limited speech and inability to read, Cardiac patent foramen ovale

None

UNK

Lower extremity deep vein thromboses, pulmonary thromboses, cerebral thromboses and hemorrhage, death

1486852

7/20/21

COVID19

PFIZER\BIONTECH

4/15/21

4/12/21

4/14/21

Terminal echo 30- 35 % EF WBC 43.3 ABG PH 6.8 BE-28

None

fever 101.6 for 3 days after vaccine

none

4/14/21 became confused and had cardiac arrest with seizure EMS called 1757 was taken to 2 hospitals with multiple resuscitation efforts and defibrillations declared deceased 0042 4/15/2021

1489530

7/21/21

COVID19

JANSSEN

UNK

PASSED AWAY; This spontaneous report received from a consumer via a company representative via social media concerned a 5 decade old male. The patient’s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported, expiry date: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient passed away due to vaccination. The cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender’s Comments: V0: 20210732113-COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

1490255

7/21/21

COVID19

MODERNA

7/21/21

4/21/21

7/21/21

Hypothyroidism, diabetes mellitus, depressive disorder, schizophrenia

Family reported patient had increased seizures after receiving vaccines. No documented hx of seizures prior to vaccines.

1490255

7/21/21

COVID19

MODERNA

7/21/21

4/21/21

7/21/21

Hypothyroidism, diabetes mellitus, depressive disorder, schizophrenia

Family reported patient had increased seizures after receiving vaccines. No documented hx of seizures prior to vaccines.

1490902

7/21/21

COVID19

PFIZER\BIONTECH

7/19/21

7/15/21

7/19/21

diphenhydrAMINE/lidocaine/aluminum hydroxide/magnesium hydroxide/simethicone mucous membrane suspen , HX SIG – FOR REFERENCE ONLY: SWISH AND SPIT 5 ML BY MOUTH EVERY TWO HOURS AS NEEDED FOR SORE THROAT, MOUTH IRRITATION OR PAIN, Mouth or th

Sarcoidosis with recurrent syncope and possible tachyarrhythmia, concern for possible cardiac vs CNS sarcoid (7/9/21) Bipolar disorder Chronic pain/opioid use

Opioid overdose and hospitalization (5/27/21) Asthma Autoimmune sensorineural hearing loss Bipolar disorder Constipation Elevated creatine kinase level Fibromyalgia Long term methotrexate user Low back pain Morbid obesity Neuropathy History of Non-Hodgkin lymphoma PTSD – Post-traumatic stress disorder Sarcoidosis Syncope Tachycardia

morphine (Anaphylaxis) immune globulin intravenous (Rash)

Pfizer COVID vaccine dose #2 administered 15 Jul 2021 @ 07:59. ED physician documentation on 19 Jul 2021: “37-year-old female came the emergency department after found down by her husband. Has a history of attempted overdose in the past,, she was found down by her husband at 545, and unresponsive on scene. Medic was on scene and patient was noted to be in V. fib and therefore CPR was started, compressions were in progress upon arrival, however the patient remained in cardiac arrest. Other history was able to be gathered from the patient or family, however EMS stated that they had found that her glucose was 99 on scene, and she been given full dose Narcan as well on scene. And was shocked 3 times a 200 J, she was given 2 doses of epinephrine, as well as 300 of amiodarone. They attempted to intubate the patient however the patient was clamped down, and therefore they could not pass any sort of apparatus to control the airway, therefore they placed a nasal trumpet. Pertinent physical exam findings: Jaw clamped shut, pupils fixed, and was obviously cyanotic, no palpable pulses. No chest rise. EKG as interpreted by me (ED attending): Monitor showed that the patient was in asystole the entire time. Medical Decision making and plan of care: Patient was immediately moved from gurney onto bed, and chest compressions were continued without interruption. Given that the patient was in V. fib in the field, we did decide to place dual pads for dual sequential defibrillation, is on the plats however, the patient was noted to be in asystole, therefore chest compressions were continued, epinephrine, as well as calcium, as well as bicarb. See code chart for further details. IO was also placed in the patient’s left proximal tibia. Regarding the patient’s airway, several attempts were made to pass an ET tube, as well as paralyzed the patient with rocuronium, however tube passing was unsuccessful, and therefore I performed a cricothyrotomy. Followed by bilateral finger thoracostomies. See procedure notes below for further details. Despite 5 rounds of ACLS, with multiple doses of epinephrine, as well as bicarb and calcium carbonate administered, the patient remained in cardiac arrest, death was declared at 1851.”

1497990

7/23/21

COVID19

PFIZER\BIONTECH

7/4/21

3/24/21

7/4/21

102

Death

1498078

7/23/21

COVID19

MODERNA

7/19/21

1/23/21

7/18/21

176

None

He passed away in the bathroom very suddenly. Never had any medical issues.

1498080

7/23/21

COVID19

PFIZER\BIONTECH

7/22/21

7/18/21

7/22/21

none at this time

Lopressor 25mg BID

Diagnosed May 2021 hypertrophic cardiomyopathy

unknown

7/22/2021 Child collapsed on soccer field while playing soccer at a local camp. CPR was initiated immediately. EMS arrived and found patient in vtac. Shock x 5. ACLS, intubation attempted. Transported to Medical Center. Patient had covid in April 2021. Dx in May 2021 hypertrophic cardiomyopathy. Started on lopressor 25mg BID. Patient had reported to parents that he had not recently taken his medications. Patient had his second covid vaccine on Sunday 7/18/2021.

1498080

7/23/21

COVID19

PFIZER\BIONTECH

7/22/21

7/18/21

7/22/21

none at this time

Lopressor 25mg BID

Diagnosed May 2021 hypertrophic cardiomyopathy

unknown

1499689

7/24/21

COVID19

PFIZER\BIONTECH

5/11/21

6/3/21

Temp: 36.9 C Resp: 40 HR: 141 BP: 185/136 O2: 97 CXR: abnormal 06/03/2021 EKG: abnormal 06/03/2021 sinus tachycardia, left atrial enlargement, right axis deviation, poor R wave progression nonspecific ST abnormalities. prolonged QT at 575 ECHO: abnormal 06/03/2021 EF is mildly reduced, 40-45% without any significant pericardial effusion. Respiratory Viral Panel: negative 06/03/2021 Urine Tox: neg proBNP: abnormal 5507 pg/mL Troponin: abnormal 2 ng/mL

N/A: Data collected from report pulled. Limited details available in report.

N/A: Data collected from report pulled. Limited details available in report. Report mentions cardiovascular disease, HTN,

N/A: Data collected from report pulled. Limited details available in report.

DX: Myocarditis Onset of S/S 06/02/2021 S/S:Dyspnea on exertion, Fever/chills,Tachypnea Found to have acute basilar ischemic stroke, taken for emergent thrombectomy, but experienced progressive edema and ultimately tonsillar herniation. 35 year old man with medical history notable for likely untreated hypertension and tobacco use disorder who presented with reported fever, confusion, shortness of breath, and facial swelling, initially treated for allergic reaction/angioedema without effect, progressed to respiratory failure, found to have acute basilar ischemic stroke, taken for emergent thrombectomy, but experienced progressive edema and ultimately tonsillar herniation resulting in death. Regarding cardiac picture, patient with abnormal ECG, mildly reduced EF on echo (though could be due to untreated hypertension or to respiratory failure/critical illness), borderline troponin (need to check reference range). ED note initially mentions concern for myocarditis due to vaccine causing heart failure and subsequent respiratory failure, but appears this piece was written prior to MRI showing basilar stroke. Death note has myocarditis listed as a cause of death (among many), though a bit unclear if this was intentionally listed or just reflects a list of all hospital problems. Also had a CT of his head which showed scattered foci of gas within intraorbital soft tissues along with mild proptosis; unclear etiology for this (perhaps a fall with facial injuries prior to arriving at hospital?) Awaiting additional physician notes/imaging reports.

1500191

7/24/21

COVID19

MODERNA

4/1/21

4/3/21

UNK

Death

1500834

7/24/21

COVID19

MODERNA

5/15/21

5/11/21

5/15/21

She got very sick, was already not feeling well before vaccine. She died may 15, 2021.

1500862

7/24/21

COVID19

PFIZER\BIONTECH

7/8/21

7/7/21

Antidepressants

Depression

None

On first day, patient was feeling tired, dizzy and foggy and 18 hours later was found dead on the floor.

1502047

7/26/21

COVID19

MODERNA

6/12/21

4/16/21

6/12/21

Autopsy report still pending for 4-5 months.

Vyvanse 40 mg

sports ashthma

allergic to bee stings and mosquito bites. She got bit up by mosquito’s on Sunday June 6, 2021 the bites swelled up but she wouldn’t put any antiseptic cream on them

Patient found deceased in her bed on june 12, 2021, reported to Strongsville Police Department at 10:15am., taken to Cuyahoga Medical Examiner’s Office the same day. Autopsy done. Results still pending for 4-5 months.

1502098

7/26/21

COVID19

PFIZER\BIONTECH

7/23/21

4/17/21

6/28/21

UNK

death D69.6 – Thrombocytopenia, unspecified N93.9 – Vaginal bleeding JAUNDICE BLOATED SHORTNESS OF BREATH

1505250

7/27/21

COVID19

PFIZER\BIONTECH

7/27/21

7/1/21

7/27/21

CBC, CMP normal except slightly elevated glucose COVID PCR negative

one dose of dramamine given in the evening prior to arrival.

none

none, remote history of asthma

none

UNK

patient arrived in ventricular tachycardia via EMS, but responsive. deteoriarated to pulseless ventricular tachycardia, PEA and ultimately death.

1505509

7/27/21

COVID19

MODERNA

7/17/21

5/18/21

7/9/21

Prescription Vitamin D

Patient is deceased.

1509872

7/28/21

COVID19

PFIZER\BIONTECH

4/10/21

4/4/21

4/10/21

Unknown hospital would have these.

Prilosec, and normal vitamins

None

None except pain meds make me nausea

I died at home in the morning of April 10th at approx. 10:30 am my husband had to give me CPR and revive me. Then in rescue squad I died again and the EMTs had to revive me. Then at the hospital i was in the Trauma room, they sent me to get a CT Scan and I died for 5 minutes on the CT table. Then spent 3 days in a medical comma on a ventilator in ICU, then 4 days in a hospital room.

1510268

7/28/21

COVID19

JANSSEN

7/14/21

7/6/21

7/7/21

Autopsy pending, I am reporting by report only. I did not give the vaccine, and the patients mother has given the information I have. She felt very bad for days after the vaccine, and then went to sleep and apparently had a seizure and died. She was otherwise heatlthy with no seizure history at all. Death date is assumed per patients mothers report, we cannot confirm at this time.

sprintec ocp. xanax prn 1 mg.

none known

anxiety, ptsd

nkda

UNK

Patient died.

1511613

7/29/21

COVID19

MODERNA

7/8/21

weakness; difficulty breathing; unable to move his legs; Lung problem; neuromyletis optica; This spontaneous case was reported by a consumer and describes the occurrence of NEUROMYELITIS OPTICA SPECTRUM DISORDER (neuromyletis optica), ASTHENIA (weakness), DYSPNOEA (difficulty breathing), HYPOKINESIA (unable to move his legs) and LUNG DISORDER (Lung problem) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROMYELITIS OPTICA SPECTRUM DISORDER (neuromyletis optica) (seriousness criteria death, hospitalization and medically significant), ASTHENIA (weakness) (seriousness criteria death and hospitalization), DYSPNOEA (difficulty breathing) (seriousness criteria death and hospitalization), HYPOKINESIA (unable to move his legs) (seriousness criteria death and hospitalization) and LUNG DISORDER (Lung problem) (seriousness criteria death and hospitalization). The patient was hospitalized on 09-Jun-2021 due to ASTHENIA, DYSPNOEA, HYPOKINESIA, LUNG DISORDER and NEUROMYELITIS OPTICA SPECTRUM DISORDER. The patient died on 08-Jul-2021. The reported cause of death was Neuromyelitis optica. It is unknown if an autopsy was performed. No concomitant medication was reported. The patient was placed on ventilator and had a tracheotomy tube. No treatment information was provided. No laboratory data was provided. Very limited information regarding the events has been provided at this time. Reporter did not allow further contact; Sender’s Comments: Very limited information regarding the events has been provided at this time.; Reported Cause(s) of Death: Neuromyelitis optica

1512561

7/29/21

COVID19

PFIZER\BIONTECH

5/9/21

2/24/21

5/8/21

Positive COVID test on 5/8/21

Patient received both doses of the Pfizer vaccine on 2/24/21 and 3/17/21. Patient came to the ER on 5/8/21 with chest pain, where she tested positive for COVID. While patient was receiving a precordial drain she went into V. tach but was successfully resuscitated. She went to ICU but went into cardiopulmonary arrest and died on 5/9/21.

1512561

7/29/21

COVID19

PFIZER\BIONTECH

5/9/21

2/24/21

5/8/21

Positive COVID test on 5/8/21

1512749

7/29/21

COVID19

PFIZER\BIONTECH

6/19/21

1/12/21

6/4/21

143

Anoxic brain injury, DVT, HTN, seizures, pulmonary embolism, severe TBI, chronic respiratory failure

39 Male tested positive 6/4/2021. Vaccinated with Pfizer 12/22/2021 & 1/12/2021. 6/4/2021 hospital admission for tracheo-esophageal fistula (TEF) transfer from hospital. Diminished breathing sounds, minimally conscious. Removed from ventilator support 6/17/2021. Problems at time of death 6/19/2021 – chronic respiratory failure, COVID-19, history of severe TBI, TEF, trach vent/PEG dependent.

1512749

7/29/21

COVID19

PFIZER\BIONTECH

6/19/21

1/12/21

6/4/21

143

Anoxic brain injury, DVT, HTN, seizures, pulmonary embolism, severe TBI, chronic respiratory failure

1513095

7/29/21

COVID19

PFIZER\BIONTECH

7/9/21

7/8/21

7/9/21

None

acetaZOLAMIDE 250 mg oral tablet, 250 mg, 1 tablet, ORAL, Daily amiodarone 200 mg oral tablet, 300 mg, 1.5 tablet, ORAL, qPM (once a day in the evening) dilTIAZem 240 mg/24 hours oral capsule, extended release, 240 mg, 1 capsule, ORAL, BI

Acute on chronic heart failure with preserved ejection fraction (HFpEF) Anemia due to blood loss Lymphedema Microcytic anemia scrotal bleeding

DM, PAF, GERD, Transgender, OSA , severe morbid obesity, asthma, depression

Peanuts, Topamax

UNK

Death. Died on 7-9-21 (approximately 24 hours after vaccine).

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Can someone die from taking a COVID-19 vaccine?

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