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From the 1/14/2022 release of VAERS data:

Found 22,193 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

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Case Details

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VAERS ID: 1593718 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure abnormal, Blood pressure measurement, Body temperature, Cardiac arrest, Chills, Coma scale, Dizziness, Dyspnoea, Fall, Head injury, Heart rate, Heart rate decreased, Interstitial lung disease, Loss of consciousness, Oxygen saturation, Oxygen saturation decreased, Pneumothorax, Respiratory rate decreased, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BAYASPIRIN; PREDNISOLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder; Hospitalisation; Interstitial pneumonia; Renal disease; Restlessness
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: BP; Result Unstructured Data: Test Result:not increased easily; Test Date: 20210709; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210712; Test Name: JCS; Result Unstructured Data: Test Result:100; Comments: During computerised tomography; Test Date: 20210712; Test Name: JCS; Result Unstructured Data: Test Result:300; Test Date: 20210712; Test Name: HR; Result Unstructured Data: Test Result:decreased; Test Date: 20210712; Test Name: SpO2; Result Unstructured Data: Test Result:70s %; Comments: with oxygen mask at 10 L; Test Date: 20210712; Test Name: Xp; Result Unstructured Data: Test Result:right pneumothorax; Test Date: 20210712; Test Name: Xp; Result Unstructured Data: Test Result:Alleviated pneumothorax
CDC Split Type: JPPFIZER INC202101051319

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21123477. An 87-year and 5-month-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0201, Expiration date 30Sep2021) via an unspecified route of administration on 09Jul2021 (the day of vaccination, at age of 87 years old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included heart disease and kidney disease. The patient had been admitted and treated for interstitial pneumonia from 03Jun2021 to 25Jun2021; patient with strong restlessness was discharged. Body temperature before vaccination was 36.3 degrees Centigrade on 09Jul2021. The patient family history was not reported. Concomitant medications included acetylsalicylic acid (BAYASPIRIN) as a blood thinner, and oral prednisolone (PSL; PREDNISOLONE). On 18Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 10Jul2021 (1 day after the vaccination), the patient experienced interstitial pneumonia. On 11Jul2021 (2 days after the vaccination), the patient was admitted to the reporting physician''s hospital. On 12Jul2021 (3 days after the vaccination), the patient died. The outcome of the event was fatal. The course of the event was as follows: On 09Jul2021 (the day of vaccination), the patient received the second dose of COVID-19 vaccine. On 10Jul2021 (1 day after the vaccination), the patient presented with dizziness, chills and dyspnoea. The patient fell down three times, and hit the back of the head. Neither wound nor queasy was present. On 11Jul2021 (2 days after the vaccination), dizziness, chills and dyspnoea persisted. However, the patient did not visit hospital or consult on the phone. He kept an eye on his own symptoms. As the symptoms persisted even at night, the patient visited the reporting physician''s hospital after contacting by phone. On 12Jul2021 at 03:00 (3 days after the vaccination), after hospitalization, respiratory condition was gradually aggravated. Oxygen saturation (SpO2) was 70s% even with oxygen mask at 10 L, so nurse call was answered. A call was made to the patient''s eldest son. Informed consent (IC) was done, and Do Not Attempt Resuscitation (DNAR) was reaffirmed. Central venous catheter (CV) was inserted. After CV insertion, right pneumothorax was revealed through X-ray photograph (Xp) performed for confirmation. During computerised tomography (CT), level of consciousness depressed at 100 on Japan Coma Scale (JCS). Shortly after returning the room, drainage for right pneumothorax was performed using a CV tube. Approximately 500 cc air was drained. Pneumothorax was confirmed to be alleviated by Xp later. Urgent drainage made lung expansion. However, blood pressure (BP) was not increased easily, level of consciousness was at 300 on JCS, heart rate (HR) decreased, breathing became feeble. Then, the patient went into cardiac arrest (arrest). Despite DNAR, cardiopulmonary resuscitation (CPR) was performed; however, the patient did not come back to life. As natural course, the death was confirmed at 07:03. Events Interstitial pneumonia, dizziness, chills, dyspnoea reported hospitalized from 11Jul2021 to 12Jul2021. Events Interstitial pneumonia, dizziness, chills, dyspnoea, right pneumothorax resulted in physician office visit. Treatment received for events Interstitial pneumonia, cardiac arrest, dizziness, chills, dyspnoea, right pneumothorax, Oxygen saturation (SpO2) was 70s%. The outcome of events Interstitial pneumonia and cardiac arrest was fatal, the event right pneumothorax was recovering, while of the other events was unknown. It was not reported if an autopsy was performed. The reporting physician classified the event interstitial pneumonia as serious (hospitalization) and assessed it was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was interstitial pneumonia. Reporter comment: The patient had been admitted and treated for interstitial pneumonia from 03Jun2021 to 25Jun2021. Then, the patient with strong restlessness was discharged. Due to aggravated respiratory condition, he was readmitted on 11Jul2021. The patient had been taking oral prednisolone (PSL; PREDNISOLONE).; Reported Cause(s) of Death: cardiac arrest; Interstitial pneumonia.


VAERS ID: 1593719 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-31
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood pressure decreased, Blood pressure measurement, Blood sodium, Body temperature, C-reactive protein, Computerised tomogram, Heart rate, Ileus, Radioallergosorbent test, Vital signs measurement, White blood cell count, pH body fluid
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal obstruction (narrow), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blister (blisters of lower limbs (unknown cause)); Epilepsy; Ileus (At the age of 25, the patient had undergone laparotomy for ileus due to pica.); Ileus adhesive; Laparotomy (At the age of 25, for ileus due to pica.); Pica (At the age of 25, the patient had undergone laparotomy for ileus due to pica.); Psychomotor development impaired; Psychosomatic disease; Seafood allergy (possibility of seafood allergy (3.56 for shrimps and 3.60 for crabs on RAST)
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: auscultation; Result Unstructured Data: Test Result:Sound in the abdomen was weak; Comments: with metallic sound; Test Date: 20210801; Test Name: BP; Result Unstructured Data: Test Result:75/44; Comments: after examinations; Test Date: 20210801; Test Name: BP; Result Unstructured Data: Test Result:97/64; Test Date: 20210801; Test Name: BP; Result Unstructured Data: Test Result:decreased were noted during the surgery; Test Date: 20210731; Test Name: Na; Result Unstructured Data: Test Result:140; Test Date: 20210726; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination; Test Date: 20210731; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210801; Test Name: CT; Result Unstructured Data: Test Result:ileus was diagnosed; Comments: At 10:45; Test Date: 20210731; Test Name: CRP; Result Unstructured Data: Test Result:1.52; Test Date: 20210731; Test Name: HR; Result Unstructured Data: Test Result:70s; Test Date: 20210731; Test Name: pH; Result Unstructured Data: Test Result:7.389; Test Name: RAST; Result Unstructured Data: Test Result:3.56 for shrimps and 3.60 for crabs; Test Date: 20210801; Test Name: vital signs; Result Unstructured Data: Test Result:poor vital signs; Comments: such as blood pressure decreased; during the surgery; Test Date: 20210731; Test Name: WBC; Result Unstructured Data: Test Result:9500
CDC Split Type: JPPFIZER INC202101056683

Write-up: This is a spontaneous report from a contactable physician received via Regulatory Authority; the Regulatory Authority report number is v21123584. A 50-year and 7-month-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 26Jul2021 09:52 (Batch/Lot Number: EY4834; Expiration Date: 31Aug2021) at the age of 50-year-old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications including antiepileptic agent within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included repeated blisters of lower limbs (unknown cause), suggestive of a possibility of seafood allergy (3.56 for shrimps and 3.60 for crabs on radioallergosorbent test [RAST]) (no history of immediate reaction). Other medical history included delayed psychomotor development of unknown cause, severe psychosomatic disease, epilepsy, ileus, pica, and ileus adhesive. At the age of 25, the patient had undergone laparotomy for ileus due to pica. After that, the patient had a history of several episodes of ileus adhesive, which had been improving with conservative therapy at each time. The patient family history has nothing in particular. On 05Jul2021, at the age of 50-year-old, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. On 26Jul2021 at 09:52 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection. Body temperature before vaccination was 36.1 degrees Centigrade. On 31Jul2021, the patient experienced ileus. The event resulted in emergency room/department or urgent care, hospitalization and death. The patient was hospitalized on 01Aug2021 and discharged on 02Aug2021. On 01Aug2021 (6 days after the vaccination), the patient died. The outcome of the event was fatal with treatment including partial intestinal tract resection, and the intensive care such as artificial respiration management and vasopressor administration. The course of the event was as follows: On 31Jul2021 at around 05:00 (5 days after the vaccination), 2 episodes of yellow bloody vomiting, and abdominal distension developed. Enema administration enabled a large amount of soft feces excretion. Body temperature (BT) was 36.2 degrees Centigrade, and heart rate (HR) was 70s. Laboratory data included that white blood cell count (WBC) was 9500, C-reactive protein (CRP) 1.52, pH 7.389, and sodium (Na) 140. Fluid replacement was initiated, and then the patient was given nothing to eat. In the afternoon, enema was administered again, but there was a small amount of feces reaction. Although abdominal distension was improved, tense abdomen persisted. On 01Aug2021 at 01:25, enema was administered as tense abdomen persisted, and a large amount of normal feces was observed. Afterward, the patient had 4 episodes of bile-like vomiting. At 06:00, gastric tube was inserted. Air and 590 mL of bile-like fluid were drained. Sound in the abdomen was weak with metallic sound. Fluid replacement challenge was initiated. At 10:45, computerised tomography (CT) was performed, and ileus was diagnosed. After examinations, blood pressure (BP) decreased to 75/44, for which extracellular fluid challenge was given at the maximum dose, then BP was improved to 97/64. The patient was transported to another hospital, where he underwent laparotomy for partial intestinal tract resection. However, poor vital signs such as blood pressure decreased were noted during the surgery. Despite the intensive care including catecholamine at higher than maximum dose, the patient could not be saved. On 02Aug2021, the patient was discharged dead from the hospital. Autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19. The reporting physician classified the event as serious (Death, Hospitalized) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases: ''''At the age of 25, the patient had undergone laparotomy for ileus due to pica. After that, the patient had a history of several episodes of ileus adhesive, which had been improving with conservative therapy at each time. '''' The reporting physician commented as follows: With having delayed psychomotor development of unknown cause, he was a severe psychosomatic disease patient, currently treated with bed rest and in need of total assistance. The patient had a history of laparotomy, and ileus was repeated. For that, bowel management such as enema and faecal disimpaction was continued for days. At this time, the event abruptly occurred without any symptoms until the previous day. Causality with BNT162b2 vaccine was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: blood pressure decreased; ileus


VAERS ID: 1593720 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-03
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Dyspnoea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Cardioembolic stroke; Ischaemic heart disease; Stent placement (4 to 5 years before)
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101058245

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21123517. The patient was an 83-year and 1-month-old male. Body temperature before vaccination was 36.3 degrees centigrade on 27Jul2021. The family history was not provided. The patient had medical histories of cardioembolic stroke, cardiac stent placement, ischaemic heart disease, and angina pectoris. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) for COVID-19 immunisation. On 27Jul2021 at 10:48 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) via an unspecified route of administration as a single dose at the age of 83-year-old for COVID-19 immunization. On 03Aug2021 at 04:00 (6 days/17hours/12 minutes after the vaccination), the patient experienced dyspnoea. On 03Aug2021 (7 days after the vaccination), the outcome of the event was fatal. It was unknown if an autopsy was performed. The course of the event was as follows: The patient underwent cardiac stent placement 4 to 5 years before. After the patient was admitted to the reporting hospital, he complained of chest pressure sensation several times; however, the symptom did not persist, and he was followed up. On 02Aug2021 (6 days after vaccination), in the morning, although the patient had chest symptom, no obvious objective findings were observed. On 03Aug2021, at around 04:00 (6 days, 17 hours, and 12 minutes after vaccination), the patient complained of dyspnoea. At 04:10 (6 days, 17 hours, and 22 minutes after vaccination), when the patient was examined by the doctor on duty, he had cardio-respiratory arrest. Although cardiopulmonary resuscitation (CPR) was performed for approximately 1 hour, no return of spontaneous circulation was obtained. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was ischaemic heart disease. The reporting physician commented as follows: The patient had medical history of ischaemic heart disease. However, the event occurred 1 week after the vaccination, and thus, it could not be ruled out that the event was a side reaction.; Reported Cause(s) of Death: Dyspnoea; Cardio-respiratory arrest


VAERS ID: 1593721 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101058278

Write-up: This is a spontaneous report from a contactable physician received via sales representative. A 58-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown), via an unspecified route of administration on 14Aug2021 at age of 58-year-old as single dose for covid-19 immunisation. The patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) on unknown date for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 14Aug2021 (the same day of the vaccination), the patient experienced death. The outcome of the event was fatal. Cause of death was not reported. It was not reported if an autopsy was performed. The reporting physician''s seriousness and causality assessment of the event was not reported. The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender''s Comments: The causal relationship between bnt162b2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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: Death.


VAERS ID: 1593722 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood glucose abnormal, Blood pressure fluctuation, Blood pressure measurement, Body temperature, Chills, Fatigue, Heart rate, Oxygen saturation, Pyrexia, Respiratory arrest, Tremor, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-13
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRAZENTA; THYRADIN S; POLYFUL; CALCIUM LACTATE; CELECOXIB; REBAMIPIDE; FUROSEMIDE; AZILVA; AMLODIPINE BESILATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Osteoporosis; Trochanteric femoral fracture (was admitted to the reporting hospital on 22Jun2021 for rehabilitation after surgery); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210813; Test Name: blood sugar; Result Unstructured Data: Test Result:245; Comments: at 22:30; Test Date: 20210813; Test Name: blood pressure; Result Unstructured Data: Test Result:101/56; Comments: at 08:00; Test Date: 20210813; Test Name: blood pressure; Result Unstructured Data: Test Result:75/50; Comments: at 20:00; Test Date: 20210813; Test Name: blood pressure; Result Unstructured Data: Test Result:85/66; Comments: at 21:20; Test Date: 20210813; Test Name: blood pressure; Result Unstructured Data: Test Result:131/70; Comments: at 22:30; Test Date: 20210812; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210812; Test Name: body temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Comments: at 15:00; Test Date: 20210812; Test Name: body temperature; Result Unstructured Data: Test Result:39.4 Centigrade; Comments: at 16:35; Test Date: 20210812; Test Name: body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Comments: at 20:00; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Comments: at 07:00; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Comments: at 10:00; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Comments: at 14:00; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:38.9 Centigrade; Comments: at 20:00; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Comments: at 21:20; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Comments: at 22:30; Test Date: 20210813; Test Name: pulse rate; Result Unstructured Data: Test Result:120; Comments: at 20:00; Test Date: 20210813; Test Name: pulse rate; Result Unstructured Data: Test Result:67; Comments: at 22:30; Test Date: 20210813; Test Name: pulse rate; Result Unstructured Data: Test Result:40s; Comments: at 22:45; Test Date: 20210812; Test Name: SpO2; Test Result: 97 %; Comments: at 20:00; Test Date: 20210813; Test Name: SpO2; Test Result: 97 %; Comments: at 07:00; Test Date: 20210813; Test Name: SpO2; Test Result: 99 %; Comments: at 08:00; Test Date: 20210813; Test Name: SpO2; Test Result: 88 %; Comments: at 20:00; Test Date: 20210813; Test Name: SpO2; Result Unstructured Data: Test Result:88 to 94 %; Comments: at 21:20; Test Date: 20210813; Test Name: SpO2; Result Unstructured Data: Test Result:88 to 96 %; Comments: at 22:30
CDC Split Type: JPPFIZER INC202101058606

Write-up: Respiratory arrest; blood pressure was 101/56, 75/50, 85/66, 131/70; upper navel pain; Pyrexia of 39.4 degrees Celsius; Chills; Tremor; Fatigue; Vomiting; This is a spontaneous report from a contactable nurse received from the Regulatory Authority. The regulatory authority report number is v21123564. An 89-year and 1-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 12Aug2021 at 10:10 (the day of vaccination) (Lot number FC8736, Expiration date 30Sep2021) at the age of 89 years, as dose 1, single for COVID-19 immunization. The patient had medical histories of type 2 diabetes mellitus, osteoporosis, and hypertension. On 22Jun2021, the patient was admitted to the reporting hospital for rehabilitation after surgery for right trochanteric femoral fracture (at another hospital). The concomitant medications included oral linagliptin (TRAZENTA), oral levothyroxine sodium (THYRADIN-S), oral polycarbophil calcium (POLYFUL), oral calcium lactate, oral celecoxib, oral rebamipide, oral furosemide, oral azilsartan (AZILVA), and oral amlodipine besilate. Body temperature before vaccination was 36.3 degrees centigrade. On 12Aug2021 at 16:35 (6 hours and 25 minutes after the vaccination), the patient experienced pyrexia of 39.4 degrees Celsius, chills, fatigue, tremor, and vomiting. On 13Aug2021 at 07:00 (20 hours 50 minutes after the vaccination), the patient experienced upper navel pain. On 13Aug2021 at 22:47 (one day and 12 hours 37 minutes after the vaccination), the patient experienced respiratory arrest. On 13Aug2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 12Aug2021, 11:30, the patient took one pack of Mei Balance Mini as a side dish. At 15:00, the body temperature was 37.3 degrees Celsius, and the patient had no symptoms. At 16:35, the body temperature was 39.4 degrees Celsius, and the patient had chills, tremor, and fatigue, and she vomited a small amount of food component. The patient was instructed to orally take acetaminophen (CALONAL). The patient had vomiting again, and she was unable to orally take the drug. The patient did not eat dinner. At 20:00, the body temperature was 37.8 degrees Celsius, and the SpO2 was 97%, and no fatigue, queasy, or vomiting was noted. On 13Aug2021, at 07:00, the body temperature was 38.3 degrees Celsius, the SpO2 was 97%. No pulmonary sound was heard, no queasy was noted, and upper navel pain was noted. At 08:00, when the patient drunk a half bottle of milk for breakfast, she vomited a small amount. The blood pressure was 101/56, the SpO2 was 99%. At 10:00, the body temperature was 37.3 degrees Celsius. The patient took a pack of Mei Balance Mini and a pudding for lunch. At 11:30, administration of TRIFLUID 500 and metoclopramide hydrochloride was performed. At 14:00, the body temperature was 37.9 degrees Celsius, and no queasy was noted. Administration of SOLULACT 500 was performed. At 20:00, the body temperature was 38.9 degrees Celsius, the pulse rate was 120, the blood pressure was 75/50, and the SpO2 was 88%. The patient responded to being called. Pulmonary sound were observed and aspiration was performed. An oxygen 5 L was initiated with reservoir. At 21:20, the body temperature was 38.5 degrees Celsius, the SpO2 was 88-94%, the blood pressure was 85/66. The patient had nodding of head. Administration of meropenem hydrate (MEROPENEM) 0.5 g was performed. At 22:30, the body temperature was 37.8 degrees Celsius, the SpO2 was 88-96%, the blood pressure was 131/70, and the pulse rate was 67. The respiration was calm. The blood sugar was 245. At 22:45, the pulse rate was 40s on the monitor. At 22:47, the patient had respiratory arrest. Cardiac massage was performed, and administration of (illegible character), VEEN-D 500, an intravenous injection of etilefrine hydrochloride (EFFORTIL) 1/2 A, administration of physiological saline 100, and dopamine hydrochloride (INOVAN INJECTION) 1A were initiated. At 23:26, the patient was confirmed to die (at 23:20, the family members arrived). Outcome of respiratory arrest was fatal, of all other events was unknown. The reporting other healthcare professional (nurse) classified the event as serious (death) and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: respiratory arrest


VAERS ID: 1593723 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101070070

Write-up: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 73-year-old female patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported), via an unspecified route of administration on 03Aug2021 (the day of vaccination), as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Aug2021, the patient died. The cause of death was not reported. It was unknown if an autopsy was performed. The inoculator (physician) requested the detail information to the patient family. Information regarding lot/batch number has been requested.; Sender''s Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of unknown cause of death cannot be 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1593809 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, International normalised ratio increased, Rash macular
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101045730

Write-up: This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00661089. An 81-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on 14Apr2021 as dose 2, single for COVID-19 immunization. Medical history included myocardial infarction from an unknown date. Concomitant medications include unspecified anticoagulants from 2015. The patient had no previous COVID-19 infection. The patient previously received the first dose of BNT162B2 (COMIRNATY), on 10Mar2021, for COVID-19 immunization and experienced INR increased. The patient experienced cerebral bleeding, blood values too high after first and second vaccination/INR increased, and little red dots on his skin on an unspecified date. The patient was hospitalized for the events. The patient died in the hospital on 02May2021. It was not reported if an autopsy was performed. Information on the batch/lot number has been requested.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty):yes. ADRs: Blood values at thrombosis clinic too high Date:10Mar2021 Diagnostic procedures:No, the sudden death from the brain haemorrhage has not been associated with the vaccination by the hospital.I did see that after the first injection my father''s blood values started to fluctuate and after the second he died.After his death I saw small red dots on his skin.; Reported Cause(s) of Death: INR increased; Little red dots on his skin; cerebral hemorrhage


VAERS ID: 1593811 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chills, Fatigue, Gastrointestinal haemorrhage, Malaise, Mouth haemorrhage, Myalgia, Pulmonary haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Ischaemic colitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADALAT; LORAZEPAM; VITAMIN D [COLECALCIFEROL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (no longer since Sep2020 after osmotic demyelination); Cardiac disorder; Hyponatraemia; Osmotic demyelination syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101054646

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00662069. A 46-year-old male patient received the second dose of bnt162b2 (COMIRNATY) on 21Jul2021 (lot number: FF0688) via unknown route of administration at single dose for COVID-19 immunisation. Medical histories included hyponatraemia; Osmotic demyelination syndrome; Alcohol abuse from unknown date to Sep2020 (no longer since Sep2020 after osmotic demyelination); Cardiac disorder. Concomitant medications included nifedipine (ADALAT); lorazepam; colecalciferol (VITAMIN D). Previous COVID-19 infection was reported as No. Patient received the first dose of bnt162b2 (COMIRNATY) on 16Jun2021 via unknown route of administration at single dose for covid-19 immunisation and experienced No adverse event. Patient experienced Myalgia, Not feeling well, Cold chills, Fatigue; both on 28Jul2021. See above, possible gastrointestinal/lung hemorrhage, although no blood seen in bed or on outside. DD cardiac arrest. Patient was found deceased 9 days on 30Jul2021 after 2nd vaccination, old blood in mouth, possible gastric bleeding. 2 days before death not well with earlier mentioned complaints, patient did not want to see a general practitioner despite family contacting the practice about this. Of course it cannot be determined that there is a relation with the (2nd) vaccination. Patient also used nifedipine, vitamin D and once daily Lorazepam. Patient had no cardiac history, but was familiar with rehabilitation after osmotic demyelination upon correction of hyponatremia. Could live independently again. In history alcohol abuse, but not since Sep2020 after osmotic demyelination. The outcome of events Patient was found deceased 9 days after 2nd vacc, old blood in mouth, possible gastric bleeding/ possible gastrointestinal/lung hemorrhage; lung hemorrhage; cardiac arrest was fatal. The outcome of other events was unknown. At autopsy no striking findings, mortician found old blood in mouth. Differential diagnosis: gastric bleeding? Sender Comment: Although vaccination date was given as 28Jul all reactions were reported with latency times in days, that consistently pointed towards a vaccination date of 21Jul, therefore adapted. Reporter''s Comments Text: Patient was found deceased 9 days after 2nd vacc, old blood in mouth, possible gastric bleeding. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Patient was found deceased 9 days after 2nd vacc, old blood in mouth, possible gastric bleeding.; Reported Cause(s) of Death: Patient was found deceased 9 days after 2nd vacc, old blood in mouth, possible gastric bleeding; lung hemorrhage; cardiac arrest; Patient was found deceased 9 days after 2nd vacc, old blood in mouth, possible gastric bleeding/ possible gastrointestinal.


VAERS ID: 1593812 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-07-15
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7082 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSARTAN; ALLOPURINOL; DISTIGMINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101056223

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00664825. A 74-year-old male patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 23May2021 (Batch/Lot Number: FA7082) as single dose for covid-19 immunisation. The patient medical history was not reported. Patient did not have COVID-19 infection previously. Concomitant medication included losartan; allopurinol and distigmine. The patient previously took first dose of BNT162B2 (COMIRNATY, strength: 0.3ml), via an unspecified route of administration on 18Apr2021 as single dose for covid-19 immunisation. On 15Jul2021, patient experienced sudden hard death: sudden death, without any reason/sudden cardiac death. The outcome of the event was fatal. The patient died on 15Jul2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden hard death: Sudden death, without any reason/Sudden cardiac death


VAERS ID: 1593832 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210838682

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority (PHIFDA, PH-PHFDA-300098943) concerned a 63 year old male with an unspecified race and ethnic origin. 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: 213C21A expiry: Unknown) dose was not reported, 1 total administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient experienced cough, difficulty breathing, covid infection. On an unspecified date, the patient died due to cough, (difficulty breathing), and covid infection. 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: 20210838682-COVID-19 VACCINE AD26.COV2.S- cough, (dob) difficulty breathing, COVID infection. 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: COUGH; DOB; COVID INFECTION


VAERS ID: 1593837 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-27
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Cough
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: Blood pressure; Result Unstructured Data: ELEVATED
CDC Split Type: PHJNJFOC20210838885

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300099469] concerned a 71 year old male of unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, and expiry: unknown) dose was not reported, with frequency time 1 total administered on 27-JUL-2021 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 27-JUL-2021, at 11:23 the patient experienced hypertension and cough. Laboratory data included: Blood pressure (NR: not provided) elevated. On an unspecified date, the patient died due to hypertension and cough. It was unknown, if an 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: V0:20210838885-COVID-19 VACCINE AD26.COV2.S-Hypertension, Cough. 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: HYPERTENSION; COUGH.


VAERS ID: 1593840 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-14
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, Death, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-18
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Hypertension
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210838972

Write-up: This spontaneous report received from a patient via a company representative concerned a 40 year old Asian male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included hypertension, and diabetes mellitus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 02-AUG-2021 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 14-AUG-2021, the patient experienced loss of smell and taste. On 18-AUG-2021, the patient experienced sudden breathing difficulty, rushed to the hospital and died on arrival at hospital due to unknown cause. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sudden difficulty of breathing, loss of smell and loss of taste was not reported. This report was serious (Death).; Sender''s Comments: V0: 20210838972-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


VAERS ID: 1593842 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Cough, Dyspnoea, Fatigue, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839013

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300098732] concerned a 74 year old male of unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: unknown) dose was not reported, 1 total administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 08:00, the patient experienced cough, fever, chest heaviness, easy fatigability, dyspnea and was hospitalized (date unspecified). On an unspecified date, the patient died from cough, fever, chest heaviness, easy fatigability, and dyspnea. It was unspecified whether the autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210839013-COVID-19 VACCINE AD26.COV2.S- cough, fever, chest heaviness, easy fatigability, dyspnea . 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: COUGH; FEVER; CHEST HEAVINESS; EASY FATIGABILITY; DYSPNEA.


VAERS ID: 1593843 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839052

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300098559] concerned a 39 year old female of unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the patient experienced dyspnea. On an unspecified date, the patient died from dyspnea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0- 20210839052-covid-19 vaccine ad26.cov2.s-Dyspnea. 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: DYSPNEA


VAERS ID: 1593850 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Autonomic neuropathy
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839363

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300098833] concerned a 71 year old female of unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) frequency 1 total , dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. Initially patient did not reported any symptoms after vaccination. On 04 -AUG-2021, the partner of the patient came home and saw patient was lying on the floor presenting symptoms similar to stroke. On an unspecified date, the patient died from cardiovascular disease (CVD). 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: 20210839363- COVID-19 VACCINE AD26.COV2.S- CVD. This event is considered unassessable. The event 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.; Reported Cause(s) of Death: CARDIOVASCULAR DISEASE (CVD).


VAERS ID: 1593851 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-27
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: ECG; Result Unstructured Data: flat line
CDC Split Type: PHJNJFOC20210839598

Write-up: This spontaneous report received from a consumer via a Regulatory Authority [PHIFDA, PH-PHFDA-30009850] concerned an 82 year old female of unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on 27-JUL-2021 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 27-JUL-2021, the patient experienced no symptoms or side effect. On 03-AUG-2021, Laboratory data included: ECG (NR: not provided) with result as flat line. On an unspecified date, the patient died from unconsciousness. It was unknown whether autopsy done or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210839598- COVID-19 VACCINE AD26.COV2.S- no symptoms or side effect. This event is considered unassessable. The event 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.; Reported Cause(s) of Death: UNCONSCIOUS


VAERS ID: 1593855 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210840799

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300098262] concerned a 77 year 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, intramuscular, batch number was not reported) dose was not reported, 1 total administered on 06-AUG-2021 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 08-AUG-2021, the patient was dead on arrival. The patient died from an unknown cause of death. 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: 20210840799-covid-19 vaccine ad26.cov2.s-dead on arrival. 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.


VAERS ID: 1593857 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Back pain, Chest pain, Decreased appetite, Diarrhoea, Irritability, Limb discomfort, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210838411

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300099516] concerned a 68 year old male of unspecified race and ethnic origin. 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, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, with frequency 1 total administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021, the patient experienced abdominal pain, diarrhea, injection site soreness, heaviness at the injection site, chest pain, irritable, back pain, decreased in appetite. On an unspecified date, the patient died from abdominal pain, diarrhea, injection site soreness, heaviness at the injection site, chest pain, irritable, back pain, and decreased in appetite. It was unspecified 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: 20210838411-COVID-19 VACCINE AD26.COV2.S -abdominal pain, diarrhea, injection site soreness, heaviness at the injection site, chest pain, irritable, back pain, decreased in appetite. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: ABDOMINAL PAIN; DIARRHOEA; INJECTION SITE SORENESS; HEAVINESS AT THE INJECTION SITE; CHEST PAIN; IRRITABLE; BACK PAIN; DECREASED IN APPETITE


VAERS ID: 1593867 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6029 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Cardiac arrest, Cardiopulmonary failure, Circulatory collapse, Myocardial infarction
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202101056255

Write-up: This is a spontaneous report from a contactable consumer (patient''s son) downloaded from the Regulatory Authority-WEB [PL-URPL-DML-MLP.4401.2.514.2021]. A 60-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 14Jul2021 (Lot Number: FE6029) (at the age of 60-year-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient weight: 75 kg and height: 168 cm and very good health. The patient experienced asystolia (24 hours after vaccination), heart attack (24 hours after vaccination), acute cardiopulmonary failure (24 hours after vaccination), acute circulatory and respiratory failure on 15Jul2021. Ambulance Service - CPR (cardiopulmonary resuscitation) - Asystolia. An autopsy was not performed. Additional information: No medications, no diseases of any kind, condition. The patient died on 15Jul2021. An autopsy was not performed. Sender Comment: Due to the close time relationship between the administration of the vaccine and the occurrence of side effects and the lack of known comorbidities, a causal relationship was assessed as possible. URPL, taking into account the death of the patient and the nature of the side effects, classified the report as severe. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: acute cardiopulmonary failure; Acute Circulatory and respiratory failure; Acute Circulatory and respiratory failure; Heart attack; Asystolia


VAERS ID: 1593901 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-07-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EC5435 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiorenal syndrome
SMQs:, Cardiac failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101054754

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This is a report received INFARMED regulatory authority report number PT-INFARMED-T202107-4277 with Safety Report Unique Identifier PT-INFARMED-T202107-4277. An 85-year-old female patient received bnt162b2 (COMIRNATY) (strength: 30 mcg/0.3 ml), intramuscular on 23Jun2021 (Batch/Lot Number: EC5435) as dose number unknown, 0.3ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cardiorenal syndrome on 01Jul2021. The patient presented a picture of cardiorenal syndrome associated with the use of bnt162b2 mRNA vaccine against COVID-19 (with modified nucleoside), 30 mcg/0.3 ml, concentrate for injectable dispersion, (lot EC5435), it is not known whether first or second dose, for active immunization to prevent COVID-19 caused by the SARS-CoV-2 virus, with dosage of two single doses of 0.3 mL (each), IM. Information on clinical history is unknown. Previous infection with the SARS-CoV-2 virus is unknown. The adverse reaction appeared approximately 8 days after the administration of the vaccine (01Jul2021) (it is not known whether in the first or second dose). According to the notifier, the reaction evolved to the patient''s death. Other information about patient admission, medical intervention/care, targeted treatment, or cause of death is unknown. The measure taken regarding suspension or compliance with the vaccination schedule is unknown. There is no suspicion of drug interactions. Information on previous reactions to other drugs or identified allergies is unknown. The need for specific treatment of the reaction is unknown. Additional data: No information on the cause of death was reported, or an autopsy report was made available. The patient died on 13Jul2021 (12 days after the reaction was identified). The type of relationship established by the notifier between the reported Cardiorenal syndrome reaction and the patient''s death is unknown. However, due to important information gaps, a request for clarification was made, with no response until the case was finalized. Evolution of ADR was death. The patient died on 13Jul2021. It was not reported if an autopsy was performed. The reporters assessment of the causal relationship of the [Cardiorenal syndrome] with the suspect product was [, Method of assessment: unknown, Result of Assessment: probable]. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiorenal syndrome.


VAERS ID: 1593902 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EC5435 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardiac failure, Cardiac index, Chronic obstructive pulmonary disease, Drug ineffective, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Lack of efficacy/effect (narrow), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive lung disease
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: CI; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210717; Test Name: SARS-CoV2 PCR; Test Result: Positive
CDC Split Type: PTPFIZER INC202101054750

Write-up: This is a spontaneous report from a contactable health care professional (nurse) downloaded from the Regulatory Authority -WEB. This is a report received from INFARMED Regulatory authority report number PT-INFARMED-T202107-4395. An 83-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3ml), intramuscular on 22Apr2021 (Batch/Lot Number: ET6956) as dose number unknown (it is unknown whether the first or second dose), 0.3 ml, single, and intramuscular from unspecified date at as dose number unknown (it is unknown whether the first or second dose), 0.3 ml, single (Batch/Lot Number: EC5435) for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease. The patient''s concomitant medications were not reported. Spontaneous notification refers to a case sent by a nurse about an elderly, male, 83 years old, who presents a picture of probable vaccine failure associated with the use of Comirnaty/mRNA vaccine against a COVID-19 (with nucleoside modified), 30 mcg / 0.3 ml, Concentrate for Injectable Dispersion, (lot EC5435), it is unknown whether the first or second dose, for active immunization to prevent COVID-19 caused by the SARS-CoV-2 virus, with the dosage of two single doses of 0.3 mL (each), IM. Clinical Background: Chronic Obstructive Pulmonary Disease. Previous infection with the SARS-CoV-2 virus is unknown. Vaccine failure was identified approximately 3 months after vaccine inoculation. According to the notifier, the virus infection led to hospitalization, and the patient died following hospitalization. There is no suspicion of drug interactions. Information on previous reactions to other drugs or identified allergies is unknown. The need for specific treatment of the violation by SARS-CoV-2 is unknown. Additional data: a test for the Detection of Nucleic Acids (amplification by PCR) of SARS-CoV2 was performed in a biological sample, with a positive result on 17Jul2021. The risky contact that could have been at the origin of this contagion is unknown. There was no information on the cause of death, or an autopsy report made available. The following information was corrected: patient had COPD (Chronic Obstructive Pulmonary Disease), HF (Unknown meaning), worsening of usual dyspnea within 1 week of evolution, was admitted to the ER (emergency room) due to altered conscious status and prostration. The patient died in the hospital on 17Jul2021 (at dawn). As information gaps became important, a request for clarification was made, with no response until the case was finalized. Evolution of RAM: death on 17Jul2021. Outcome of COPD and HF was unknown. It was unknown if an autopsy was performed. Reporter comment: Other information-day 17Jul2021- records in Trace, "CLHO": COPD, CI, worsening of usual dyspnea with 1 week of evolution, 17Jul2021 was admitted today due to altered state of consciousness and prostration (from the last 3 days). died at dawn on 17Jul2021, The reporter assessment of the causal relationship of the vaccination failure and SARS-CoV-2 test positive with the suspect product was: Relatedness of drug to reaction(s)/event(s):Vaccination faiure (death) and SARS-CoV-2 test positive Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: possible. No follow-up attempts are possible. No further information expected.; Reporter''s Comments: Other information-day 17Jul2021- records in Trace, CLHO : COPD, CI, worsening of usual dyspnea with 1 week of evolution, 17Jul2021 was admitted today to the SU HSFX due to altered state of consciousness and prostration (from the last 3 days). died at dawn on 17Jul2021; Reported Cause(s) of Death: SARS-CoV-2 test positive; vaccine failure probable.


VAERS ID: 1593921 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute leukaemia, Death
SMQs:, Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202101037724

Write-up: This is a spontaneous report from a contactable physician received via a sales representative. A 65-year-old male patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date in Jan2021 (batch/lot number was not reported) at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. After 5 days the patient was diagnosed with acute leukemia on an unspecified date in 2021. The patient''s medical history was not known if he had previous pathologies. The patient died on an unspecified date in 2021. The cause of death was unknown. It was not reported if an autopsy was performed. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: The association between the event death and acute leukemia can not be fully excluded based on the temporal relationship and limited information. 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: unknown cause of death.


VAERS ID: 1593922 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute leukaemia, Death
SMQs:, Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202101037726

Write-up: died; acute leukemia; This is a spontaneous report from a contactable physician via a sales representative. A 70-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration in Jun2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration in Jun2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included arterial hypertension. The patient''s concomitant medications were not reported. The patient had symptoms that required medical consult. He was diagnosed with acute leukemia. The relatives went to PRIVACY country with the patient for treatment. The outcome of acute leukemia was unknown. The patient died one month after vaccination. The patient died on an unspecified date. It was not reported if an autopsy was performed. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events of acute leukaemia and death cannot be totally excluded/assessed. The case will be reassessed if additional information becomes available. 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: died


VAERS ID: 1593965 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-02
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW5279 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug-induced liver injury, Encephalitis, Hepatic failure, Liver function test
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Malignant neoplasm of choroid; Metastases to kidney (choroidal malignant melanoma); Metastases to lung (choroidal malignant melanoma)
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarct
Allergies:
Diagnostic Lab Data: Test Date: 20210502; Test Name: Pathological liver tests; Result Unstructured Data: Test Result:drug-induced hepatitis; Comments: Assessed after investigation as drug-induced (ipilimumab/nivolumab) encephalitis and hepatitis.
CDC Split Type: SEPFIZER INC202101026740

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-067288. A 68-year-old male patient received a unknown dose number of bnt162b2 (COMIRNATY) via an unspecified route of administration on 28Apr2021 (Lot Number: EW5279) as single dose for covid-19 immunisation; nivolumab and ipilimumab both via intravenous from 01Apr2021 (Lot Number: unknown) to an unspecified date at an unknown dose and frequency for malignant melanoma. Medical history included myocardial infarction from 2014 and was not ongoing; he was diagnosed with choroidal malignant melanoma in the summer of 2019 (ongoing) and metastases to lung and kidney from Feb2021 and ongoing. The patient''s concomitant medications were not reported. The patient experienced drug-induced hepatitis and drug-induced encephalitis on 02May2021, and experienced liver failure in 2021. The action taken in response to the events for bnt162b2 was not applicable, for nivolumab and ipilimumab was unknown. Therapeutic measures were taken as a result of events drug-induced hepatitis and drug-induced encephalitis. The patient died from drug-induced hepatitis and drug-induced encephalitis and liver failure on an unspecified date. It was not reported if an autopsy was performed. The clinical course was reported as follows: The patient was diagnosed with choroidal malignant melanoma in the summer of 2019. In February 2021, micro-metastases were found in a kidney and lungs. WHO.0. Tumor-inhibiting therapy with ipilimumab plus nivolumab was initiated. The first treatment was given in early April and the second three weeks later. Received Covid-19 vaccine six days after that. Admitted acutely to medical clinic four days after vaccination (on 02May2021) with headache, cognitive impairment and fever. Pathological liver tests. Assessed after investigation as drug-induced (ipilimumab/nivolumab) encephalitis and hepatitis. Encephalitis symptoms resolved on high-dose cortisone but liver function never recovered despite maximal braking therapy. Died in picture as liver failure about two months after hospitalization. Cared for last two weeks at home with support of home health care. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Liver failure; drug-induced hepatitis; drug-induced encephalitis.


VAERS ID: 1593996 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Hypopituitarism, Investigation, Magnetic resonance imaging, Magnetic resonance imaging head, Malignant hypertension, Metastases to pituitary gland, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EPIRUBICIN; VINORELBINE; CAPECITABINE; CYKLOFOSFAMID; DOXORUBICIN; PACLITAXEL; ERIBULIN
Current Illness: Metastatic breast cancer (bilateral triple negative lobular type breast cancer)
Preexisting Conditions: Medical History/Concurrent Conditions: Bone metastases (skeletal metastasis); Gamma radiation therapy to breast (gamma knife treatment); Radiation therapy (radiation-treated against C1 and the pelvis in May 2020 and rib-irradiated in June 2021)
Allergies:
Diagnostic Lab Data: Test Name: MRI brain; Result Unstructured Data: Test Result:showed new metastasis in the hypothalamus; Comments: showed new metastasis in the hypothalamus with growth towards the pituitary gland.; Test Name: samples taken; Result Unstructured Data: Test Result:showed pituitary failure; Comments: showed pituitary failure and the woman received SoluCortef.; Test Name: MRI back; Result Unstructured Data: Test Result:no medullary process; Comments: showed no medullary process according to the attached medical record.
CDC Split Type: SEPFIZER INC202101055207

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-070404. A 50-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), via unspecified route of administration in Jun2021 (Batch/Lot Number: unknown) as single dose for COVID-19 immunisation. The medical history included ongoing widespread metastatic breast cancer (bilateral triple negative lobular type breast cancer), Bone metastases (skeletal metastasis), gamma knife treatment in 2018, radiation treatment for c1, pelvis and ribs (radiation-treated against C1 and the pelvis in May2020 and rib-irradiated in Jun2021). The patient''s concomitant medications included cyclophosphamide (CYKLOFOSFAMID), epirubicin, capecitabine, doxorubicin, paclitaxel, vinorelbine, eribulin. The patient experienced progression of paralysis symptoms, pituitary insufficiency in Jun2021. The clinical course was reported as: The patient developed weakness and loss of sensation in her right arm already 6 days before the vaccination and MRI full back taken 2 days later at a doctor''s appointment showed no medullary process according to the attached medical record. It also appears in the medical record that the patient 8 days before the vaccination had started radiation treatment for cervical spine C1. About two days after the vaccination, the patient''s condition worsened with progressive neurological loss and according to the doctor, the patient could barely stand on her feet, had poor coordination, dizziness, nausea, had eye motor disorders and double vision. Examination with MRI brain showed new metastasis in the hypothalamus with growth towards the pituitary gland. Severe hypertension was also observed which was judged to be malignant hypertension where acute hypertension treatment was initiated, and samples taken showed pituitary failure and the patient received hydrocortisone sodium succinate (SOLUCORTEF). However, her condition gradually worsened with increasing awareness, and she switched to symptom treatment instead. The patient died about 16 days after the vaccination in Jun2021. The outcome of the events progression of paralysis symptoms, pituitary insufficiency and metastasis in the hypothalamus with growth towards the pituitary gland was fatal. The outcome of the other events was unknown. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: new metastasis in the hypothalamus with growth towards the pituitary gland; Cancer; Pituitary insufficiency; Progression of Paralysis symptoms


VAERS ID: 1594044 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-07-15
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TRPFIZER INC202101055818

Write-up: My brother died of a heart attack on July 15,2021 after receiving his first dose of Biontech vaccine on June 21,2021; This is a spontaneous report based on information received by Pfizer from LLP Biontech 80109, license party for BNT 162B2. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 21Jun021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient died of a heart attack on July 15,2021 after receiving his first dose of Biontech vaccine on June 21,2021. The outcome of the event was fatal. The lot number for [bnt162b2 ], was not provided and will be requested during follow up; Reported Cause(s) of Death: My brother died of a heart attack on July 15,2021 after receiving his first dose of Biontech vaccine on June 21,2021


VAERS ID: 1617474 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213021A / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Dysphagia, Dysstasia, Eating disorder, Gait disturbance, Lymphocyte count, Monocyte count, Neutrophil count, Platelet count normal, Pyrexia, Syncope, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aspirin Atorvastatim Amlodiphine Vitamin B complex
Current Illness: High blood pressure
Preexisting Conditions: Stroke patient
Allergies: None
Diagnostic Lab Data: Blood Chem Hemotocrit ~ 34.3 Hemoglobin ~ 11.4 Wbc ~ 6.2 Segmenters ~ 61 Lymphicyte ~ 38 Monocyte ~ 1 Platelet ~ 128
CDC Split Type:

Write-up: July 28 to Aug. 6 2021 Lbm ~ july 29 ~ Aug. 1/loperamide Difficulty swallowing ~ july 28 Difficuly eating ~ july 30 Difficulty standing and walking alone ~ july 28 onwards On and off high fever ~ july 27/7:00pm onwards Collapse while sitting ~ july 29 and 31


VAERS ID: 1620326 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiovascular disease, unspecified
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210836511

Write-up: This spontaneous report received from a patient via a company representative concerned a 36 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: cardiovascular illness. 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, 1 total administered 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 experienced cerebral hemorrhage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0;20210836511 -COVID-19 VACCINE AD26.COV2.S-Cerebral haemorrhage. 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).


VAERS ID: 1620331 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-29
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Decreased appetite, Dyspnoea, Nausea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210838808

Write-up: FEVER; LOSS OF APPETITE; LOSS OF TASTE; DIFFICULTY OF BREATHING; NAUSEA; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300099633] concerned a 73 year old female of unspecified race and ethnicity. 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, intramuscular, batch number: 212C21A, expiry: unknown) dose was not reported,1 total administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021 at 16:00, the patient experienced fever, loss of appetite, loss of taste, difficulty of breathing and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from fever, loss of appetite, loss of taste, difficulty of breathing and nausea on an unspecified date. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210838808-COVID-19 VACCINE AD26.COV2.S-Fever,Loss of appetite,Loss of taste,Difficulty breathing,Nausea. 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: FEVER; LOSS OF APPETITE; LOSS OF TASTE; DIFFICULTY OF BREATHING; NAUSEA


VAERS ID: 1622911 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-07-24
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002616 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death NOS; This case was received via Regulatory Authority (Reference number: BX20217173) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death NOS) in an 84-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002616) for COVID-19 vaccination. No Medical History information was reported. On 18-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Death occurred on 24-Jul-2021 The patient died on 24-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product information was not provided by reporter. No treatment information was provided. Company Comment: Very limited information regarding this event has been provided at this time. However, patient''s advanced age remains a contributory factor. Further information can''t be requested.; Sender''s Comments: Very limited information regarding this event has been provided at this time. However, patient''s advanced age remains a contributory factor. Further information can''t be requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1622994 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Death, Fatigue, Headache, Hyperpyrexia, Injection site haematoma, Injection site inflammation, Injection site pain, Injection site warmth, Malaise, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: hyperpyrexia; Result Unstructured Data
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: NL-LRB-00658719) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This Regulatory Authority case was reported by a consumer and describes the occurrence of DEATH, FATIGUE, CHILLS, HEADACHE, INJECTION SITE HAEMATOMA, MALAISE, HYPERPYREXIA, INJECTION SITE PAIN, INJECTION SITE INFLAMMATION, MYALGIA, ARTHRALGIA, INJECTION SITE WARMTH and NAUSEA in a 50-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 11-May-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 11-May-2021, the patient experienced FATIGUE, CHILLS, HEADACHE, INJECTION SITE HAEMATOMA, MALAISE, HYPERPYREXIA ), INJECTION SITE PAIN, INJECTION SITE INFLAMMATION, MYALGIA, ARTHRALGIA, INJECTION SITE WARMT and NAUSEA. The patient died on 26-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hyperpyrexia: high (High): 40.5, 42 degrees Celsius. Treatment information not provided. Concomitant medication not provided. This case refers to a 50-year-old female patient who died 16 days after receiving the dose 2 of the product mRNA-1273. Cause of death not reported. Very limited information regarding the event of death has been provided at this time insufficient for causality assessment. Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the remaining events, a causal relationship cannot be excluded.; Sender''s Comments: This case refers to a 50-year-old female patient who died 16 days after receiving the dose 2 of the product mRNA-1273. Cause of death not reported. Very limited information regarding the event of death has been provided at this time insufficient for causality assessment. Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: (Body did not make antibodies against the corona virus (that is what the hospital claims)


VAERS ID: 1622999 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839035

Write-up: DEATH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300099533] concerned an 81-year-old female patient of unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 24-JUL-2021 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 10-AUG-2021, the patient eventually died due to unknown cause. It was not reported if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to unknown cause of death on 10-AUG-2021. This report was serious (Death).; Sender''s Comments: V0:20210839035- 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


VAERS ID: 1623000 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Headache, Nausea, Syncope, Vaccination site pain, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839048

Write-up: FAINTING; HEADACHE; NAUSEA AND AMP; VOMITING; REDNESS; LOCAL SITE PAIN; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300099287] concerned a 30 year 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: 213C21A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 31-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021; 20:00, the patient experienced local site pain. On 03-AUG-2021; 20:00, the patient experienced redness. On 04-AUG-2021; 20:00, the patient experienced nausea and amp. On 04-AUG-2021; 20:00, the patient experienced vomiting. On an unspecified date, the patient experienced headache, and fainting. On an unspecified date, the patient died from local site pain, redness, nausea and amp, vomiting, headache, and fainting. 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: 20210839048-covid-19 vaccine ad26.cov2.s-Fainting, local site pain, redness, nausea and amp, vomiting, headache. 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: LOCAL SITE PAIN; REDNESS; NAUSEA AND AMP; VOMITING; HEADACHE; FAINTING


VAERS ID: 1623001 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-27
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839072

Write-up: Fever; Chills; Fatigue; This spontaneous report received from a health care professional via a Regulatory Authority [PHFDA-300098515] concerned a 77 year 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, intramuscular, and batch number: 213C21A expiry: UNKNOWN) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021, after vaccination at 8:00pm, the patient experienced mild fever and headache. On 27-JUL-2021, the patient also experienced chills and fatigue. On 29-JUL-2021, the patient experienced events of vomiting, diarrhea and nausea. On 01-AUG-2021, The patient daughter consulted in a private doctor via telephone and got all prescription. On 02-Aug-2021, the patient was stable but still have body weakness. On 03-AUG-2021, the patient was stable until the patient experienced hiccups on and off that last the whole night so the patient''s daughter called their private doctor and advised them to bring the patient to the nearest hospital, they went to 4 hospitals but not admitted because of full capacity, so they decided to bring the patient in their home until the patient died. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date of AUG-2021, the patient died from fever, chills and fatigue. It was unspecified if an autopsy was performed. This report was serious (Death).; Sender''s Comments: 20210839072- covid-19 vaccine ad26.cov2.s -Fever, chills & fatigue. 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: FEVER; CHILLS; FATIGUE


VAERS ID: 1623002 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Malaise, Toothache
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IVERMECTIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839109

Write-up: body malaise; loss of appetite; tooth ache; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300099150] concerned a 72 year old female. 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, intramuscular, batch number: 212C21A) dose was not reported, 1 total, administered on 29-JUL-2021 for prophylactic vaccination. Concomitant medications included ivermectin. The patient had no other complains except tolerable injection site pain after vaccination. On 03-AUG-2021, the patient experienced body malaise, loss of appetite and tooth ache. The caregiver tele-consulted the hospital for complains of toothache. On 04-AUG-2021, the patient complained of body malaise and loss of appetite, did not report to hospital. On 07-AUG-2021, the patient complained of abdominal pain. Ivermectin capsule given without prescription. The medicine acquired from relative. On 08-AUG-2021, the ivermectin given twice a day without prescription. On 09-AUG-2021, ivermectin given twice a day without prescription. The dark spots noted at the lower extremities. On 10-AUG-2021, around 01:00 AM, ivermectin given and unknown tablet given according to caregiver. At 08:35 AM, patient died at home. On 10-AUG-2021 08:35, the patient died from body malaise, and loss of appetite. It was not specified if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tooth ache was not reported. This report was serious (Death).; Sender''s Comments: V0; 20210839109 -covid-19 vaccine ad26.cov2. s - Body malaise, and Loss of appetite -. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: BODY MALAISE; LOSS OF APPETITE


VAERS ID: 1623003 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-29
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839148

Write-up: VOMITING; This spontaneous report received from a health care professional via a Regulatory Authority [PHFDA-300098973] concerned a 64 year 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, intramuscular, batch number: 213C21A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021; 16:00, the patient experienced vomiting and was hospitalized (date unspecified). On an unspecified date, the patient died from vomiting. 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, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210839148-COVID-19 VACCINE AD26.COV2.S-Vomiting. 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: VOMITING


VAERS ID: 1623004 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Nasopharyngitis, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839388

Write-up: COUGH; FEVER; COLDS; This spontaneous report received from a health care professional via a Regulatory Authority [PHFDA-300099020] concerned an 81 year old female of unspecified race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, 07:00, the patient experienced cough, fever and colds. On an unspecified date in Aug-2021, the patient died from cough, fever, and colds. 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: V0-20210839388-Covid-19 vaccine ad26.cov2.s-Cough, fever, and colds. This event(s) is considered unassessable. The event(s) has an 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: COUGH; FEVER; COLDS


VAERS ID: 1623005 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-08
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839494

Write-up: LOSS OF CONSCIOUSNESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHFDA-300099103] concerned a 40 year 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, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021, at 01:00, the patient experienced loss of consciousness. On an unspecified date in AUG-2021, the patient died from loss of consciousness. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210839494 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- loss of consciousness (fatal outcome)-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: LOSS OF CONSCIOUSNESS


VAERS ID: 1623023 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-05-02
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001938 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROMODERNATX, INC.MOD20212

Write-up: Myocardial infarction; This case was received via Regulatory Authority (Reference number: SPCOV12123) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a non-health professional and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial infarction) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3001938) for Active immunisation. Concurrent medical conditions included Arterial hypertension. On 16-Apr-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-May-2021, after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criteria death and medically significant). The patient died on 09-May-2021. The reported cause of death was Myocardial infarction. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment information was not provided. The medical assessor of the Competent Authority requested the investigation of the case at National Centre for Communicable Diseases Surveillance and Control (CNSCBT), to no result yet. Company comment Very limited information regarding this event 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 event, a causal relationship cannot be excluded. However, patient''s underlying medical condition of arterial hypertension remains a contributory factor. Further information can''t be requested.; Sender''s Comments: Very limited information regarding this event 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 event, a causal relationship cannot be excluded. However, patient''s underlying medical condition of arterial hypertension remains a contributory factor. Further information can''t be requested.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1623225 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Skin discolouration
SMQs:, Lack of efficacy/effect (narrow), Hypotonic-hyporesponsive episode (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: COJNJFOC20210840783

Write-up: DIED DUE TO COVID; LACK OF EFFICACY; SKIN STAINS; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) 1 total 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 patient died on an unspecified date due to covid, after having some skin stains because of the vaccine. The patient experienced the lack of efficacy. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the skin stains and lack of efficacy was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0:20210840783-covid-19 vaccine ad26.cov2.s-Died due to covid, Lack of efficacy. 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: DIED DUE TO COVID


VAERS ID: 1624364 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anorexia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 47-year-old female patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. The patient''s past medical history included Anorexia. On 28-Apr-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on 28-Apr-2021 The patient died on 28-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication not reported. Treatment medication not reported. Company comment: Based on the current available information and temporal association between the use of the product and the reported death of the patient, a causal relationship cannot be excluded. Event term, onset date and outcome captured per RA Authority reporting. Events seriousness per assessment by Authority and per IME list. Cause of death not provided.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the reported death of the patient, a causal relationship cannot be excluded. Event term, onset date and outcome captured per RA Authority reporting. Events seriousness per assessment by Authority and per IME list. Cause of death not provided; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1624875 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-07-01
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Emphysema pulmonary; Hypertension arterial; Liver cirrhosis
Preexisting Conditions: Medical History/Concurrent Conditions: Kidney failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: COVID-19 respiratory infection; Vaccination failure; This case was received via Regulatory Authority (Reference number: PA20211318) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 respiratory infection) and VACCINATION FAILURE (Vaccination failure) in a 77-year-old male patient who received mRNA-1273 (Spikevax) for Prophylaxis. The patient''s past medical history included Kidney failure. Concurrent medical conditions included Hypertension arterial, Emphysema pulmonary, Liver cirrhosis and Diabetes mellitus. In March 2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2021, the patient experienced COVID-19 (COVID-19 respiratory infection) (seriousness criterion death) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion life threatening). The patient died on an unknown date. The reported cause of death was COVID-19 respiratory infection. It is unknown if an autopsy was performed. At the time of death, VACCINATION FAILURE (Vaccination failure) had not resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. Very limited information regarding this event/s has been provided at this time. Further information has been requested. The causality for the event Covid-19 will be considered as "Not Applicable".; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. The causality for the event Covid-19 will be considered as "Not Applicable".; Reported Cause(s) of Death: COVID-19 respiratory infection


VAERS ID: 1624882 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214010 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Arrest cardiac; This case was received via Regulatory Authority (Reference number: PB20215062) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Arrest cardiac) in a 61-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214010) for COVID-19 vaccination. The patient''s past medical history included Hypertension and Obesity. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced CARDIAC ARREST (Arrest cardiac) (seriousness criteria death and medically significant). The patient died on 30-Jul-2021. The reported cause of death was Arrest cardiac. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported . Treatment information was not provided. Company comments: Very limited information regarding this event has been provided at this time. No further follow up information is expected.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: Arrest cardiac


VAERS ID: 1625406 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-06-15
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocardial infarction, SARS-CoV-2 test
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Heart attack; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25801136) on 15-Aug-2021 and was forwarded to Moderna on 15-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Suspected COVID-19 since 07-Jun-2021. On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). The patient died on 27-Jun-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. Concomitant product use was not provided by the reporter. Patient had blood clot caused heart attack. Patient is not enrolled in clinical trial. No treatment information was provided. This is a case of myocardial infarction with fatal outcome in a 37-year-old male who died 24 days after receiving one dose of vaccine. Very limited information regarding this event has been provided. No further information is expected at this time.; Sender''s Comments: This is a case of myocardial infarction with fatal outcome in a 37-year-old male who died 24 days after receiving one dose of vaccine. Very limited information regarding this event has been provided. No further information is expected at this time.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1625500 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dementia, Paranoia
SMQs:, Dementia (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness: Unspecified paranoid state
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC202101027714

Write-up: suddenly aggravated paranoia; sudden appearance of symptoms of early dementia; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority number HU-OGYI-672321. A 88-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EW4815), dose 1 intramuscular, administered in Arm Left on 22Apr2021as Dose 1,0.3 mL single for covid-19 immunisation. Medical history included ongoing paranoia. Concomitant medications included apixaban (ELIQUIS) taken for deep vein thrombosis from 2017 to an unspecified stop date.The patient experienced suddenly aggravated paranoia, sudden appearance of symptoms of early dementia on 23Apr2021.The events were assessed as serious. The outcome of events was not recovered on unknown date. Sender''s comments: Dementia and aggravation of paranoia are neither listed nor expected after Comirnaty vaccination. TTO was 1 day. The causal relationship between the reported death and Comirnaty is unassessable. The case is serious due to medically important events. No follow-up attempts possible. No further information expected.


VAERS ID: 1625501 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002188 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram head, Delirium tremens
SMQs:, Noninfectious encephalopathy/delirium (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol withdrawal syndrome; Alcoholic cardiomyopathy; Carotid artery stenosis; Cerebral atherosclerosis; Spondylosis; Syncope
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Brain CT; Result Unstructured Data: known carotid artery stenosis
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: Delirium tremens; This case was received via Regulatory Authority (Reference number: 673521) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DELIRIUM TREMENS (Delirium tremens) in a 68-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002188) for COVID-19 vaccination. The patient''s past medical history included Spondylosis, Alcoholic cardiomyopathy, Syncope, Carotid artery stenosis, Alcohol withdrawal syndrome and Cerebral atherosclerosis. Concurrent medical conditions included Hypertension. On 01-Jun-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 02-Jun-2021, after starting mRNA-1273 (Spikevax), the patient experienced DELIRIUM TREMENS (Delirium tremens) (seriousness criteria death, hospitalization and medically significant). The patient died on 10-Jun-2021. The reported cause of death was Delirium tremens. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2021, Computerised tomogram head: abnormal (abnormal) known carotid artery stenosis. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered DELIRIUM TREMENS (Delirium tremens) to be not related. There was no concomitant medication reported. There was no treatment medication reported. Company Comment : This is a case of death in a 68-year-old male subject, with a history of Alcoholic cardiomyopathy, Carotid artery stenosis, Cerebral atherosclerosis and Hypertension who died 9 days after receiving first dose of vaccine due to delirium tremens. Based on reporter''s causality, the event is assessed as unlikely related to mRNA-1273.; Reporter''s Comments: The patient died 9 days after vaccination with COVID-19 Vaccine Moderna due to delirium tremens. The event and the vaccine is considered not related. The case is serious due to hospitalization and fatal outcome.; Sender''s Comments: This is a case of death in a 68-year-old male subject, with a history of Alcoholic cardiomyopathy, Carotid artery stenosis, Cerebral atherosclerosis and Hypertension who died 9 days after receiving first dose of vaccine due to delirium tremens. Based on reporter''s causality, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Delirium tremens


VAERS ID: 1625720 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Foetal heart rate abnormal, Maternal exposure before pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101060370

Write-up: Missed miscarriage discovered on 03Aug. At 8 weeks the heart stopped beating while I was 12 weeks pregnant. The exorcism has yet to take place.; Vaccination 3 months before pregnancy; fetal demise; This is a spontaneous report from a contactable consumer reported different events for different patients. This is second of two reports. This is the child case. The first report was downloaded from the Regulatory Authority-WEB [NL-LRB-00651922]. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via transplacental from a mother who received the dose 2 on 14Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Patient''s mother previously took dose 1 on 24Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fetal demise on an unspecified date, missed miscarriage discovered on 03aug2021 at 8 weeks the heart stopped beating while patient''s mother was 12 weeks pregnant and "the exorcism has yet to take place", vaccination 3 months before pregnancy. The patient died on an unspecified date. It was not reported if an autopsy was performed.Course of events: The patient''s mother missed abortion was discovered at a pregnancy duration of about 12 weeks. The fetal demise occurred at a pregnancy duration of about 8 weeks. Both Covid vaccinations took place a few months before pregnancy. It was found out that patient''s mother had a "missed miscarriage". At 8 weeks the heart stopped beating while patient''s mother was 12 weeks pregnant. The exorcism has yet to take place. Between 8 and 12 weeks. No follow-up attempts are possible, information on batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101017609 mother/child case.; Reported Cause(s) of Death: Fetal heartbeat absent; fetal demise


VAERS ID: 1625759 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210838944

Write-up: MUSCLE PAIN; This spontaneous report received from a health care professional via a Regulatory Authority [PHFDA-300099916] concerned a 72 year old male of unspecified race and ethnicity.. 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, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, 1 total, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, he experienced fever a day after immunization, body weakness and muscle pain at lower extremities, loss of consciousness, hypotension, coma. On 30-JUL-2021, the patient experienced muscle pain (in lower extremities) and on an unspecified date the patient died of it. 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: 20210838944 -covid-19 vaccine ad26.cov2.s- muscle pain. 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: MUSCLE PAIN


VAERS ID: 1625760 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210838968

Write-up: LOSS OF CONSCIOUSNESS; This spontaneous report received from a health care professional via a Regulatory Authority (PHFDA-300098549) concerned a 20 year old male of an unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205C21A, expiry: unknown) dose was not reported, with frequency time 1 total administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021 at 08:00, the patient died from loss of consciousness was reported. 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: V0:20210838968 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- loss of consciousness (fatal outcome)-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: LOSS OF CONSCIOUSNESS


VAERS ID: 1625764 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: PHJNJFOC20210839223

Write-up: SUSPECTED SERIOUS AEFI; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300099152] concerned a 67 year old female of unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, 1 total administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021 (Thursday) patient coordinate for ambulance assistance. She was admitted in hospital for Suspected Serious AEFI (adverse event following immunization). On 09-AUG-2021(Monday) her RT PCR (polymerase chain reaction) result received which was positive. On 12-AUG-2021 (Thursday) one of Regulatory Authority said that vaccine died (cause of death unknown). It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause of death (Suspected Serious adverse event following immunization) on AUG-2021. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210839223-Covid-19 vaccine ad26.cov2.s-Suspected Serious AEFI. 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


VAERS ID: 1625766 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-27
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Diarrhoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839234

Write-up: FEVER; COUGH; DIARRHEA; This spontaneous report received from a health care professional via a Regulatory Authority (PHFDA-300098570)concerned a 70 year old male of unspecified race and ethnic origin. 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, intramuscular, batch number: 213C21A and expiry: unknown) dose was not reported, 1 total administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021 at 06:30, the patient died from fever, cough, colds and diarrhea were reported. It was unknown, if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2. s was not applicable. The patient died of fever, cough and diarrhea on 27-JUL-2021. This report was serious (Death).; Sender''s Comments: V0: 20210839234-Covid-19 vaccine ad26.cov2.s- Fever, Cough, Diarrhea . 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: FEVER; COUGH; DIARRHEA


VAERS ID: 1625770 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Malaise, Nausea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839328

Write-up: NAUSEA; VOMITING; COUGH; DYSPNEA; BODY MALAISE; This spontaneous report received from a health care professional via a Regulatory Authority [PHFDA-300098970] concerned a 73 year 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, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021 10:00, the patient experienced nausea, vomiting, cough, dyspnea, and body malaise. The patient was hospitalized (date and duration unspecified). On AUG-2021, the patient died from nausea, vomiting, cough, dyspnea, and body malaise. 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, Hospitalization Caused / Prolonged, and Life Threatening).; Sender''s Comments: V0:20210839328- covid-19 vaccine ad26.cov2.s - nausea, vomiting, cough, dyspnea,body malaiseThis 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: NAUSEA; VOMITING; COUGH; DYSPNEA; BODY MALAISE


VAERS ID: 1625810 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-04-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anencephaly, Congenital central nervous system anomaly, Maternal exposure during pregnancy
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; FERROUS SULFATE; CLOMID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SAPFIZER INC202101063129

Write-up: Anencephaly; Exencephaly; Maternal exposure during pregnancy; This is a spontaneous report from a contactable pharmacist. This pharmacist reported events for both the mother and baby. This is the report for the baby. A fetus patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 transplacental on 30Apr2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation; clomifene citrate (CLOMID), transplacental from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for polycystic ovaries (PCOs). The patient medical history was not reported. Concomitant medications included folic acid and ferrous sulfate taken for an unspecified indication, start and stop date were not reported. The patient experienced maternal exposure during pregnancy on 30Apr2021, anencephaly and exencephaly (reported as Exanencephaly) on 29Jul2021. The mother''s ultrasound report showed Single viable fetus. FL: 11 mm = 13+4 weeks. Absent fetal cranium with hernation of brain tissue; IMP: Anencephaly and Exanencephaly. Therefore, she was admitted for pregnancy termination. This ADR may be related to the Clomid or the COVID19 vaccine. Therapeutic measures were taken as a result of anencephaly and exencephaly which included pregnancy termination. The action taken in response to the events for clomifene citrate was unknown. The events were considered to cause congenital anomaly and the patient died on an unspecified date. The outcome of the events was fatal. The lot number for bnt162b2, was not provided and will be requested during follow up; Sender''s Comments: The events anencephaly and congenital central nervous system anomaly are more likely related to the use of clomifene citrate, and are considered unrelated to the suspect drug. This case will be reassessed upon receipt of additional information.,Linked Report(s) : SA-PFIZER INC-202101048808 Mother case; Reported Cause(s) of Death: Anencephaly; Exanencephaly


VAERS ID: 1628956 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MILGAMMA [BENFOTIAMINE;CYANOCOBALAMIN]; TAMSULOSIN HYDROCHLORIDE; FURORESE [FUROSEMIDE]; KALNORMIN
Current Illness: Alcoholic polyneuropathy; Alcoholism; Arterial hypertension; Cholecystectomy; Diabetes mellitus ((diet)); Fecal incontinence; Insufficiency cardiac; Liver cirrhosis; Multimorbidity; Osteoporosis; Smoker; Urinary retention (permanent urinary catheter); Vertebrogenic pain syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy (not treated due to non compliance); Gastric ulcer surgery; Incisional herniorrhaphy; Lumbar spine compression fracture
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZJNJFOC20210838247

Write-up: DEATH; This spontaneous report received from a physician via a Regulatory Authority concerned a 66 year old male of unknown race and ethnic origin. The patient''s weight was 75 kilograms, and height was 165 centimeters. The patient''s past medical history included: incisional herniorrhaphy, epilepsy, lumbar spine compression fracture, and gastric ulcer surgery, and concurrent conditions included: diabetes mellitus, alcoholism, vertebrogenic pain syndrome, alcoholic polyneuropathy, smoking, fecal incontinence, multimorbidity, liver cirrhosis, arterial hypertension, urinary retention, osteoporosis, insufficiency cardiac, and cholecystectomy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 expiry: UNKNOWN) 1 dosage forms, frequency one total, administered on 03-AUG-2021 for covid-19 immunization. Concomitant medications included benfotiamine/cyanocobalamin, furosemide, potassium chloride, and tamsulosin hydrochloride. On 04-AUG-2021, the patient experienced death. On 04-AUG-2021, the patient died from death from natural causes. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, Other Medically Important Condition, and Life Threatening).; Sender''s Comments: V0: 20210838247- Covid-19 vaccine ad26.cov2.s- Death. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY; Reported Cause(s) of Death: DEATH FROM NATURAL CAUSES


VAERS ID: 1629000 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-09
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210839152

Write-up: MYOCARDIAL INFARCTION; This spontaneous report received from a physician via a Regulatory Authority [DE-PEI-202100166172] concerned a 66 year old female of unknown ethnicity and race. 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 administration not reported, batch number: XE393 expiry: unknown) dose was not reported, 1 total administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-AUG-2021, the patient experienced myocardial infarction and died. It was unknown if the 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: 20210839152- Covid-19 vaccine ad26.cov2.s- Myocardial infarction. 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: INFARCT MYOCARDIAL


VAERS ID: 1629122 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-07-08
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1526 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy brain, Blood test, Leukoencephalopathy, Lumbar puncture, Magnetic resonance imaging, Multiple organ dysfunction syndrome, Septic shock, Specialist consultation, Ultrasound scan
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Noninfectious encephalopathy/delirium (narrow), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: brain biopsy; Result Unstructured Data: Test Result:inconspicuous; Test Name: blood cultures; Result Unstructured Data: Test Result:showed the following; Comments: showed the following of S. marescens, the detection of S. hominis was seen as contamination; Test Date: 20210727; Test Name: blood cultures; Result Unstructured Data: Test Result:S.hominis in the blood cultures; Comments: S.hominis in the blood cultures; Test Name: lumbar puncture; Result Unstructured Data: Test Result:inconspicuous; Test Date: 20210709; Test Name: MRI; Result Unstructured Data: Test Result:pronounced generalised, partially diffusion-distur; Comments: pronounced generalised, partially diffusion-disturbed medullary edema supratentorially with involvement of the putamina.; Test Date: 20210715; Test Name: MRI; Result Unstructured Data: Test Result:increase of the extensive leukoencephalopathy wit; Comments: increase of the extensive leukoencephalopathy with progressive cytotoxic oedema; Test Name: experts in leukodystrophies and other metabolic myelin diseases; Result Unstructured Data: Test Result:genetic metabolic leukoencephalopathy could be rul; Comments: genetic metabolic leukoencephalopathy could be ruled out due to the acute course of the disease.; Test Name: neuroradiology department; Result Unstructured Data: Test Result:neuroradiology department was consulted; the colle; Comments: neuroradiology department was consulted; the colleague assumed a metabolic etiology; Test Name: Sonography; Result Unstructured Data: Test Result:pleural effusions showed a regressed; Comments: pleural effusions showed a regressed
CDC Split Type: DEPFIZER INC202101061868

Write-up: Multiorgan failure; Septic shock; Leukoencephalopathy; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, Safety Report Unique Identifier: DE-PEI-202100165293. A 38-year-old male patient received bnt162b2 (COMIRNATY mRNA TOZINAMERAN), dose 1 via an unspecified route of administration on 11Jun2021 at the age of 38-year-old (Batch/Lot Number: FC1526) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. 7 weeks after vaccination, on 02Aug2021 the patient experienced Multiorgan failure, Septic shock. On 08Jul2021 the patient experienced Leukoencephalopathy. Clinical course: Detection of Serratia marcencens and Staphylococcus hominis in the blood cultures. Excluded diagnoses: ADEM, leukodystrophies, MS, PMI, PRES, lymbic encephalitis, pathogen-induced leukoencephalopathy. The cMRI of 09Jul2021 showed a pronounced generalised, partially diffusion-disturbed medullary edema supratentorially with involvement of the putamina. A barrier disturbance is not recognizable. No haemorrhage. The MRI of 15Jul2021 shows an increase of the extensive leukoencephalopathy with progressive cytotoxic oedema. Further no barrier disturbances or haemorrhage. A reliable classification of this leukoencephalopathy is not possible morphologically. Due to the progressive nature of the findings, the neuroradiology department was consulted; the colleague assumed a metabolic etiology. For further clarification, a biopsy was discussed with them and considered useful. A telephone consultation with experts in leukodystrophies and other metabolic myelin diseases took place. In his opinion, a genetic metabolic leukoencephalopathy could be ruled out due to the acute course of the disease. Due to the inconspicuous lumbar puncture, MRI and brain biopsy, we considered an inflammatory event (as is the case with a vaccine-associated reaction) to be less likely. A tentative diagnosis of toxic leukoencephalopathy (e.g. due to syntetic cannabinoids) DD lmpfassociated leukoencephalopathy was made. On 31Jul2021 there was an increase in the infection parameters and fever. Renewed collection of material was carried out. Sedation was deepened during periods of stress. In CPAP mode, oxygenation and hypercapnia worsened, lactate increased slightly. There was a clearly negative balance under intensified diuretic therapy for pleural effusions. Sonographically, the pleural effusions showed a regressed. In the course of the study, the catecholamine requirement increased up to 0.9 mg noradrenalin/h. On detection of S.hominis in the blood cultures of 27Jul2021, antibiotic treatment with Unezolid was started, volume bolus of 1.51 was administered. 1.51 was administered, ventilation was continued in a lung-protective BIPAP mode. Thereafter, the catecholamine requirement initially showed a decrease to 0.5mg norepinephrine/h, lactate falling, oxygenation and decarboxylation improved. On 01Aug2021 the infection parameters showed a massive increase. Consultation with the microbiology colleagues. The blood cultures from the previous day showed the following of S. marescens, the detection of S. hominis was seen as contamination. On recommendation, the antibiotic treatment was changed to ceftazidime. In the course of the brain biopsy was performed by the neurosurgical colleagues during the course of the day. After transfer circulatory and respiratory situation essentially unchanged. As possible focus of the defect was considered to be an inserted Shaldon catheter and removed. Sedation was changed to isoflurane anaesthesia. On the evening of 01Aug2021 there was a massive acute deterioration of the respiratory and haemodynamic situation. Ventilation had to be intensified to the maximum with FiO2 of 100%. The treatment of the manifest septic shock with multiple organ failure was started with forced volume administration (5l full electrolyte solution) hydrocortisone and argipressin, and high doses of catecholamine. The antibiotic therapy was extended to include meropenem and vancomycin linezolid and ceftazidime were administered again. With maximally invasive ventilation ECMO was indicated, which was then performed in the event of further haemodynamic problems deterioration in the acute situation, ECMO could no longer be successfully performed in the acute situation. Despite the measures taken, the patient died on 02Aug2021 at 1:04. It was not reported if an autopsy was performed. This report is serious - death, hospitalization. The patient''s outcome was: fatal for Multiorgan failure, fatal for Septic shock, fatal for Leukoencephalopathy. Multiorgan failure/ PEI/ D. Unclassifiable; Septic shock/ PEI/ D. Unclassifiable; Leukoencephalopathy/ PEI/ D. Unclassifiable. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Multiorgan failure; Leukoencephalopathy; Septic shock


VAERS ID: 1629266 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-03
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8142 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Haemoglobin
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALENDRONAT AUROBINDO; ENALAPRIL KRKA; IBUPROFEN; FERRO DURETTER; KODEIN; CYMBALTA; PLAVIX; ZARATOR [ATORVASTATIN CALCIUM]; BETOLVEX [CYANOCOBALAMIN-TANNIN COMPLEX]; KALEORID; PANTOPRAZOL ACTAVIS; QUETIAPIN ACCORD; BRICANYL TURBUHALER
Current Illness: Bronchospasm; Chronic obstructive lung disease; Depression; Esophageal acid reflux; Hypercholesterolaemia; Hypertension; Iron deficiency; Osteoporosis; Tiredness (Contacted physician duo to tiredness (NOT ADR)); Vitamin B12 deficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarct; Discoloured stools (Dark stool. Dark stools have ceased at the time of medical contact. (NOT ADR)); Headache (Was recomendented to use Ibuprofen instead of Kodein. (NOT ADR)); Potassium supplementation; Thrombosis prophylaxis
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: Haemoglobin; Result Unstructured Data: Test Result:6.9; Comments: Unit not specified
CDC Split Type: DKPFIZER INC202101061613

Write-up: Found dead on 3Aug2021; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0082689. A 69-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: FA8142) as single dose for covid-19 immunisation. The patient previously took first dose of bnt162b2 (COMIRNATY) for COVID-19 immunisation on 18Jun2021 (Batch/Lot Number: FC5295; Expiration Date: 30Sep2021). Medical history included discoloured stools from 2021 to 20Jul2021 (Dark stool. Dark stools have ceased at the time of medical contact. (NOT ADR)), cerebral infarction from Feb2021 to an unknown date, Tiredness from 20Jul2021 and ongoing (Contacted physician duo to tiredness (NOT ADR)), ongoing chronic obstructive pulmonary disease, headache from Jul2021 to an unknown date (Was recomendented to use Ibuprofen instead of Kodein. (NOT ADR)), ongoing osteoporosis, ongoing vitamin b12 deficiency, ongoing bronchospasm, ongoing depression, ongoing hypertension, ongoing Iron deficiency, ongoing Esophageal acid reflux, ongoing Hypercholesterolaemia, Potassium supplementation, thrombosis prophylaxis. The patient had no previous history of headache or migraine. Concomitant medications included alendronate sodium (ALENDRONAT AUROBINDO) taken for osteoporosis from 26Feb2020 to an unspecified stop date; enalapril maleate (ENALAPRIL KRKA) taken for hypertension from 16Jan2017 to an unspecified stop date; ibuprofen taken for headache from 20Jul2021 to an unspecified stop date; ferrous sulfate (FERRO DURETTER) taken for iron deficiency from 20Jul2021 to an unspecified stop date; codeine phosphate (KODEIN) taken for headache from 20Jul2021 to an unspecified stop date; duloxetine hydrochloride (CYMBALTA) taken for depression from 12Jul2016 to an unspecified stop date; clopidogrel bisulfate (PLAVIX) taken for thrombosis prophylaxis from 02Feb2021 to an unspecified stop date; atorvastatin calcium (ZARATOR) taken for hypercholesterolaemia from 01Feb2021 to an unspecified stop date; cyanocobalamin-tannin complex (BETOLVEX) taken for vitamin b12 deficiency from 12Jul2016 to an unspecified stop date; potassium chloride (KALEORID) taken for Potassium supplementation from 05Jan2017 to an unspecified stop date; pantoprazole sodium sesquihydrate (PANTOPRAZOL ACTAVIS) taken for esophageal acid reflux from 20Jul2021 to an unspecified stop date; quetiapine fumarate (QUETIAPIN ACCORD) taken for depression from 31May2018 to an unspecified stop date; terbutaline sulfate (BRICANYL TURBUHALER) taken for bronchospasm from 30Jan2019 to an unspecified stop date. The patient was found dead on 03Aug2021, 4 days after the 2nd vaccination. The patient underwent lab tests and procedures which included haemoglobin: 6.9 unit not specified on 20Jul2021. An autopsy was not performed (also reported an autopsy had been ordered. (Results awaits)). Causality: Reporter sees possible causal link to the COMIRNATY vaccination based on the short time from 2nd vaccination to death. The reporter describes the death as unexpectedly, despite the fact that the deceased was not "completely healthy". No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Found dead


VAERS ID: 1629274 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-14
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MAREVAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: EEPFIZER INC202101061501

Write-up: Ischaemic stroke; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the WEB, regulatory authority number EE-SAM-46702107313. A 90-year-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 04Jun2021 (Batch/Lot Number: Unknown) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included stroke from 2011 to 2011. Concomitant medication included warfarin sodium (MAREVAN) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included first dose of Comirnaty on unspecified date for COVID-19 immunisation and the patient had no special complaints. The patient was vaccinated with the second dose of Comirnaty vaccine on 04Jun2021. On the early morning of 14Jun2021, the patient died of a stroke. Disruption of blood supply to the brain, unconsciousness until death. Additional information on 05Aug2021: after vaccination with the first dose, the patient had no special complaints. After the second dose of the vaccine, only balance disorder occurred, but they had been also present before the vaccine, but not as frequently. 10 years ago, the patient had a stroke, from which he successfully recovered. There were no life-threatening complications. During the stroke, his mind was clear, but he could not speak, and his body was motionless. The patient used Marevan. According to the doctor who reported the situation, surprisingly, both arteries had closed at the same time and the brain had no blood supply, brain damage and death for about 12 hours. The patient experienced ischaemic stroke on 14Jun2021. Event seriousness criteria was death and medically significant. The patient died on 14Jun2021. It was not reported if an autopsy was performed. Sender''s comments: Serious, not listed side effect. The temporal relationship exists but the patient had previously taken blood thinners, in addition to old age. The causal link is considered doubtful. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Ischaemic stroke


VAERS ID: 1629436 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-08-04
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2083 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Valaciclovir
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Herpes genitalis; Overweight; Comments: herpes genital
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101055619

Write-up: Ischemic stroke; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency -WEB, regulatory authority number FR-AFSSAPS-BX20217294. A 34-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscularly on 16Jul2021 (Lot Number: FE2083) as dose 2, single for covid-19 immunisation; valaciclovir, oral from 30Jul2021 (Batch/Lot Number: Unknown) to 02Aug2021, at 1 DF, 1x/day for genital herpes. Medical history included herpes genitalis, overweight, both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced severe ischemic stroke followed by death on 04Aug2021. The action taken in response to the event for valaciclovir was unknown. The patient died on 04Aug2021. It was unknown if an autopsy was performed. The outcome of event was fatal. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Ischemic stroke


VAERS ID: 1629437 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-26
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death NOS; This case was received via Agency (Reference number: FR-AFSSAPS-BX20217295) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death NOS) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch no. Not found) for COVID-19 immunization. No Medical History information was reported. On 13-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (Parenteral) 1 dosage form. Death occurred on 26-Jul-2021 The patient died on 26-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment- Very limited information regarding this event/s has been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. No further information is expected.; Reported Cause(s) of Death: death NOS


VAERS ID: 1629438 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-06
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Extra dose administered, Incorrect route of product administration, Off label use, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Drug abuse and dependence (broad), Medication errors (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension arterial; Kidney disorder; Kidney transplant
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101055165

Write-up: Vaccination failure; COVID-19; third dose; third dose; intradermal third dose; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency-WEB, regulatory authority number FR-AFSSAPS-BX20217314. A 65-year-old male patient received BNT162B2 (COMIRNATY) single dose for COVID-19 immunisation, intradermal third dose on 06May2021 (Lot Number: EX2405; Expiration Date: 31Aug2021), unspecified route first and second dose on an unspecified date; at 65-year-old. Medical history included hypertension arterial, diabetes, kidney transplant, kidney disease. The patient''s concomitant medications were not reported. The patient experienced vaccination failure on 31Jul2021, COVID-19 on 31Jul2021. Vaccine failure was confirmed 2 and a half months after Dose 3 with death of a 65-year-old patient for serious infection by COVID. Hospitalization involved. Lab test included positive sars-cov-2 test. The patient died on an unspecified date. It was unknown if an autopsy was performed. Conclusion: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EX2405. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The investigative process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Reported Cause(s) of Death: COVID-19; Vaccination failure


VAERS ID: 1629441 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-08-03
   Days after vaccination:187
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOZAPINE; SERESTA; KARDEGIC
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: Covid-19 virus test; Test Result: Positive ; Test Date: 2021; Test Name: RT-PCR Covid-19 virus test; Test Result: Positive ; Comments: Presence of the L452R mutation (suggestive of the Delta variant)
CDC Split Type: FRPFIZER INC202101061631

Write-up: COVID-19 infection detected on 03Aug2021, although he had received 2 doses of vaccine on 07Jan2021 and 28Jan2021/ Covid-19 virus test positive/ COVID-19 aggravated; COVID-19 infection detected on 03Aug2021, although he had received 2 doses of vaccine on 07Jan2021 and 28Jan2021/ Covid-19 virus test positive/ COVID-19 aggravated; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority FR-AFSSAPS-CF20212370. A 90-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular in arm on 28Jan2021 (Lot Number: EJ6788; Expiration Date: Apr2021) as dose 2, single, dose 1 intramuscular in arm on 07Jan2021 (Lot Number: EM0477; Expiration Date: Apr2021) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included clozapine (CLOZAPINE); oxazepam (SERESTA); acetylsalicylate lysine (KARDEGIC). The patient died on 07Aug2021 due to a COVID-19 infection detected on 03Aug2021, although he had received 2 doses of vaccine on 07Jan2021 and 28Jan2021. The patient presented a cough from 03 to 06 August and suddenly deteriorated on 07 August with predominant digestive signs (diarrhea and vomiting), COVID-19 aggravated on 07Aug2021. Call of the internist on duty on 07Aug2021. RT-PCR test result (2021): Presence of the L452R mutation (suggestive of the Delta variant). Confirmed vaccine failure. Management included Urgent medical intervention/Life threatening but death at home. No autopsy planned. The patient underwent lab tests and procedures which included Covid-19 virus test on 04Aug2021: positive, RT-PCR Covid-19 virus test in 2021: positive, presence of the L452R mutation (suggestive of the Delta variant). The outcome of the events was fatal. The patient died on 07Aug2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 infection detected on 03Aug2021, although he had received 2 doses of vaccine on 07Jan2021 and 28Jan2021/ Covid-19 virus test positive/ COVID-19 aggravated; COVID-19 infection detected on 03Aug2021, although he had received 2 doses of vaccine


VAERS ID: 1629456 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-07-24
   Days after vaccination:165
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Drug ineffective, Oxygen saturation, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hand fracture (Hospitalization for a broken thumb + renal failure from 05Jul2021 to 20Jul2021); Obesity (Comorbidities linked to overweight); Renal insufficiency (Hospitalization for a broken thumb + renal failure from 05Jul2021 to 20Jul2021)
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: Body temperature; Result Unstructured Data: Test Result:febrile; Test Date: 20210725; Test Name: Body temperature; Result Unstructured Data: Test Result:ok; Test Date: 20210725; Test Name: saturation; Result Unstructured Data: Test Result:ok; Test Date: 20210725; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101061595

Write-up: Vaccination failure; Vaccination failure; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-GR20213464. A 64-year-old female patient received BNT162B2 (COMIRNATY) dose 2 intramuscular on 09Feb2021 (Lot Number: EP2166; Expiration Date: 31May2021) as dose 2, 0.3 ml single, dose 1 intramuscular on 19Jan2021 (Lot Number: EJ6788; Expiration Date: 30Apr2021) as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included obesity (Comorbidities linked to overweight), hospitalization for a broken thumb and renal insufficiency from 05Jul2021 to 20Jul2021. The patient''s concomitant medications were not reported. The patient experienced vaccination failure on 24Jul2021. The patient had resident febrile on 24Jul2021 in the evening. Generalized anxiety disorder on 25Jul2021. Temperature (Centigrade) and saturation were ok on 25Jul2021 at 19:00. Death certificate on 26Jul2021 at 00:45. Family visits on 23Jul2021. The patient underwent lab tests included sars-cov-2 test negative on 25Jul2021. The outcome of events was fatal. The patient died on 26Jul2021. An autopsy was not performed. Investigation results as follows: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lot EP2166. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. The reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: vaccination failure; vaccination failure


VAERS ID: 1629555 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOXAPINE; BISOPROLOL; FUROSEMIDE; VALPROMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Heart failure; Obesity (BMI at 31); Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101061820

Write-up: sudden death; felt tired; This is a spontaneous report from a contactable physician downloaded from the WEB FR-AFSSAPS-NT20213301. A 58-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FE8235), intramuscular, administered in Arm Left on 11Aug2021 (at age of 58 years old) as single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), obesity BMI at 31, schizophrenia, heart failure. Concomitant medications included loxapine; bisoprolol; furosemide; valpromide and treatment for chronic obstructive pulmonary disease. Patient is accompanied to the vaccination center by a state registered nurse on 11Aug2021 for his second dose of COMIRNATY. The state registered nurse who last saw him alive indicates that the patient felt tired after this vaccination but did not mention any pain or particular sensation. That is the state registered nurse who found him death in the evening, that is between 3 and 8 hours after vaccination. The patient presented with rigor mortis and was found pants down in the toilet, face down with a fractured nose, arms alongside his body with his back faces to the floor. The forensic obstacle has not been removed and an autopsy is in progress. In total, sudden death in a 58-year-old polymorbid patient, between 3 to 8 hours after dose 2 of COMIRNATY. The patient died on 11Aug2021. An autopsy was performed and results were not provided. The outcome of the event felt tired was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1629584 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-07-25
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3143 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMINE D
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20200811; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101061798

Write-up: Embolism pulmonary; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-PB20215461. A 38-year-old female patient received BNT162B2 (COMIRNATY) dose 2 intramuscular on 16Jun2021 (Lot Number: FC3143) as dose 2, single for covid-19 immunisation. Medical history included obesity. Concomitant medication included colecalciferol (VITAMINE D). The patient experienced embolism pulmonary on 25Jul2021. The patient underwent lab tests included COVID-19 PCR test negative on 11Aug2020. Death suggestive of pulmonary embolism occurring suddenly without warning signs. Intervention of the Emergency Medical Assistance Service, no hospital report, death at home. The patient died on 25Jul2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: pulmonary embolism


VAERS ID: 1630149 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-22
Onset:2021-01-09
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210109; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101064516

Write-up: Death; Positive COVID-19 test; Positive COVID-19 test; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108161101286530-MCZ3A, Safety Report Unique Identifier GB-MHRA-ADR 25803399. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced death on 18Jan2021, positive COVID-19 test on 09Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 09Jan2021 (Yes - Positive COVID-19 test). Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. The patient died on 18Jan2021. It was not reported if an autopsy was performed. The outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1630174 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Congenital anomaly, Foetal death, Maternal exposure during pregnancy
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021861237

Write-up: received BNT162B2 (BNT162B2, Formulation: Solution for injection), via transplacental on an unspecified date; Congenital Anomaly/Miscarriage; Congenital Anomaly/Miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202105022110060130-UMOJM. Safety Report Unique Identifier GB-MHRA-ADR 25231406. This is a spontaneous report from a contactable consumer (patient). This is the second of two reports. This consumer reported information for both mother and baby. This case is the baby case. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via transplacental route on an unspecified date as dose 1, single for COVID-19 immunization. The patient mother received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The parent medical history and concomitant medications were not reported. Patient mother has not had symptoms associated with COVID-19. Patient mother is not enrolled in clinical trial. Patient mother has not tested positive for COVID-19 since having the vaccine. The patient mother was pregnant while received BNT162B2 vaccine (Maternal exposure during pregnancy). On 09Apr2021, the patient experienced congenital anomaly and patient was expired (fetal death, miscarriage of mother). It was unknown autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021492546 Case for mother; Reported Cause(s) of Death: Fetal death


VAERS ID: 1630202 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-10
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Pyrexia
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UROREC; SILODYX; LECALCIF; OLARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Flu vaccination; Hyperplasia of prostate (benign hyperplasia of prostate); Obesity; Vitamin D deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: Fever; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: GRPFIZER INC202101056137

Write-up: Drug ineffective; SEVERE COVID-19; This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number GR-GREOF-20216555. A 67-year-old male patient received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an intramuscular route of administration on 06May2021 as DOSE 2, SINGLE and the patient received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an intramuscular on 14Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included influenza immunisation from Oct2020 to an unknown date, hypertension, obesity, benign prostatic hyperplasia (benign hyperplasia of prostate), vitamin d deficiency. The patient concomitant medications included silodosin (UROREC) 10 DF, 1x/day (once per day), orally taken for benign prostatic hyperplasia; silodosin (SILODYX), 5 DF, 1x/day (once per day), orally taken for benign prostatic hyperplasia; colecalciferol (LECALCIF) 2500 U/WK, taken for vitamin d deficiency; olmesartan medoxomil (OLARTAN) 1 DF, 1x/day (once per day), orally taken for hypertension. It was reported that on 10May2021, the patient experienced drug ineffective, severe covid-19. Time Interval between last dose of drug and start of reaction / event (number) was 4 days. On 10May2021, the patient underwent lab tests and procedures which included pyrexia was 38 centigrade. It was reported that, the patient died on 03Jun2021. It was not reported if an autopsy was performed. It was stated that, the patient had close contact with covid-19 patient (familial) who presented mild disease (06May2021). The outcome of event was Fatal. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1630257 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-07-11
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Angiocardiogram
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLIC ACID; FAMOTIDINE; AMLODIPINE + ATORVASTATIN; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Generalised arteriosclerosis; Hemiparesis (left); Hypertension; Ischemic stroke; Myocardial infarction
Allergies:
Diagnostic Lab Data: Test Name: Urgent coronarography; Result Unstructured Data: Test Result:unknown
CDC Split Type: HUPFIZER INC202101054458

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-696821. A 68-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 26Jun2021 (Batch/Lot Number: FD0168) as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation. The patient previously took Comirnaty for COVID-19 immunisation on 25May2021 (Batch/Lot Number: FC3558). Medical history included ischaemic stroke from 2008 to an unknown date, not ongoing, depression, not ongoing, Hemiparesis (left) from 2008 to an unknown date, not ongoing, myocardial infarction, not ongoing, hypertension, not ongoing, Generalised arteriosclerosis, not ongoing. Concomitant medications included acetylsalicylic acid once daily for an unspecified indication, start and stop date were not reported; famotidine 20 mg once daily for an unspecified indication, start and stop date were not reported; amlodipine besilate, atorvastatin calcium (AMLODIPINE + ATORVASTATIN) once daily for an unspecified indication, start and stop date were not reported; ramipril taken 2.5 mg, once daily for an unspecified indication, start and stop date were not reported. On 11Jul2021, the patient experienced chest pain and then he lost his consciousness. A relative began resuscitation. Paramedics detected ventricular fibrillation, the patient was defibrillated twice, and his circulation returned after 20 minutes of CPR. During transportation to the hospital, there were two more episodes of ventricular fibrillation. Right bundle branch block and extensive anterior acute myocardial infarction was confirmed in the hospital. Urgent coronarography was performed, during which percutaneous coronary intervention (PCI) and drug-eluting stent (DES) were performed on the left anterior descending artery. His circulation temporarily required catecholamine support and then stabilized. On 20Jul2021, the patient developed left ventricular failure and massive pulmonary embolism that did not respond to the intravenous drug therapy used. Following an unsuccessful resuscitation, the patient died on 20Jul2021 at 10:50 p.m. Autopsy was done, the cause of death was acute myocardial infarction. The patient experienced acute myocardial infarction (death, hospitalization) on 20Jul2021. Therapeutic measures were taken as a result of acute myocardial infarction. The patient died on 20Jul2021. An autopsy was performed that revealed acute myocardial infarction (acute myocardial infarction). The patient died due to acute myocardial infarction 24 days after Comirnaty vaccination. Based on the medical history, the causal relationship between the event and Comirnaty is considered unlikely. The case is serious due to hospitalization and fatal outcome. No follow-up attempts are needed. No further information is expected; Reported Cause(s) of Death: Acute myocardial infarction; Autopsy-determined Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1630258 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC202101054459

Write-up: Sudden death; 1st dose was administrated on 23May2021/ dose 2 on 21Jul2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority, regulatory authority number HU-OGYI-697521. A 76-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Right on 21Jul2021 at age of 76-year-old (Batch/Lot Number: FF0680) as Dose 2, 0.3 mL single for covid-19 immunisation. Comirnaty 1st dose was administrated on 23May2021 (batch number: FA4598). The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced sudden death on 25Jul2021. The patient died on 25Jul2021. An autopsy was performed and results were not provided. The patient died suddenly 4 days after Comirnaty vaccination. Autopsy was requested, further information is expected. The causal relationship between the reported death and Comirnaty is not assessable due to lack of information. The case is serious due to fatal outcome. No follow-up attempts are needed. No further information is expected; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1630279 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bradykinesia, Cognitive disorder, General physical health deterioration, Pneumonia aspiration
SMQs:, Dementia (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Hypertension; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101056040

Write-up: PROGRESSIVE COGNITIVE DECLINE; FUNCTIONAL DECLINE; BRADYKINESIA; BILATERAL ASPIRATION PNEUMONIA; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority, regulatory authority number IE-HPRA-2021-080181. A 87-year-old male patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 17Mar2021 (Lot Number: ER0641) as dose 2, single, dose 1 via an unspecified route of administration on 17Feb2021 (Lot Number: ER7812) as dose 1, single for COVID-19 immunisation. Medical history included parkinson''s disease, depression, hypertension. The patient''s concomitant medications were not reported. The patient experienced progressive cognitive decline (cognitive disorder) (death, hospitalization) on an unspecified date, functional decline (general physical health deterioration) (death, hospitalization) on an unspecified date, bradykinesia (bradykinesia) (death, hospitalization) on an unspecified date, bilateral aspiration pneumonia (pneumonia aspiration) (death, hospitalization) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Days to weeks following vaccination, the patient experienced progressive cognitive and functional decline. On an unknown date, the patient was admitted to hospital with bradykinesia and bilateral aspiration pneumonia. According to the reporter the patient was discharged (date unspecified) with palliative support and sadly passed away (date unspecified). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: PROGRESSIVE COGNITIVE DECLINE; FUNCTIONAL DECLINE; BRADYKINESIA; BILATERAL ASPIRATION PNEUMONIA


VAERS ID: 1630289 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1131 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Choking sensation, Death, Dizziness, Heart rate, Heart rate increased, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: Heart rate; Result Unstructured Data: Test Result:Increased
CDC Split Type: ITPFIZER INC2021667350

Write-up: death; Immediate allergic reaction after administration of Pfizer with raised heartbeats and choking the following days of muscle pain dizziness and death; Immediate allergic reaction after administration of Pfizer with raised heartbeats and choking the following days of muscle pain dizziness and death; Immediate allergic reaction after administration of Pfizer with raised heartbeats and choking the following days of muscle pain dizziness and death; Immediate allergic reaction after administration of Pfizer with raised heartbeats and choking the following days of muscle pain dizziness and death; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-738589. A 41-year-old female patient received second dose of BNT162B2 (COMIRNATY; formulation: solution for injection; Batch/Lot Number: FC1131) intramuscularly on 31May2021 (at the age of 41-year-old), as a dose 2, 0.3 mL, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY; Solution for injection) for COVID-19 immunization. On 31May2021 (same day of vaccination), the patient experienced immediate allergic reaction after administration of pfizer with raised heartbeats and choking the following days of muscle pain dizziness and death. The patient underwent lab tests and procedures which included heart rate: increased on 31May2021. The outcome of events was fatal. Reporter''s comments: Allergic Sender''s comments: I will ask for more information about the "allergic" reaction No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: Allergic; Reported Cause(s) of Death: Immediate allergic reaction after administration of Pfizer with raised heartbeats and choking the following days of muscle pain dizziness and death; Immediate allergic reaction after administration of Pfizer with raised heartbeats and choking the fol


VAERS ID: 1630389 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214014 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aortic stenosis, Death, Incorrect dose administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: Inappropriate dose of vaccine administered; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-768969) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH and AORTIC STENOSIS in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214014) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .3 milliliter in total. On 06-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced DEATH (seriousness criteria death and medically significant) and AORTIC STENOSIS (seriousness criteria death and medically significant). On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered). The patient died on 07-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment was reported. Company comment: This is a case of sudden death in a 72-year-old female subject, with reported serious unlisted event Aortic stenosis , who died 2 days after receiving unknown dose of vaccine, no medical history was reported, cause of death was not specified, It is unknown if an autopsy was performed, Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 72-year-old female subject, with reported serious unlisted event Aortic stenosis , who died 2 days after receiving unknown dose of vaccine, no medical history was reported, cause of death was not specified, It is unknown if an autopsy was performed, Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1630405 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular disorder
SMQs:, Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction; Atherosclerosis; Cardiac failure chronic; Chronic renal failure; Hypercholesteremia; Hypertension arterial; Hypertension pulmonary; IHD; Intermittent claudication; Non-sustained ventricular tachycardia.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101061874

Write-up: death due to probable cardiovascular event in the definition phase.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency-WEB [IT-MINISAL02-769893]. A 61-year-old male patient received BNT162B2 (COMIRNATY), 1st dose intramuscularly, administered in Arm Left on 30Jul2021 (Lot Number: FF3318; Expiration Date: 15Oct2021) age of 61 years old as 0.3ml, a single dose for covid-19 immunisation. Medical history included Atherosclerosis, Non-sustained ventricular tachycardia, Hypercholesteremia, Intermittent claudication, Chronic renal failure, Hypertension arterial, all from an unknown date and unknown if ongoing, acute myocardial infarction from 01Jul1998 to an unknown date, pulmonary hypertension from 09Sep2019 to an unknown date, cardiac failure chronic from 01Jul2019 to an unknown date, IHD from 02Mar2017 to an unknown date. The patient''s concomitant medications were not reported. The patient experienced death due to probable cardiovascular event in the definition phase on 30Jul2021. The patient died on 30Jul2021. It was not reported if an autopsy was performed. Description: Patient refused ICD [Implantable Cardioverter Defibrillator] implantation. Sender Comment: 11Aug2021 Required material to support the diagnosis. Waiting for a medical report and /or necropsy. 12Aug2021 Attachment of Dr. PRIVACY medical report specifying that he is not in possession of the card because his family members did not produce it. Since family members have reported complaints and there is an open investigation file, we are not given much more to know. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: death due to probable cardiovascular event in the definition phase.


VAERS ID: 1630415 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-07-18
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Knee injury (didnot take drugs other than painkillers for a knee pain where he had suffered a trauma years before)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101067088

Write-up: transient stomach pains. cardiac arrest; transient stomach pains. cardiac arrest; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-771112. A 57-years-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FC3098), via intramuscular route of administration, administered in Arm Left (left shoulder) on 11Jun2021 as single dose for COVID-19 immunisation. Medical history included knee trauma from an unknown start and stop date (did not take drugs other than painkillers for a knee pain where he had suffered a trauma years before). The patient''s concomitant medications were not reported. The patient experienced transient stomach pains and cardiac arrest on 18Jul2021. Therapeutic measures were taken as a result of transient stomach pains. cardiac arrest. Impact on quality of life was 2/10. The patient did not suffer from any pathologies. The patient died on an unspecified date due to transient stomach pains and cardiac arrest. It was not reported if an autopsy was performed. Health authority comment: no previous illness. Senders comment: Local Center of Pharmacovigilance: requests for further information and possible autopsy examination. Waiting for autopsy results and contact with the attending physician No follow up attempts needed, no further information is expected; Reporter''s Comments: no previous illness; Reported Cause(s) of Death: transient stomach pains. cardiac arrest; transient stomach pains. cardiac arrest


VAERS ID: 1630507 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-29
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm rupture, Aortic dissection, Body temperature, Cardiac tamponade, Cardio-respiratory arrest, Imaging procedure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210515; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 202105; Test Name: Imaging procedure; Result Unstructured Data: Test Result: aortic dissection and cardiac tamponade
CDC Split Type: JPPFIZER INC202101042814

Write-up: Thoracic aortic aneurysm rupture; Cardio-respiratory arrest; Aortic dissection; Cardiac tamponade; This is a spontaneous report from contactable physicians received via Regulatory Authority with Regulatory authority report number v21123348. A 31-year and 2-month-old patient received BNT162b2 (COMIRNATY, Solution for injection), intramuscular, administered in left arm on 15May2021 at 16:06 (the day of vaccination) (Batch/Lot Number: EW4811; Expiration Date: 31Jul2021) (at the age of 31-years-old) as dose 1, single for COVID-19 immunisation. The patient had no allergies to medications, food, or other products. The patient had no other medical history. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Body temperature before vaccination was 36.3 degrees centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient experienced cardio-respiratory arrest on 29May2021 between the time from 22:40 to 22:45 (14 days 6 hours, and 34-39 minutes after the vaccination). On 30May2021 (15 days after the vaccination), the outcome of the cardio-respiratory arrest was fatal. The events resulted in emergency room/department visit or urgent care and death. The course of the event was reported as follows: The patient was in a condition of cardio-respiratory arrest. The patient was transferred to a university hospital, but the spontaneous circulation did not resume, and the patient was confirmed dead. The patient did not receive any treatment for the events. Imaging showed aortic dissection and cardiac tamponade. The reporting physician classified the events as serious (fatal) and assessed that the events was unrelated to BNT162b2. There was no other possible cause of the event such as any other diseases. The patient died on 30May2021. Cause of death was thoracic aortic aneurysm rupture. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Considering the nature of the reported events, there was not a reasonable possibility that the events aortic dissection, cardiac tamponade, thoracic aortic aneurysm rupture, and cardio-respiratory arrest were related to the suspect product BNT162B2 (COMIRNATY). This case will be re-assessed should additional information becomes available.; Reported Cause(s) of Death: Thoracic aortic aneurysm rupture


VAERS ID: 1630508 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-16
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Hemiplegia, Pneumonia aspiration
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: URSO [URSODEOXYCHOLIC ACID]; NOBELZIN; LANSOPRAZOLE; MYSLEE; HOCHUEKKITO [ANGELICA ACUTILOBA ROOT;ASTRAGALUS SPP. ROOT;ATRACTYLODES LANCEA RHIZOME;BUPLEURUM FALC; RISPERIDONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction (Hospitalized); Dementia (Hospitalized); Diabetes mellitus (Hospitalized); Hepatic cancer (Hospitalized); Hepatitis C (Hospitalized); Hospitalisation; Pressure sore (Hospitalized); Reflux esophagitis (Hospitalized)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101046489

Write-up: possibility of pneumonia aspiration; Right sided complete paralysis due to cerebral infarction; Right sided complete paralysis due to cerebral infarction; This is a spontaneous report from a contactable physician received from the Regulatory Authority. This is the second of two reports. The first report was received under regulatory authority report number v21123522. A 74-year-old male patient received first dose of BNT162b2 (COMIRNATY), intramuscular, administered in arm left on 06Jul2021 at 12:00 (Lot Number: EY5422; Expiration Date: 31Aug2021) (at the age of 74-year-old) as single dose for COVID-19 immunisation. Medical history included dementia, hepatitis C, hepatic cancer, diabetes mellitus, reflux esophagitis, cerebral infarction and pressure sore (the patient was in the reporting hospital due to dementia, hepatitis C, hepatic cancer, diabetes mellitus, reflux esophagitis, cerebral infarction, and pressure sore). The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient had no allergies. Concomitant medications included oral ursodeoxycholic acid (URSO), oral zinc acetate (NOBELZIN), oral lansoprazole, oral zolpidem tartrate (MYSLEE), oral angelica acutiloba root/astragalus spp. Root/atractylodes lancea rhizome/bupleurum falcatum root/cimicifuga spp. Rhizome/citrus aurantium peel/glycyrrhiza spp. Root/panax ginseng root/zingiber officinale rhizome/ziziphus jujuba fruit (HOCHUEKKITO) and oral risperidone as needed. On 06Jul2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Lot number: not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16Jul2021 (10 days after the vaccination), the patient experienced right sided complete paralysis due to cerebral infarction. On unspecified date, the patient experienced "a possibility of pneumonia aspiration". The course of the events was as follows: the patient was in the reporting hospital due to dementia and reflux esophagitis. On 06Jul2021, the patient received the first dose of BNT162b2. On 16Jul2021, the patient experienced right sided complete paralysis due to cerebral infarction. Afterwards, the symptom tended to improve. The patient was receiving piperacillin sodium/tazobactam sodium (TAZOPIPE) via a lateral injection tube for a possibility of pneumonia aspiration. Originally, the swallowing ability was not sufficient; however, decreased swallowing ability was observed and sputum increased a few days ago. On 27Jul2021 at 15:30, the patient received the second dose of BNT162b2. On 28Jul2021 at 11:50, the patient experienced respiratory arrest. The patient was determined to have asphyxia due to aspiration. The outcome of the events "right sided complete paralysis due to cerebral infarction" was recovering. The outcome of the event "a possibility of pneumonia aspiration" was not reported. Seriousness of the event "right sided complete paralysis due to cerebral infarction" and "a possibility of pneumonia aspiration", and causality assessment for the events were not reported. The patient died on 28Jul2021. No autopsy was done. The cause of patient death was reported as follows: aspiration or gastroesophageal reflux (swallowing ability was decreased due to dementia, reflux esophagitis and cerebral infarction; thus, the patient was prone to aspiration).; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101026440 Same reporter/patient/drug, Different event/dose; Reported Cause(s) of Death: Asphyxia due to aspiration or gastroesophageal reflux; Asphyxia due to aspiration or gastroesophageal reflux; Asphyxia due to aspiration or gastroesophageal reflux


VAERS ID: 1630511 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-26
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure measurement, Body temperature, C-reactive protein increased, Chest discomfort, Chronic obstructive pulmonary disease, Decreased appetite, Heart rate, Oxygen saturation, Pleurisy, Pneumonia, White blood cell count
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   Days after onset: 40
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMBROXOL HYDROCHLORIDE; CLOPIDOGREL SULFATE; REBAMIPIDE; CELECOXIB; RIKKUNSHITO; TULOBUTEROL; PHYSIOLOGICAL SALINE SOLUTION; BISOLVON; VENETLIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchitis chronic; Femoral head replacement; Femur fracture; Gastrectomy total; Gastric tube reconstruction; Ischaemic enterocolitis; Lumbar spine compression fracture; Macular degeneration; Oesophageal cancer (after total gastrectomy, gastric reconstruction); Otitis externa; Pneumonia; Pneumonia aspiration; Retinal detachment
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: blood pressure; Result Unstructured Data: Test Result:99/45 mmHg; Comments: at 08:20; Test Date: 20210611; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210702; Test Name: body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Comments: at 08:20; Test Date: 20210630; Test Name: CRP; Result Unstructured Data: Test Result:2.67; Test Date: 20210702; Test Name: pulse rate; Result Unstructured Data: Test Result:84; Comments: at 08:20; Test Date: 20210702; Test Name: SpO2; Test Result: 91 %; Comments: at 08:20; Test Date: 20210531; Test Name: SpO2; Result Unstructured Data: Test Result:93-94 %; Test Date: 20210630; Test Name: WBC; Result Unstructured Data: Test Result:5350
CDC Split Type: JPPFIZER INC202101049805

Write-up: Pneumonia suspected (aggravation of COPD suspected); Pneumonia suspected (aggravation of COPD suspected); Pleurisy suspected; precordial discomfort; bilateral shoulder pain; appetite impaired; This is a spontaneous report from contactable physicians received from the Regulatory authority. Regulatory authority report number is v21123370. The patient was an 83-year and 10-month-old male. Body temperature before vaccination was 36.4 degrees centigrade. The patient had no particular family history. Medical history included status post surgery for oesophageal cancer (total gastrectomy, gastric reconstruction) in 2006, bronchitis chronic (COPD), pneumonia aspiration in Jun2019, lumbar spine compression fracture, femur fracture, artificial femoral head insertion in 2019, macular degeneration in the left eye, retinal detachment in the left eye, ischaemic enterocolitis, otitis externa left, and pneumonia. Concomitant medications included ambroxol hydrochloride (AMBROXOL HYDROCHLORIDE OD Tablets 45 mg) 1 tablet, clopidogrel sulfate (CLOPIDOGREL 75 mg) 1 tablet once daily in the morning, rebamipide (REBAMIPIDE OD 100 mg) 2 tablets, celecoxib (CELECOXIB 100 mg) 2 tablets twice daily in the morning and evening, TSUMURA Rikkunshi-to 3 pack daily before each meal, tulobuterol (TULOBUTEROL Tape 1 mg), (inhalation) physiological saline 4.0 mL, bromhexine hydrochloride (BISOLVON) 2.0 mL, and salbutamol sulfate (VENETLIN) 0.5 mL in the morning and evening. It was reported that on 11Jun2021 at 10:14 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 26Jun2021 at 07:30 (15 days after the vaccination), the patient experienced precordial discomfort, bilateral shoulder pain, and appetite impaired. On 02Jul2021 (21 days after the vaccination), the patient was admitted to the hospital. On 05Aug2021 at 0:10 (55 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient had medical history of lumbar spine compression fracture and femur fracture (artificial femoral head insertion in 2019). On 10Apr2021, the patient was admitted for the treatment of pneumonia to Hospital A. On 11Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination. From around 26Jun2021, (15 days after vaccination), the patient had bilateral shoulder pain, precordial discomfort, and appetite impaired. On 30Jun2021 (19 days after vaccination), the WBC was 5350, the CRP was 2.67. Angina pectoris was deniable on the ECG. On 02Jul2021, at 08:10 (21 days after vaccination), rale was heard on both lungs. At 08:20, the body temperature was 37.7 degrees Celsius, the pulse rate was 84, the blood pressure was 99/45 mmHg, and the SpO2 was 91%. Thus, the patient was transferred to and seen at Hospital, where the patient was hospitalised for pleurisy suspected. The reporting physician classified the event as serious (death, hospitalization) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases included COPD. The reporting physician commented as follows: The events occurred on 26Jun2021 which was 15 days after the first dose of BNT162b2 vaccination on 11Jun2021. In addition, the patient had an underlying disease of COPD, and thus, the assessment was difficult. However, the possibility could not be ruled out that pleurisy and pneumonia were triggered by the vaccination. The provision of information (to Hospital): Age: 83, Gender: Male, The level of care needed: 2. The name of injuries and diseases: Pneumonia suspected (aggravation of COPD suspected), oral intake was impossible. Medical history: Status post surgery for oesophageal cancer (status post total gastrectomy and gastric reconstruction) in 2006, bronchitis chronic (COPD), pneumonia aspiration in Jun2019, lumbar spine compression fracture, femur fracture, artificial femoral head insertion in 2019, macular degeneration in the left eye, retinal detachment in the left eye, ischaemic enterocolitis, otitis externa left, and pneumonia. The disease condition: 02Jul2021. On 10Apr2021, the patient was diagnosed with pneumonia, for which he was admitted to and received treatment in Hospital. On 31May2021(as reported date), the SpO2 was low as 93 to 94%, and the patient had sputum. Thus, an inhalation was initiated in the morning and evening (physiological saline 4.0 mL, bromhexine hydrochloride (BISOLVON) 2.0 mL, and salbutamol sulfate (VENETLIN) 0.5 mL; per dose). Since the amount of meal intake was small, the reporting physician have the patient drink one bottle of Mei Balance Mini. Since the respiratory condition and the amount of meal intake improved, and the patient wished to go home. Thus, the inhalation was changed to tulobuterol (TULOBUTEROL Tape) 2 mg on 11Jun2021 (on this day, the patient received the first dose of BNT162b2 vaccination). From aroung 26Jun2021 (15 days after vaccination), the patient had bilateral shoulder pain, precordial discomfort, and appetite impaired.On 30Jun2021 (19 days after vaccination), the laboratory data was as follows: the WBC was 5350 and the CRP was 2.67. On 01Jul2021 (20 days after vaccination), an intravenous drip infusion (DIV) was initiated; however, it leaked. Since the patient underwent total gastrectomy, gastrostomy was impossible. The reporting physician told the patient''s family about deathwatch. However, the family wished the inpatient treatment. On 02Jul2021, at 08:10 (21 days after vaccination), rale was significantly heard on both lungs. The body temperature was 37.7 degrees Celsius, the pulse rate was 84, the blood pressure was 99/45 mmHg, and the SpO2 was 91%.; Reported Cause(s) of Death: Pleurisy suspected; Pneumonia suspected (aggravation of COPD suspected); Pneumonia suspected (aggravation of COPD suspected)


VAERS ID: 1630516 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-07
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Cardiomyopathy, Chest discomfort, Decreased appetite, Dyspnoea, Feeding disorder
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-16
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101058712

Write-up: Acute exacerbation of cardiac failure; cardiomyopathy; chest distress; appetite impaired; dyspnoea; unable to eat; This is a spontaneous report from a contactable pharmacist received from the Agency. Regulatory authority report number is v21123554. The patient was a 72-year and 2-month-old male. Body temperature before vaccination was not reported. The patient''s family history and medical history were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Concomitant medications were not reported. On unknown date, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot# EW0203, Expiration date 30Sep2021) via an unspecified route of administration as dose 1, single for COVID-19 immunisation. On 31Jul2021 (the day of vaccination), the patient received?the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FD0889, Expiration date 30Sep2021) via an unspecified route of administration as dose 2, single (at age of 72-year-old) for COVID-19 immunisation. On 11Aug2021 at 13:00 (11 days after the vaccination), the patient experienced acute exacerbation of cardiac failure. On 11Aug2021 (11 days after the vaccination), the patient was admitted to the hospital. On 16Aug2021 (16 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 02Nov2015, the patient underwent aortic replacement. From 31Jul021, 1 week after the second dose of vaccination, the patient started to complain of chest distress. He had appetite impaired at the same time. From around 07Aug2021, the patient became unable to eat (but was barely able to drink water). On 11Aug2021, the patient was admitted to the reporting hospital because cardiac failure or cardiomyopathy was suspected. Treatment for chronic cardiac failure was performed, and since dyspnoea was noted, palliative therapy with morphine was also given. On 16Aug2021, the patient died. It was not reported if an autopsy was performed. The reporting pharmacist classified acute exacerbation of cardiac failure as serious (death and hospitalization) and assessed the causality between the event and bnt162b2 as unassessable. Date of hospitalization : 11Aug2021, Date of discharge (death): 16Aug2021. Other possible causes of the event such as any other diseases were not reported. It was not reported if an autopsy was performed. Outcome of acute exacerbation of cardiac failure was fatal. The outcome of other events was unknown.; Reported Cause(s) of Death: Acute exacerbation of cardiac failure


VAERS ID: 1630517 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Electrocardiogram, Heart rate
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardio-respiratory arrest; Myocardial infarction (Diagnosed with myocardial infarction); Percutaneous coronary intervention (occlusion was noted)
Allergies:
Diagnostic Lab Data: Test Date: 20210812; Test Name: waveform; Result Unstructured Data: Test Result:VF; Comments: Initial waveform showed VF; Test Date: 20210812; Test Name: pulse check; Result Unstructured Data: Test Result:VF
CDC Split Type: JPPFIZER INC202101059302

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable other health professional received from the Regulatory authority. Regulatory authority report number is v21124101. A 47-year-old male patient received COVID-19 vaccine (Manufacture unknown), dose 1 via an unspecified route of administration on 12Aug2021 13:45 (the day of vaccination) (Batch/Lot number and Expiration date were not reported) as single dose for covid-19 immunisation. Body temperature before vaccination was not reported. Medical history was as follows: CPA (cardiopulmonary arrest) developed on 11Mar2021, and myocardial infarction was diagnosed. The patient underwent elective PCI (percutaneous coronary intervention) on 01Apr2021 and 20May2021. Concomitant medications and family history were not provided. On 12Aug2021 at 20:48 (7 hours and 3 minutes after the vaccination), the patient experienced acute myocardial infarction. At 23:32, the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: On 12Aug2021, after the vaccination, the patient was at home without any change. He exercised on a treadmill for the purpose of rehabilitation, and shortly after he said that he felt dizziness, he collapsed. His family run up to him and found that he had lost consciousness and developed convulsion. Supraduction was noted. At 20:49, an emergency service was requested. When an emergency team arrived, chest compression was being performed by his family. Initial waveform showed VF (ventricular fibrillation). At 20:55, DC (direct current) defibrillation was performed. Two minutes later, pulse check revealed VF again. At 20:57, DC was performed for the second time. Cardiac massage was carried out by the emergency team. LT (laryngeal tube) was inserted and BVM (bag valve mask) was placed. Adrenaline 1 ampule was intravenously administered. At 21:20, the emergency team arrived. Although resuscitation was attempted, at 23:32, the patient died. The reporting other health professional classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Possible causes of the event were reported as follows: On 11Mar2021, while the patient was working, he developed CPA. He was diagnosed with myocardial infarction, and he underwent PCI. Since a lot of occlusion was noted, elective PCI was performed on 01Apr2021 and 20May2021. The lot number for bnt162b2, was not provided and will be requested during follow up. ; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1630520 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Cardio-respiratory arrest, Dehydration, Hyperkalaemia
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CABPIRIN; VALSARTAN; LASIX [FUROSEMIDE]; EPADEL [EICOSAPENTAENOIC ACID ETHYL ESTER]; ASTOMIN [DIMEMORFAN PHOSPHATE]; SPIOLTO RESPIMAT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; COPD; Hypertension; Pulmonary hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101062425

Write-up: Acute renal failure; hyperkalaemia; Dehydration; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received via database, also from the Agency. Regulatory authority report number is v21124119. The patient was a 84-year-8-month-old male. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included acetylsalicylic acid, vonoprazan fumarate (CABPIRIN); valsartan; furosemide (LASIX); eicosapentaenoic acid ethyl ester (EPADEL); dimemorfan phosphate (ASTOMIN); olodaterol hydrochloride, tiotropium bromide monohydrate (SPIOLTO RESPIMAT), all taken for an unspecified indication from an unspecified start date and ongoing, within 2 weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient had allergies to medications, food, or other products. Other medical history included cardiac failure chronic, pulmonary hypertension, COPD, and hypertension. On 09Jul2021, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot# EY5423, Expiration date 31Aug2021) via an unspecified route of administration at the age of 84-year-old for COVID-19 immunisation. On 30Jul2021 at 14:30 (the day of vaccination), the patient received the second single dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021) via intramuscular route of administration in the left arm at the age of 84-year-old for COVID-19 immunisation. On 30Jul2021 at 16:50 (2 hours/20 minutes after the vaccination),the patient experienced cardio-respiratory arrest. The reporting physician classified cardio-respiratory arrest as serious (death) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible causes of the event such as any other diseases were acute renal failure and hyperkalaemia. On 30Jul2021 (2 hours after the vaccination, as reported), the patient experienced death. The event resulted in death. The outcome of the event was fatal with treatment including adrenaline and cardiac massage. The reporting physician assessed the event as serious (death). Since the vaccination, the patient has not been tested for COVID-19. The reported event was as follows: On 30Jul2021 (the day of vaccination), at 14:30, the patient received the second dose of bnt162b2 vaccination. On the same day, at around 16:50 (around 2 hours and 20 minutes after vaccination), the patient was found to collapse on the road by the post-office clerk, and an ambulance was called. After the patient was found, cardiac massage was initiated. The last time when the patient was fine was unknown. The laryngeal mask airway (LMA) and cardiac massage were continued, and adrenaline 5A was administered; however, no return of spontaneous circulation was obtained. At 18:15 (3 hours and 45 minutes after vaccination), the patient was confirmed to die. Cause of death was acute renal failure and hyperkalaemia. Therapeutic measures were taken as a result of events. The patient died on 30Jul2021. No autopsy was performed. The reporting physician commented as follows: When the patient was transferred, the patient was not examined, and thus, the details were unknown. Dehydration, renal failure, and hyperkalaemia were suspected on the medical record. The outcome of dehydration was unknown. The outcome of other events was fatal.; Sender''s Comments: The event of Cardio-respiratory arrest, Acute renal failure and Hyperkalaemia is assessed as possibly related to the suspect drug Comirnaty based on strong temporal association, but consider also possible contributory effects from patient''s medical history of Cardiac failure chronic, Pulmonary hypertension, COPD and Hypertension. 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: acute renal failure; hyperkalaemia; Cardio-respiratory arrest


VAERS ID: 1630552 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Blood immunoglobulin M, COVID-19, COVID-19 pneumonia, Histology, Polymerase chain reaction
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sickness
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: Autopsy; Result Unstructured Data: signs of pneumonia; Test Name: COVID-19; Result Unstructured Data: positive for COVID; Test Name: Histology; Result Unstructured Data: pending; Test Name: PCR; Result Unstructured Data: negative; Test Name: IgM; Result Unstructured Data: positive
CDC Split Type: LSJNJFOC20210842115

Write-up: COVID-19 PNEUMONIA; This spontaneous report was received from a consumer and from Health Authority via a company representative, and concerned a 73 year old female. Initial information was processed with additional information received on 23-AUG-2021. The patient''s height and weight were not reported. The patient''s concurrent conditions included: sickness. Her son reported that on the 25-JUL-2021 she was complaining of pain on the forehead, cough, tiredness, chest pain and back pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose and vaccination site not reported, administered on 02-AUG-2021 for prophylactic vaccination. Vaccine was kept in good condition; no issue on vaccine quality was found. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 pneumonia. Following vaccination on 02-AUG-2021, the patient had dizziness and was helped by other patients attending the clinic to get a taxi home. The patient lived with a helper/maid and her two grand-children. When she got home she slept. On the 03-AUG-2021, patient''s son was called, because the patient was having chest pain, and coughing thick sputum mixed with blood. The patient also had fever. She refused to be taken to see the doctor, but called her priest who came and prayed for her. On 05-AUG-2021 at 20:40, the patient complained of chest heaviness, difficulty breathing, hungry for air and was restless. Soon after the patient was noted to not be breathing. The neighbors were also called to assist, but then death was reported to have occurred at about 20:50. Autopsy was done. Preliminary postmortem findings: signs of pneumonia were found in the lung during the autopsy. Postmortem COVID test was positive for COVID-19, COVID-19 IgM was positive, PCR was negative. Tissue for histology (site not reported) was taken; results pending. Reporter causality classification: co-incidental. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome was fatal. This report was serious (Death). This case is associated with product quality complaint; PQC number pending. This case, from the same reporter is linked to 20210816486, 20210816515, 20210816481, 20210842145 and 20210842105.; Sender''s Comments: V0: This spontaneous report received from a patient''s son and from a Health Authority concerns a 73-year-old female who died of Covid-19 pneumonia 3 days after receiving the Janssen Covid-19 vaccine. The patient had a concurrent "sickness"; 8 days before vaccination, the patient complained of forehead pain, cough, tiredness, chest pain, and back pain. No concomitant medications were reported. On the same day as vaccination, she experienced dizziness. One day post-vaccination, she was having chest pain and fever and was coughing thick sputum mixed with blood. She did not want to see a doctor at that time but asked her priest to pray for her. Three days post-vaccination, she complained of chest heaviness, difficulty breathing, hungry for air and was restless. Soon after, the patient stopped breathing and she died that evening. Preliminary postmortem autopsy findings included signs of pneumonia and positive testing for COVID-19; COVID-19 IgM was positive, PCR was negative. Results for tissue histology (site not reported) were pending. The reporter considered the fatal event coincidental to vaccination. Considering the presence of sickness prior to vaccination which could represent Covid-19 infection and that death due to Covid-19 pneumonia occurred on post-vaccination day 3 prior to the vaccine becoming efficacious, the relationship of the fatal event is assessed to be inconsistent to vaccination.


VAERS ID: 1630565 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MAJNJFOC20210841913

Write-up: DEATH BY VACCINE; This spontaneous report received from social media from a consumer via a company representative concerned a patient of unknown age, sex, ethnicity and race. Initial information was received on 27-JUL-2021 and was processed with further information received on 13-AUG-2021. This case was created to replace AER 20210763684 which was nullified in error. All relevant information will be submitted under this case (Manufacturer Case Number 20210841913). 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, intramuscular, batch number was not reported) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient died by vaccine. The cause of death was unknown. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210763797. This case is associated with Product Quality Complaint Number 90000189506.; Sender''s Comments: V0: This spontaneous report received from social media from a consumer via a company representative concerned a patient of unknown age, sex, ethnicity and race. No past medical history or concomitant medications were reported. On an unspecified date, the patient died by vaccine. The cause of death was unknown. It was unknown if autopsy was performed. Information in the case is limited which precludes a meaningful medical assessment. Thus, the event is considered to have an indeterminate relationship to vaccine.; Reported Cause(s) of Death: DEATH DUE TO UNKNOWN CAUSE


VAERS ID: 1630767 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD (stabiele COPD)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This case was received via Agency (Reference number: 00662375) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PULMONARY OEDEMA, FATIGUE and DYSPNOEA in a 71-year-old female patient who received mRNA-1273 for COVID-19 vaccination. Concurrent medical conditions included COPD. On 03-Jul-2021, the patient received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (unknown route) .5 ml. On 03-Jul-2021, the patient experienced FATIGUE (seriousness criteria death and hospitalization prolonged). On 05-Jul-2021, the patient experienced PULMONARY OEDEMA (seriousness criteria death, hospitalization prolonged and medically significant). On an unknown date, the patient experienced DYSPNOEA (seriousness criteria death and hospitalization prolonged). The patient died on 28-Jul-2021. It is unknown if an autopsy was performed. No concomitant medication was given. No treatment medication was given. Company comment: Very limited information regarding these events have been provided at this time. Further information cannot be requested.; Sender''s Comments: Very limited information regarding these events have been provided at this time. Further information cannot be requested.; Reported Cause(s) of Death:


VAERS ID: 1630796 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Death, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: Body temperature; Result Unstructured Data: Mild fever; Test Date: 20210812; Test Name: Body temperature; Result Unstructured Data: High fever
CDC Split Type: PHJNJFOC20210838404

Write-up: DEATH; CHILLS; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA PH-PHFDA-300099973] concerned an 86 year old male of unspecified race and ethnicity. 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, intramuscular, batch number: 213C21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 11-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. The patient experienced a mild fever after vaccinated on 11-AUG-2021 and took biogesic (Paracetamol) every 4 hours. On 12-AUG-2021 patient still had a mild fever and progress to high fever and chills until 13-AUG-2021. On 14-Aug-2021 around 01:45 the informant said that the patient noticed of not moving and breathing and was rushed to hospital. Patient was declared dead on 14-AUG-2021. It was unspecified if an autopsy was performed. On 11-AUG-2021, Laboratory data included: Body temperature (NR: not provided) mild fever. On 12-AUG-2021, Laboratory data included: Body temperature (NR: not provided) high fever. On 14-AUG-2021, the patient died from fever, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210838404-covid-19 vaccine ad26.cov2.s-Death,chills,fever.This event is considered unassessable. The event 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; Reported Cause(s) of Death: FEVER; CHILLS


VAERS ID: 1630798 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Pain, Pneumonia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210838865

Write-up: PNEUMONIA; BODY PAIN; CHILLS; BODY WEAKNESS; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 71 year old male of an unspecified race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A expiry: Unknown) dose was not reported, 1 total administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021 at 01:00 hours, the patient experienced fever, body pain, chills and body weakness. On 13-AUG-2021 at 20:08 hours, the patient experienced pneumonia. On an unspecified date in AUG-2021, the patient died from fever, chills, body pain, body weakness, and pneumonia. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to fever, chills, body pain, body weakness and pneumonia. This report was serious (Death).; Sender''s Comments: V0: 20210838865-COVID-19 VACCINE AD26.COV2.S- Pneumonia, fever, chills, body pain, body weakness. 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: FEVER; CHILLS; BODY PAIN; BODY WEAKNESS; PNEUMONIA


VAERS ID: 1630801 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Result Unstructured Data: not provided
CDC Split Type: PHJNJFOC20210845091

Write-up: COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Reporter stated that on an unspecified date, after taking vaccination (in the evening), the patient started experiencing symptoms and assumed those side effects of vaccine and continued normal routine. Patient developed low grade fever and cough. On sixth day of vaccination patient got swab arranged and was admitted to hospital on day seven and was transferred to Intensive Care Unit (ICU) later on seventh day. On 12-AUG-2021, the patient died from covid-19 infection. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0-20210845091-COVID-19 VACCINE AD26.COV2.S-Covid-19 Infection( Fatal)-This event is considered un-assessable. The event 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.; Reported Cause(s) of Death: COVID-19 INFECTION


VAERS ID: 1630930 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-06-01
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hepatocellular carcinoma, Ultrasound abdomen
SMQs:, Liver malignant tumours (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatitis C
Allergies:
Diagnostic Lab Data: Test Date: 20200720; Test Name: Ultrasound abdomen; Result Unstructured Data: No focal lesions
CDC Split Type: SIMODERNATX, INC.MOD20212

Write-up: onset of hepatic disease - HCC; This case was received via regulatory authority (Reference number: SI-JAZMP-NCPHV-2021SI0809_0809) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of HEPATOCELLULAR CARCINOMA (onset of hepatic disease - HCC) in a 63-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Hepatitis C on 02-Dec-2020. On 16-May-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Jun-2021, after starting mRNA-1273 (Spikevax), the patient experienced HEPATOCELLULAR CARCINOMA (onset of hepatic disease - HCC) (seriousness criteria death and medically significant). The patient died on 29-Jun-2021. The reported cause of death was onset of hepatic disease - hcc. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2020, Ultrasound abdomen: normal (normal) No focal lesions. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. On an unknown date in Jun-2021 the laboratory exams performed to further understand the event included were Ultrasound scan and CT scan and the results were unknown. Company comment: Very limited information regarding this event 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 event, a causal relationship cannot be excluded. However, patient''s underlying disease remains a contributory factor. Further information can''t be requested.; Sender''s Comments: Very limited information regarding this event 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 event, a causal relationship cannot be excluded. However, patient''s underlying disease remains a contributory factor. Further information can''t be requested.; Reported Cause(s) of Death: onset of hepatic disease - HCC


VAERS ID: 1631908 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-28
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Muscular weakness, Myalgia, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210835692

Write-up: JOINT PAIN; MUSCLE WEAKNESS; SEVERE TREMBLING; CHILLS; MUSCLE PAIN; This spontaneous report received from a health care professional via a Regulatory Authority (EVHUMAN Vaccines, NL-LRB-00664003) concerned a 26 year old male of unspecified race and ethnicity. The patient''s weight was 85 kilograms, and height was 182 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 dosage forms, frequency one total, administered on 27-JUL-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The drug start period was one hour. On 28-JUL-2021, the patient experienced muscle pain. On 29-JUL-2021, the patient experienced severe trembling, muscle weakness and chills. On an unspecified date, the patient experienced joint pain. On 29-JUL-2021, the patient died from vaccination complication, and unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of severe trembling, joint pain, muscle weakness, muscle pain and chills on 29-JUL-2021. This report was serious (Death).; Sender''s Comments: V0: 20210835692-COVID-19 VACCINE AD26.COV2.S-severe trembling, muscle weakness, muscle pain, chills. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210835692-COVID-19 VACCINE AD26.COV2.S- joint pain. This event is considered unassessable. The event 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.; Reported Cause(s) of Death: VACCINATION COMPLICATION; UNKNOWN CAUSE OF DEATH


VAERS ID: 1632115 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-07
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Administration site pain, Anti-platelet antibody, Blood fibrinogen, Body temperature, C-reactive protein, Cerebral haemorrhage, Cerebral venous thrombosis, Deep vein thrombosis, Disseminated intravascular coagulation, Electrocardiogram, Fibrin D dimer increased, Headache, Heparin-induced thrombocytopenia test, Heparin-induced thrombocytopenia test positive, Immunology test, Influenza like illness, International normalised ratio, Laboratory test, Magnetic resonance imaging head, Muscle spasms, Myalgia, Platelet count, Pregnancy test, Prothrombin time, Prothrombin time shortened, SARS-CoV-2 test, Superior sagittal sinus thrombosis, Thrombocytopenia, Ultrasound Doppler
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Comments: She was not on hormonal contraception
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: Body temperature; Result Unstructured Data: 39 C; Test Date: 20210510; Test Name: Body temperature; Result Unstructured Data: 39 C; Test Date: 20210514; Test Name: Thrombocyte count; Result Unstructured Data: 296 x1000/microL; Test Date: 20210514; Test Name: EKG; Result Unstructured Data: confirmed thrombosis; Test Date: 20210514; Test Name: Thrombocyte count; Result Unstructured Data: $g200: normal; Test Date: 20210514; Test Name: C-reactive protein; Result Unstructured Data: 19 mg/dL; Test Date: 20210514; Test Name: Body temperature; Result Unstructured Data: 37.32 C; Test Date: 20210514; Test Name: APTT; Result Unstructured Data: 30 S; Test Date: 20210514; Test Name: Laboratory test; Result Unstructured Data: 119 AUC (postmortem); Test Date: 20210514; Test Name: Prothrombin time; Result Unstructured Data: 99 %; Test Date: 20210514; Test Name: INR; Result Unstructured Data: 1; Test Date: 20210517; Test Name: Body temperature; Result Unstructured Data: normal; Test Date: 20210517; Test Name: Fibrinogen; Result Unstructured Data: 0.8 g/L; Test Date: 20210517; Test Name: Thrombocyte count; Result Unstructured Data: < 25 g/L, Thrombocytopenia; Test Date: 20210517; Test Name: Thrombocyte count; Result Unstructured Data: 25 g/L; Test Date: 20210517; Test Name: Pregnancy test; Result Unstructured Data: Negative; Test Date: 20210517; Test Name: C-reactive protein; Result Unstructured Data: 19 mg/dL; Test Date: 20210517; Test Name: Venous Doppler; Result Unstructured Data: See relevant lab tests; Test Date: 20210517; Test Name: COVID-19 PCR test; Result Unstructured Data: Negative; Test Date: 20210519; Test Name: Head MRI; Result Unstructured Data: See relevant lab tests; Test Date: 20210519; Test Name: Prothrombin time; Result Unstructured Data: 48 %; Test Date: 20210519; Test Name: APTT; Result Unstructured Data: ratio 1.19; Test Date: 20210519; Test Name: Thrombocyte count; Result Unstructured Data: 50 g/L; Comments: (40 on citrate); Test Date: 20210519; Test Name: Fibrin D dimer abnormal; Result Unstructured Data: over 35000; Test Date: 20210519; Test Name: Fibrinogen; Result Unstructured Data: 91; Test Date: 20210520; Test Name: Laboratory test; Result Unstructured Data: 348 AUC (postmortem); Test Date: 20210520; Test Name: Laboratory test; Result Unstructured Data: 27 AUC (postmortem); Test Date: 20210520; Test Name: Anti-platelet antibodies; Result Unstructured Data: positive; Test Date: 20210520; Test Name: Laboratory test; Result Unstructured Data: 91 AUC (postmortem); Test Name: ELISA; Result Unstructured Data: PF4 assay negative; Test Name: Heparin-induced platelet antibody; Result Unstructured Data: positive
CDC Split Type: SIJNJFOC20210550911

Write-up: CEREBRAL VENOUS THROMBOSIS; SAGITTAL SINUS THROMBOSIS; INTRACEREBRAL BLEED; DISSEMINATED INTRAVASCULAR COAGULATION; HEPARIN-INDUCED THROMBOCYTOPENIA TEST POSITIVE; Fibrin D dimer increased; Prothrombin time decreased; THROMBOCYTOPENIA; DEEP VEIN THROMBOSIS; MUSCLE CRAMPS; INFLUENZA LIKE ILLNESS; MYALGIA; administration site pain; HEADACHE; This spontaneous report was received from a physician and pharmacist via a Regulatory Authority [EMEA EVHUMAN NLP, SI-JAZMP-NCPHV-2021SI0598_0598, PBE-FAMHP-DHH-N2021-92848] and from online article, and concerned a 37 year old female. The social media article reported that an adult female aged 41 died due to rare thrombosis; previous reports also mentioned a female under 40. The patient''s height, weight, and medical history were not reported. The patient''s was not on hormonal contraception. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, vaccination site not reported, batch number: XD955 expiry: 28/2/2023) 1 dosage form, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included paracetamol. On 07-MAY-2021, the same day as receiving the vaccine, the patient experienced administration site pain and headache, both for 2 days. On 08-MAY-2021, the patient experienced malaise, tiredness (both recovering), and increased body temperature 39 Celsius. On 10-MAY-2021, (3 days post vaccine) the patient had flu-like symptoms including chills for 1 day, sore throat with linings and was diagnosed angina tonsillitis, difficulty swallowing, myalgia and arthralgia for 36 hours (all recovering), malaise, headache, tiredness, body temperature 39 degrees Celsius. On 14-MAY-2021, the patient experienced muscle cramps and thrombosis leg (fatal) as confirmed by electrocardiogram (ECG). The patient also had consultation for influenza like illness. She had normal thrombocytes 296 x1000/microL (Normal range (NR) not provided). On 14-MAY-2021, laboratory data included: APTT (NR: not provided) 30 S, Body temperature (NR: not provided) 37.32 C, C-reactive protein (NR: not provided) 19 mg/dL, EKG (NR: not provided) confirmed thrombosis, INR (NR: not provided) 1, Laboratory test (NR: not provided) 119 AUC (postmortem) and Prothrombin time (NR: not provided) 99 %. On 17-MAY-2021, following swelling of the leg, a deep vein thrombosis in the calf was detected. Treatment started with low molecular weight heparin, Innohep (tinzaparine) 10.000 once a day for 2 injections total despite thrombocytopenia 25 g/L. On 17-MAY-2021, laboratory data included: Body temperature (NR: not provided) normal, C-reactive protein (NR: not provided) 19 mg/dL, COVID-19 PCR test (NR: not provided) Negative, Fibrinogen (NR: not provided) 0.8 g/L, Pregnancy test (NR: not provided) Negative, and Venous Doppler showed acute deep popliteal venous thrombosis of all veins of the right leg; the femoral vein was transient. On 19-MAY-2021, patient was seen at emergency service for disturbance of consciousness and hemiplegia during the night. It was detected that patient had disseminated intravascular coagulation and cerebral hemorrhage (bilateral, intraparenchymatous) facilitated by a venous thrombosis of sagittal sinus thrombosis, thrombocytopenia due to vaccine-induced prothrombotic immune thrombocytopenia (VIPIT) and anticoagulation treatment (coded to thrombocytopenia). Laboratory data included: APTT ratio 1.19, Fibrin D-dimer abnormal over 35000, fibrinogen 91 (fibrogenopenia), prothrombin time 48%, and thrombocyte count 50 g/L (40 on citrate); normal ranges not reported for all results. On 19-MAY-2021, a head magnetic resonance (MRI) showed supratentorially in both (brain) hemispheres numerous areas of bleeding, more on left; areas of hemorrhage are mainly extra axial along the cerebral falx, by dissection of the corpus callosum, and by effusion into the left (lateral) ventricle. Dilated venous thrombosis of the upper sagittal sinus on convexity was seen. Diffusion imaging showed changes with features of venous ischemia in almost the entire left hemisphere that spread to the paramedian areas and to the cerebral cortex of the right frontal and parietal lobes. A large mass effect was seen with transtentorial descending hernia, compression of the third ventricle of the diencephalon and midbrain (mesencephalon) and with significant obliteration (squeezing) of the fourth ventricle and cerebrospinal fluid spaces in the posterior (cranial) cavity. The neuroradiologist concluded that there was dilated sagittal sinus thrombosis at the vertex level, areas of intra- and extra-axial hemorrhage with intraventricular hemorrhage in the left lateral ventricle, and ischemia with venous features throughout the left hemisphere and part in the right hemisphere in the paramedian; and parietal lobe. Transtentorial displacement with mesencephalon / brainstem compression was also seen. Patient was admitted to intensive care unit, intubated, placed on mechanical ventilation and sedation. Treatment medications included mannitol 15 g in 15 minutes, polyvalent immunoglobulins 1g/kg/day for 2 days. Innohep (tinzaparine sodium) was discontinued and switch to Orgaran (danaparoid sodium) with monitoring of "anti Xa activity", dexamethasone 40 mg per day for 4 days. On 20-MAY-2021, the subject died from thrombosis, hemorrhage intracerebral, and thrombocytopenia after her hospitalization. Autopsy was performed and it proved venous thrombosis and intracranial hemorrhage, but written autopsy report could not be gained persuant to legislation. On 20-MAY-2021, Laboratory data included: Anti-platelet antibodies (NR: not provided) positive, and Laboratory test (NR: not provided) 27 AUC (postmortem), 348 AUC (postmortem), 91 AUC (postmortem). On 25-MAY-2021, positive test result was received for heparin-induced thrombopenia (HIT II). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of disseminated intravascular coagulation, thrombocytopenia, cerebral hemorrhage, fibrin d dimer increased, prothrombin time decreased, sagittal sinus thrombosis, deep vein thrombosis and cerebral venous thrombosis on 20-MAY-2021, was recovering from administration site pain, and myalgia, and the outcome of influenza like illness, headache, muscle cramps, and heparin-induced thrombocytopenia test positive was not reported. Sender''s Comment: External expert advices :Expert 1 : The PF4 assay. was negative by ELISA but positive by functional test. If we receive written confirmation of the positivity of the functional PF4 testing, there is in my view a clear causal link. We should also know whether this lady was on oral contraception with EE. Expert 2: The clinical presentation, the delay in vaccination, the age of the patient, the absence of other known favourable factors, the platelet count at the diagnosis of DVT at D10, the evolution towards a CVST with a low platelet count at D12 are strongly in favour of a TTS secondary to the vaccination. However, we do not have any information concerning the possible previous exposure to heparin treatment (necessary for classification according to the Brighton collaboration). We do not have either an echodoppler protocol concerning the diagnosis of lower limb DVT whereas this clinical presentation seems rare in the previously described cases (other cases of VIPIT with lower limb DVT). So highly suspicious case but incomplete information to give you a definitive analysis. Expert 3: At the time of writing this assessment, I have not yet received the results of the requested PF4 functional test (positive according to verbal information from Prof. x, no written protocol yet).Nevertheless, the diagnosis of a "thrombosis with thrombocytopenia syndrome" (TTS) seems to me to be highly probable (level 1). It is not mentioned in the case description if an echo-Doppler and/or a brain scan were performed to prove the thrombosis. I am not sure if the deep venous thrombosis of the lower limb was objectified (venous Doppler on 5/17) but the description of the cerebral findings requires imaging and it seems logical to me to think that the cerebral venous thrombosis and cerebral hemorrhage were objectified, along with the thrombocytopenia, which is sufficient to make the diagnosis. Additional elements in favor of this diagnosis are the timing after vaccination (D10), the flu-like symptoms (showing a strong immune response), the cerebral venous thrombosis immediately complicated by hemorrhage, the decreased PTT, the very high D-dimer values and unfortunately the fatal course of the disease. In my opinion, there is no other etiology than the vaccine to plausibly explain the occurrence of these medical events. I identify as "probable" the link with the vaccine but it could be "certain" in case of definitive confirmation of the presence of anti-PF4 antibodies. Expert 4 :The course, clinic, and biochemical tests do indeed fit a VITT. I would consider the correlation probable/likely (code 2).Strictly speaking, initially a HIT could not be excluded, but there were already low platelets at first presentation and no obvious heparin exposure beforehand, as far as known. The subsequent course would also be a short time frame for HIT. The positive anti-PF4-ELISA very strongly suggest a VITT, with strong reactivity in the absence of heparin (argues against HIT) and no additional increase with increasing concentrations of heparin. Thus, this fits the diagnosis of VITT according to the typical described biochemical and clinical course. This report was serious (Death, and Hospitalization Caused / Prolonged). This case is linked to duplicate cases 20210550864, 20210550753. Additional information was received on 17-AUG-2021 via Regulatory Authority. The following information was updated and incorporated into the case narrative: date of death was updated from 21-MAY-2021 to 20-MAY-2021, serious criteria of life threatening removed, events added (heparin-induced thrombocytopenia test positive and cerebral venous thrombosis), onset dates updated for events (thrombocytopenia and influenza like illness), and event terms updated (deep vein thrombosis and intracerebral bleed). Upon review, the following information was amended: Social Media added as source in structured field.; Sender''s Comments: Follow-up updated date of death and event details. This spontaneous report received from health professionals via regulatory authority & from an online article concerned a 37-year-old woman who died after experiencing thrombocytopenia on day 10 & cerebral venous sinus thrombosis (CVST) on day 12 after receiving Janssen Covid-19 vaccine. Medical history was not reported. Concomitant medications included paracetamol and the patient was not using hormonal contraception. Day 3, she had flu-like symptoms (chills, sore throat, malaise, myalgia, headache, & fever). Day 7, platelet count was 296,000. Day 10, a deep vein thrombosis was detected in right leg via venous doppler; Covid-19 PCR was negative. Treatment was initiated with low molecular weight heparin despite new thrombocytopenia (25,000). Day 12, the patient presented to the emergency department for disturbance of consciousness & hemiplegia during the night. She had disseminated intravascular coagulation (DIC). MRI showed cerebral hemorrhage with a CVST of sagittal sinus and transtentorial displacement with mesencephalon/brainstem compression. Lab data included: high D-dimer $g 35000, low fibrinogen 91, platelet count 50,000. Patient was intubated & placed on mechanical ventilation. Treatment medications included mannitol and polyvalent immunoglobulins for 2 days & dexamethasone for 4 days; tinzaparine was discontinued & switched to danaparoid. Patient died on day 12 from thrombosis, hemorrhage intracerebral, & thrombocytopenia. Autopsy confirmed venous thrombosis & intracranial hemorrhage. Anti-platelet antibody test & heparin-induced thrombopenia test were positive. Although the use of heparin may have contributed, based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (per definition from Brighton Collaboration), considering the low platelet count prior to heparin use and temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination.; Reported Cause(s) of Death: THROMBOSIS; INTRACEREBRAL BLEED; THROMBOCYTOPENIA; Autopsy-determined Cause(s) of Death: THROMBOSIS; INTRACEREBRAL BLEED


VAERS ID: 1632116 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-25
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Diarrhoea, Dizziness, Fatigue, Oxygen saturation, Oxygen saturation decreased, Rash, Swelling face, Vomiting
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 75
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210518; Test Name: saturation; Result Unstructured Data: Test Result:less than 80
CDC Split Type: BEPFIZER INC202101067806

Write-up: heart failure; saturation lower than 80; dizzy; vomiting; diarrhoea; bloated face; tired; a light rash on neck and back; This is a spontaneous report from a contactable consumer. A young male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 16Apr2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Apr2021, the patient experienced for the first time a light rash on neck and back. From 06May2021, he had to stay at home because of illness (diarrhea, rash, tired and bloated face). From 09May2021, he became dizzy and started vomiting. On 10May2021, we went to the family doctor and he thought it was because of the vaccine. He stayed at home that week but he did not get better. On 18May2021 we went back to the family doctor where a saturation of less than 80 was established. That day he was admitted to the hospital via emergency room and was diagnosed with heart failure. The link with the vaccine was described in hospital as "coincidental". On 02Jul2021 he was admitted again with heart failure and died on 09Jul20210. It was not reported if an autopsy was performed. The outcome of heart failure was fatal. The outcome of dizzy and vomiting was not resolved. The outcome of other events was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: heart failure


VAERS ID: 1632184 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-07-19
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002912 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Encephalitis
SMQs:, Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a pharmacist and describes the occurrence of ENCEPHALITIS and DEATH (Death) in a 21-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 3003606 and 3002912) for COVID-19 vaccination. The patient''s past medical history included Migraine in 2019. On 12-Jun-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Jul-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jul-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced ENCEPHALITIS (seriousness criteria death and medically significant). The patient died on 24-Jul-2021. The reported cause of death was Meningoencephalitis. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. On an unknown date, laboratory test performed (result not reported). Regarding the event of Encephalitis, based on the current available information and temporal association between the use of the product and the start date of the event, 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. No treatment information was provided. Company Comment: Regarding the event of Encephalitis, based on the current available information and temporal association between the use of the product and the start date of the event, 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 event of Encephalitis, based on the current available information and temporal association between the use of the product and the start date of the event, 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: Meningoencephalitis; Death


VAERS ID: 1633205 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 10020A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Disseminated intravascular coagulation, International normalised ratio, Multiple organ dysfunction syndrome, N-terminal prohormone brain natriuretic peptide, Platelet count, Prothrombin time, Pulmonary haemorrhage, Pyrexia, Septic shock, Troponin T
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dysphagia; Extremely preterm (less than 28 weeks); Hypoxic-ischaemic encephalopathy; Posthaemorrhagic hydrocephalus; Reflux oesophagitis; Respiratory insufficiency; Symptomatic epilepsy
Allergies:
Diagnostic Lab Data: Test Name: pTT; Result Unstructured Data: Test Result:$g180 seconds; Test Name: INR; Result Unstructured Data: Test Result:4.9; Test Name: proBNP; Result Unstructured Data: Test Result:24937 pg/mL; Test Name: Platelets; Result Unstructured Data: Test Result:min 3410x31uml; Test Name: Quick; Result Unstructured Data: Test Result:<10; Test Name: Troponin T; Result Unstructured Data: Test Result:1580 pg/mL
CDC Split Type: DEPFIZER INC202101072828

Write-up: Disseminated intravascular coagulation; Lung hemorrhage; Pyrexia; Multiorgan failure; Septic shock; This is a spontaneous report from a non-contactable other HCP. DE-PEI-202100168078. A 13-yars-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for Injection, Batch/Lot Number: 10020A) dose 2 0.3 mL via an unknown route of administration on 11Aug2021 (at the age of 13-years-old) as dose 1, single for COVID-19 immunisation. The patient''s medical history included extremely preterm (less than 28 weeks), Hypoxic-ischaemic encephalopathy, posthaemorrhagic hydrocephalus, symptomatic epilepsy, dysphagia, respiratory insufficiency, reflux oesophagitis on an unspecified date. The patient previously received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for Injection) dose 1, Batch/Lot number unknown) for COVID-19 immunisation on 16Jun2021. Concomitant medications were not reported. The patient underwent lab tests and procedures which included platelets min 3410x 31uml, Quick <10, INR$g4.9, pTT $g180 sec, proBNP 24937 pg/ml, Trop T 1580 pg/ml on an unknown date. The patient experienced multiorgan failure, lung hemorrhage, disseminated intravascular coagulation, pyrexia and septic shock on 13Aug2021. The patient died due to Unknown cause of death on 14Aug2021. Seriousness for the events was reported as death, hospitallization and life threatening. The autopsy details were not reported. Sender Comment: Platelets min 3410^31uml, Quick <10, INR$g4,9; pTT $g180 sec, proBNP 24937 pg/ml, Trop T 1580 pg/ml Relatedness of drug to reaction(s)/event (s) Result of Assessment D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1633532 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101089712

Write-up: died; This is a spontaneous report by a contactable consumer (patient''s aunt) via a Pfizer colleague. A 21-year-old female patient received bnt162b2 (COMIRNATY) on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient died on 20Aug2021 diue to the Comirnaty vaccine, but without informing details. The event occurred after using the product. It was unknown if Autopsy Done. The outcome of the event was fatal. Reporter comments: today that her niece, who is 21 years old, died on 20Aug2021 diue to the Comirnaty vaccine, but without informing details. Information on the batch number has been requested.; Reporter''s Comments: today that her niece, who is 21 years old, died on 20Aug2021 diue to the Comirnaty vaccine, but without informing details.; Reported Cause(s) of Death: died


VAERS ID: 1633664 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-06-29
   Days after vaccination:95
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101077679

Write-up: PNEUMONIA; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 80972], license party for Comirnaty. A contactable consumer (brother-in-law) reported that a 72-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications was not reported. The patient experienced pneumonia (death, hospitalization, medically significant) on 29Jun2021. Therapeutic measures were taken as a result of pneumonia. The patient died. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101073976 Same reporter, same drug, same event, different patient; Reported Cause(s) of Death: pneumonia


VAERS ID: 1633692 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute aortic syndrome, Acute myocardial infarction, Angiocardiogram, Blood pressure systolic, Electrocardiogram, Electroencephalogram, Mean arterial pressure, Physical examination
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidemia; Hypertension arterial; Obesity; Smoker
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Coronary angiography; Result Unstructured Data: Test Result:thrombotic occlusion; Comments: Coronary angiography showed thrombotic occlusion of a non-dominant circumflex coronary artery with failed angioplasty due to difficult percutaneous access, being a vessel of small caliber and development; Test Date: 2021; Test Name: Systolic Blood Pressure; Result Unstructured Data: Test Result:80 mmHg; Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:lateral rectification; Comments: isoelectric SR and ST with lateral rectification; Test Date: 2021; Test Name: Electrocardiography; Result Unstructured Data: Test Result:high lateral ST elevation; Comments: high lateral ST elevation (posterolateral acute myocardial infarction) and mono-antiagregate with acute aortic syndromes (AAS); Test Date: 20210707; Test Name: Electroencephalography; Result Unstructured Data: Test Result:postanoxic encephalopathy; Comments: compatible in the clinical context of the patient with severe postanoxic encephalopathy with epileptiform activity; Test Date: 2021; Test Name: Mean Arterial Pressure; Result Unstructured Data: Test Result:55 mmHg; Test Date: 2021; Test Name: physical examination; Result Unstructured Data: Test Result:Hemodynamically stable and with Sinus Rhythm; Test Date: 2021; Test Name: mean arterial pressure; Result Unstructured Data: Test Result:55
CDC Split Type: ESPFIZER INC202101067739

Write-up: Acute myocardial infarction; mono-antiagregate with acute aortic syndromes (AAS); This is a spontaneous report from a contactable other Health Professional downloaded from the regulatory authority-WEB, regulatory authority number. A 56-year-old male patient received BNT162B2 (COMIRNATY), intramuscularly, administered in arm (deltoid) on 30Jun2021 (Batch/Lot Number: FE3065) as dose 2 at 0.3 ml, single for COVID-19 immunisation. Medical history included obesity, active smoking, dyslipidemia, hypertension arterial which were considered as cardiovascular risk factors. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY), intramuscularly on 09Jun2021 (Lot Number: FC3143) at 0.3 ml, single for COVID-19 immunisation. The patient presented cardiac arrest on 02Jul (received the 2nd dose of Comirnaty on 30Jun2021), which took 13 minutes of basic resuscitation + 17 minutes of advanced cardiopulmonary resuscitation. Electrocardiography showed high lateral ST elevation (posterolateral acute myocardial infarction) and mono-antiagregate with acute aortic syndromes (AAS). Arrived at the hospital hemodynamically stable and with sinus rhythm. Coronary angiography showed thrombotic occlusion of a non-dominant circumflex coronary artery with failed angioplasty due to difficult percutaneous access, being a vessel of small caliber and development, so it was decided to finish the procedure. Admitted to the Observation Care Unit with isoelectric SR and ST with lateral rectification. Hypotension arterial marked with systolic blood pressure 80 and mean arterial pressure of 55 and persistent cephalic contractions. Therapeutic hypothermia protocol was performed (33T). Currently sedated, relaxed and analgesic. Electroencephalography 07Jul: Electroencephalography performed 5 days after cardiorespiratory resuscitation, compatible in the clinical context of the patient with severe postanoxic encephalopathy with epileptiform activity. The patient died on 14Jul2021. It was unknown if an autopsy was performed. The event acute myocardial infarction was considered serious due to fatal event and hospitalization. No follow-up attempts are needed. No further information is expected. ; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1633693 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101067188

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the, regulatory authority number ES-AEMPS-975938. A 73-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), intramuscularly on 04May2021 (at the age of 73-year-old) as dose 1 at 0.3 ml, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient started symptoms of precordial pain 2 hours after the COMIRNATY vaccine (04May2021) improved with aspirin 100 mg but presented progressive worsening of precordial pain on the afternoon of 04May, then cardiorespiratory arrest and Cardiac Resuscitation at home without success, the patient''s death was confirmed 05May2021. The patient died on 05May2021. Clinical autopsy confirmed diagnosis of acute myocardial infarction as cause of death. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: acute myocardial infarction; Autopsy-determined Cause(s) of Death: acute myocardial infarction


VAERS ID: 1634320 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-15
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Inconclusive
CDC Split Type: GBPFIZER INC202101069515

Write-up: Death; This is a spontaneous report from a contactable consumer. The regulatory authority report number is GB-MHRA-WEBCOVID-202108171351024440-XG6VV. Safety Report Unique Identifier GB-MHRA-ADR 25810478. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. Unsure if patient has had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medications included unspecified drugs (reported as SARS-COV-2 VIRUS). The patient experienced death (death, hospitalization, disability, medically significant, life threatening) on 15Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: inconclusive on an unspecified date. The patient died on 15Aug2021. It was not reported if an autopsy was performed. Outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1634325 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101069177

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable consumer. The regulatory authority report number is GB-MHRA-WEBCOVID-202108172111564640-2CPPS, Safety Report Unique Identifier GB-MHRA-ADR 25813789. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Aug2021 (Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. No health issues. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced pulmonary embolism (death, medically significant) on 16Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 16Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient died on an unspecified date. An autopsy was not performed. Outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1634376 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202101073470

Write-up: UNKNOWN CAUSE OF DEATH; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (regulatory authority number: Not Applicable) based on information received by Pfizer from BioNtech SE (manufacturer control number), license party for bnt162b2 (COMIRNATY). This HCP reported same event for three patients. This is the first of three reports. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. In the preceding week till 11:59 pm on 08Aug2021, DH received three death reports involving individuals who had received COVID-19 vaccination within 14 days before passing away. The cases involved three males aged from 53 to 63. This case was split for 1 of 3 death cases. A male patient with unknown age started to receive COVID-19 vaccine on unspecified date via unknown route at single dose (reported as unspecified dosing frequency) for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. There was no clinical evidence that the incident arose from vaccination. The cases were pending assessment by the Expert Committee. The event unknown cause of death was met the seriousness criterion of death. The action taken for COVID-19 vaccine regarding the event was not applicable. Patient died on an unknown date. It was unknown if the autopsy was done. Initial report was received on 12Aug2021. This is one of seven reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS003099 (master case), 2021FOS003100, 2021FOS003101, 2021FOS003102, 2021FOS003103, 2021FOS003104 and 2021FOS003105. Fosun is a marketing authorization holder of one of COVID-19 vaccine Tozinameran in Hong Kong. This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities. Follow-up closed, no further information is possible. Causality assessment between the event and bnt162b2 was possible per reporter and company. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101073468 same reporter, same product, same event, different patient.;HK-PFIZER INC-202101073469 same reporter, same product, same event, different patient.;HK-2021FOS003104 ;HK-2021FOS003105; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


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