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From the 10/15/2021 release of VAERS data:

Found 17,128 cases where Vaccine is COVID19 and Patient Died



Case Details

This is page 122 out of 172

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VAERS ID: 1375410 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-05-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure acute, Cardio-respiratory arrest, Coronary artery occlusion, Myocardial infarction
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic (regularly visited a hospital once a month for the treatment (since 2012)); Cardiac pacemaker insertion; Sinus node dysfunction
Allergies:
Diagnostic Lab Data: Test Date: 20210523; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021622794

Write-up: Cardiac failure acute (Cardio-respiratory arrest); Cardiac failure acute (Cardio-respiratory arrest); suspected myocardial infarction (coronary artery occlusion); suspected myocardial infarction (coronary artery occlusion); This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21110189. The patient was a 91-year-old male. Body temperature before vaccination was 36.5 degrees Centigrade. The patient had underlying diseases of sinus node dysfunction and cardiac failure chronic, and the patient underwent permanent cardiac pacemaker insertion. The patient had no relevant family history. No information on concomitant medication was reported. On 23May2021 at 09:40 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 25May2021 at 01:15 (2 days after the vaccination), the patient experienced cardiac failure acute (CPA [cardio-respiratory arrest]) and suspected myocardial infarction (coronary artery occlusion). On 25May2021 at 02:05 (2 days after the vaccination), the patient died of cardiac failure acute (CPA [cardio-respiratory arrest]) and suspected myocardial infarction (coronary artery occlusion). It was not reported if an autopsy was performed. The course of the events was as follows: The patient underwent permanent cardiac pacemaker insertion for sinus node dysfunction. Afterwards, for the treatment of cardiac failure chronic, the patient had been regularly visiting a hospital on foot as an outpatient once a month (since 2012). On 25May2021, within 48 hours of receiving the vaccination, he went to the bathroom in the midnight, and suddenly fell down. He developed cardio-respiratory arrest. The patient was transferred to a hospital by an ambulance. On 25May2021 at 02:05, the patient''s death was confirmed. The reporting physician classified the events as serious (fatal outcome). The causality assessment between BNT162b2 and the events was not provided. It was not reported if there was other possible cause of the events such as any other diseases. The reporting physician commented as follows: It was considered that acute cardiomegaly and pulmonary congestion developed. The cardiac pacemaker was ineffective. Myocardial infarction was suspected (coronary artery occlusion).; Reported Cause(s) of Death: Cardiac failure acute (Cardio-respiratory arrest); Cardiac failure acute (Cardio-respiratory arrest); suspected myocardial infarction (coronary artery occlusion); suspected myocardial infarction (coronary artery occlusion)


VAERS ID: 1375411 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-31
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Arrhythmia, SARS-CoV-2 test
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NU-LOTAN; CRESTOR; RABEPRAZOLE NA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: PCR test; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: JPPFIZER INC2021632496

Write-up: Acute myocardial infarction/Chest discomfort; Arrhythmia; This is a spontaneous report from a contactable physician received via the Agency. The patient was a 56-year-old male. The patient previously received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EP9605, Expiration Date: 30Jun2021) (at the age of 56-years-old) intramuscular in the arm right on 21Apr2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received NU-LOTAN tablet 50MG, CRESTOR tablet 2.5MG and RABEPRAZOLE NA tablet 10MG within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient had allergies to medications, food, or other products or not. Other medical history included Hypertension. On 12May2021 (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31-AUG-2021) (at the age of 56-years-old) intramuscular in the arm right for COVID-19 immunization. On 31May2021 at 13:00 (19 days and 13 hours after the vaccination), the patient experienced Acute myocardial infarction, Arrhythmia and Chest discomfort. The event resulted in Clinic/Emergency room/department or urgent care. The outcome of the events was death with treatment including BOSMIN Injection 1MG, MEYLON Injection 7%, DOPAMINE HYDROCHLORIDE Injection 600mg. The reporting physician assessed the events as serious (death). An autopsy was not performed. The PCR test with nasal swab was performed on 31May2021, which showed negative results. The clinical course was as follows: On 31May2021, the patient complained of Chest discomfort during the work on the farm and, visited reporter''s hospital. After arrival to the outpatient, Cardiac/Respiratory arrest were noted and, cardiopulmonary resuscitation was performed. A diagnosis of Myocardial infarction and Arrhythmia were made and, treatment was given. 1 hour and 30 minutes after his arrival, death of the patient was confirmed.; Sender''s Comments: A possible contributory effect of suspect BNT162B2 on reported events 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: Acute myocardial infarction/Chest discomfort; Arrhythmia


VAERS ID: 1375433 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-02
Onset:2021-05-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac tamponade, Chills, Fatigue, Malaise, Myalgia, Myocardial infarction, Nausea, Vaccination site erythema, Vaccination site inflammation, Vaccination site pain, Vaccination site warmth
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   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: EZETIMIBE; ATORVASTATIN; DUOTRAV; COVERSYL ARG; ASCAL BRISPER CARDIO NEURO; YELLOX; COLECALCIFEROL; PANTOPRAZOL [PANTOPRAZOLE]; METOPROLOL SUCCINATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021616456

Write-up: Patient died the night after vaccination: myocardial infarction; Patient has had a heart attack with tamponade; Muscle pain; Reaction at or around the injection site: warmth; Inflammatory reaction at the reaction site: redness, warmth, pain; Reaction at or around the injection site: redness; Nausea; Fatigue; Reaction at or around the injection site: pain; Cold shivers; Not feeling well; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB NL-LRB-00535420, received from Regulatory Authority. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02May2021 at single dose for COVID-19 immunisation. Lot number was ET6956. Medical history included myocardial infarction and diabetes mellitus. Concomitant medications included ezetimibe, atorvastatin, timolol maleate, travoprost , perindopril arginine, carbasalate calcium, bromfenac sodium, colecalciferol, pantoprazol, metoprolol succinate. On 02May2021, the patient experienced myalgia, vaccination site warmth, Vaccination site inflammation, Vaccination site erythema, nausea, fatigue, vaccination site pain, chills, malaise, heart attack with tamponade. The patient was treated with myalgia, fatigue and malaise. The outcome of myalgia, vaccination site warmth, Vaccination site inflammation, Vaccination site erythema, nausea, fatigue, vaccination site pain, chills, malaise, was unknown. On 03May2021, the patient died due to heart attack with tamponade. Autopsy results: heart attack with tamponade No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: heart attack with tamponade; heart attack with tamponade; Autopsy-determined Cause(s) of Death: heart attack with tamponade; heart attack with tamponade


VAERS ID: 1375439 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cerebrovascular accident, Fatigue
SMQs:, 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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   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: PANADOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis (Blood vessels constrict)
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:unknown
CDC Split Type: NLPFIZER INC2021616448

Write-up: Stroke; Fatigue; This is a spontaneous report from a contactable consumer or other non-HCP downloaded from the Agency Regulatory Authority-WEB (Regulatory Authority Number NL-LRB-00552571). A 78-year-old female patient received the first dose of BNT162b2 (COMIRNATY, Lot number unknown) via an unspecified route of administration on 10May2021 at single dose for COVID-19 immunisation. Relevant medical history included atherosclerosis (blood vessel constrict). Concomitant medications included paracetamol (PANADOL, Tablet 500mg) taken for an unspecified indication. On 14May2021 the patient had fatigue and on 18May2021 she had a stroke. The patient died on 19May2021, both events were fatal. It was reported that one week before her death the patient was administered with the vaccine and blood values were being investigated further regarding her death. Before death or heart attack (as reported) she complained of fatigue. It was unknown whether an autopsy was performed. No follow-up attempts are possible; information on batch number cannot be obtained.; Reported Cause(s) of Death: cva; fatigue


VAERS ID: 1375483 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Internal haemorrhage
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   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: PLPFIZER INC2021616447

Write-up: Internal haemorrhage; Blood pressure decreased; This is a spontaneous report from a contactable consumer or other non hcp downloaded from a regulatory authority-WEB PL-URPL-DML-MLP.4401.2.317.2021. An 81-year-old female patient received BNT162b2 (COMIRNATY, Lot number unknown) via an unspecified route of administration on 18Mar2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 20Mar2021, the patient experienced a severe internal bleeding and pressure drop. On 21Mar2021 the patient died. Cause of death: internal hemorrhage, but both events were fatal. An autopsy was performed. Result: death. Autopsy results were not available. The reporting person marked the severity criterion: death. A regulatory authority classified the application as serious. Sender''s comment: Bleeding is an unexpected side effect of Comirnaty. Comirnaty is currently investigated for an association with immune thrombocytopenia, which can cause bleeding, but massive internal bleeding (and associated pressure drop) as the only sign of thrombocytopenia is unlikely. There is a time relationship between the administration of the vaccine and the occurrence of side effects. The reporting person marked the severity criterion: death. A regulatory authority classified the application as serious. Comirnaty. Relatedness of drug to reaction(s)/event(s): Blood pressure decreased, Internal hemmorhage: Source of assessment: (unlisted) Method of assessment: (unlisted), Result of Assessment: Unlikely. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Blood pressure decreased; Internal haemorrhage


VAERS ID: 1375484 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       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: 2021-05-07
   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: Atrial fibrillation; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021616455

Write-up: Cardiac arrest; This is a spontaneous report received from a contactable consumer (friend of the patient''s daughter) downloaded from a regulatory authority-WEB PL-URPL-DML-MLP.4401.2.324.2021. A 73-year-old male patient received the second dose of BNT162b2 (COMIRNATY), intramuscularly on 06May2021 morning (at the age of 73-years-old) at 2nd dose, single for COVID-19 immunisation. Medical history included atrial fibrillation, hypertension. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced cardiac arrest on 07May2021 around 21:00. The patient died due to the event on 07May2021. It was unknown if an autopsy was performed. Sender comment: Cardiac arrest is an unexpected adverse reaction for a vaccine. Considering the patient''s age, co-morbidities, it is not possible to conclude conclusively what contributed to the adverse reaction. The temporal relationship supports a cause and effect relationship. A regulatory authority assessed the notification as severe (death). Causality assessment: Source (unlisted), Method (unlisted), Result Possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1375561 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood gases, Blood glucose, Blood pressure measurement, Blood test, Cardiopulmonary failure, Coma scale, Computerised tomogram, Computerised tomogram thorax, Dehydration, Dysarthria, Dyspnoea, Electrocardiogram, Fibrin D dimer, Heart rate, Hyperchromic anaemia, Hypernatraemia, Hypokalaemia, Inflammation scan, Oxygen saturation, Platelet count, Red blood cell count, Renal function test, Respiratory failure, Respiratory rate, SARS-CoV-2 test, Supraventricular extrasystoles, Thrombocytopenia, Vital signs measurement
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), 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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow), Hypokalaemia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ACIDUM FOLICUM; FURON [FUROSEMIDE]; SPIOLTO RESPIMAT; NOLPAZA; SORBIFER DURULES [ASCORBIC ACID;FERROUS SULFATE]; CARVEDILOL; URSOSAN; CALTRATE [CALCIUM CARBONATE]
Current Illness: Hypoacusis
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Atherosclerosis; Chronic heart failure (Left ventricular ejection fraction increased (45-50%)); Chronic kidney disease (stage G2); Chronic obstructive pulmonary disease (GOLD III-IV/C, hospitalisation in Aug2020 for COPD exacerbation); Cirrhosis liver (exotoxic etiology); COVID-19; Encephalopathy (etyltoxic); Femur fracture (Femur pertrochanteric and subtrochanteric fracture); Haemorrhoidectomy; Immobilisation syndrome; Ischemic heart disease; Living in residential institution; Polyneuropathy (etyltoxic); Therapeutic embolisation (hospitalisation for COPD exacerbation, pulmonary arterial embolisation); Thrombosis mesenteric vein; Thrombosis portal vein
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: ABG (arterial blood gas test); Result Unstructured Data: Test Result:hypoxemic-hypercapnic respiratory insufficiency; Test Date: 202103; Test Name: glycemia; Result Unstructured Data: Test Result:6.8 mmol/L; Comments: During the transport; Test Date: 202103; Test Name: Blood pressure; Result Unstructured Data: Test Result:140/80 mmHg; Comments: During the transport; Test Date: 202103; Test Name: Blood pressure; Result Unstructured Data: Test Result:140/75 mmHg; Comments: During the transport; Test Date: 202103; Test Name: markers for cardiac failure; Result Unstructured Data: Test Result:slightly increased; Test Date: 202103; Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:15; Comments: During the transport; Test Date: 202103; Test Name: CT scan of brain; Result Unstructured Data: Test Result:small ischaemic loci of older date; Comments: result of small ischaemic loci of older date without other pathologic signs; Test Date: 202103; Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result:without signs of pulmonary embolism and inflammato; Comments: without signs of pulmonary embolism and inflammatory process; Test Date: 202103; Test Name: ECG; Result Unstructured Data: Test Result:with SVES (supraventricular extrasystoles); Comments: without ischemic signs; Test Date: 202103; Test Name: D-dimer; Result Unstructured Data: Test Result:increased; Test Date: 202103; Test Name: Heart rate; Result Unstructured Data: Test Result:76/81/min; Comments: During the transport; Test Date: 202103; Test Name: inflammatory parameters; Result Unstructured Data: Test Result:increased; Test Date: 202103; Test Name: oxygen saturation; Test Result: 91 %; Comments: During the transport; Test Date: 202103; Test Name: oxygen saturation; Test Result: 96 %; Comments: During the transport; Test Date: 202103; Test Name: oxygen saturation; Test Result: 98 %; Comments: During the transport; Test Date: 202103; Test Name: platelet count; Result Unstructured Data: Test Result:thrombocytopenia (light stage); Test Date: 202103; Test Name: RBC; Result Unstructured Data: Test Result:macrocytic hyperchromic anaemia (light stage); Test Date: 202103; Test Name: renal laboratory parameters; Result Unstructured Data: Test Result:worsened during the hospitalisation; Comments: it was found dehydratation, hyperosmolar hypernatraemia, hypokalaemia mild stage; Test Date: 202103; Test Name: respiratory rate; Result Unstructured Data: Test Result:28-24/min; Comments: During the transport; Test Date: 20210316; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210318; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210325; Test Name: vital signs; Result Unstructured Data: Test Result:without vital signs
CDC Split Type: SKPFIZER INC2021617897

Write-up: Breathing difficult / after 2nd dose of vaccine it had worsened / aggravated difficulty breathing; Cardio-respiratory failure; SVES; macrocytic hyperchromic anaemia (light stage); thrombocytopenia (light stage); dehydratation; hyperosmolar hypernatraemia; hypokalaemia mild stage; hypoxemic hypercapnic respiratory insufficiency; dysarthria; This is a spontaneous report from a contactable consumer and contactable physician downloaded from a regulatory authority- WEB (Regulatory Authority number SK-SUKLSK-20213025). An 81 years old male patient received the second single dose of BNT162B2 (COMIRNATY) intramuscular, on 11Mar2021 (lot ET1831), for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (GOLD III-IV/C), arterial hypertension, chronic heart failure (left ventricular ejection fraction increased (45-50%)), thrombosis mesenteric superior vein, thrombosis portal vein, cirrhosis liver (exotoxic etiology), femur pertrochanteric and subtrochanteric fracture, immobilisation syndrome, atherosclerosis, chronic kidney disease (stage G2), polyneuropathy (etyltoxic), encephalopathy (etyltoxic), haemorrhoidectomy in 2014, COVID-19 in Apr2020, hospitalisation in Aug2020 for chronic obstructive pulmonary disease exacerbation, pulmonary arterial embolization, ongoing hypoacusis. The patient received the first dose of Comirnaty on 11Feb2021 (Batch / Lot number: EJ6790) and experienced dyspnoea, oedema of lower limbs and coughing grey sputum. Concomitant medications included acidum folicum orally, 1 DF, 1x/day 1-0-0, furosemide (FURON; 40 mg) orally, 1.5 DF 1-1/2-0, olodaterol hydrochloride, tiotropium bromide monohydrate (SPIOLTO RESPIMAT; 2.5 ug + 2.5 ug) 2 DF, 2-0-0, pantoprazole sodium sesquihydrate (NOLPAZA; 40 mg) orally, 1 DF, 1-0-0, ascorbic acid, ferrous sulfate (SORBIFER DURULES) orally, 1 DF, 1x/day, 1-0-0, carvedilol (12.5 mg) orally, 1/2-0-1/4, ursodeoxycholic acid (URSOSAN; 250 mg) orally, 2 DF, 0-0-2 and calcium carbonate (CALTRATE; 600 mg) orally, 1 DF, 1x/day, 0-1-0. The patient lived in social service home, where he reported difficulty breathing since an unspecified date in Mar2021. The patient had problems with breathing in the last 22 years, but after 2nd dose of vaccine it had worsened. For about 3 days he felt aggravated difficulty breathing and could not walk more than 4,5 m because of dyspnoea due to which emergency service was needed and the patient was hospitalised from 16Mar2021 to 25Mar2021. During the transport the following investigations were performed: blood pressure: 140/80 mmHg, 140/75 mmHg, heart rate: 76/81 min, respiratory rate: 28-24/min, oxygen saturation: 91, 96, 98%, glycemia 6.8 mmol/l, GCS (Glasgow Coma Scale) 15. Corrective treatment was administered during the transport including intravenous aminophylline (SYNTOPHYLLIN) 40 mg and intravenous furosemide 2 x20 mg. During the admission to the hospital, the physician reported difficulty communication with the patient because of hypoacusis. The patient had no other difficulties (as pain on chest, cough, heart throbbing, body temperature, pain, faint). The patient was cardio-pulmonary decompensated (signs of anasarca), hypoxemic with a spastic breathing. ECG with SVES (supraventricular extrasystoles), without ischemic signs. Laboratory tests: inflammatory parameters increased (not specified), markers for cardiac failure (slightly increased), macrocytic hyperchromic anaemia (light stage), thrombocytopenia (light stage). Because of dyspnoea and increased D-dimer it was made CT pulmonary angiogram without signs of pulmonary embolism and inflammatory process. Because of dysarthria, it was performed CT scan of brain with the result of small ischaemic loci of older date without other pathologic signs. During the hospitalisation the renal laboratory parameters were worsened, it was found dehydratation, hyperosmolar hypernatraemia, hypokalaemia mild stage, ABG (arterial blood gas test) test with hypoxemic hypercapnic respiratory insufficiency. COVID-19 PCR test was negative on 16Mar2021 and on 18Mar2021. On 19Mar2021 the patient was transferred in another department and the treatment was continued. Despite of the treatment, the patient condition was unfavorable, he was found by the healthcare staff without vital signs and on 25Mar2021 at 08 30 a.m. he was pronounced dead. Cardio-respiratory failure was reported with a fatal outcome. Breathing difficult had not resolved at the time of patient death. The other events outcome was unknown. Reporter comment: Cardio-respiratory failure was considered as the immediate cause of death by the physician. The patologist assessed the causality as not related to vaccination (unlikely). The physician recommended an autopsy (but it was unknown if it was performed or not). Sender Comment: The causality was verified by the patologist and was assessed as not related (unlikely). No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Cardio-respiratory failure was considered as the immediate cause of death by the physician. The patologist assessed the causality as not related to vaccination (unlikely).; Sender''s Comments: Linked Report(s) : SK-PFIZER INC-2021621163 same patient/vaccine, different dose/events; Reported Cause(s) of Death: Cardio-respiratory failure


VAERS ID: 1375562 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-04-14
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   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: SKPFIZER INC2021617833

Write-up: Pulmonary embolism; This is a spontaneous report received from a contactable consumer (patient daughter) downloaded from the regulatory authority-WEB (Regulatory Authority number SK-SUKLSK-20214142). A 72-year-old male patient received BNT162B2 (COMIRNATY) intramuscular, on 29Mar2021, at single dose, for COVID-19 immunisation. Medical history was not reported. Concomitant medications included unspecified anticoagulants. On 14Apr2021 the patient experienced pulmonary embolism and died on the same day. The event was reported with a fatal outcome. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1377208 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza, Pneumonia, SARS-CoV-2 test
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VIMOVO; ACEMIN [ACECLOFENAC]; SEDACORON; ELIQUIS; MEXALEN; CONCOR; CAL-D-VITA; OLEOVIT D3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (Heart failure and atrial fibrillation(but condition was stable according to internist)); Cardiac insufficiency (Heart failure and atrial fibrillation(but condition was stable according to internist)); COVID-19 PCR test negative
Allergies:
Diagnostic Lab Data: Test Name: PCR test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: ATMODERNATX, INC.MOD20211

Write-up: Bilateral bacterial pneumonia; Flu symptoms; This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA (Bilateral bacterial pneumonia) in a 73-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Cardiac insufficiency (Heart failure and atrial fibrillation(but condition was stable according to internist)), Atrial fibrillation (Heart failure and atrial fibrillation(but condition was stable according to internist)) and COVID-19 PCR test negative. Concomitant products included ACECLOFENAC (ACEMIN [ACECLOFENAC]) for COVID-19 vaccination, ESOMEPRAZOLE MAGNESIUM, NAPROXEN (VIMOVO), AMIODARONE HYDROCHLORIDE (SEDACORON), APIXABAN (ELIQUIS), PARACETAMOL (MEXALEN), BISOPROLOL FUMARATE (CONCOR), CALCIUM CARBONATE, COLECALCIFEROL (CAL-D-VITA) and COLECALCIFEROL (OLEOVIT D3) for an unknown indication. On 10-Apr-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PNEUMONIA (Bilateral bacterial pneumonia) (seriousness criterion death) and INFLUENZA (Flu symptoms). On 26-Apr-2021, INFLUENZA (Flu symptoms) outcome was unknown. The patient died on 26-Apr-2021. The reported cause of death was Pneumonia and Decompensation cardiac. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. Treatment medications were not reported. Very limited information regarding this patient''s death has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Translation received on 02-JUN-2021 and added lab data.; Sender''s Comments: Very limited information regarding this patient''s death has been provided at this time.; Reported Cause(s) of Death: Pneumonia; Decompensation cardiac


VAERS ID: 1377209 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Pneumonia aspiration
SMQs:, 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)

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: AUPFIZER INC2021634817

Write-up: Cerebrovascular accident; Pneumonia aspiration; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 559671. A 70-year-old female patient received bnt162b2 (COMIRNATY, lot/batch number unknown) via an unspecified route of administration on 12May2021 at unknown single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced cerebrovascular accident, and pneumonia aspiration on 14May2021. The events resulted in death. The patient died on an unknown date. It was not reported if an autopsy was performed. The cause of death were cerebrovascular accident, and pneumonia aspiration. The outcome of event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cerebrovascular accident; Pneumonia aspiration


VAERS ID: 1377256 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute, Death
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 8
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: DEPFIZER INC2021616454

Write-up: Unknown cause of death; Acute cardiac insufficiency; This is as spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100077664. An elderly male patient of an unknown age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 20Apr2021 (Lot Number: Unknown) as 0.3 mL single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On 23Apr2021 patient experienced acute cardiac insufficiency and on 01May2021 patient experienced unknown cause of death. Both events were considered serious due to fatal outcome. An autopsy was not performed. Relatedness of drug to reactions/events (All events) was reported as D. Unclassifiable. Source of assessment: PEI No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Acute cardiac insufficiency; Unknown cause of death


VAERS ID: 1377257 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Asthenia, Decreased appetite, Generalised oedema
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Angioedema (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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
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: DEPFIZER INC2021616451

Write-up: Appetite lost; General debility; Acute kidney failure; Generalised oedema; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100077679. A 92-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY) via an unspecified route of administration on 01Feb2021 (Batch/Lot number was not reported) as single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY) via an unspecified route of administration in Jan2021 as single dose, for COVID-19 immunization. On an unspecified date the patient experienced appetite lost, general debility, acute kidney failure and generalized oedema. All the events were reported as being fatal. The patient died in Mar2021. An autopsy was not performed. The causality assessment between the events and the vaccine was unclassifiable. Source of assessment: Regulatory Authority No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: appetite lost; general debility; acute kidney failure; generalized oedema


VAERS ID: 1377269 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RAMILICH; ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021619343

Write-up: acute leukemia; cerebral haemorrhage; This is a spontaneous report from a contactable physician received via Regulatory Authority portal. A 61-year-old male patient received first dose of BNT162B2 (COMIRNATY), intramuscular, administered in arm left on 10May2021 (Batch/Lot Number: Unknown) (at the age of 61-year-old) as single dose for COVID-19 immunisation. Medical history included arterial hypertension from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. Concomitant medications included ramipril (RAMILICH) and atorvastatin, both taken for an unspecified indication, start and stop date were not reported. The patient experienced acute leukemia on 14May2021 and died of it on 27may2021, cause of death was reported as cerebral haemorrhage. The events required doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included intensive therapy (as reported). An autopsy was not performed. The information on the lot/batch number has been requested.; Sender''s Comments: Events acute leukemia and cerebral haemorrhage represent intercurrent medical conditions and unrelated to BNT162B2 . 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: Cerebral hemorrhage; acute leukemia


VAERS ID: 1377270 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C007A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, 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: 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: Bypass surgery; Diabetes; Overweight
Allergies:
Diagnostic Lab Data: Test Name: continuous blood sugar measurement; Result Unstructured Data: Test Result:no low blood sugar
CDC Split Type: DEPFIZER INC2021626869

Write-up: died suddenly a week after the second vaccination; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 59174], license party for Comirnaty. This is a spontaneous report from a contactable physician. A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: ER 9480) as 1st dose, single, dose 2 via an unspecified route of administration on 18May2021 (Batch/Lot Number: 1C007A) as 2nd dose, single for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing , overweight from an unknown date and unknown if ongoing , bypass surgery from an unknown date and unknown if ongoing. The patient had no cough, no edemas. The patient''s concomitant medications were not reported. The patient experienced "died suddenly a week after the second vaccination" on an unspecified date. The patient underwent lab tests and procedures which included continuous blood glucose measurement: no low blood sugar. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 1377395 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-23
Onset:2021-01-29
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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: 2021-01-29
   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 INC2021617743

Write-up: Myocardial infarction; This is a spontaneous report received from a contactable physician from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 25354584. A 74-year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly on 23Jan2021 (Batch/Lot number was not reported) at 0.3 ml single for covid-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced myocardial infarction on 29Jan2021 which led to patient''s death on the same date. An autopsy was not performed. No follow-up attempts possible. No further information expected. Lot/Batch number cannot be obtained.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1377489 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-02
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Coma, Confusional state, Contusion, Dyspnoea, Hemiparesis, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Tendinopathies and ligament disorders (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: Medical History/Concurrent Conditions: Automobile accident; Below knee amputation; Gingival disorder NOS; Rehabilitation therapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021589797

Write-up: Coma; hemiparesis left; Shortness of breath; Confusion; bruises and pain in the leg; bruises and pain in the leg; Cerebral haemorrhage; This is a spontaneous report from a contactable consumer, received from regulatory authority, downloaded from the regulatory authority-WEB. The regulatory authority report number is AT-BASGAGES-2021-28025. A 59-year-old female patient received BNT162B2 (COMIRNATY, batch/lot number and expiration date unknown) via an unspecified route of administration on an unspecified date in Apr2021 (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient''s medical history included gingival disorder NOS from Apr2021, automobile accident from 1987, below knee amputation from 1987, rehabilitation therapy from Apr2021. Concomitant medications were not reported. On 02May2021 the patient experienced bruises and pain in the leg, confusion, shortness of breath (medically significant), hemiparesis left, coma, cerebral haemorrhage. The outcome of the events hemiparesis left, coma, and cerebral haemorrhage was fatal; outcome of unknown for other events. The patient died on an unspecified date. It was not reported if an autopsy was performed. The cause of death was hemiparesis left, coma, and cerebral haemorrhage. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage; Coma; hemiparesis left


VAERS ID: 1377491 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-18
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Cardiogenic shock
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), 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), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   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: Diabetes mellitus non-insulin-dependent (NIDDM)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021590479

Write-up: Cardio-respiratory arrest; Cardiogenic shock; This is a spontaneous report from a contactable physician. This is a report received from the Agency Regulatory Authority-WEB. Regulatory authority or other manufacturer number AT-BASGAGES-2021-28078. A 64-years-old male patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 14May2021 (Batch/Lot Number: FA4598) as single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus non-insulin-dependent (NIDDM). The patient''s concomitant medications were not reported. On 18May2021 18:10 the patient experienced Cardio-respiratory arrest, hospitalization, life threatening. 18May2021 ~18:10 patient collapsed while gardening -$g Cardiopulmonary resuscitation ca.45 min, stabilization after lysis therapy (10,000 IU metalysis 18:35). 18:50 Return of Spontaneous Circulation (ROSC) -$g transfer. Treatment of side effect: noradrenaline 10mg/50ml to 1?g/kg/min 18May to 19May and levosimendan 12.5 mg for stabilization. Sevorane (MAC 0.8-1.0) and Ultiva 5mg/50ml for sedation. The pat died in cardiogenic shock at 06:05 on 19May2021. The patient''s outcome was: recovered/resolved for cardio-respiratory arrest, fatal for cardiogenic shock. An autopsy was ordered. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: cardiogenic shock


VAERS ID: 1377496 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-05-02
   Days after vaccination:81
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   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: INSULIN
Current Illness: Insulin-requiring type II diabetes mellitus (diabetic management II requires insulin)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210502; Test Name: PCR; Test Result: Positive
CDC Split Type: ATPFIZER INC2021628393

Write-up: Vaccination failure; COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-29279. An 88-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 10Feb2021, dose 1 via an unspecified route of administration on 19Jan2021 both as single dose for covid-19 immunisation. Medical history included ongoing insulin-requiring type 2 diabetes mellitus (diabetic management II requires insulin). The patient had permanent care condition. The patient''s concomitant medications included insulin. The patient experienced covid-19 pneumonia on 02May2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 02May2021. The patient died on 06May2021 due to covid-19 pneumonia. It was not reported if an autopsy was performed. Senders comments: BASGAGES comment: Follow-up information has been requested. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: covid-19 pneumonia


VAERS ID: 1377497 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-03-01
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, COVID-19, COVID-19 pneumonia, Cough, Critical illness, Drug ineffective, Gait disturbance, General physical health deterioration, Pyrexia, Retching, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   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: VOLTAREN EMULGEL; INKONTAN; CEOLAT; DOMINAL [PROTHIPENDYL HYDROCHLORIDE]; PRAM [CITALOPRAM HYDROBROMIDE]; NITROLINGUAL; QUETIALAN; TAMSULOSIN HEXAL; QUETIAPIN GENERICON; MEXALEN; CARVEDILOL HEXAL; MOLAXOLE; LATANOPROST AGEPHA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Amblyopia; Arterial hypertension; Astigmatism; Atherosclerotic plaque (flat plaque of carotis); Behaviour disorder (dementia associated behaviour disorder); Cyst (Parapelvine Cysts); Degeneration macular; Dementia vascular; Diabetes mellitus; Dyspnoea exertional (slight Dyspnoea exertional); Extrasystoles; Fibromatosis (Fibromatosis of pancreas); Glaucoma (open angle glaucoma); Hard of hearing (profound hearing impairment both sides); Impaired self-care (self-care eating dring impaired, self-sufficiency deficiency at excretions); Mitral valve insufficiency; Myopia; Presbyopia; Prostatic hypertrophy (benign); Senile cataract (Cataract senilis); Swallowing difficult (swallowing impaired); Vision decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210304; Test Name: blood pressure; Result Unstructured Data: Test Result:220 / 110; Test Date: 20210304; Test Name: blood pressure; Result Unstructured Data: Test Result:200 / 100; Test Date: 20210209; Test Name: SARS-CoV-2 Antigen Test; Result Unstructured Data: Test Result:negative; Test Date: 20210212; Test Name: SARS-CoV-2 Antigen Test; Result Unstructured Data: Test Result:negative; Test Date: 20210304; Test Name: SARS-CoV-2 Antigen Test; Result Unstructured Data: Test Result:negative
CDC Split Type: ATPFIZER INC2021639001

Write-up: COVID-19 pneumonia; Critical condition; Fever; COVID-19 positive; Cough; General physical condition decreased; COVID-19 pneumonia/Vaccination failure; Retching; pronounced Gait instability; This is a spontaneous report from a contactable other Healthcare Professional downloaded from the regulatory authority-WEB local regulatory authority number AT-BASGAGES-2021-29654. A 81-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EJ6797; Expiration Date: 30Apr2021) via an unspecified route of administration, administered at an unspecified anatomical location 02Feb2021 (age at vaccination was unknown) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient''s medical history and concurrent conditions included hard of hearing, myopia, astigmatism, presbyopia, glaucoma, degeneration macular, senile cataract, amblyopia, mitral valve insufficiency, extrasystoles, diabetes mellitus, dyspnoea exertional, arterial hypertension, fibromatosis, cyst, atherosclerotic plaque, prostatic hypertrophy (benign), dementia vascular, behaviour disorder, impaired self-care, vision decreased, swallowing difficult. Concomitant medications included diclofenac diethylamine (VOLTAREN EMULGEL) from 31Aug2020 to 13Mar2021, trospium chloride (INKONTAN)dose of 15mg from 17Nov2020 to 13Mar2021, dimeticone (CEOLAT) dose of 1mg/ml from 16Dec2020 to 13Mar2021, prothipendyl hydrochloride (DOMINAL) dose of 80mg from 07Dec2020 to 13Mar2021, citalopram hydrobromide dose of 40mg from 12Oct2020 to 13Mar2021, glyceryl trinitrate (NITROLINGUAL) dose of 0.4mg from 14Sep2020 to 13Mar2021, quetiapine fumarate (QUETIALAN) dose of 50 mg from 30Nov2020 to 13Mar2021; tamsulosin hydrochloride (TAMSULOSIN HEXAL) dose of 0.4 mg from 17Nov2020 to 13Mar2021, quetiapine fumarate (QUETIAPIN GENERICON) dose of 25 mg from 29Oct2020 to 13Mar2021, paracetamol (MEXALEN) dose of 500 mg from 23Oct2020 to 13Mar2021, carvedilol (CARVEDILOL HEXAL) dose of 25mg from 11May2020 to 13Mar2021, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOLAXOLE) from 04Mar2021 to 13Mar2021, latanoprost (LATANOPROST AGEPHA) dose of 50 ug/ml from 11May2020 to 13Mar2021. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EJ6796; Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location 12Jan2021 (age at vaccination was unknown) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. On 01Mar2021, the patient experienced gait instability. On 04Mar2021, the patient experienced retching, cough, general physical condition decreased. On 04Mar2021 at 20:30 pm, the patient was hospitalized. On 04Mar2021, the patient underwent lab tests and procedures which included blood pressure measurement: 220/110 and 200/100 and sars-cov-2 test: negative on 09Feb2021, 12Feb2021 and 04Mar2021. On 05Mar2021, the patient experienced COVID-19. On 06Mar2021, the patient experienced fever, critical illness and COVID-19 pneumonia. On 13Mar2021, the patient died. It was unknown if an autopsy was performed. The reporter''s causality assessment was reported as related. The outcome of the event COVID-19 pneumonia was fatal. The outcome of the event retching was unknown. The outcome of the event gait instability was resolved on 03Mar2021. The outcome of the events cough, general physical condition decreased, fever, critical illness and COVID-19 was not resolved. No follow-up attempts needed. No further information is expected, batch/lot.no. has already been reported. ; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 1377591 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-09
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3014 / UNK - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   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: DUPHALAC [LACTULOSE]; DICLOFENAC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral atherosclerosis (With occasional dizziness/head spinning); Chronic ischemic heart disease, unspecified; Constipation; Dizziness; Essential hypertension; Vertebrogenic pain syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021590040

Write-up: Sudden cardiac death; Sudden death; sudden cardiac death/fatal failure of one of the organs; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority number is CZ-CZSUKL-21005455. A 78-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, on 29Apr2021 (batch/lot number: EY3014), as 2nd dose, single dose, for COVID-19 immunisation. Medical history included vertebrogenic pain syndrome, cerebral atherosclerosis with occasional dizziness/head spinning, chronic ischemic heart disease, unspecified, essential hypertension, and constipation. Concomitant medications included lactulose lactulose (DUPHALAC) taken for constipation; diclofenac (DICLOFENAC) taken for an unspecified indication; and unspecified dietary supplements, immune-boosting and over-the-counter medications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (COMIRNATY Solution for injection) on 08Apr2021 (batch/lot number: EW2246), for COVID-19 immunisation. The patient experience sudden cardiac death and sudden death on 09May2021. It was reported that the patient died suddenly on 09May2021 without any previous symptoms. According to the reporter, due to the very good condition of the patient, it is believed that the death was caused by the administration of a vaccine against SARS-CoV-2. Record of the coroner''s departure on 09May2021: Examination of the body by a coroner stated that "No traces of external injuries were found during the examination. A mobile, self-sufficient senior living alone in an apartment, found by her grandson on a bed lying dressed in pyjamas. On the right side in a rest position. A non-compliance patient who had only Diclofenac of the drugs per scriptum, otherwise many dietary supplements, immune-boosting and over-the-counter medications (Duphalac for constipation). Most likely hypertension, chronic ischemic heart disease, cerebral atherosclerosis with occasional dizziness, but she had never had a myocardial infarction, stroke, pulmonary embolism. She did not complain about anything but verterobrogenic algic syndrome. Postmortem stiffness almost fully formed and postmortem stains marginally extrudable by the edge. Cause of death was set as a sudden cardiac death." The outcome of the events was fatal. Causes of death were "Sudden cardiac death. An autopsy was not ordered. The second dose of Comirnaty is most likely the cause death. This drug probably caused fatal failure of one of the organs" (as reported), sudden death, and "sudden cardiac death/fatal failure of one of the organs". No autopsy was performed. The health authority assessed the event sudden cardiac death as serious (death) and the event sudden death as serious (death, life-threatening, medically significant). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden cardiac deathAn autopsy was not ordered. The second dose of Comirnaty is most likely the cause death. This drug probably caused fatal failure of one of the organs.; Sudden death; sudden cardiac death/fatal failure of one of the organs


VAERS ID: 1377606 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arterial rupture, Coma, Multiple organ dysfunction syndrome
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant 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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021590610

Write-up: Multiorgan failure; Coma; Arterial rupture; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-202100071816. A 78-year-old male patient received bnt162b2 (COMIRNATY, mRNA TOZINAMERAN), via an unspecified route of administration on 05Apr2021 as unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 06Apr2021 the patient experienced Arterial rupture. On 08Apr2021 the patient experienced Coma. On 04May2021 the patient experienced Multiorgan failure. Patient died on 04May2021. The patient''s outcome was: fatal for Arterial rupture, fatal for Coma, fatal for Multiorgan failure. Relatedness of drug to reactions from Regulatory Authority was "Unclassifiable". Unknown if autopsy done. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Multiple organ failure; Arterial rupture; Coma


VAERS ID: 1377607 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-10
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, SARS-CoV-2 test, Septic shock
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), 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), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   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: Adipositas per magna; Arterial hypertension; Chronic diarrhea; Chronic renal insufficiency (stage III); Hypochromic microcytic anemia; Ulcer of lower limbs, excl decubitus ulcer; Urinary tract infection
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol addiction
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021590652

Write-up: Acute renal failure; Septic shock; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100071817. A 68-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Apr2021 (at age 68-years-old) (Batch/Lot Number: ET3674) as 2nd dose, 0.3 mL, single for covid-19 immunisation. The first dose was received on 25Feb2021 at age 68-years-old. Medical history included urinary tract infection from Mar2021 and ongoing, alcohol addiction, ongoing chronic kidney disease stage III, ongoing hypochromic anaemia, ongoing chronic diarrhea , ongoing arterial hypertension, ongoing Adipositas per magna, and ongoing ulcer of lower limbs, excl decubitus ulcer. The patient''s concomitant medications were not reported. The patient experienced acute renal failure and septic shock on 10Apr2021 which resulted in death. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on Jan2021. The patient died on 12Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute renal failure; septic shock


VAERS ID: 1377610 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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: Artificial cardiac pacemaker wearer
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021590645

Write-up: Ventricular fibrillation; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, Regulatory authority or other manufacturer number DE-PEI-202100071820. A 75-year-old male patient received bnt162b2 (COMIRNATY), on 04May2021 (Lot Number: EX8679) at age of 75-year-old as UNKNOWN DOSE, 0.3mL, single for covid-19 immunisation. Medical history included Artificial cardiac pacemaker wearer. The patient''s concomitant medications were not reported. The patient experienced also Ventricular fibrillation, Unknown cause of death. The patient''s outcome was fatal. Autopsy Done but Autopsy Results not Available. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Ventricular fibrillation


VAERS ID: 1377611 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-03-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, General physical health deterioration, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-27
   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: Cardiac insufficiency; COPD; Decompensation cardiac; Macrocytic hyperchromic anemia; Tachyarrhythmia
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of oesophagus; Colon diverticulitis; Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021590581

Write-up: General physical health deterioration; Tiredness; Sweating; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number DE-PEI-202100071822. An 87-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Mar2021 (Lot Number: ER7812) at the age of 87-years-old as single dose for covid-19 immunisation. Medical history included decompensation cardiac from Sep2018 and ongoing , adenocarcinoma of oesophagus, ongoing COPD (chronic obstructive pulmonary disease), ongoing macrocytic hyperchromic anemia, ongoing tachyarrhythmia, colon diverticulitis, pneumonia, ongoing cardiac insufficiency. The patient''s concomitant medications were not reported. On 27Mar2021 the patient experienced general physical health deterioration, tiredness, sweating, oxygen supplementation. All the events caused patient death. The events lasted for 9 hours. The patient died on 27Mar2021. An autopsy was performed and results were not available. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: General physical health deterioration; tiredness; sweating


VAERS ID: 1377619 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-13
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-07
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: 2021-05-13
   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: DEPFIZER INC2021616446

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority -WEB. The regulatory authority report number is DE-PEI-202100077671. A 79-year-old male patient received BNT162b2 (COMIRNATY, Lot number unknown) via an unspecified route of administration on 04May2021 (at the age of 79-year-old) at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient died on 13May2021. Cause of death was unknown. Autopsy was not performed. The causality assessment for suspect drug to event was reported as follows: Source of assessment a regulatory authority. Result of Assessment Unclassifiable. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1378609 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Blood culture, Blood pressure measurement, C-reactive protein, Cerebral haemorrhage, Cerebral infarction, Cerebral ischaemia, Cerebrovascular accident, Coma scale, Computerised tomogram head, Dyspnoea, General physical health deterioration, Hemiparesis, International normalised ratio, Neutrophil count, Pain, Platelet count, Pneumonia, White blood cell count
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 8
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: IBUMETIN
Current Illness: Diabetes; Hypercholesterolaemia
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Blood culture; Result Unstructured Data: Test Result:S. aureus; Test Date: 20210503; Test Name: Blood pressure; Result Unstructured Data: Test Result:Slightly elevated (expected); Test Date: 20210504; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:14; Comments: (afternoon) No unit; Test Date: 20210504; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:3; Comments: (evening) No unit; Test Date: 20210503; Test Name: CT brain scan; Result Unstructured Data: Test Result:Sign of newly emerged cerebral ischaemia; Comments: Sign of newly emerged cerebral ischaemia on CT. Large parenchymal frontoparietal haemorrhage right hemisphere with breakthrough to subarachnoid spaces corresponding to sulcus and large volumes of blood in ventricular system. 12 mm midline shift to the left. Diffuse hypodense changes in the largest part of right hemisphere consistent with newly infarct. Nothing pathological in the skull.; Test Date: 20210503; Test Name: C-reactive protein; Result Unstructured Data: Test Result:306; Comments: Unit not specfied; Test Date: 20210504; Test Name: C-reactive protein; Result Unstructured Data: Test Result:275; Comments: Unit not specfied; Test Date: 20210503; Test Name: INR; Result Unstructured Data: Test Result:1.3; Comments: Unit not specfied; Test Date: 202105; Test Name: Neutrophil count; Result Unstructured Data: Test Result:13.9; Comments: Unit not specified; Test Date: 20210503; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:281 x10 9/l; Test Date: 20210504; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:240 x10 9/l; Test Date: 202105; Test Name: Leukocyte count; Result Unstructured Data: Test Result:16.2; Comments: Unit not specified
CDC Split Type: DKPFIZER INC2021590304

Write-up: sign of newly emerged cerebral ischaemia on CT; Large parenchymal frontoparietal haemorrhage; sign of newly emerged cerebral infarction on CT; disturbance in speech; pain in left side; Cerebral apoplexy; Dyspnoea; Weakness left or right side; Pneumonia; general condition reduced since vaccination.; This is as spontaneous report received from a contactable Physician downloaded from the regulatory authority-WEB. The regulatory authority report number is DK-DKMA-WBS-0064919. A 72 years old male patient received the first dose of BNT162B2 (COMIRNATY, Batch number: EY4834) Intramuscular at single dose for Covid-19 immunisation on 26Apr2021. Relevant history included arthritis, diabetes and hypercholesterolaemia. The patient had no history of thrombosis. Concomitant medication included Ibuprofen (IBUMETIN) for Arthritis since 26Sep2017. There was no information regarding past medication. On 26Apr2021 the patient experienced Reduced general condition, on 27Apr2021 the patient developed pneumonia, and 30Apr2021 the patient developed Dyspnoea, Weakness left or right side and apoplexy. 03May2021 the patient experienced disturbance in speech (Aphasia) and pain localized. 03May2021 a CT signs of newly emerged Cerebral infarction, Cerebral ischaemia and Cerebral haemorrhage was discovered. The ADRs were reported as resulting in hospitalisation (on 03May2021) and was fatal on 04May2021 by the original reporting physician. The patient was treated with insulin, simvastatin, saltwater I.V. piperacillin/tazobactam (piperacillin and beta-lactamase inhibitor) and hjertemagnyl (acetylsalicyclic acid) and was given morphine on 04May2021. The ADRs apoplexy, cerebral haemorrhage, cerebral infarction and cerebral ischaemia were reported as fatal and the outcome of aphasia, dyspnea, pain localized, pneumonia, reduced general condition and weakness left or right side was unknown. Reported causes of death: apoplexy, Cerebral haemorrhage, Cerebral infarction and Cerebral ischaemia. Only usual/normal confirmation of death was performed post mortem. No autopsy was performed. All events were reported hospitalization, life-threatening and disability. Lab tests in May2021 included: Blood culture: S. aureus; Leukocyte count: 16.2; Neutrophil count: 13.9. 03May2021. CT brain scan: sign of newly emerged cerebral ischaemia on CT. Large parenchymal frontoparietal haemorrhage right hemisphere with breakthrough to subarachnoid spaces corresponding to sulcus and large volumes of blood in ventricular system. 12 mm midline shift to the left. Diffuse hypodense changes in the largest part of right hemisphere consistent with newly infarct. Nothing pathological in the skull. C-reactive protein: 306; Thrombocyte count: 281 10^9/L; INR: 1.3; Blood pressure: Slightly elevated (expected). 04May2021: C-reactive protein: 275; Thrombocyte count: 240 10^9/L; Glasgow coma scale: 14 (afternoon); Glasgow coma scale: 3 (evening). Fibrin D dimer and thrombocyte antibody test not performed. Causality: the second physician states that there is nothing unusual about the cause of the disease. No thrombosis suspected anywhere else in the body, therefore only CT of the brain. Sender''s Comments: Additional test results: CT brain scan: sign of newly emerged cerebral ischaemia on CT. Large parenchymal frontoparietal haemorrhage right hemisphere with breakthrough to subarachnoid spaces corresponding to sulcus and large volumes of blood in ventricular system. 12 mm midline shift to the left. Diffuse hypodense changes in the largest part of right hemisphere consistent with newly infarct. Nothing pathological in the skull. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Apoplexy; Cerebral infarction; Cerebral haemorrhage; Cerebral ischaemia


VAERS ID: 1378610 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-03-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: LATANOPROST STADA; VENTOLINE [SALBUTAMOL SULFATE]; GABAPENTIN; VENTOLINE [SALBUTAMOL SULFATE]; PANODIL; CLARITYN [LORATADINE]; FEMAR; PREDNISOLON [PREDNISOLONE]; IMOVANE; CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]; FLIXOTIDE; OXYCODON ACT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Breast cancer; Glaucoma; Pain; Palliative care (palliative care for breast cancer); Sleeplessness; Urticaria
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021628164

Write-up: Type A aortic dissection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0065512. A 74-year-old female patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 30Mar2021 (Lot Number: ET3674; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included urticaria, pain, sleeplessness, glaucoma, asthma, palliative care (for breast cancer) and breast cancer, all from an unknown date and unknown if ongoing. Concomitant medications included latanoprost (formulation: eye drops, solution, strength: 50ug/ml) ophthalmic taken at 1 drop, daily for glaucoma from 05Dec2019 to an unspecified stop date; salbutamol sulfate (VENTOLINE, formulation: inhalation powder, strength: 0.2 mg) resp inhalation taken at 0.2 mg, daily for asthma from 05Dec2019 to an unspecified stop date; gabapentin (formulation: capsule, hard, strength: 300 mg) oral taken at 900 mg, daily for pain from 05Apr2019 to 07Apr2021; salbutamol sulfate (VENTOLINE, formulation: pressurized inhalation, suspension, strength: 0.1 mg) resp inhalation taken at 0.1 mg, as needed, max 6 times daily for asthma from 04Mar2020 to an unspecified stop date; paracetamol (PANODIL, formulation: film-coated tablet, strength: 500 mg) oral taken at 1000 mg, as needed, max 4 times daily for pain from 15Jul2020 to an unspecified stop date; loratadine (CLARITYN, formulation: tablet, strength: 10 mg) oral taken at 10 mg, as needed, max 1 time daily for urticaria from 05Dec2019 to an unspecified stop date; letrozole (FEMAR, formulation: film-coated tablet, strength: 2.5 mg) oral taken at 2.5 mg, daily for breast cancer from 23Jun2020 to an unspecified stop date; prednisolon [prednisolone] (strength: 5 mg) oral taken at 5 mg, as needed, max 2 times daily for glucocorticoid therapy from 08Dec2020 to an unspecified stop date; zopiclone (IMOVANE, formulation: film-coated tablet, strength: 7.5 mg) taken at 7.5 mg, daily for sleeplessness from 12Dec2019 to 04Apr2021; calcium, colecalciferol (CALCIUM & VITAMIN D, strength: 400 mg/19 ug) oral taken at 2 dose form, daily for calcium supplementation from 05Dec2019 to an unspecified stop date; fluticasone propionate (FLIXOTIDE, formulation: inhalation powder, strength: 250 ug) resp inhalation taken at 500 ug, daily for asthma prophylaxis from 05Dec2019 to an unspecified stop date; oxycodone hydrochloride (OXYCODON ACTAVIS, formulation: capsule, hard, strength: 5 mg) oral taken at 5 mg for pain from 25Dec2019 to an unspecified stop date and acetylcysteine (MUCOMYST, strength: 200 mg) oral taken at 200 mg, as needed, max 2 times daily for an unspecified indication from 03Mar2020 to an unspecified stop date. The patient previously received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 09Mar2021 (Lot Number: EP9605; Expiration Date: 30Jun2021) as single dose for COVID-19 immunisation. The patient experienced type A aortic dissection (fatal) on 31Mar2021. The patient died on 01Apr2021. The reporter stated that the epicrisis did not state whether the case has been reported to the police and whether a forensic autopsy has been performed. There is no information regarding test results. The physician (reporter) does not suspect that there is a connection between the vaccine and the death, but wants to maintain his report since the patient passed away two days after the vaccination. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Type A aortic dissection


VAERS ID: 1378611 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-05-07
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Loss of consciousness, Myocardial infarction
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), 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: 2021-05-07
   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: SPIRIVA; PANODIL; IBUMETIN; SPARKAL MITE; LETROZOL ACCORD; ENALAPRIL KRKA; ZOLEDRONIC ACID FRESENIUS KABI
Current Illness: Breast cancer (surgery for breast cancer); Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer surgery; Chronic obstructive pulmonary disease; Pain
Allergies:
Diagnostic Lab Data: Test Date: 20210507; Test Name: EKG; Result Unstructured Data: Test Result:PEA (Pulseless electrical activity)
CDC Split Type: DKPFIZER INC2021628194

Write-up: Heart attack; The patient has during a walk suddenly collapsed and is uncontactable; This is a spontaneous report from a contactable pharmacist and two physicians downloaded from -WEB (Regulatory Authority number DK-DKMA-WBS-0065634, Safety Report Unique Identifier DK-DKMA-ADR 25273181). A 75 years old female patient received the second single dose of BNT162B2 (COMIRNATY; lot/batch EW6126, expiry date Jul2021) intramuscular, on 03May2021, for COVID-19 immunisation. Medical history included ongoing breast cancer (surgery for breast cancer), ongoing hypertension, pain and chronic obstructive pulmonary disease. The first dose of Comirnaty was administered on 12Apr2021 (lot number: EW4811 Expiration date: 31Jul2021) for COVID-19 immunisation. Concomitant medications included tiotropium bromide (SPIRIVA; 18 ug) from 2017, 1 DF, 1x/day, for COPD, paracetamol (PANODIL; 500 mg tablet) from 17Feb2017, 1000 mg, as needed, max 4 times daily, for pain, ibuprofen (IBUMETIN; 400 mg tablet) from 28Oct2019, 400 mg, as needed, max 3 times daily, for pain, amiloride hydrochloride, hydrochlorothiazide (SPARKAL MITE) from 09Apr2021, 1 DF, 1x/day, for hypertension, letrozole (LETROZOL ACCORD; 2.5 mg tablet) from 18Sep2018, 2.5 mg, 1x/day, for breast cancer, enalapril maleate ENALAPRIL KRKA 10 mg tablet) 10 mg, 1x/day, for hypertension, zolendronic acid (ZOLEDRONIC ACID FRESENIUS KABI) from 09Dec2019, for breast cancer. On 07May2021 the patient experienced heart attack and during a walk suddenly collapsed and was uncontactable. The events were reported by both reporters as fatal (date of death 07May2021). Resuscitation has been attempted and adrenaline was given. The patient was dead on arrival at hospital. Reported cause of death: heart attack. It was unknown if an autopsy was actually performed, however it was reported that autopsy will be performed (result was awaiting). EKG (electrocardiogram): PEA (Pulseless electrical activity) on 07May2021. COMMENT FROM a regulatory authority: Two reporters have simultaneously submitted on the same patient-drug reaction. Duplicate case DK-DKMA-WBS-0065669 (DK-DKMA-ADR 25275940) has been merged with this master case before submission to a regulatory authority. A regulatory authority should therefore consider version 2 of the master as the initial report. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1378650 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-03
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory 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), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   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: Alcohol abuse chronic; Anxiety; Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210519346

Write-up: CARDIO RESPIRATORY ARREST; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, ES-AEMPS-852187] concerned a 72 year old female of unknown ethnicity. The patient''s height, and weight were not reported. The patient''s past medical history included anxiety, alcohol abuse chronic, and depression. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD955 expiry: unknown) 0.5 ml, 1 total, administered on 25-APR-2021 for covid-19 vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject died from cardio respiratory arrest. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0 20210519346-COVID-19 VACCINE AD26.COV2.S- cardio respiratory arrest. 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: CARDIO RESPIRATORY ARREST


VAERS ID: 1378663 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7015 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation, Pyrexia, Slow response to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 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: Medical History/Concurrent Conditions: Alzheimer''s disease (GDS 6)
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:130/80; Test Name: blood pressure; Result Unstructured Data: Test Result:119/82; Test Name: body temperature; Result Unstructured Data: Test Result:38.0 Centigrade; Test Name: body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Test Name: heart beat; Result Unstructured Data: Test Result:110; Test Name: heart beat; Result Unstructured Data: Test Result:75; Test Name: oxygen saturation; Test Result: 99 %; Test Name: oxygen saturation; Test Result: 92 %
CDC Split Type: ESPFIZER INC2021590912

Write-up: Decreased reactivity; Febricula; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB and received via Regulatory Authority ES-AEMPS-864811. A 93-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 05May2021 (Lot Number: EY7015) as a single dose for COVID-19 immunization. Medical history included dementia alzheimer''s type (GDS 6). The patient''s concomitant medications were not reported. On 06May2021 the patient experienced decreased reactivity (slow response to stimuli), febricula. The chronological course was reported as follows: 93-Year-old patient with medical history of Alzheimer. Received Pfizer vaccine 2nd dose 48 hours ago and average temperature 37.5 ?C, temperature: 38.0 Systolic blood pressure: 130 Diastolic blood pressure: 80. Remarks: paracetamol now and I will return to store. Yesterday the fever started and they see she somewhat was less reactive. 48 hours ago 2nd dose Pfizer. Functional examination: answer questions. Arrhythmic AC without murmurs. Normal AP. Skin and mucous membranes. Paracetamol. I give advice. They will call if it persists. Temperature: 37.9 T?, place takes: Armpit. Systolic blood pressure: 119, Diastolic blood pressure: 82, Heart rate: 110, Oxygen Saturation: 99, warning for persistence of fever with normal cardiorespiratory examination continue the same with paracetamol. Home warning: low-grade fever persists (up to 37.8?C, morning) and decay. In addition, increased expectoration, something dark and occasional respiratory sounds. I give a urine collection bag but they cannot collect it. Functional examination: Sat O 92%. Arrhythmic AC (Cardiac action) without murmurs, at 75 ppm. AP(Pulmonary action) good ventilation with some isolated rhonchi. (A) PRES-E - (A) CEFUROXIMA 500 MG, Tablet, Left PCA hypoventilation. Somewhat agitated. 1 IM vial of METAMIZOL 2000 is administered at home (DUE). Control by Primary attention doctor. Pauto CEFTACIDIMA 1000 IM 1 vial / 24 hours 5 vials (visa request / authorization for benefits = control). I explain that this is usually the beginning of the end and they do not want to be transferred to the hospital. Palliative measures. I explain not to force food or drink, wet the mouth. Control Temperature. (A) PRES-E - (A) CEFTAZIDIMA 1000 MG INJECTABLE. NURSING INTERVENTIONS (NIC): Medication administration: IM: YES, Obs :: metamizole 2 gr, Home notice: since this morning without fever. Less reactive, loss of functional capacity. Do not eat nor drink. Less diuresis. Repeated movements. They do not perceive pain, nervousness, restlessness ... Functional examination: does not respond. Maintains mobility type mannerisms. AP (Pulmonary action) does not collaborate, I did not hear extra noises. Arrhythmic AC (Cardiac action) at 90 ppm. Nondescript abdomen. PPRB neg. Complains of pain with mobilization. I explain Px and measures to take into account. 24 h infusion pump: Midazolam 10 mg + Morphine 10 mg Rescue: yes nerves Midazolam 1 mg (2 ml of 5 mg in 10 cc SF) if pain Morina 1 mg (1 ml of 10 mg in 10 cc SF). 16May2021: Inactive due to death exitus at 3:00 p.m. I certify. The patient died on 16May2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Lot/batch number was provided; Reported Cause(s) of Death: Decreased reactivity; Febricula


VAERS ID: 1378676 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-05-01
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001532 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cardio-respiratory 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), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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: FLUOROURACILO; IRINOTECAN
Current Illness: Metastatic colon cancer
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Embolism pulmonary
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of CARDIO-RESPIRATORY ARREST in a 59-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001532) for COVID-19 vaccination. Co-suspect product included non-company product PANITUMUMAB for Metastatic colon cancer. The patient''s past medical history included Dyslipidaemia and Embolism pulmonary in 2012. Concurrent medical conditions included Metastatic colon cancer. Concomitant products included FLUOROURACILO from an unknown date to 29-Apr-2021 and IRINOTECAN from an unknown date to 29-Apr-2021 for Colon cancer. On 12-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient started PANITUMUMAB (unknown route) at an unspecified dose. On 01-May-2021, the patient experienced CARDIO-RESPIRATORY ARREST (seriousness criteria death and medically significant). The patient died on 01-May-2021. The reported cause of death was Cardio-respiratory arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The co-suspect product was started on an unknown date in 2021. Treatment details were not provided. Very limited information regarding the events have been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding the events have been provided at this time. No further information is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1378696 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-23
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory 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), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   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: ADIRO; INDAPAMIDE; PROVISACOR; DUODART; COMBIPRASAL; BUDESONIDE; NASACORT; PECTOX LISINA; ROCALTROL; TERBASMIN [TERBUTALINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute cholecystitis; Aneurysm (Right popliteal aneurysm); Aneurysm (Asymptomatic left popliteal aneurysm operated on (October 2018).); Aortic sclerosis; Arterial hypertension; Cholangitis; Cholecystectomy; Chronic kidney disease stage 3; Circulatory failure (short graft due to hemodynamic failure (August 2015)); COPD; Dyslipidemia; Ex-smoker; Femoropopliteal artery bypass; Hypertensive heart disease, unspecified (with intermediate Left Ventricular Ejection Fraction (LVEF) 45%. Slightly dilated Left atrial (LA)); Nephrectomy (related to renal cell carcinoma); Pneumonia (in right lower lobe); Pneumonia (in left lower lobe); Prostatic hypertrophy (Grade II); Renal cell carcinoma; Urticarial symptom (Penicillin)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021588571

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-870254. A 90-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 04Mar2021 (Batch/Lot Number: EP2163) as 1ST DOSE, 0.3 mL, SINGLE DOSE for covid-19 immunisation. Medical history included urticarial reaction (Penicillin), ex-smoker, hypertensive heart disease (with intermediate Left Ventricular Ejection Fraction (LVEF) 45%. Slightly dilated Left atrial (LA)), aortic sclerosis, chronic obstructive pulmonary disease (COPD), stage III chronic kidney disease, pneumonia in left lower lobe from Jun2016, pneumonia in right lower lobe from Aug2016, left clear cell renal cell carcinoma, nephrectomy from Sep2009 (related to renal cell carcinoma), grade II prostatic hypertrophy, right popliteal aneurysm, femoropopliteal bypass from Oct2014, asymptomatic left popliteal aneurysm and was operated in Oct2018, cholangitis from Nov2011, acute cholecystitis, cholecystectomy from Jan2012, arterial hypertension, dyslipidemia, and short graft from Aug2016 due to hemodynamic failure. Concomitant medications included acetylsalicylic acid (ADIRO); indapamide; rosuvastatin calcium (PROVISACOR); dutasteride, tamsulosin hydrochloride (DUODART); ipratropium bromide monohydrate, salbutamol sulfate (COMBIPRASAL); budesonide; triamcinolone acetonide (NASACORT); carbocisteine lysine (PECTOX LISINA); calcitriol (ROCALTROL); and terbutaline (TERBASMIN [TERBUTALINE]). On 23Mar2021, the patient experienced cardio-respiratory arrest which led to fatal outcome. It was further reported that death was sudden and unexpected, although he presented clinical deterioration and his death could be feasible. The patient died on an 23Mar2021. It was not reported if an autopsy was performed. Causal assessment: Sudden death 19 days after receiving 1st dose of vaccine. Multiple cardiovascular risk factors. The role of the vaccine in death cannot be confirmed or ruled out. No follow-up attempts are possible. No information is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1378706 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-11-26
Onset:2021-05-04
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain, Apathy, Back pain, Blood pressure increased, Computerised tomogram abdomen, Fatigue, Hepatic haemorrhage, Hyperhidrosis, Malaise, Pallor, Post vaccination syndrome
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   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: Gastrointestinal stromal tumor
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210512; Test Name: Abdomen CT; Result Unstructured Data: Test Result:Abdominal CT with and without contrast; Comments: Abdominal CT with and without contrast: liver metastasis in V with data of apparently active arterial contrast extravasation dependent on the right hepatic artery, which conditions moderate hemoperitoneum. Fill defect in the right hepatic artery as it passes through the vicinity of the metastasis. Significant increase in liver metastasis size compared to previous exploration (it has gone from 27 mm to 69 mm), with numerous foci of contrast extravasation in its interior and rupture to the peritoneum. Also enlargement of the retroperitoneal mass in the pancreatectomy bed, which pulls and invades the adjacent structures, including the right ureter, complete invasion of the inferior vana cava, main portal vein, splenic vein and previously formed collateral branches, with ischemia splenic and diminished spleen size.
CDC Split Type: ESPFIZER INC2021590791

Write-up: nonspecific malaise and a certain local (inflammatory); Uncommon nonspecific digestive symptoms (bloating, back pain, fatigue and apathy).; Uncommon nonspecific digestive symptoms (bloating, back pain, fatigue and apathy).; Uncommon nonspecific digestive symptoms (bloating, back pain, fatigue and apathy).; Uncommon nonspecific digestive symptoms (bloating, back pain, fatigue and apathy).; Crisis of abdominal pain, with great reaction of sweating, paleness, elevation of BP,; Crisis of abdominal pain, with great reaction of sweating, paleness, elevation of BP,; Crisis of abdominal pain, with great reaction of sweating, paleness, elevation of BP,; elevation of BP; Hepatic haemorrhage; Post vaccination syndrome; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB and received via Regulatory Authority ES-AEMPS-870818.A 35-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 04May2021 (Batch/Lot Number: EW6126) as 1ST DOSE, SINGLE for covid-19 immunisation; sunitinib malate (SUTENT), oral from 05Feb2021 (Batch/Lot Number: Unknown) to an unspecified date, at 60 mg, cyclic (2 times for week every 28 days) for an unspecified indication; bemiparin sodium (HIBOR), subcutaneous from 26Nov2020 (Batch/Lot Number: Unknown) to an unspecified date, at 1 DF, 1x/day for Mesenteric artery thrombosis. Medical history included Gastrointestinal stromal tumor from 2014 and ongoing. The patient''s concomitant medications were not reported. The patient previously took imatinib for gastrointestinal stromal tumour. He had Post vaccination syndrome on 04May2021.For 48 hours he had a nonspecific malaise and a certain local (inflammatory) reaction. On 08 and 09May2021,he experienced uncommon nonspecific digestive symptoms (bloating, back pain, fatigue and apathy).On 10May21,he experienced crisis of abdominal pain, with great reaction of sweating, paleness, elevation of BP, etc. On 11May2021 at dawn the table from the previous day is accentuated or repeated, valued by 112, evacuated in Ambulance12May2021 Hepatic embolization: abdominal aortogram and selective arteriography of the right hepatic artery are performed. Effective embolization.13May21 In spite of everything, the patient evolves erratically, being death.Tumor bleeding is described in FT among the warnings and complications of SUTENT.The patient underwent lab tests and procedures which included computerised tomogram abdomen: abdominal ct with and without contrast on 12May2021 Abdominal CT with and without contrast: liver metastasis in V with data of apparently active arterial contrast extravasation dependent on the right hepatic artery, which conditions moderate hemoperitoneum. Fill defect in the right hepatic artery as it passes through the vicinity of the metastasis. Significant increase in liver metastasis size compared to previous exploration (it has gone from 27 mm to 69 mm), with numerous foci of contrast extravasation in its interior and rupture to the peritoneum. Also enlargement of the retroperitoneal mass in the pancreatectomy bed, which pulls and invades the adjacent structures, including the right ureter, complete invasion of the inferior vana cava, main portal vein, splenic vein and previously formed collateral branches, with ischemia splenic and diminished spleen size. The action taken in response to the event(s) for sunitinib malate was not applicable , for bemiparin sodium was dose not changed. Outcome of Hepatic haemorrhage was fatal, of Post vaccination syndrome and malaise was recovered, others was unknown.The patient died on 13May2021.It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Lot/batch number was provided; Reported Cause(s) of Death: Tumour haemorrhage


VAERS ID: 1378707 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-16
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7015 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood count, Cerebral haemorrhage, Coagulation test, Computerised tomogram head
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 0
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: Gilbert''s syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210516; Test Name: blood count; Result Unstructured Data: Test Result:normal; Comments: Normal platelets; Test Date: 20210516; Test Name: coagulation; Result Unstructured Data: Test Result:normal; Test Date: 20210516; Test Name: Head CT; Result Unstructured Data: Test Result:left frontoparietal intraparenchymal hematoma with; Comments: left frontoparietal intraparenchymal hematoma with significant mass effect associated with a 9 mm midline deviation and signs of incipient uncal herniation.
CDC Split Type: ESPFIZER INC2021590828

Write-up: Cerebral hemorrhage; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB and received via Regulatory Authority ES-AEMPS-870825. A 75-years-old female patient received first dose of bnt162b2 (COMIRNATY) intramuscular on 05May2021 (Lot Number: EY7015) as 0.3ml single for covid-19 immunisation. Medical history included Gilbert''s disease, did not have high blood pressure, dyslipidemia, or diabetes mellitus. No data on cognitive impairment. The patient''s concomitant medications were not reported. She did not receive regular treatment. On 16May2021, patient woke up at 7:00 a.m., reporting weakness in the left arm and language disorder. Clinical progression. She was admitted to a hospital. Analytical: normal blood count and coagulation. Normal platelets. Head CT: left frontoparietal intraparenchymal hematoma with significant mass effect associated with a 9 mm midline deviation and signs of incipient uncal herniation. The Neurology Service dismisses intervention. At 10:45 a.m. neurological deterioration. Scan: GCS M2V1E1. respiratory stridor, with bilateral decerebrate responses to painful stimuli, without eye opening or sound emission. Very unreactive middle pupils. Palliative sedation was decided. She passes away at 4:30 PM on 16May2021. Clinical judgment: Spontaneous left frontoparietal intraparenchymal hemorrhage (cerebral hemorrhage). The patient died on 16May2021. It was not reported if an autopsy was performed. CAUSATION ASSESSMENT (SEFV algorithm): chronology compatible with the vaccine, there is no description in the technical data sheet. a causal relationship with the vaccine cannot be ruled out or confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebral hemorrhage


VAERS ID: 1378907 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-05-07
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Decreased appetite, Dysphagia, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   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: Adenocarcinoma of prostate (treated with radiotherapy and hormone therapy); Anxiety; Bronchogenic cyst; Dementia; Depression; Hormone therapy; Hypertension arterial; Infarct myocardial; Radiotherapy
Allergies:
Diagnostic Lab Data: Test Date: 20210507; Test Name: O2 saturation; Test Result: 78 %; Test Date: 20210510; Test Name: Covid-19 PCR test; Result Unstructured Data: Test Result:Positive, specific country variant
CDC Split Type: FRPFIZER INC2021628343

Write-up: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; oxygen saturation decreased; swallowing disorder; loss of appetite; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-2021059585. An 81-year-old male patient received BNT162B2 (COMIRNATY), dose 2 intramuscular, administered in arm left on 10Feb2021 (Batch/Lot Number: EJ6795) as 0.3 mL single dose and dose 1 via an unspecified route of administration on 20Jan2021 (Batch/Lot number was not reported) as single dose, both for COVID-19 immunisation. Medical history included myocardial infarction, hypertension arterial, bronchogenic cyst, anxiety, adenocarcinoma of prostate treated with radiotherapy and hormone therapy, dementia and depression, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced on 07May2021 appearance of symptoms of pulmonary decompensation with 78% saturation and neurological with absence, loss of appetite and swallowing disorder. Patient put on O2. On 10May2021 the patient tested positive to SARS-COV-2 PCR test (specific country variant). The patient died on 12May2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Covid-19 respiratory infection


VAERS ID: 1378957 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH E51688 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia, SARS-CoV-2 test
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FENBID; LAXIDO; LACRI-LUBE; MOMETASONE; CETIRIZINE; BISOPROLOL; CITALOPRAM; FOLIC ACID; FELODIPINE; BETAHISTINE; GLYCERYL TRINITRATE; CYANOCOBALAMIN; PARACETAMOL; LOSARTAN; LANSOPRAZOLE; CARBOMER; AMOXICILLIN; ISOSORBIDE MONONITRATE
Current Illness: Bedridden; Frailty; Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Abnormal loss of weight; Acute coronary syndrome; Aortic incompetence; Aortic regurgitation; Aortic stenosis; Basal cell carcinoma (Nodular.); Cataract extraction (And implant.); Chronic kidney disease stage 3; Circulatory collapse; Colon diverticulitis (On computerised tomography (CT) cologram.); Coronary artery bypass graft; Depressive disorder; Diverticular disease (Moderate at colonscopy.); Diverticular disease; Dizziness; Essential hypertension; Faecal occult blood positive; Fall (Accidental.); Foot pain; Gastrooesophageal reflux; Headache; Housebound; Hyperlipidaemia; Ischaemic heart disease; Knee osteoarthritis; Low mood; Melaena; Mitral regurgitation; Non ST segment elevation myocardial infarction (Thrombolysed, angiogram.); Non ST segment elevation myocardial infarction; Oedema; Phacoemulsification (Lens insertion prosthetic replacement.); Pleural effusion (Drained.); Recurrent urinary tract infection; Swelling of legs; Total knee replacement (Total prosthetic replacement of knee joint using cement.); Transient cerebral ischaemia (Affecting left side.); Unspecified cerebrovascular disease
Allergies:
Diagnostic Lab Data: Test Date: 20200628; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021619983

Write-up: Bronchopneumonia; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is GB-MHRA-ADR 25354606. An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 31Dec2020 (Batch/Lot Number: E51688) as 0.3 mL single dose for COVID-19 immunisation. Medical history included asthenia from 23Sep2020 and ongoing , living in residential institution from Jun2020 and ongoing , bedridden from Jun2020 and ongoing , depression from 01Jul2020 to an unknown date, fall (accidental) on 16Jun2020, headache from 29Apr2020 to an unknown date, basal cell carcinoma (nodular) from 04Oct2019 to an unknown date, dizziness from 27Sep2019 to an unknown date, oedema from 11Jun2019 to an unknown date, occult blood positive on 26Mar2019, abnormal loss of weight from 06Mar2019 to an unknown date, housebound from 19Feb2019 to an unknown date, depressed mood from 06Dec2018 to an unknown date, acute myocardial infarction from 01Dec2018, pain in extremity from 18Jan2018 to an unknown date, aortic stenosis from 22Aug2017 to an unknown date, aortic regurgitation from 22Aug2017, Mitral valve incompetence from 22Aug2017, Peripheral swelling from 07Aug2017, Diverticulitis from 04May2017, Diverticulum from 14Dec2015, Circulatory collapse from 14Mar2014, Cerebrovascular disorder from 01May2012, Chronic kidney disease from 11Jan2011, Osteoarthritis from 26Feb2003, Myocardial ischaemia from 16Jan2003, Urinary tract infection from 01Nov1999, Hyperlipidaemia from 18Jan1999, Essential hypertension from 1975, Aortic valve incompetence from an unknown to an unknown date, Pleural effusion (drained) from 24Nov2014 t0 16Feb2015, Coronary artery bypass on 05Nov2014, Acute myocardial infarction on 22Oct2014, Lens insertion prosthetic replacement on 08Feb2014, Acute coronary syndrome from 13Dec2012, Transient ischaemic attack (Affecting left side) from 01May2012, Coronary artery bypass on 27Dec2011, Acute myocardial infarction on 23Dec2011, cute myocardial infarction on 07Nov2011, Knee arthroplasty (Total prosthetic replacement of knee joint using cement) on 06Jul2011, Melaena on 25Sep2009, Diverticulum on 20Oct2008, Cataract operation (And implant) on 07Jul2001, Gastrooesophageal reflux disease from 16Feb1999. Concomitant medications included ibuprofen (FENBID) taken for an unspecified indication from an unspecified start date to 02Sep2020; macrogol 3350/potassium chloride/sodium bicarbonate/sodium chloride (LAXIDO) taken for an unspecified indication from an unspecified start date to 18Aug2020; mineral oil light/petrolatum/wool fat (LACRI-LUBE) taken for an unspecified indication, start and stop date were not reported; mometasone (MOMETASONE) taken for rash from an unspecified start date to 08Dec2020; cetirizine taken for rash from an unspecified start date to 11Jan2021; bisoprolol taken for an unspecified indication from an unspecified start date to 04Jan2021; citalopram taken for an unspecified indication from an unspecified start date to 04Jan2021; folic acid taken for an unspecified indication from an unspecified start date to 05Aug2020; felodipine taken for an unspecified indication from an unspecified start date to 04Jan2021; betahistine taken for an unspecified indication from an unspecified start date to 12Jun2020; glyceryl trinitrate taken for an unspecified indication from an unspecified start date to 11Jun2020; cyanocobalamin taken for an unspecified indication from an unspecified start date to 02Jun2020; paracetamol taken for an unspecified indication from an unspecified start date to 21Oct2020; losartan taken for an unspecified indication from an unspecified start date to 04Jan2021; lansoprazole taken for an unspecified indication from an unspecified start date to 04Jan2021; carbomer taken for an unspecified indication from an unspecified start date to 11Jan2021; amoxicillin taken for an unspecified indication from an unspecified start date to 13Jan2021; isosorbide mononitrate taken for an unspecified indication from an unspecified start date to 04Jan2021. The patient previously took nitrofurantoin and experienced vomiting on 02Jun2014, spironolactone and experienced nausea on 16Jan2014, tramadol hydrochloride and experienced circulatory collapse on09Jan2014, bendrofluazide and experienced adverse drug reaction on 20Dec2013, pravastin and experienced pain on 01Mar2013, indapamide and experienced dizziness, calcium channel blockers and experienced feeling abnormal on 01Mar2013, bisoprolol fumarate and ezperienced headache on 26Oct2012, felopine and experienced dizziness on 15Jan2009, atorvastatin and experienced adverse drug reaction on 29Aug2008, enalapril maleate an experienced headache on 27Jun2005, fenofibrate on 27May2005 and experienced fatigue, moxonidine on 04Apr2005 and experienced fatigue, lercanidipine hydrochloride and experienced dyspnoea on 14Feb2005, oxybutynin hydrochloride and experienced abdominal pain on 24Jan2005, labetalol hydrochloride and experienced headache on 20Dec2004, simvastatin and experienced alopecia on 27Sep2004, tolterodine tartrate an experienced abdominal distension on 27Sep2004, ramipril and experienced flushing on 26Mar2001, antibiotics and experienced Adverse drug reaction on 09Nov2000, bisoprolol fumarate and experienced fatigue 14Feb2000, doxazosin mesylate and experienced circulatory collapse on 17Dec1999, amlodipine besilate and experienced adverse drug reaction on 06Sep1999, atenolol and experienced disturbance in attention on 22Jul1999, lisinopril and experienced peripheral swelling on 19May1999, prochlorperazine maleate and experienced sedation on 07Oct1998, received bacillus clostridium tetani (tetanus vaccine) for immunization on 30Jun2013 . The patient experienced bronchopneumonia (fatal) on Jan2021. Therapeutic measures were taken as a result of the event and included treatment with antibiotics. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 28Jun2020. The patient died on 14Jan2021 at 21:50. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Bronchopneumonia


VAERS ID: 1379816 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock, Dyspnoea, Fibrin D dimer, Inappropriate schedule of product administration, Myocardial infarction, Platelet count, Platelet factor 4, Pulmonary oedema, SARS-CoV-2 test negative, Troponin T
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210417; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:Raised; Test Date: 202104; Test Name: Platelet count; Result Unstructured Data: Test Result:363; Comments: lowest platelet count after vaccine; Test Name: Platelet factor 4; Result Unstructured Data: Test Result:Anti-PF4 antibodies were not identified; Test Name: COVID-19 virus test; Test Result: Negative ; Test Name: Troponin T; Result Unstructured Data: Test Result:UNKNOWN
CDC Split Type: GBPFIZER INC2021620097

Write-up: Myocardial infarction; pulmonary oedema; cardiogenic shock; received the 2nd dose on 16Apr2021, 78 days from 1st dose; Increased shortness of breath; This is a spontaneous report received from a contactable physician from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202105251206554760-ONMNM, Safety Report Unique Identifier GB-MHRA-ADR 25355943. A 75-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as single dose at the age of 75-year-old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No additional medical history, that relates to previous venous or arterial thromboses. The patient had no previous reactions to medications, especially heparin or anticoagulants. The patient had not confirmed or suspected autoimmune or inflammatory disease, including vasculitis. No history of, or current, malignancy and intracranial malignancy. No concurrent or recent intracranial infections. No recent surgical or medical interventions to the central nervous system (including lumbar puncture). No recent trauma/head injury. The patient previously took heparin. Vaccine history included: bnt162b2 (COMIRNATY) dose 1 on 28Jan2021 for COVID-19 immunisation. On an unspecified date the patient experienced myocardial infarction (death, medically significant), pulmonary oedema (death, medically significant), cardiogenic shock (death, medically significant). On 17Apr2021 the patient experienced increased shortness of breath (death, medically significant). The patient received the 2nd dose on 16Apr2021, 78 days from 1st dose (non serious). The course of events was as follows: Patient attended emergency department (ED) with shortness of breath on 17Apr2021 and passed away cause of death noted as: cardiogenic shock, pulmonary oedema and myocardial infarction. The patient underwent lab tests and procedures which included: fibrin D dimer: raised on 17Apr2021, platelet count: 363 (lowest platelet count after vaccine) in Apr2021, platelet factor 4: anti-pf4 antibodies were not identified, Sars-cov-2 test: negative, troponin T: unknown. Patient has not tested positive for COVID-19 since having the vaccine. No haemorrhage was identified. The patient died on 18Apr2021. It was not reported if an autopsy was performed. The reporting physician assessed that this report related to possible blood clots or low platelet counts. No follow-up Information on batch/lot number cannot be obtained attempts are possible. No further information expected. ; Reported Cause(s) of Death: Cardiogenic shock; Myocardial infarction; Pulmonary oedema


VAERS ID: 1379820 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Cardiac hypertrophy, Dyspnoea, Inappropriate schedule of product administration, Myocardial infarction, Myocardial ischaemia, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (narrow), Other ischaemic heart disease (narrow), Respiratory failure (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   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: Medical History/Concurrent Conditions: Ischaemic heart disease; Stent placement
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021616872

Write-up: biventricular cardiac hypertrophy; ischaemic heart disease; cardiac arrest; shortness of breath; Myocardial infarction; inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202105261210127970-HQPOG, Safety report unique identifier GB-MHRA-ADR 25364108. A 75-year old male patient received his second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 14Apr2021 (Batch/Lot Number: ER1741) (at the age of 75-year old) as single dose for covid-19 immunisation. Medical history included Ischaemic heart disease with previous stenting. The patient received first dose of the same vaccine on 29Jan2021 (lot number EL0739). Relevant concomitant medications were not reported. In the evening of 14Apr2021 the patient developed sudden onset shortness of breath and had out of hospital cardiac arrest at 23:58. Resuscitation later stopped in ED. COVID-19 virus test was negative on 15Apr2021. The patient died on 15Apr2021. Post mortem conducted, causes of death were myocardial re-infarction, ischaemic heart disease, biventricular cardiac hypertrophy. Unlikely that patient''s death/MI is related to the vaccine but have reported the incident as it was on the same day as vaccine. No follow-up attempts are possible. No additional information expected.; Reported Cause(s) of Death: Myocardial re-infarction; Ischaemic heart disease; biventricular cardiac hypertrophy


VAERS ID: 1379821 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 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: 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: Overweight; Stroke
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021617745

Write-up: Death; This is a spontaneous report received from a contactable physician from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202105261244255230-8FTBU, Safety Report Unique Identifier GB-MHRA-ADR 25364305. A 64-year old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route of administration on 14May2021 (Batch/lot number EW4109) as single dose for Covid-19 immunization. relevant medical history included stroke in the past and very obese. The patient was found death at the toilet on 17May2021. A COVID-19 virus test performed on an unknown date was negative. Autopsy was not done. Cause of death was unknown. No follow-up attempts possible. No further information expected. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 1380008 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-05-09
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1B002A / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Encephalopathy, Nervous system disorder, Neuromyotonia, Sepsis, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Malignancy related conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 0
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: HKPFIZER INC2021639995

Write-up: ENCEPHALOPATHY; SEPSIS; SEVERE NEUROLOGICAL DEFICIT; ACS; DIFFUSE SUBARACHNOID HEMORRHAGE (SAH); This is a spontaneous report from a non-contactable healthcare professional (HCP) via department of health (Regulatory No: DH/21/ 2733) based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS001662), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via department of health. The regulatory authority report number is DH/21/ 2733. A 73-year-old female patient received 2nd dose of bnt162b2 (COMIRNATY; lot number: 1B002A) on 22Apr2021 via unknown route at single dose for COVID-19 immunization. The 1st dose was received on an unknown date for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. The patient experienced encephalopathy, Death 17 days after vaccination (09May2021). Provisional diagnoses were diffuse subarachnoid hemorrhage (SAH) with severe neurological deficit, acute coronary syndrome (ACS) and sepsis all on 09May2021. Diffuse SAH with severe neurological deficit, ACS and sepsis, encephalopathy, met the seriousness criterion of hospitalization occurred in 2021 and death. The patient died on 09May2021. It was unknown if autopsy was done. Causality assessment was reported as possible per reporter and per company (BioNtech SE). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: ENCEPHALOPATHY; SEVERE NEUROLOGICAL DEFICIT; SEPSIS; ACS; DIFFUSE SAH


VAERS ID: 1380063 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-03-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, 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: 2021-03-01
   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: CORDARONE; TULIP [SIMVASTATIN]; FURSEMID [FUROSEMIDE]; COUPET; LANTUS; OLICARD; ACIPAN; CO DALNEVA; KALINOR [CITRIC ACID;POTASSIUM BICARBONATE;POTASSIUM CITRATE]; CONCOR COR; GLUCOPHAGE [METFORMIN HYDROCHLORIDE]; PREDUCTAL; MARTEFARIN
Current Illness: Arterial hypertension; Atherosclerosis; Atrial fibrillation; Diabetes mellitus; Diverticula of colon; Gastritis chronic; Gastroduodenitis; Hypertensive cardiomyopathy; Lipid metabolism disorder NOS; Mitral valve disease
Preexisting Conditions: Medical History/Concurrent Conditions: Edema pulmonary; Post MI; Respiratory insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210301; Test Name: CT of the abdomen; Result Unstructured Data: Test Result:unknown results
CDC Split Type: HRPFIZER INC2021589070

Write-up: Death sudden/Collapsed and died after examination; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [Regulatory authority number HR-HALMED-300047566]. An 83-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 26Feb2021 (Batch/Lot Number: EP9598) as 1st dose, 0.3 mL, single for COVID-19 immunization. Ongoing medical history included hypertensive cardiomyopathy, mitral valve disease, diverticula of colon, atherosclerosis, gastroduodenitis, chronic gastritis, diabetes mellitus, dysfunctions of lipoprotein metabolism, arterial hypertension and atrial fibrillation. The patient also had pulmonary oedema, post myocardial infarction (MI) and respiratory insufficiency from Nov2020 to an unknown date. Concomitant medications included pantoprazole sodium sesquihydrate (ACIPAN) taken for chronic gastritis from unknown therapy dates; and amiodarone hydrochloride (CORDARONE), simvastatin (TULIP), furosemide (FURSEMID), rosuvastatin calcium (COUPET), insulin glargine (LANTUS), isosorbide mononitrate (OLICARD), amlodipine besilate, indapamide, perindopril erbumine (CO DALNEVA), citric acid, potassium bicarbonate, potassium citrate (KALINOR), bisoprolol fumarate (CONCOR COR), metformin hydrochloride (GLUCOPHAGE), trimetazidine hydrochloride (PREDUCTAL) and warfarin sodium (MARTEFARIN) all taken unspecified indications and therapy dates. It was reported that the patient was called for a second dose of the vaccine and it was learned from their son that the patient had died. It was narrated that the patient went for an earlier scheduled CT of the abdomen (unknown results) on 01Mar2021 and after the examination he collapsed and died (death sudden). It was not reported if an autopsy was performed. Health Authority Comment: 13May2021: The reporter was requested to provide follow-up information on the case including autopsy report, death cause, relevant hospitalization data. 14May2021: Follow-up information was received containing only data on previous hospitalization / diagnostic procedures, medical conditions / history and medication list (data from 2020). The reporter did not receive any information from the patient''s family on the cause of death or information if the autopsy has been made. Comirnaty: Regulatory Authority/ Health Authority / Unassessable/Unclassifiable. Causality assessment from the Regulatory Authority meeting is still awaited. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Collapsed and died after examination


VAERS ID: 1380067 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-07
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: 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: 2021-05-07
   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: SIOFOR; TENOX [AMLODIPINE MALEATE]; TRITAZIDE; TRICOR [FENOFIBRATE]; COUPET; CONCOR COR
Current Illness: Diabetes mellitus; Hyperlipidemia; Hypertonia (hypertonia arterialis)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRPFIZER INC2021630142

Write-up: death / died suddenly; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the ERegulatory Authority-WEB (HR-HALMED-300047965). A 67-year-old male patient received bnt162b2 (COMIRNATY) intramuscular on 29Apr2021 (Batch/Lot Number: EX3599) at 0.3 mL single (unknown if first or second dose) for COVID-19 immunisation. Relevant medical history included ongoing hyperlipidaemia, ongoing diabetes mellitus and ongoing hypertonia arterialis. Concomitant medications included metformin hydrochloride (SIOFOR); amlodipine maleate (TENOX); hydrochlorothiazide/ramipril (TRITAZIDE); fenofibrate (TRICOR); rosuvastatin calcium (COUPET); bisoprolol fumarate (CONCOR COR); all taken for unspecified indications, start and stop dates were not reported. On 07May2021, the patient died suddenly. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: death / died suddenly


VAERS ID: 1380069 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-21
Onset:2021-02-27
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Computerised tomogram head, Facial paresis, Hemianopia homonymous, Hemiparesis, Ischaemic stroke, SARS-CoV-2 test
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   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: MIRZATEN; ZYLLT; NEO FERRO FOLGAMMA; ATORVASTATIN TEVA; CLEXANE; RIVOTRIL; KVENTIAX; KVENTIAX; PANTOPRAZOL 1A PHARMA; LATANOPROST PFIZER; MEMORIL [PIRACETAM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm; Alcohol dependence syndrome; Atherosclerosis; Carotid artery occlusion; Hyperlipidaemia; Hypertension; Mental deterioration; Percutaneous coronary intervention; Thrombosis
Allergies:
Diagnostic Lab Data: Test Date: 20210227; Test Name: Chest X-ray; Result Unstructured Data: Test Result:unspecified infiltrations; Test Date: 20210227; Test Name: Brain CT; Result Unstructured Data: Test Result:hemorrhage excluded; Comments: only known carotid artery occlusion was seen on the left side; Test Date: 20210228; Test Name: Brain CT; Result Unstructured Data: Test Result:extensive ischemic lesion; Comments: at the area of middle cerebral artery right side; Test Date: 20210308; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210308; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021628076

Write-up: Ischemic stroke; left sided central facial paresis; homonym hemianopia; hemiparesis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-343121. A 68-years-old female patient received BNT162B2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 21Feb2021 (Batch/Lot Number: EP2163) as 0.3 mL, single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, mental impairment from an unknown date and unknown if ongoing, thrombosis from Aug2020 to an unknown date, arteriosclerosis from an unknown date and unknown if ongoing, percutaneous coronary intervention from 2007 to an unknown date, alcoholism from an unknown date and unknown if ongoing, carotid artery occlusion from 2016 to an unknown date, aortic aneurysm from Aug2020 to an unknown date, hyperlipidaemia from an unknown date and unknown if ongoing. The patient received BNT162B2 (COMIRNATY), dose 1, on 31Jan2021 (Batch/Lot Number: EJ6134) for covid-19 immunisation. Concomitant medications included mirtazapine (MIRZATEN) taken for an unspecified indication, start and stop date were not reported; clopidogrel bisulfate (ZYLLT) taken for an unspecified indication, start and stop date were not reported; ferrous sulfate, folic acid (NEO FERRO FOLGAMMA) taken for an unspecified indication, start and stop date were not reported; atorvastatin calcium (ATORVASTATIN TEVA) taken for an unspecified indication, start and stop date were not reported; enoxaparin sodium (CLEXANE) taken for an unspecified indication, start and stop date were not reported; clonazepam (RIVOTRIL) taken for an unspecified indication, start and stop date were not reported; quetiapine fumarate (KVENTIAX) taken for an unspecified indication, start and stop date were not reported; quetiapine fumarate (KVENTIAX) taken for an unspecified indication, start and stop date were not reported; pantoprazole sodium sesquihydrate (PANTOPRAZOL 1A PHARMA) taken for an unspecified indication, start and stop date were not reported; latanoprost (LATANOPROST PFIZER) taken for an unspecified indication, start and stop date were not reported; piracetam (MEMORIL [PIRACETAM]) taken for an unspecified indication, start and stop date were not reported. On 27Feb2021 the patient experienced right hemispheric symptoms. Hemorrhage was excluded on brain CT, only known carotid artery occlusion was seen on the left side. Chest X-ray showed unspecified infiltrations, antibiotic therapy was started. On 28Feb2021, brain CT showed extensive ischemic lesion on the right side of the middle cerebral artery. The patient received clopidogrel, LMWH and fluids. On 03Mar2021, the patient''s roommate tested positive for COVID-19, the patient was seperated. On 08Mar2021, after two negative COVID-19 PCR tests, the patient was taken back to neurology, her condition improved and she was discharged on 16Mar2021 with homonym hemianopia, left sided central facial paresis and hemiparesis. On 25Mar2021 at 16:30, the patient died due to the ischemic stroke. Autopsy was not done. Outcome of the other events at the time of death was unknown. Reporters comment: Ischemic stroke occurred 6 days after, and the patient died 32 days after Comirnaty vaccination. Autopsy was not done. The causal relationship between the event and Comirnaty is considered unlikely. The case is serious due to fatal outcome.; Sender''s Comments: Based on the current available information, the event Ischemic stroke is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. Medical history of hypertension, arteriosclerosis, alcoholism , aortic aneurysm, and hyperlipidaemia may provide explanations for the event.; Reported Cause(s) of Death: ischemic stroke


VAERS ID: 1380070 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-27
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 10
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: Adenocarcinoma of lung stage IV (patient was under oncological treatment); Femoropopliteal artery bypass; Hypertension; Lung neoplasm surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: Chest CT; Result Unstructured Data: Test Result:not typicial for pneumonia; Test Date: 20210427; Test Name: COVID-19 rapid POC test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021628079

Write-up: COVID-19 pneumonia; COVID-19 rapid POC test positive; drug ineffective; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-344221. A 66-years-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 10Apr2021 (Batch/Lot number was not reported) as 1st dose, 0.3 mL, single for covid-19 immunisation. Medical history included peripheral artery bypass from an unknown date and unknown if ongoing, lung adenocarcinoma stage iv from an unknown date and unknown if ongoing (patient was under oncological treatment), lung neoplasm surgery from 2016 to an unknown date, hypertension from an unknown date and unknown if ongoing. On 27Apr2021 the patient was hospitalized due to fever, dyspnoea and positive COVID-19 rapid test. Chest CT was not typical for COVID-19 pneumonia. Antiviral and antibiotic therapy was started. His condition initially stabilized, then his inflammatory parameters increased, and his oxygenation deteriorated. Due to deteriorating respiratory mechanics and deteriorating state of consciousness, mechanical ventilation was considered, but they could not properly connect a mechanical ventilator to the patients tracheostoma. His respiratory insufficiency progressed. The tracheostoma was replaced with endotracheal tube. The patient had circulatory disturbances, he became bradycardic, advanced level resuscitation failed, the patient died on 07May2021 at 20:56. The patient underwent lab tests and procedures which included computerised tomogram thorax not typicial for pneumonia on 27Apr2021, sars-cov-2 test: positive on 27Apr2021. The patient died on 07May2021. It was not reported if an autopsy was performed. COVID-19 rapid test became positive 17 days after, and the patient died 27 days after the first dose of COMIRNATY due to COVID-19 pneumonia. Immunity has not developed after the first dose. The case is serious due to hospitalization and fatal outcome. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19; Drug ineffective


VAERS ID: 1380071 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-04-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Atypical pneumonia, Cardiomegaly, Chest X-ray, Chronic obstructive pulmonary disease, Computerised tomogram thorax, Death, Echocardiogram, Fibrin D dimer, Hypotension, Hypotonia, Oedema peripheral, Troponin I
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   Days after onset: 14
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: Asthma bronchial; COPD; Dyspnoea (before vaccination); Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210424; Test Name: Chest X-ray; Result Unstructured Data: Test Result:atypical pneumonia, cardiomegaly; Test Date: 20210426; Test Name: Chest CT; Result Unstructured Data: Test Result:severe coronary calcification; Comments: calcareous mitral valve and aortic valve / stenosis ?, dilated left ventricle; Test Date: 20210424; Test Name: Echocardiography; Result Unstructured Data: Test Result:mitral valve insufficiency, aortic stenosis; Comments: suspicion of NSTEMI; Test Date: 20210505; Test Name: Echocardiography; Result Unstructured Data: Test Result:anterior wall akinesia in addition to diffuse; Comments: anterior wall akinesia in addition to diffuse hypokinesis. Left ventricular function showed further deterioration, elevated right ventricular pressure was still measurable and significant aortic stenosis was considered. The echocardiographic examination and the increase in troponin were suggestive of NSTEMI.; Test Date: 20210424; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:$g10000; Test Date: 20210424; Test Name: Troponin I; Result Unstructured Data: Test Result:1660; Test Date: 20210505; Test Name: Troponin I; Result Unstructured Data: Test Result:increased
CDC Split Type: HUPFIZER INC2021628077

Write-up: death; increasing leg edema; hypotonic; hypotension; aortic dissection; atypical pneumonia; cardiomegaly; acute excerbation of COPD; This is a spontaneous report from a contactable other HCP downloaded from the Regulatory Authority-WEB HU-OGYI-344421. A 75-year-old male patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number ET6956), via intramuscular, on 24Apr2021 at 0.3 ml single dose in the right arm for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number EP2166), via intramuscular, on 20Mar2021 at 0.3 ml single dose for COVID-19 immunisation. Relevant medical history included chronic obstructive pulmonary disease (COPD), hypertension and asthma bronchial all from an unknown date and stopped on unknown date; and dyspnea appeared on 24Apr2021 (before vaccination). No relevant concomitant medications were provided. On 24Apr2021, before vaccination, the patient experienced dyspnoea, which resolved, then reoccurred again after vaccination. It was considered as acute excerbation of COPD. Chest X-ray was performed on 24Apr2021, atypical pneumonia and cardiomegaly were seen. Laboratory tests on 24Apr2021 showed Fibrin D dimer above 10000 and elevated Troponin I (1660). Echocardiography on 24Apr2021 showed mitral valve insufficiency, aortic stenosis, and suspicion of NSTEMI. Due to the patient''s dyspnoea, chest CT could only be performed on 26Apr2021, which showed severe coronary calcification, calcareous mitral valve and aortic valve, and possibly aorta stenosis, dilated left ventricle. Pulmonary embolism was excluded. Further examination of the patient was not possible due to his arbitrary leaving from hospital. One week after emission, on 05May2021, the patient experienced sudden dyspnoea and increasing leg edema. Repeated echocardiography revealed anterior wall akinesia in addition to diffuse hypokinesis. Left ventricular function showed further deterioration, elevated right ventricular pressure was still measurable and significant aortic stenosis was considered. The echocardiographic examination and the increase in troponin were suggestive of NSTEMI. On day 3 of treatment, the patient became hypotonic, which did not resolve after discontinuation of a previously adjusted ACE inhibitor and beta-blocker, and dobutamine was also initiated. Aortic dissection was considered in the setting of severe right shoulder pain as well as hypotension, however, this could not be verified due to the unstable condition of the patient. His hypotension did not resolve with pressor amine support, his condition deteriorated rapidly, and no further tests were possible to perform. Despite treatment, the patient died on 08May2021 at 19:20. The cause of death was not provided. It was unknown if an autopsy was performed. Sender Comment: The patient symptoms started on the day of COMIRNATY vaccination and died 14 days after. NSTEMI, exacerbation of COPD and presumably aortic dissection played role in the patient''s death. There is no information whether autopsy was done. 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 possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1380072 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-05-07
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Eastern Cooperative Oncology Group performance status, Neoplasm progression, SARS-CoV-2 test
SMQs:, Malignancy related conditions (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   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: Adenocarcinoma; Cachexia; Lung metastases; Lymphatic system neoplasm (Malignant neoplasm of lymph nodes of several regions); Metastasis; Ovarian cancer metastatic
Allergies:
Diagnostic Lab Data: Test Name: ECOG; Result Unstructured Data: Test Result:3-4; Test Date: 20210507; Test Name: COVID-19 rapid POC test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021628086

Write-up: death; This is as spontaneous report received from a contactable Healthcare Professional downloaded from the Regulatory Authority-WEB. The regulatory authority report number is HU-OGYI-344521. A 46-year-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (nucleoside modified)/Tozinameran (COMIRNATY) concentrate for dispersion for injection, strength: 1 dose (0.3 mL) containing 30 micrograms of COVID-19 mRNA Vaccine, intramuscularly, in left arm, batch number: EW4815 on 17Apr2021, at 46 years of age. No events occurred after vaccination. Medical history included multiple metastatic high-grade serous ovarian carcinoma. Malignant neoplasm of lymph nodes of several regions, secondary malignancy of lung, adenocarcinoma, pancreatic metastasis. From 22Jan2021, the size and number of the lymph nodes increased. From 03Feb2021, the patient was in hospice care. In addition to severe cachexia (from 2021), Oncology 3-4 performance status developed, followed by symptomatic therapy. The patient was admitted to hospital on 07May2021 in moribund condition and died that same day at 17:55. A COVID-19 rapid test performed on 07May2021 resulted negative. Sender Comment: The patient died in metastatic high-grade serous ovarian carcinoma 20 days after COMIRNATY vaccination. There is no information whether autopsy was done. The event and COMIRNATY vaccination are not related. The case is serious due to fatal outcome. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The patient''s demise is unrelated to BNT162B2 vaccine, being rather the fatal evolution of the underlying very advanced malignancy (ovarian carcinoma).; Reported Cause(s) of Death: Neoplasm progression


VAERS ID: 1380073 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   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: PERINDOPRIL; SIRDALUD; FURON [FUROSEMIDE]; VITAMIN D3; SKUDEXA; THEOSPIREX [THEOPHYLLINE]; FEMIFLO; KALDYUM; PANTOPRAZOLE
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 pneumonia; Hip dislocation; Kidney failure chronic; Multiple sclerosis; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210509; Test Name: COVID-19 antigen test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210509; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: Covid-19 v?rus; COVID-19 pneumonia; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-May-2021 and was forwarded to Moderna on 31-May-2021. This regulatory authority case was reported by a physician and describes the occurrence of SUSPECTED COVID-19 (Covid-19 v?rus) and COVID-19 PNEUMONIA (COVID-19 pneumonia) in a 72-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Multiple sclerosis, Kidney failure chronic, COVID-19 pneumonia, Suspected COVID-19 and Hip dislocation. Concurrent medical conditions included Hypertension. Concomitant products included PERINDOPRIL, TIZANIDINE HYDROCHLORIDE (SIRDALUD), FUROSEMIDE (FURON [FUROSEMIDE]), COLECALCIFEROL (VITAMIN D3), DEXKETOPROFEN TROMETAMOL, TRAMADOL HYDROCHLORIDE (SKUDEXA), THEOPHYLLINE (THEOSPIREX [THEOPHYLLINE]), FLUCONAZOLE (FEMIFLO), POTASSIUM CHLORIDE (KALDYUM) and PANTOPRAZOLE for an unknown indication. On 06-May-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced SUSPECTED COVID-19 (Covid-19 v?rus) (seriousness criterion death) and COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria death and medically significant). The patient died on 09-May-2021. The reported cause of death was COVID-19 pneumonia and Suspected COVID-19. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter considered SUSPECTED COVID-19 (Covid-19 v?rus) and COVID-19 PNEUMONIA (COVID-19 pneumonia) to be unlikely related. Treatment for the events were not provided. Company Comment: According to the SmPC of COVID-19 VACCINE MODERNA, immunity usually develops 14 days after the second dose of the vaccine. The patient started having Covid-19 symptoms 1 day after the second dose, therefore immunity may have not developed yet. Covid pneumonia was also confirmed. Based on the above, the causal relationship is unlikely between the adverse events and the suspected drug. The case is serious because the outcome was fatal. Further information is not expected.; Sender''s Comments: According to the SmPC of COVID-19 VACCINE MODERNA, immunity usually develops 14 days after the second dose of the vaccine. The patient started having Covid-19 symptoms 1 day after the second dose, therefore immunity may have not developed yet. Covid pneumonia was also confirmed. Based on the above, the causal relationship is unlikely between the adverse events and the suspected drug. The case is serious because the outcome was fatal. Further information is not expected.; Reported Cause(s) of Death: COVID-19 Pneumonia; Suspected COVID-19


VAERS ID: 1380074 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-04-04
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Neoplasm progression
SMQs:, Malignancy related conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 0
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: SANDOSTATIN LAR; TEMOZOLOMIDE ACCORD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cecal cancer; Endometrial adenocarcinoma; Hiatus hernia; Hypertension; Hysterectomy; Liver adenocarcinoma; Meningioma
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021628083

Write-up: Death/the adverse event as related to the patient''s primary diseases (cancer with metastases); This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is HU-OGYI-345421. A 78-year-old female patient received BNT162b2 (COMIRNATY), intramuscular, administered in left arm, on 18Mar2021 (Batch/Lot Number: EP2166) as 2nd single dose, at 0.3 ml, for COVID-19 immunisation. Medical history included cecal, liver and endometrial adenocarcinoma, hypertension, meningioma, hysterectomy and hiatus hernia. Concomitant medications included octreotide acetate (SANDOSTATIN LAR) from 25Mar2021, and temozolomide (TEMOZOLOMIDE ACCORD) from 24Feb2021. The first dose of BNT162b2 was administered on 25Feb2021. This case concerns the occurrence of death after BNT162b2 second injection. The patient was hospitalized on 29Mar2021 because of severe agranulocytosis and bleeding. The patient received antibiotics, GSF and thrombocyte transfusion. Her condition temporarily got better, but then it started to deteriorate. Later, pulmonary edema occurred. On 04Apr2021 at 9:00 the patient passed away. An autopsy was not performed. The event reported was ''death'' with no cause of death specified. Further information is not expected. Sender''s Comments: The reporter physician assessed the adverse event as related to the patient''s primary diseases (cancer with metastases), therefore the causal relationship is unlikely between the suspected drug and the event of death. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death/the adverse event as related to the patient''s primary diseases (cancer with metastases)


VAERS ID: 1380075 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-29
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Neoplasm progression
SMQs:, Malignancy related conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   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: Adenocarcinoma of prostate; Cachexia; Small cell carcinoma of the lung
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021628084

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-346021. A 85-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 12Apr2021 (Lot Number: EW9127) as 0.3 ml single for covid-19 immunisation. Medical history included small cell lung cancer from 2020, prostate cancer, cachexia (events were not ongoing). The patient''s concomitant medications were not reported. The patient was under chemotherapy. The patient died on 29Apr2021. An autopsy was not performed. The reporter considered the death to be related to the patient''s underlying diseases, autopsy was not considered necessary. Sender Comment: The 85 year-old patient died 17 days after Comirnaty vaccination. The reporter considered the death to be related to the patient''s underlying diseases, autopsy was not considered necessary. The causal relationship between the reported death and Comirnaty is considered unlikely. The case is serious due to fatal outcome. No follow-up attempts are needed. No further information is expected; Sender''s Comments: Based on the information currently available the event neoplasm progression resulting in patient''s death is attributed to underlying prostate cancer and assessed unrelated to BNT162B2 (COMIRNATY) vaccine.; Reported Cause(s) of Death: neoplasm progression


VAERS ID: 1380076 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-16
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19 pneumonia, Chest X-ray, Computerised tomogram thorax, SARS-CoV-2 test, SARS-CoV-2 test positive, Ultrasound abdomen
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   Days after onset: 13
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: Atrial fibrillation; Chronic renal insufficiency; Hypertension; Non-insulin-dependent diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: fever; Result Unstructured Data: Test Result:fever; Test Date: 20210316; Test Name: Chest X-ray; Result Unstructured Data: Test Result:fracture of VIII. - X. ribs left side; Comments: fracture of VIII. - X. ribs left side , and ifiltration showed on both sides; Test Date: 20210318; Test Name: Chest CT; Result Unstructured Data: Test Result:Lung parenchyma abnormalities; Comments: Lung parenchyma abnormalities suggestive of COVID 19 virus infection; Test Date: 20210316; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210316; Test Name: Ultrasound abdomen; Result Unstructured Data: Test Result:fluid in the left renal environment
CDC Split Type: HUPFIZER INC2021628080

Write-up: COVID-19 pneumonia; COVID-19 antigen test positive; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB HU-OGYI-346121. A 78-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number EJ6790), via intramuscular in the left arm, on 04Mar2021 at 0.3 ml single dose for COVID-19 immunisation. Relevant medical history included non-insulin-dependent diabetes mellitus, chronic renal insufficiency, atrial fibrillation, and hypertension all from an unknown date and no longer ongoing. No relevant concomitant medications were provided. On 16Mar2021, the patient COVID-19 antigen test became positive. He was admitted to hospital due to increasing dyspnoea, fever, general deterioration, and weakness. He fell several times in his home. On 16Mar2021, chest X-ray showed fracture of VIII. - X. ribs on left side and infiltration on both sides while abdominal ultrasound confirmed fluid in the left renal environment, raised the possibility of renal congestion, for which abdominal and pelvic CT was requested, in which abdominal parenchymal organ injury, free abdominal fluid was not confirmed. Due to traumatic injury, no anticoagulant therapy was used. On 18Mar2021, chest CT showed pulmonary parenchymal abnormalities suggestive of COVID 19, which caused 30% parenchymal involvement. The patient was infused. Parenteral dexamethasone and oral antiviral therapy were initiated, parenteral diuretics were added. Oxygen supplementation was used at high flow. During observations, in addition to the high-level therapy used, his condition gradually progressed. On 29Mar2021 at 04:40 a.m., the patient died among the symptoms of cardiorespiratory insufficiency. Autopsy was not considered necessary. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19 antigen test positive


VAERS ID: 1380077 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-09
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   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: Atrial fibrillation; Dementia; Hypertension; Hyperthyroidism; Insulin dependent diabetic; Struma nodosa
Allergies:
Diagnostic Lab Data: Test Date: 20210309; Test Name: SARS-CoV-2 PCR test positive; Test Result: Positive
CDC Split Type: HUPFIZER INC2021628091

Write-up: COVID-19 PCR test positive; death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB: HU-OGYI-348021. A 77-year-old female patient received the first dose of BNT162B2 (Comirnaty, batch/lot number: EJ6790) intramuscularly in the left arm on 03Mar2021 at 8:34 a.m at 0.3 mL single for COVID-19 immunization. Medical history included hyperthyroidism, struma nodosa, insulin dependent diabetes mellitus, hypertension, atrial fibrillation and dementia. The patient was treated in Cardiology until 31Jan2021 due to progressive effort intolerance, dyspnoea, and swelling of feet. The patient was admitted to the Psychiatric Department on 08Feb2021 for examination and medication adjustment, she had not had any psychiatric treatment or examination before. Internal medicine examinations have also found the patient often extremely restless and desoriented. As a result of the drug adjustment, her condition improved. On 03Mar2021 the patient received BNT162B2, no events occurred after vaccination. But on 09Mar2021, before emittion, the patient''s PCR test became positive and her infection was confirmed. COVID-19 symptoms has not occurred during observations. Anxiolytic medication was stopped, but her condition was characterized by negativism, and antihypertensive drugs were also discontinued due to low tension. Laboratory abnormalities have been attempted to be normalized by parenteral medication. Despite the treatment according to the protocol, her condition progressed further, and the patient died among the symptoms of cardiorespiratory insufficiency on 22Mar2021 at 21:40 . Autopsy was not done, the patient''s death was considered to be related to her underlying diseases. Sender''s comment: COVID-19 PCR test became positive after 6 days, and the patient died 19 days after Comirnaty vaccination. Immunity has not developed after the first dose. Autopsy was not done, the patient''s death was considered to be related to her underlying diseases. The case is serious due to hospitalization and fatal outcome. No further information is expected.; Reported Cause(s) of Death: Death; COVID-19


VAERS ID: 1380078 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-12
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   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: HUPFIZER INC2021628096

Write-up: Death; This is as spontaneous report received from a contactable physician downloaded from the Regualtory Authority-WEB. The regulatory authority report number is HU-OGYI-349621. A 64-year-old female patient received BNT162B2 (COMIRNATY, lot/batch EX6537) as 0,3ml single dose, on 06May2021, intramuscularly in the left arm for Covid-19 immunization. On 12May2021, the patient passed away. No other information was provided such as medical or concomitant drugs. It was unknown if an autopsy was performed. Sender''s Comments: Due to unsuccessful follow-up and lack of information, the case cannot be assessed, but is serious because the outcome was fatal. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1380079 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-04-01
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Chest X-ray, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 14
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: COVID-19; COVID-19 pneumonia; Glaucoma; Hypertension; Kidney failure chronic; NIDDM; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Confirmed Covid-19 pneumonia
CDC Split Type: HUPFIZER INC2021628095

Write-up: COVID-19 pneumonia; COVID-19; drug ineffective; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-349921. This spontaneous, serious case was reported on 13May2021 by a physician via the national competent authority for vaccines and concerns the occurrence of Covid-19 infection and pneumonia resulting in death after COMIRNATY injection for active immunization to prevent COVID-19. An 84-year old female patient received her first dose of BNT162B2 (COMIRNATY) intramuscularly on 20Mar2021 (batch/Lot number ET1831) at 0.3 mL single for Covid-19 immunization. Relevant medical history included hypertension, NIDDM, chronic kidney failure, osteoporosis, glaucoma, Covid-19 and Covid-19 pneumonia. Concomitant medications were not reported. The patient was admitted in the hospital on 13Apr2021 because she has been experiencing coughing and breathing difficulty for the last 3-4 days. Chest X-ray confirmed Covid-19 pneumonia. The patient had to be intubated because her oxygen saturation worsened and had tachypnea. Despite the therapy, the patient passed away on 15Apr2021 at 22:18 due to ARDS, multiple organ failure and tissue hypoxia caused by the Covid-19 infection. The case was investigated by the national competent authority for vaccines, the investigator did not find any irregularities regarding the transportation and storage of the vaccine. Sender Comment: As the patient got infected with Covid-19 after the first dose, immunity may have not developed yet, therefore the causal relationship is unlikely between the suspected drug and the adverse event. The investigator via the national competent authority for vaccines also assessed the events as not related to the vaccine. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19; Covid-19 pneumonia


VAERS ID: 1380097 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Death, Ischaemia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   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: ITJNJFOC20210606910

Write-up: DEATH; ISCHEMIA; DEEP COMA; This spontaneous report received from a consumer via a company representative concerned a 68 year old male unknown ethnicity and race. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 24-MAY-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 02-JUN-2021, the patient experienced ischemia and went in deep coma. On 03-JUN-2021, the patient died. He died from 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. The patient died on 03-JUN-2021, had not recovered from deep coma, and the outcome of ischemia was not reported. This report was serious (Death, and Life Threatening). This case, from the same reporter is linked to 20210606849.; Sender''s Comments: V0: 20210606910-covid-19 vaccine ad26.cov2.s-Death, Ischemia, Deep coma. This event(s) is considered un-assessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1380108 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute pulmonary oedema, Alanine aminotransferase, Amylase, Aspartate aminotransferase, Atrial natriuretic peptide, Azotaemia, Blister, Blood bilirubin, Blood calcium, Blood creatine phosphokinase, Blood creatine phosphokinase MM, Blood creatinine, Blood fibrinogen, Blood potassium, C-reactive protein, Diabetes mellitus management, Ecchymosis, Electrocardiogram, Fibrin D dimer, Full blood count, Gamma-glutamyltransferase, Lipase increased, Myoglobin blood, Necrotising fasciitis, Oedema, Pain in extremity, Procalcitonin, Protein albumin ratio, Prothrombin time, SARS-CoV-2 test, Subcutaneous emphysema, Troponin, Ultrasound scan
SMQs:, Acute renal failure (narrow), Cardiac failure (narrow), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), 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: 2021-03-07
   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: ZYLORIC; LERCADIP [LERCANIDIPINE]; TARDYFER; PANTORC; ELIQUIS; ATENOLOLO; TOTALIP; MACULAR; PROSTAMOL [SERENOA REPENS]
Current Illness: Benign prostatic hyperplasia; Hyperplasia adrenal cortex; Pancreatitis chronic
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis (coronary and aortic); Laparotomy
Allergies:
Diagnostic Lab Data: Test Date: 20210307; Test Name: APTT; Result Unstructured Data: Test Result:39,3; Test Name: ALT/GPT; Result Unstructured Data: Test Result:unknown results; Test Name: alpha amylase; Result Unstructured Data: Test Result:unknown results; Test Date: 20210307; Test Name: SGOT; Result Unstructured Data: Test Result:149; Test Name: enzyme natriuretic; Result Unstructured Data: Test Result:unknown results; Test Date: 20210307; Test Name: Azotaemia; Test Result: 59 mg; Test Name: total and fractionated bilirubin; Result Unstructured Data: Test Result:unknown results; Test Name: total bilirubin; Result Unstructured Data: Test Result:unknown results; Test Name: total calcium; Result Unstructured Data: Test Result:unknown results; Test Name: serum CPK; Result Unstructured Data: Test Result:unknown results; Test Date: 20210307; Test Name: Creatine kinase MM; Test Result: 65.52 ng; Test Name: serum creatinine; Result Unstructured Data: Test Result:unknown results; Test Name: functional fibrinogen; Result Unstructured Data: Test Result:unknown results; Test Name: serum potassium; Result Unstructured Data: Test Result:unknown results; Test Name: c-reactive protein; Result Unstructured Data: Test Result:unknown results; Test Name: glycemia; Result Unstructured Data: Test Result:unknown results; Test Name: ECG; Result Unstructured Data: Test Result:unknown results; Test Date: 20210307; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:unknown results; Test Name: complete blood count; Result Unstructured Data: Test Result:unknown results; Test Name: Gamma-Glutamyl Transferase; Result Unstructured Data: Test Result:unknown results; Test Name: lipasemia; Result Unstructured Data: Test Result:unknown results; Test Date: 20210307; Test Name: Myoglobin blood; Test Result: 17.358 ng; Test Name: procalcitonin; Result Unstructured Data: Test Result:unknown results; Test Name: serum protein; Result Unstructured Data: Test Result:unknown results; Test Name: prothrombin time; Result Unstructured Data: Test Result:unknown results; Test Name: rapid swab; Test Result: Negative ; Test Name: troponin; Result Unstructured Data: Test Result:unknown results; Test Name: arterial or venous limb/district ultrasound; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC2021628321

Write-up: Subcutaneous emphysema; acute bilateral pulmonary edema; Pain in arm; Oedema/hard edema of the limb; Necrotising fasciitis; ecchymotic streaks; replaced by water blisters; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number IT-MINISAL02-716695. An 81-year-old patient of an unspecified gender received first dose of BNT162B2 (COMIRNATY), intramuscular, administered in deltoid right on 05Mar2021 at 11:37 (Batch/Lot Number: EP2166; Expiration Date: 31May2021) as single dose for COVID-19 immunisation. Medical history included ongoing pancreatitis chronic, laparotomy, arteriosclerosis (coronary and aortic), ongoing benign prostatic hyperplasia and ongoing hyperplasia adrenal cortex. Concomitant medications included allopurinol (ZYLORIC, formulation: tablet, strength: 300 mg); lercanidipine (LERCADIP, formulation: film-coated tablet, strength: 20 mg); ferrous sulfate (TARDYFER, formulation: prolonged-release tablet, strength: 80 mg); pantoprazole sodium sesquihydrate (PANTORC, formulation: gastro-resistant tablet, strength: 20 mg); apixaban (ELIQUIS, formulation: film-coated tablet, strength: 5 mg); atenolol (formulation: film-coated tablet, strength: 100 mg); atorvastatin calcium (TOTALIP, formulation: film-coated tablet, strength: 20 mg); ascorbic acid/cupric oxide/tocopheryl acid succinate/xantofyl/zeaxanthin/zinc oxide (MACULAR) and serenoa repens (PROSTAMOL), all concomitants were taken for an unspecified indication, start and stop date were not reported. On 07Mar2021, the patient experienced subcutaneous emphysema, acute bilateral pulmonary edema, pain in arm, oedema and necrotising fasciitis. The evets were serious (fatal). Clinical course was reported as follows: on 07Mar2021 appearance of pain in the right arm. As the hours passed, the pain extended to the whole limb and was accompanied by the appearance of ecchymotic streaks then replaced by water blisters some of which opened upon arrival in the Emergency Department. Physical examination: adverse reactions except for the presence of water blisters dorsal surface elbows and third inferomedial arm, some already de-epithelialized with hard edema of the limb, poorly assessable arterial pulses. The patient underwent lab tests and procedures which included ALT/GPT, alpha amylase, enzyme natriuretic, total and fractionated bilirubin, total calcium, serum CPK, serum creatinine, functional fibrinogen, serum potassium, c-reactive protein, glycemia, ECG, complete blood count, Gamma-Glutamyl Transferase, lipasemia, procalcitonin, serum protein, prothrombin time, troponin and arterial or venous limb/district ultrasound, all on an unspecified date and unknown results, SARS-COV-2 test (rapid swab): negative on an unspecified date; APTT: 39,3, SGOT:149, azotaemia (10-50): 59 mg, Creatine kinase MM: 65.52 ng, Fibrin D dimer: unknown results, myoglobin blood (25-72): 17.358 ng, all on 07Mar2021. Therapeutic measures were taken as a result of the events and included treatment with sodium chloride 0.9%, PANTORC IV 40 mg (1FL in drip), arthrosylene 160 mg/2ml (1fl in drip), URBASON IV 40 mg (1fl in 100 cc of physiological solution), trimeton 10 mg/1 ml (1 fl intramuscular), MERREM 1000 mg (1 fl in 500 cc), VANCOTEX 1 g (1 fl IV), BENTELAN 4mg/2ml (1 fl IV). The patient died on 07Mar2021. An autopsy was performed, and the results were reported as follows: Anatomo-pathological report dated 09Mar2021, acute bilateral pulmonary edema in patients with morphological signs compatible with necrotizing fasciitis and vast subcutaneous emphysema of the upper limb and right hemithorax. Diffluent spleen and kidney as in initial shock stage. Hepatomegaly (liver weight 2400g), and chronic liver stasis in the second stage. Chronic pancreatitis. Non-stenosing calcific atherosclerosis of the coronary vessels and complicated aortic atherosclerosis in the abdominal area. Benign prostatic hyperplasia. Column hypertrophy of the bladder, adrenal cortical hyperplasia. Outcomes of laparotomy surgery. Multiple samples were taken for histological investigation. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Subcutaneous emphysema; Pain in arm; Necrotising fasciitis; Autopsy-determined Cause(s) of Death: Acute pulmonary oedema


VAERS ID: 1380113 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6327 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Death, Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ENOXAPARIN; OMEPRAZOLE; ENALAPRIL; SERTRALINE; PLASIL [METOCLOPRAMIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aphasia motor; Bedridden; Bladder catheterisation; Enteral nutrition (PEG); Haemorrhagic stroke (with residual deficit swallowing, and loss of sphincter control); Hemiparesis (right); Tracheostomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021590871

Write-up: lost lucidity, in sensory decay and comatose state; died; Vomiting and diarrhea; Vomiting and diarrhea; This is a spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-729014. A 82-year-old male patient received BNT162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 27Apr2021 15:45 (Batch/Lot Number: EW6327) (age at vaccination was 82 years) as single dose for COVID-19 immunisation. Medical history included bedridden, suffering from right hemiparesis and motor aphasia, following a haemorrhagic stroke which occurred on 16Jan2020, with residual deficit swallowing, and loss of sphincter control. Therefore he was a carrier of tracheostomy, PEG (for enteral nutrition) and bladder catheter. Despite the aforementioned neurological deficits he maintained a good lucidity and did not present psychic deficits. He had a good state of nutrition and hydration, with a good hydroelectrolytic balance. Concomitant medication(s) included enoxaparin (ENOXAPARIN), omeprazole (OMEPRAZOLE), enalapril (ENALAPRIL), sertraline (SERTRALINE), metoclopramide (PLASIL); indication, start and stop date were not reported. He also received antibiotics in cycles in occasion of bladder catheter replacements or bladder washes, however very rare. The patient experienced vomiting and diarrhea on 27Apr2021, resolved on an unspecified date in Apr2021 (resolved quickly); lost lucidity, in sensory decay and comatose state the late night in two days following the vaccination (29Apr2021), not resolved and then died on 29Apr2021. Clinical course: following the second dose of BNT162b2 vaccine administered on 27Apr2021 in the early afternoon, an episode of vomiting and diarrhea arose in the evening, without a feverish reaction, which resolved quickly. In the late night in two days following the vaccination the patient lost lucidity and the progressive sensory decay suggested to the cohabiting caregiver to request the intervention of 118 (Emergency call). The patient then arrived to the emergency room in a comatose state which was quickly followed by death. The reporter did not know what was the diagnosis described by the colleagues in the emergency room of the hospital, nor what was the cause of death declared for a regulatory authority purposes. No autopsy was performed. Reporter''s comments: The notification of the adverse events and the outcome reached me from the family members on 01May2021. No follow-up attempts possible. No further information expected. Information on lot number already obtained.; Reporter''s Comments: The notification of the adverse events and the outcome reached me from the family members on 01May2021; Reported Cause(s) of Death: unknown


VAERS ID: 1380181 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-04-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, C-reactive protein, Culture, Fibrin D dimer, Muscle enzyme, Myocardial infarction, Procalcitonin, Septic shock, Syncope, Thrombocytopenia, Troponin, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Toxic-septic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 5
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: Diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriovenous fistula; Chronic hemodialysis (with left proximal arteriovenous fistula); Coronary bypass (triple coronary artery bypass); Diabetic peripheral vascular disease; Hypertension; Percutaneous transluminal angioplasty; Toe amputation
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: Blood test; Result Unstructured Data: Test Result:positive for E.coli; Test Date: 20210420; Test Name: C-reactive protein; Result Unstructured Data: Test Result:1.20; Test Date: 20210420; Test Name: bronchial culture; Result Unstructured Data: Test Result:positive for Candida spp.; Test Date: 20210421; Test Name: D-dimers; Result Unstructured Data: Test Result:significantly altered; Test Date: 20210421; Test Name: muscular enzymes; Result Unstructured Data: Test Result:significantly altered; Test Date: 20210421; Test Name: procalcitonin; Result Unstructured Data: Test Result:significantly altered; Test Date: 20210420; Test Name: Platelets; Result Unstructured Data: Test Result:thrombocytopenia; Test Date: 20210421; Test Name: troponin; Result Unstructured Data: Test Result:significantly altered; Test Date: 20210330; Test Name: white blood cells; Result Unstructured Data: Test Result:5.540; Comments: /mm3; Test Date: 20210420; Test Name: white blood cells; Result Unstructured Data: Test Result:1.410; Comments: /mm3
CDC Split Type: ITPFIZER INC2021590835

Write-up: Septic shock; suspected myocardial infarction; syncope; thrombocytopenia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB IT-MINISAL02-731595. A 64-year-old male patient received first dose of BNT162B2 (COMIRNATY) Lot number EX0893, expiration date 31Jul2021, Intramuscular in right arm on 18Apr2021 09:30 at single dose for COVID-19 immunisation. Medical history included Diabetic peripheral vascular disease, triple coronary artery bypass, Hypertension, Toe amputation, Diabetes mellitus from 01Jan1980 to 25Apr2021, Chronic hemodialysis with left proximal arteriovenous fistula and Percutaneous transluminal angioplasty. Concomitant medication was not reported. The patient had Covid-19 vaccination on 18Apr2021, patient in good clinical condition also on 20Apr2021 (dialysis in the morning) then in the evening access to the emergency room for syncope, with subsequent hospitalization for suspected myocardial infarction and then resuscitation for septic shock; positive blood culture for E. coli, culture of bronchoaspirate positive for Candida spp on 20Apr2021 (rare). Died on 25Apr2021. Treatment received included In resuscitation room antibiotic therapy, intubated, supported by amines, treated with continuous dialysis (CVVH - Continuous Veno-Venous Hemofiltration). Lab data on 30Mar2021 white blood cells 5,540 / mm3; on 20Apr2021 white blood cells 1,410 / mm3 with thrombocytopenia CRP 1.20 mg / dL; From 21Apr2021 significant alteration of muscle enzymes, D-Dimer, procalcitonin and troponin. Reporter''s comments: Covid-19 vaccination on 18Apr2021, patient in good clinical condition also on 20Apr2021 (dialysis in the morning) then in the evening access to the emergency room for syncope, with subsequent hospitalization for suspected myocardial infarction and then resuscitation for septic shock; positive blood culture for E. coli, culture of bronchoaspirate positive for Candida spp on 20Apr2021 (rare). Died on 25Apr2021. Sender''s comments: 19May2021 Head of Pharmacovigilance requested detailed report with previous medical history. Asked if autopsy exam available. Waiting; Reporter''s Comments: Covid-19 vaccination on 18Apr2021, patient in good clinical condition also on 20Apr2021 (dialysis in the morning) then in the evening access to the emergency room for syncope, with subsequent hospitalization for suspected myocardial infarction and then resuscitation for septic shock; positive blood culture for E. coli, culture of bronchoaspirate positive for Candida spp. (rare). Died on 25Apr2021.; Reported Cause(s) of Death: Septic shock; suspected myocardial infarction


VAERS ID: 1380183 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7056 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Respiratory disorder
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: 2021-05-15
   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: LASIX [FUROSEMIDE]; DIAMICRON; CRESTOR; METFORMIN; VENITRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Drug allergy; Glaucoma; Hypertensive heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021590996

Write-up: cardio-circulatory arrest; respiratory deficit; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number IT-MINISAL02-731613. An 86-year-old male patient received the 2nd dose of BNT162b2 (COMIRNATY, Batch: EY7056, Expiry Date: 31Aug2021) via intramuscular route in the right shoulder on 12May2021 at 12:00 as a single dose for COVID-19 immunization. Medical history included hypertensive heart disease, diabetes, glaucoma and allergy to quinolone antibiotics. Concomitant medications included in home therapy with rosuvastatin (CRESTOR), furosemide (LASIX), metformin, glyceryl trinitrate(VENITRIN), and glicazide (DIAMICRON). The patient previously received the first dose of BNT162b2 on 21Apr2021 (Batch: EW2246, Expiry Date: Jul2021) as a single dose for COVID-19 immunization. On 15May2021 the patient entered the emergency room with respiratory deficit, CPR performed with cardiocirculatory arrest. The outcome of cardiocirculatory arrest was fatal, of respiratory deficit was unknown. The patient died on 15May2021. No autopsy was performed. Sender Comment: RLFV_17/05/21: lot, expiration date, administration 1st dose and any suspected adverse reaction; concomitant. pathologies and drugs, clinical report, possible autopsy. A regulatory authority: 19May20/21: dose, posology, indications of use and duration of therapy concomitant Drugs, clinical report Reporter comment: Patient enters the emergency room with respiratory deficit. Stops circulatory cardio; Reporter''s Comments: Patient enters the emergency room with respiratory deficit. Stops circulatory cardio; Reported Cause(s) of Death: cardio-circulatory arrest


VAERS ID: 1380206 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-19
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Respiratory failure
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), 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 (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   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: RAMIPRIL; ATORVASTATIN; ESCITALOPRAM OXALATE; EUTIROX; PRADAXA; BISOPROLOL FUMARATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiomyopathy; Thyroidectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021628334

Write-up: Respiration failure; probable cardiac arrest; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-735059. A 68-year-old female patient received second dose of BNT162B2 (COMIRNATY), intramuscular, administered in arm right on 11May2021 (Batch/Lot Number: FA5831) as 0.3 mL single dose for COVID-19 immunisation. Medical history included cardiopathic, thyroidectomy and atrial fibrillation, all from an unknown date and unknown if ongoing. Concomitant medications included ramipril taken for an unspecified indication; atorvastatin taken for an unspecified indication; escitalopram oxalate taken for an unspecified indication; levothyroxine sodium (EUTIROX) taken for thyroidectomy; dabigatran etexilate mesilate (PRADAXA, formulation: capsule hard, strength: 150 mg) oral at 300 mg daily taken for atrial fibrillation and bisoprolol fumarate taken for an unspecified indication, for all concomitants start and stop date were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY), on an unspecified date (Batch/Lot Number were not reported) the patient experienced no adverse event. The patient experienced respiratory failure on 19May2021 rescuers have reached the resuscitation with cardiac massage but must ascertain his death, due to probable cardiac arrest. The patient died on 19May2021. It was not reported if an autopsy was performed. Sender Comment: contacted by telephone at the reporter due to the impossibility of finding the person in charge, additional information was entered when entering the form. Follow-up will be carried out with the doctor regarding the clinical history. Reporter Comment: Cardiopathic subject, who died of probable cardiac arrest, date of second vaccine dose 11May, date of death 19May.; Reporter''s Comments: Cardiopathic subject, who died of probable cardiac arrest, date of second vaccine dose 11May, date of death 19May; Reported Cause(s) of Death: Respiration failure; cardiac arrest


VAERS ID: 1380212 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, Pneumonitis, Pyrexia, Renal failure, Septic shock
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 10
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: Adenocarcinoma; Hemicolectomy (for adenocarcinoma surgery)
Allergies:
Diagnostic Lab Data: Test Date: 202012; Test Name: SARS- CoV-2 infection; Result Unstructured Data: Test Result:positive
CDC Split Type: ITPFIZER INC2021645698

Write-up: Asthenia, bed rest and fever, gradual worsening, 25May ER for marked dyspnoea, diagnosis of pneumonia with septic shock and renal insufficiency; Asthenia, bed rest and fever, gradual worsening, 25May ER for marked dyspnoea, diagnosis of pneumonia with septic shock and renal insufficiency; Asthenia, bed rest and fever, gradual worsening, 25May ER for marked dyspnoea, diagnosis of pneumonia with septic shock and renal insufficiency; Asthenia, bed rest and fever, gradual worsening, 25May ER for marked dyspnoea, diagnosis of pneumonia with septic shock and renal insufficiency; Asthenia, bed rest and fever, gradual worsening, 25May ER for marked dyspnoea, diagnosis of pneumonia with septic shock and renal insufficiency; This is a spontaneous report from a contactable Physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-736640. An 83-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 17May2021 (Batch/Lot Number: FA4597) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. Medical history included hemicolectomy on Apr2021 for adenocarcinoma surgery and adenocarcinoma from an unknown date and unknown if it was ongoing. Concomitant medications were not reported. The patient experienced asthenia, bed rest and fever, gradual worsening, 25May ER for marked dyspnoea, diagnosis of pneumonia with septic shock and renal insufficiency. The patient visited emergency room for the events dyspnoea, diagnosis of pneumonia with septic shock and renal insufficiency. The events were reported as serious (fatal). The patient underwent lab tests and procedures which included covid-19: positive on Dec2020. The patient died on 28May2021. The cause of death was reported as diagnosis of pneumonia with septic shock and renal insufficiency. It was not reported if an autopsy was performed. Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: On Dec 2020 infez. from SARS COV2 treated at home, in April 2021 hemicolectomy for adenocarcinoma surgery. ; Reported Cause(s) of Death: Asthenia, bed rest and fever, gradual worsening, 25May ER for marked dyspnoea, diagnosis of pneumonia with septic shock and renal insufficiency; Asthenia, bed rest and fever, gradual worsening, 25May ER for marked dyspnoea, diagnosis of pneumonia wit


VAERS ID: 1380214 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Cardiac arrest, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   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: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021645696

Write-up: Abdominalgia and vagal symptoms and sudden loss of consciousness, cardiocirculatory arrest not recovered by rescuers; Abdominalgia and vagal symptoms and sudden loss of consciousness, cardiocirculatory arrest not recovered by rescuers; Abdominalgia and vagal symptoms and sudden loss of consciousness, cardiocirculatory arrest not recovered by rescuers; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-737092. A 52-year-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FA8016), via intramuscular, administered in arm left (left shoulder) on 28May2021 at 13:00 as 1st dose, single dose for COVID-19 immunisation. Medical history included hypertension. The patient''s concomitant medications were not reported. On 28May2021, the patient experienced abdominalgia and vagal symptoms and sudden loss of consciousness, cardiocirculatory arrest not recovered by rescuers. The patient died on 28May2021. It was not reported if an autopsy was performed. Outcome of the events fatal. Sender Comment: 30May2021 added clinical report Reporter''s comment: The relationship is temporal: the causal link has to be demonstrated. Body under judicial protection following a complaint by family members.; Reporter''s Comments: The relationship is temporal: the causal link has to be demonstrated. Body under judicial protection following a complaint by family members; Reported Cause(s) of Death: Consciousness loss; Abdominal pain; Arrest cardiac


VAERS ID: 1380215 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Body temperature, Death, Pain in extremity, Pyrexia, Terminal state
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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: 2021-05-27
   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: Test Date: 20210527; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: ITPFIZER INC2021645702

Write-up: Death; Death imminent; Hyperthermia (38); Pains in legs; Pain in back; This is a spontaneous report downloaded from the Regulatory AUthority-WEB, regulatory authority number IT-MINISAL02-737103. A contactable physician reported that an 82-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: FA8016; Expiration Date: 30Sep2021), dose 2 via intramuscular route (left shoulder as reported) on 22May2021 at 16:54 as 0.3 ml single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 27May2021, the patient experienced hyperthermia (temperature: 38 centigrade), pains in legs, death imminent, pain in back. The events were described as follows: vaccinated with 2 Pfizer dose on 22May2021, the following day, manifest hyperthermia (38) and pain in back and legs which increase until death on 27May2021. The patient died on 27May2021 and cause of death was unknown. The outcome of the events was fatal. It was not reported if an autopsy was performed. Reporter''s comments: I have been informed by the relative that expressly came to the vaccination center to report the fact. Actions taken (relative informed the vaccination center where the person had been vaccinated) - Ethnic origin (given) - COVID 19 COMIRNATY VACCINE (PFIZER) * 195 vials 0.45ML: Administration site (left shoulder) Number booster dose (2) Time of administration (16:54) Lot expiration (30Sep2021). No follow-up attempts needed. No further information expected. ; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1380221 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Dyspnoea, Headache
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LASITONE; COAPROVEL; PLAVIX; LACIREX; PANTORC; NITROGLICERIN DOC GENERICI
Current Illness: Angina unstable (In drug therapy); Atrial fibrillation (In drug therapy); Cardiac failure acute (In drug therapy); Hypertension arterial (In drug therapy)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: Blood pressure drop arterial; Result Unstructured Data: Test Result:unknown result; Test Date: 20210508; Test Name: blood pressure; Result Unstructured Data: Test Result:50/73 mmHg
CDC Split Type: ITPFIZER INC2021632881

Write-up: Breathing difficult; Ice pick headache; This a spontaneous report received from a contactable consumer (patient''s daughter). This is the 2nd of 2 reports. The 1st report was downloaded from the Regulatory Authority (RA)-WEB [Regulatory Authority report number IT-MINISAL02-734538]. A 95-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), intramuscular, on 20Mar2021, as single dose, for COVID-19 immunisation. Medical history included ongoing atrial fibrillation (in drug therapy), ongoing cardiac failure (in drug therapy), ongoing hypertension (in drug therapy), ongoing angina unstable (in drug therapy). Patient was in good general health. Concomitant medications included furosemide, spironolactone (LASITONE) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, irbesartan (COAPROVEL) taken for an unspecified indication, start and stop date were not reported; clopidogrel bisulfate (PLAVIX) taken for an unspecified indication, start and stop date were not reported; lacidipine (LACIREX) taken for an unspecified indication, start and stop date were not reported; pantoprazole sodium sesquihydrate (PANTORC) taken for an unspecified indication, start and stop date were not reported; glyceryl trinitrate (NITROGLICERIN DOC GENERICI) taken for an unspecified indication, start and stop date were not reported. The patient experienced breathing difficult (death, caused hospitalization) on 2021, ice pick headache (death, caused hospitalization) on 2021. The patient was hospitalized die to the events in Mar2021 for 2 days. The patient underwent lab tests and procedures which included blood pressure decreased: unknown result on 08May2021, blood pressure measurement: 50/73 mmhg on 08May2021. The patient died on 10May2021. It was not reported if an autopsy was performed. Clinical course: In the following days she becomes unwell with episodes of headache and breathing difficulties. She goes to the emergency room of the hospital where she is discharged with the suggestion to carry out a cardiological examination; around 06Apr2021 the patient again reported headache and breathing difficulties. She is therefore taken to the hospital where, following a cardiological visit, she has been hospitalized for a few days, skipping the date of the second dose scheduled for 10Apr2021. She was discharged in clinical conditions in general improvement and on 28Apr2021, on the advice of the doctors, she received the second dose of the vaccine at home. On 08May2021 the symptoms manifested following the 1st dose reappeared in a much more intense and acute way, with excruciating headache and difficulty in breathing but also chest pain, lowering of arterial P (minimum value detected: 50 / 73 mmHg) and aphasia. She was hospitalized again, after 2 days the death was noted. Pressure value found at the first measurement after the onset of discomfort: 50/73 mmHg. Reporter''s comment: The administration of both doses of the vaccine was carried out at home by different operators. The batch or expiry date is not indicated on the vaccination sheet issued only for the second dose. The cardiologist who followed the patient recommended taking the second dose despite the symptoms that had already occurred following the first. After the access to the emergency room around 24Mar2021 (after the 1st dose) she was discharged shortly after without any therapy; for the 2 days of hospitalization. Sender''s comment: 21May2021: lots and expirations of both doses of vaccine administered are requested from the reporter; 24May2021: information on the patient''s clinical status and drug therapy is requested from the GP, who confirms the monthly prescribed therapies as reported and reports that he has never visited the patient lately, being treated by a cardiologist specialist. No follow-up attempts are possible; information about lot/batch number cannot be obtained.Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: After the access to the emergency room around 24Mar2021 (after the 1st dose) she was discharged shortly after without any therapy; for the 2 days of hospitalization.; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-2021628330 Same patient/drug, different events; Reported Cause(s) of Death: Breathing difficult; Ice pick headache


VAERS ID: 1380350 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-05-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure, Cardio-respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), 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: 2021-05-25
   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: GLIMEPIRIDE; AMLODIPINE [AMLODIPINE BESILATE]; NESINA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Dementia; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210523; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021603789

Write-up: Cardio-respiratory arrest; cardiac failure; This is a spontaneous report from a contactable physician via a regulatory authority. This is a report received from a regulatory authority. Regulatory authority report numbers are v21109213 and v21109303. A 97-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EX3617; Expiration Date: 31Aug2021), intramuscularly in the left arm on 23May2021 at 15:30 at a single dose for covid-19 immunisation. Medical history included hypertension, diabetes mellitus, constipation, and dementia. The patient had no allergies to medications, food, or other products. Prior to vaccination or since the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included glimepiride (MANUFACTURER UNKNOWN); amlodipine besilate (MANUFACTURER UNKNOWN); alogliptin benzoate (NESINA) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 underwent lab tests and procedures which included body temperature: 36.5 degrees Centigrade on 23May2021 before vaccination. On 25May2021 at 14:00, the patient experienced cardio-respiratory arrest and cardiac failure, which was serious for death. The clinical course was as follows: on 23May2021 at 15:30 (the day of vaccination), the patient received the first dose of BNT162b2. On 25May2021 at around 14:00 (2 days after the vaccination), the patient experienced cardio-respiratory arrest. The event was further described as: on 25May2021 at 14:00 (2 days after the vaccination), the patient suddenly died without symptoms of geromarasmus, pneumonia, renal failure, or cardiac failure chronic. The event resulted in death. The outcome of the event was fatal without treatment. Death cause reported as cardiac failure. Autopsy was not performed. The patient died on 25May2021 due to cardio-respiratory arrest and cardiac failure. An autopsy was not performed. The reporting physician classified the event as serious (fatal outcome, death) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. REPORTER COMMENT: The patient was in a state of senile deterioration. There were no findings indicating pneumonia (such as pyrexia) and renal failure and she died.; Reported Cause(s) of Death: Cardio-respiratory arrest; cardiac failure


VAERS ID: 1380351 (history)  
Form: Version 2.0  
Age: 101.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardiac failure congestive, Electrocardiogram, Myocardial infarction, Stress cardiomyopathy, Urosepsis
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (narrow), Other ischaemic heart disease (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 21
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: Angina pectoris; Arrhythmia; Arterial occlusion; Cataract operation; Constipation; Femur fracture; Gonarthrosis; Hypertension; Intestinal diverticular bleeding; Limb amputation; Lumbar spinal stenosis; Neurogenic bladder; Reflux oesophagitis; Thoracic spine compression fracture; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210521; Test Name: Blood pressure; Result Unstructured Data: Test Result:increased; Test Date: 20210521; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210521; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Myocardial infarction or Tako-Tsubo cardiomyopathy; Comments: was suspected
CDC Split Type: JPPFIZER INC2021605278

Write-up: Myocardial infarction or Tako-Tsubo cardiomyopathy was suspected; Myocardial infarction or Tako-Tsubo cardiomyopathy was suspected; sepsis from urinary tract infection; cardiac failure congestive; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 101-year-old female patient received the second dose of BNT162B2 (COMIRNATY; Lot Number: EW4811; Expiration Date: 31Jul2021), intramuscularly in the left arm, on 18May2021 at 15:15 (at the age of 101-years-old) as 0.3 mL, single for COVID-19 immunisation. The vaccination was performed at the nursing home/elderly care facility. Medical history included type 2 diabetes mellitus, hypertension, angina pectoris, arrhythmia, bilateral femur fracture, thoracic spine compression fracture T12, gonarthrosis, lumbar spinal stenosis, constipation, reflux oesophagitis, non-ongoing intestinal diverticular bleeding, left cataract operation on an unspecified date, neurogenic bladder, and amputation of the lower limb after acute arterial occlusion of the right lower limb. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications, within 2 weeks of vaccination, included unspecified medications. The patient previously received the first dose of BNT162B2 (COMIRNATY; Lot number: ET3674; Expiration date: 31Jul2021), intramuscularly in the left arm, on 24Apr2021 at 14:00 for COVID-19 immunisation and experienced no problem. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021 at 14:00 (1 day and 22 hrs 45 min after the vaccination), myocardial infarction or Tako-Tsubo cardiomyopathy was suspected and the patient experienced sepsis from urinary tract infection, which required hospitalization and were reported as fatal. The patient also experienced cardiac failure congestive in May2021. The clinical course was reported as follows: On 18May2021, around 15:18 (as reported) the patient received BNT162B2 vaccination (2nd dose). Two days later, on 20May2021, passed 14:00, the patient developed wheezing, so she was on observation, but the symptom persisted. On 21May2021 at 08:40, it was reported to the reporting physician, and the physician immediately referred the patient to another hospital. At the hospital, it seems that the explanation was the patient had sepsis from urinary tract infection, and myocardial infarction or takotsubo cardiomyopathy was suspected on the electrocardiogram on 21May2021. On 21May2021 (3 days after the vaccination), pyrexia with body temperature of 39 degrees Centigrade and blood pressure increased were noted. It was suspected that pyrexia was caused by urinary tract infection. Tako-Tsubo cardiomyopathy was also recognized. The patient was hospitalized and received treatment (as reported); however, she passed away on 22May2021, at 07:41 (4 days after the vaccination). The patient died on 22May2021. The causes of death were reported as myocardial infarction, Tako-Tsubo cardiomyopathy, sepsis from urinary tract infection, and cardiac failure congestive. An autopsy was not performed. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The causality between the death and BNT162B2 vaccination, in this case, was unknown/uncertain, but it was reported because the death occurred relatively short after the vaccination, and also there was the family''s request.; Sender''s Comments: Based on the information provided, it was noted that this elderly patient with a medical history significant for type 2 diabetes mellitus, hypertension, angina pectoris, arrhythmia, bilateral femur fracture, thoracic spine compression fracture T12, gonarthrosis, lumbar spinal stenosis, constipation, reflux oesophagitis, non-ongoing intestinal diverticular bleeding, left cataract operation on an unspecified date, neurogenic bladder, and amputation of the lower limb after acute arterial occlusion of the right lower limb died due to myocardial infarction, Tako-Tsubo cardiomyopathy, sepsis from urinary tract infection, and cardiac failure congestive. The patient died 4 days after the vaccination, due to a plausible temporal association a contribution of suspect product cannot be excluded. Elderly age and underlying disease conditions are most likely contributed to the demise of the patient. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: sepsis from urinary tract infection; cardiac failure congestive; Myocardial infarction; Tako-Tsubo cardiomyopathy


VAERS ID: 1380352 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-22
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Cerebral haemorrhage, Computerised tomogram
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), 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: 2021-05-22
   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: FUROSEMIDE; AMLODIPINE; LANSOPRAZOLE; ELIQUIS; ITOROL; THEODUR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure chronic; Cerebellar infarction; Chronic kidney disease; Emphysema; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: Body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: Before vaccination; Test Date: 20210522; Test Name: CT; Result Unstructured Data: Test Result:cerebral haemorrhage
CDC Split Type: JPPFIZER INC2021607145

Write-up: Cerebral haemorrhage; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician. This is a report received from the Agency Regulatory Authority. Regulatory authority report number is v21109405. An 85-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 11May2021 at 13:27 (Batch/Lot Number: EY2173; Expiration Date: 31Aug2021) at 85-years-old as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation, chronic cardiac failure, cerebellar infarction, chronic kidney disease, hypertension, emphysema; all from an unknown date and unknown if ongoing. Concomitant medications included furosemide (MANUFACTURER UNKNOWN); amlodipine (MANUFACTURER UNKNOWN); lansoprazole (MANUFACTURER UNKNOWN); apixaban (ELIQUIS); isosorbide mononitrate (ITOROL); theophylline (THEODUR); all taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received the first dose of the bnt162b2 (COMIRNATY) for COVID-19 immunisation on 20Apr2021 at 9 decades old (as reported) (at 13:16, dose 1, Lot Number: ER7449, Expiration date: 30Jun2021). On 22May2021 19:10, the patient experienced cerebral haemorrhage (death, medically significant), and cardio-respiratory arrest (medically significant) requiring an emergency room visit. The clinical course was reported as follows: The patient was an 85-year-old male. Body temperature before vaccination was 35.6 degrees Centigrade. Family history was not reported. Medical history included atrial fibrillation, chronic cardiac failure, cerebellar infarction, chronic kidney disease, hypertension, and emphysema. The patient had no history of allergy. Concomitant medications included furosemide, amlodipine, lansoprazole, apixaban (ELIQUIS), isosorbide mononitrate (ITOROL), and theophylline (THEODUR). On 20Apr2021 at 13:16, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ER7449, Expiration date 30Jun2021). On 11May2021, at 13:27 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 22May2021 at 19:10 (11 days, 5 hours and 43 minutes after the vaccination), the patient experienced cerebral haemorrhage. On 22May2021 at 20:30 (11 days, 7 hours and 3 minutes after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 22May2021 at 19:10 (11 days, 5 hours and 43 minutes after the vaccination), the patient was found in cardio-respiratory arrest at home. While receiving resuscitative measures, the patient was emergently transported to the hospital. Computerised tomogram (CT) showed cerebral haemorrhage. Resuscitation was unsuccessful, and the patient was confirmed dead at 20:30. The reporting physician classified the event cerebral haemorrhage 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 was reported as follows: the patient had hypertension and atrial fibrillation, for which anticoagulant treatment was being performed. The reporting physician commented as follows: In this case, the patient experienced cerebral haemorrhage on Day 11 after the BNT162b2 vaccination. Since the patient had underling diseases, the causality between the event and BNT162b2 was unknown. However, since the event occurred within a relatively short period of the vaccination, this case was reported. The patient underwent lab tests and procedures which included body temperature: 35.6 Centigrade on 11May2021 (before vaccination), CT: cerebral haemorrhage on 22May2021. Therapeutic measures were taken as a result of cardio-respiratory arrest. The clinical outcome of the event, cardio-respiratory arrest, was unknown. The clinical outcome of the event, cerebral haemorrhage, was fatal. The patient died on 22May2021 due to cerebral haemorrhage. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1380355 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardiac tamponade, Cardio-respiratory arrest, Computerised tomogram, Heart rate, Myocardial infarction
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210522; Test Name: Blood pressure; Result Unstructured Data: Test Result:162/93; Comments: Before vaccination; Test Date: 20210522; Test Name: Blood pressure; Result Unstructured Data: Test Result:152/95; Comments: After vaccination; Test Date: 20210522; Test Name: Blood pressure; Result Unstructured Data: Test Result:158/99; Comments: 2 hours after vaccination; Test Date: 20210523; Test Name: Blood pressure; Result Unstructured Data: Test Result:146/92; Test Date: 20210522; Test Name: Body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: Before vaccination; Test Date: 20210522; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: After vaccination; Test Date: 20210522; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: 2 hours after vaccination; Test Date: 20210523; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210525; Test Name: CT scan; Result Unstructured Data: Test Result:Pericardial effusion was noted; Test Date: 20210522; Test Name: Pulse rate; Result Unstructured Data: Test Result:112; Comments: Before vaccination; Test Date: 20210522; Test Name: Pulse rate; Result Unstructured Data: Test Result:116; Comments: After vaccination; Test Date: 20210522; Test Name: Pulse rate; Result Unstructured Data: Test Result:116; Comments: 2 hours after vaccination; Test Date: 20210523; Test Name: Pulse rate; Result Unstructured Data: Test Result:111
CDC Split Type: JPPFIZER INC2021608078

Write-up: painless myocardial infarction; cardiac tamponade; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number is v21109496. A 90-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscularly, administered in the left arm on 22May2021 at 14:50 (Batch/Lot Number: EY4834; Expiration Date: 31Aug2021) at 90-years-old as 0.3 mL, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 25May2021 18:30, 3 days 3 hours 40 minutes after the first dose, the patient experienced cardio-respiratory arrest (death, medically significant). On 25May2021 at 20:03, 3 days 5 hours 13 minutes after the first dose, the patient experienced painless myocardial infarction (death, medically significant) and cardiac tamponade (death, medically significant). The clinical course was reported as follows: The patient was a 90-year-old male. Body temperature before vaccination was 35.6 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). No information on family history was provided. On 22May2021 at 14:50 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY4834, Expiration date 31Aug2021) 0.3 mL, intramuscularly as a single dose for COVID-19 immunization (left upper arm). On 25May2021 at 18:30 (3 days after the vaccination), the patient experienced cardio-respiratory arrest. On 25May2021 at 20:03 (3 days after the vaccination), the patient died of painless myocardial infarction and cardiac tamponade. It was not reported if an autopsy was performed. The course of the event was as follows: Before the vaccination, blood pressure was 162/93 and pulse rate was 112. On 22May2021 at 14:50, BNT162b2 0.3 mL was intramuscularly injected into the left upper arm. After the vaccination, blood pressure was 152/95, pulse rate was 116 and body temperature was 36.9 degrees Centigrade. On 22May2021, 2 hours after the vaccination, blood pressure was 158/99, pulse rate was 116 and body temperature was 37.0 degrees Centigrade. On 23May2021 (the next day of the vaccination), blood pressure was 146/92, pulse rate was 111 and body temperature was 36.6 degrees Centigrade. On 25May2021, after dinner (17:45-18:15), adventitious sound was heard. He vomited food from his mouth. He developed cardio-respiratory arrest at 18:30. He was transferred to a hospital by an ambulance. On 25May2021 at 20:03, the patient''s death was confirmed. Pericardial effusion was noted by CT scan. A diagnosis of painless myocardial infarction and cardiac tamponade were made. The reporting physician classified the events as serious (Fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Three days after the vaccination, the patient died. The causal relationship with BNT162b2 was uncertain. The patient underwent lab tests and procedures which included blood pressure: 162/93 on 22May2021 (Before vaccination), blood pressure: 152/95 on 22May2021 (After vaccination), blood pressure: 158/99 on 22May2021 (2 hours after vaccination), blood pressure: 146/92 on 23May2021, body temperature: 35.6 Centigrade on 22May2021 (Before vaccination), body temperature: 36.9 Centigrade on 22May2021 (After vaccination) , body temperature: 37.0 Centigrade on 22May2021 (2 hours after vaccination), body temperature: 36.6 Centigrade on 23May2021, computerised tomogram (CT scan): pericardial effusion was noted on 25May2021, pulse rate: 112 on 22May2021 (Before vaccination), pulse rate: 116 on 22May2021 (After vaccination), pulse rate: 116 on 22May2021 (2 hours after vaccination), pulse rate: 111 on 23May2021. Therapeutic measures were taken as a result of cardio-respiratory arrest, painless myocardial infarction, cardiac tamponade. The clinical outcome of the events was fatal. The patient died on 25May2021 due to cardio-respiratory arrest, painless myocardial infarction and cardiac tamponade. It was unknown if an autopsy was performed. ; Reported Cause(s) of Death: cardio-respiratory arrest; painless myocardial infarction; cardiac tamponade


VAERS ID: 1380356 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-21
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Computerised tomogram thorax, Oxygen saturation, Pneumonia aspiration, Pyrexia, Urinary tract infection
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: 2021-05-25
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? Yes
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: Debility (due to dementia with Lewy bodies); Dementia with Lewy bodies (debility due to dementia with Lewy bodies); General physical health deterioration; Living in nursing home; Pneumonia aspiration
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:decreased; Test Date: 20210521; Test Name: Body temperature; Result Unstructured Data: Test Result:pyrexia; Test Date: 20210515; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210525; Test Name: Chest CT; Result Unstructured Data: Test Result:revealed bilateral multiple infiltrative shadows; Test Date: 20210525; Test Name: SpO2; Result Unstructured Data: Test Result:decreased to 70 %
CDC Split Type: JPPFIZER INC2021616786

Write-up: Pneumonia aspiration; Urinary tract infection; pyrexia; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21109926. A 92-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 15May2021 15:00 (Lot Number: EY0779; Expiration Date: 31Aug2021) as single dose (at age of 92-year-old) for covid-19 immunisation. Medical history included dementia with Lewy bodies (debility due to dementia with Lewy bodies), general physical health deterioration, pneumonia aspiration. The patient had no remarkable family history. Concomitant medications were not reported. On 21May2021 patient experienced pneumonia aspiration and urinary tract infection. The patient was hospitalized for the events from 25May2021. Events were considered serious due to hospitalization and to fatal outcome. Both events required physician office visit and treatment. On 15May2021 at 15:00 (the day of vaccination), the patient received?the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 21May2021 (6 days after the vaccination), the patient experienced pneumonia aspiration and urinary tract infection. On 25May2021 (10 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient had general physical health deterioration and debility due to dementia with Lewy bodies and had a history of pneumonia aspiration. Since Apr2019, the patient has lived in a nursing home for the elderly, stayed on bed or in a wheelchair, and required assistance in almost everything. On 15May2021, the patient received the vaccine. Subsequently, the patient developed no adverse reaction such as pyrexia. On 21May2021, the patient developed pyrexia, for which the treatment with antibacterial agent was initiated for urinary tract infection at another hospital. However, on 25May2021, SpO2 decreased to 70% and the patient was hospitalized at the hospital. Chest computerised tomogram (CT) revealed bilateral multiple infiltrative shadows. Treatment with antibacterial agent was initiated; however, hypoxaemia persisted and there was a decrease in blood pressure. On the same day, on 25May2021 at 23:17, the patient died. Cause of death were pneumonia aspiration and urinary tract infection. It was not reported if an autopsy was performed. The patient underwent laboratory tests and procedures which included blood pressure measurement: decreased on 25May2021, body temperature on 15May2021 before vaccination was 36.8 centigrade, computerised tomogram thorax: revealed bilateral multiple infiltrative shadows on 25May2021, oxygen saturation: decreased to 70 % on 25May2021. The reporting physician classified the events pneumonia aspiration and urinary tract infection as serious (death) and assessed that the events were unrelated to BNT162b2. Other possible cause of the event such as any other diseases was history of pneumonia aspiration. The reporting physician commented as follows: The death was considered to be associated with the patient''s underlying disease. Influence of the vaccination was unlikely; however, the case was reported just in case because the event occurred within 2 weeks of the vaccination.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the events of pneumonia aspiration and urinary tract infection. These reported events likely represent intercurrent medical conditions. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up 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: Pneumonia aspiration; Urinary tract infection


VAERS ID: 1380357 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-05-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Body temperature, Chest pain, Computerised tomogram head, Computerised tomogram thorax, Dyspnoea, Electrocardiogram
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   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: Arteriosclerosis obliterans; Diabetes mellitus; Dyslipidaemia; Dyspnoea; Electrocardiogram ST-T change; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210516; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination; Test Date: 20210516; Test Name: Head CT; Result Unstructured Data: Test Result:no abnormal findings; Test Date: 20210516; Test Name: Chest CT; Result Unstructured Data: Test Result:coronary artery stenosis; Comments: After the patient died. Significant calcification images in the left and right coronary arteries, for which coronary artery stenosis was strongly suspected.; Test Date: 20210507; Test Name: electrocardiogram; Result Unstructured Data: Test Result:ST change; Comments: ST change was observed (ischemic change was suspected); Test Date: 20210516; Test Name: electrocardiogram; Result Unstructured Data: Test Result:Asystole; Comments: at 20:39
CDC Split Type: JPPFIZER INC2021616831

Write-up: acute myocardial infarction; Dyspnoea; chest pain; This is a spontaneous report from a contactable physician received from the regulatory authority. The Regulatory Authority report number is v21109904. The patient was an 88-year and 9-month-old male. Body temperature before vaccination was 36.1 degrees Centigrade. The patient had medical histories of diabetes mellitus, hypertension, dyslipidemia, and arteriosclerosis obliterans. From Jan2020, the patient was being treated in the reporting hospital. The patient had allergic history of pruritus caused by oral administration of Actos, Lipitor, Livalo, and Nesina. In Dec2021, the patient was aware of respiratory discomfort. However, thereafter he did not complain. On 07May2021, an electrocardiogram examination was performed as periodic checkup in the reporting hospital. ST change was observed (ischemic change was suspected), and the patient was to be referred to the cardiovascular internal medicine department. On 16May2021 at 11:09 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as single dose for COVID-19 immunization. On 16May2021 at 20:00 (8 hours and 51 minutes after the vaccination), the patient experienced chest pain and dyspnoea. On 16May2021 (the day of the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 16May2021 (the day of vaccination), at 11:09, the patient received the first dose of BNT162b2 vaccination. The patient complained of no symptoms during follow up for 30 minutes, and he went home. On the same day, at 20:08 (8 hours and 59 minutes after vaccination), the patient was aware of chest pain and dyspnoea at home, and an ambulance was called by the patient himself. At 20:18 (9 hours and 9 minutes after vaccination), an ambulant service arrived at the site, and the patient was confirmed to have cardio-respiratory arrest. A cardiopulmonary resuscitation was immediately initiated. At 20:39 (9 hours and 30 minutes after vaccination), the patient arrived at the hospital. At that time, the patient was in cardio-respiratory arrest. The electrocardiographic waveform showed asystole. Although a cardiopulmonary resuscitation was continued, no response was obtained. At 20:48 (9 hours 48 minutes after vaccination), the patient was confirmed to die. After the patient died, an autopsy imaging (AI) was performed. Head CT showed no abnormal findings. Chest CT showed significant calcification images in the left and right coronary arteries, for which coronary artery stenosis was strongly suspected. Based on the above medical histories, clinical course, and laboratory findings, the cause of death was diagnosed as acute myocardial infarction. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was myocardial infarction. The reporting physician commented as follows: Based on the medical histories, clinical course, and imaging findings, the cause of death was considered as acute myocardial infarction. It was considered that the event was unlikely related to BNT162b2; however, the details were unknown.; Reported Cause(s) of Death: acute myocardial infarction; Dyspnoea; chest pain; Autopsy-determined Cause(s) of Death: significant calcification images in the left and right coronary arteries, for which coronary artery stenosis was strongly suspected; significant calcification images in the left and right coronary arteries, for which coronary artery stenosis was stro


VAERS ID: 1380358 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory 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), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   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: Medical History/Concurrent Conditions: Dementia; Hyposthenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021617146

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. An 85-year-old female patient received her first dose of BNT162B2 (COMIRNATY) via unspecified route of administration on 26May2021 at 14:00 (at the age of 85-year old) (Batch/Lot number not provided) as single dose for Covid-19 immunization. The patient had underlying disease of dementia, and she was in hyposthenia. The patient was being treated at home. Concomitant medications were not reported. On 27May2021 at 15:00 the patient was found to have cardio-respiratory arrest and she was confirmed to die. The reporting physician classified the event as serious (death) and assessed that the event was possibly related to BNT162b2. Information on the lot/batch number has been requested.; Sender''s Comments: Event cardio-respiratory arrest represents an intercurrent medical condition for this 85 years old patient and unrelated to BNT162B2 . 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: Cardio-respiratory arrest


VAERS ID: 1380359 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-21
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure, Chest X-ray, Pneumonia aspiration
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   Days after onset: 6
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: Cholecystitis (several times); Dementia Alzheimer''s type; Pneumonia aspiration (several times)
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210521; Test Name: Body temperature; Result Unstructured Data: Test Result:38.8 Centigrade; Comments: in the afternoon; Test Date: 20210521; Test Name: chest X-ray; Result Unstructured Data: Test Result:bilateral pneumonia
CDC Split Type: JPPFIZER INC2021617319

Write-up: Pneumonia aspiration; cardiac failure; This is a spontaneous report from a contactable physician received from the a regulatory authority. Regulatory authority report number is v21109927. The patient was a 95-year-old female. Body temperature before vaccination was 36.5 degrees Centigrade. Medical history included dementia Alzheimer''s type, pneumonia aspiration and cholecystitis. No information on concomitant medications was provided. The patient had no relevant family history. On 14May2021 at 15:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY0779, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 21May2021 at 12:30 (7 days after the vaccination), the patient experienced acute pneumonia and cardiac failure with fatal outcome. It was not reported if an autopsy was performed. The course of the event was as follows: The patient was being hospitalized for the treatment of dementia Alzheimer''s type. She had been bedridden because of advanced disease, and she needed almost total assistance. She repeatedly experienced pneumonia aspiration and cholecystitis and developed them several times. On 14May2021 at 15:00, the patient received the first dose of the vaccination. Thereafter, there had not been any symptoms in particular suggesting adverse reactions of the vaccination, and no pyrexia had been noted. On 21May2021 in the afternoon, the temperature measurement revealed pyrexia of 38.8 degrees Centigrade, and chest X-ray showed bilateral pneumonia. The treatment with antibacterial drugs was performed, but cardiac failure caused by pneumonia was combined, and her disease was aggravated. On 27May2021 at 04:27, the patient died. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was not related to BNT162b2. Pneumonia aspiration caused by her underlying disease was reported as other possible cause of the event. The reporting physician commented as follows: The patient''s death was considered to be caused by her underlying disease. It was unlikely to consider that the vaccination caused the event, however, the event occurred within 2 weeks of the vaccination, therefore this case was reported.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the events of pneumonia aspiration and cardiac failure. These reported events likely represent intercurrent medical conditions in this elderly 95 year old patient. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up 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: Pneumonia aspiration; cardiac failure


VAERS ID: 1380360 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory 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), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   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: JPPFIZER INC2021622824

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is v21110139. A 73-year and 4-month old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, on 25May2021 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cardio-respiratory arrest on 27May2021 at 19:30 (2 days, 19 hours, and 30 minutes after the vaccination), which was reported as fatal. The course of the event was as follows: On 25May2021 (the day of vaccination), the patient received a dose of BNT162B2 vaccination. On 26May2021 (one day after vaccination), the patient underwent dialysis at his primary hospital. On 27May2021, at 10:00 (2 days and 10 hours after vaccination), the patient was finally confirmed to be healthy. At 18:55 (2 day, 18 hours, and 55 minutes after vaccination; as reported), when the patient''s family member visited the patient''s room, the patient was found to have cardio-respiratory arrest on the futon (thick bedquilt). At 19:15 (2 days, 19 hours, and 15 minutes after vaccination), the patient was transferred to the reporting hospital; however, resuscitation could not be performed, and she was confirmed to die at 19:30 (2 days, 19 hours, and 30 minutes after vaccination). The patient died on 27May2021 at 19:30. The cause of death was reported as cardio-respiratory arrest. It was not reported if an autopsy was performed. The reporting physician assessed that the causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1380362 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-08
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: 2021-05-18
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CELECOXIB; AMLODIPINE; ALPHACALCIDOL; MEMANTINE; SENNOSIDES; MAGMITT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Compression fracture; Dementia Alzheimer''s type; Hypertension; Spinal stenosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021622924

Write-up: Pneumonia; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. The patient was a 90-year-old female. Medical history included spinal stenosis, compression fracture of lumbar region, asthma, dementia Alzheimer''s type, and hypertension. Concomitant medication included celecoxib, amlodipine, alphacalcidol, memantine, sennoside a+b (SENNOSIDES), and magnesium oxide (MAGMITT). On 13May2021 (the day of vaccination), the patient received?BNT162b2 (COMIRNATY, Solution for injection, Dose number, Lot number, and Expiration date were not reported) at the age of 90 years, 0.3 mL via an unspecified route of administration as a single dose for COVID-19 immunization. On 16May2021 (3 days after the vaccination), the patient experienced pneumonia. On 16May2021 (3 days after the vaccination), the patient was admitted to the hospital. On 18May2021 (5 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 13May2021, the patient received COMIRNATY at another hospital. On 16May2021, the patient was admitted to the reporting hospital for pneumonia (the patient was seen by emergency physician and part-time physician). On 18May2021 at night, the patient died of pneumonia (the patient was seen by a part-time physician on duty). The patient was hospitalized at the reporting hospital for 3 days and attending physician was an internist. Seriousness criteria and causality assessment was not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, the event pneumonia represents an intercurrent medical condition that was unlikely related to BNT162b2 (COMIRNATY) vaccine. 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: Pneumonia


VAERS ID: 1380364 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Death, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), 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 (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dialysis; Renal failure chronic
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021630586

Write-up: unknown cause of death; Cardio-respiratory arrest; pyrexia; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. An 84-year-old female patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 28May2021 (at the age of 84-year-old) (Batch/Lot number was not reported) as single dose (unknown if first or second dose) for COVID-19 immunisation. Relevant medical history included chronic renal failure, for which she was receiving dialysis. Concomitant medications were not reported. Body temperature before vaccination was not provided. The patient family history was not provided. On 29May2021 (one day after the vaccination), the patient was admitted to the hospital (no reason for hospitalization reported). On 30May2021 (2 days after the vaccination), the patient experienced cardio-respiratory arrest and died. The course of the event was as follows: on 28May2021 (the day of vaccination), the patient received BNT162b2 vaccination. On 29May2021 (one day after vaccination), although the patient had pyrexia, she visited the reporting hospital for receiving dialysis. The patient was admitted to the hospital. On 30May2021 (2 days after vaccination), the patient experienced cardio-respiratory arrest. The outcome of the event was fatal. The reporting physician classified the event as serious (death) and assessed that the event was probably related to BNT162b2. The cause of death was reported as ''Unknown''. It was not reported whether an autopsy was performed. The information on the batch number has been requested.; Sender''s Comments: Based on the information currently available, the pre-existing chronic renal failure might have contributed to the clinical course leading to the patient''s demise. However, unless further information regarding specific cause of death provided, at present, the reported event death, cause unknown, is assessed as possibly related to suspect drug, as a cautionary measure and for reporting purposes. 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any 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: 1380365 (history)  
Form: Version 2.0  
Age: 102.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Cardio-respiratory arrest, Chest X-ray, Electrocardiogram, Investigation, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), 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: 2021-05-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210512; Test Name: Chest X-ray; Result Unstructured Data: Test Result:no significant changes; Test Date: 20210512; Test Name: ECG; Result Unstructured Data: Test Result:supraventricular premature beats (rare); Test Date: 20210512; Test Name: biochemical examination; Result Unstructured Data: Test Result:included white cell nucleated (WNR)
CDC Split Type: JPPFIZER INC2021630603

Write-up: Suspected cardiac failure; suspected cardio-respiratory arrest; Sudden death; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory Authority report number v21110380. A 102-year-old female patient received the first dose of BNT162b2 (COMIRNATY) via an unspecified route of administration on 20May2021 (at the age of 102-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient was a 102-year and 11-month-old female. Body temperature before vaccination was unknown. The patient had no particular family history. 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). On 24May2021 at 11:00 (4 days, and 11 hours after the vaccination), the patient experienced suspected cardiac failure. On 21May2021 (one day after the vaccination), the patient was admitted to the hospital. On 24May2021 (4 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: on 12May2021, chest X-ray showed no significant changes. ECG showed only supraventricular premature beats (rare). The biochemical examination included white cell nucleated (WNR). On 20May2021 (the day of vaccination), in the afternoon, the patient received mass vaccination of BNT162b2. On 21May2021 (one day after vaccination), the patient was admitted to the reporting hospital for short stay. On 24May2021, 07:30 (4 days, 7 hours, and 30 minutes after vaccination), during the short stay, the patient had no pain on defecation, and when the staff member visited her room for preparation for going home, the patient had suspected cardio-respiratory arrest. The patient was emergently transferred to another hospital, where she was confirmed death. The date of death was 24May2021. Cardiac failure was suspected. Head CT was not performed because the family member did not wish to. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: the patient had no underlying disease which was the cause of the sudden death, and she was healthy for her age. However, since the patient was oldest old, the causality between the event and BNT162b2 was unknown. The information on the batch number has been requested.; Reported Cause(s) of Death: Suspected cardiac failure; Sudden death; suspected cardio-respiratory arrest


VAERS ID: 1380366 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory 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), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   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: AIMIX; TRADIANCE; CRESTOR OD; METGLUCO; DELLEGRA; INSULIN GLARGINE BS
Current Illness: Dyslipidaemia; Hypertension; Rhinitis allergic; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210521; Test Name: Body temperature; Result Unstructured Data: Test Result:normal; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021630777

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician via a Pfizer sales representative. The patient was a 64-year-old female. Body temperature before vaccination was normal. Medical history included hypertension, dyslipidaemia, type 2 diabetes mellitus and rhinitis allergic (all underlying disease). Concomitant medications included amlodipine besilate, irbesartan (AIMIX COMBINATION TABLETS HD) at 1T, empagliflozin, linagliptin (TRADIANCE COMBINATION TABLETS BP) at 1T, rosuvastatin calcium (CRESTOR OD) at 2.5 mg 1T, metformin hydrochloride (METGLUCO) 500 mg at 4T 2x/day, fexofenadine hydrochloride, pseudoephedrine hydrochloride (DELLEGRA COMBINATION TABLETS) at 4T 2x/day, insulin glargine biosimilar 1 (INSULIN GLARGINE BS INJECTION [LILLY]) at 300 unit/single pen. On 21May2021 at unknown time (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 28May2021 in the morning (7 days after the vaccination), the patient experienced cardio-respiratory arrest and died. As of the reporting date, the outcome of the event was fatal. It was unknown whether autopsy was done. The course of the event was as follows: On 21May2021 (the day of vaccination), the patient received the first bnt162b2 vaccination intramuscularly. On this day, the patient had no problem in her physical condition and had normal body temperature. On 28May2021 in the morning (7 days after the vaccination), there was a contact from the police saying that the patient was found in a state of cardio-respiratory arrest. Details were unknown as no subsequent contact was received from the bereaved family or the police. The seriousness and causality of the event were not reported.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1380367 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Cyanosis, Moaning
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), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   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 subdural haematoma (Left); Cerebral infarction; Diabetes mellitus; Hypertension; Lumbar spine compression fracture (L2)
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021631158

Write-up: Cardio-respiratory arrest; groans; cyanosis; This is a spontaneous report from a 2 contactable physicians and a contactable pharmacist via a Pfizer sales representative and via the Regulatory Authority (RA). The Regulatory authority report number is v21110531. The patient was an 86-year-old female. The patient had a medical history of hypertension, diabetes mellitus, cerebral infarction, acute left subdural haematoma and lumbar spine (L2) compression fracture. Body temperature before vaccination was reported as 36.7 degrees Centigrade. On 28May2021 at noon, the patient received bnt162b2 (COMIRNATY, Solution for injection, Dose number 1, Lot# FA4597, Expiration date 31Aug2021) 0.3 mL intramuscularly as a single dose for COVID-19 immunisation at a related nursing home from the reporting physician. While the patient was being monitored for 15 minutes after the vaccination, no abnormalities were noted. On 29May2021, at 01:00, groans and cyanosis appeared. The blood pressure could not be measured, and then immediately the patient developed cardio-respiratory arrest. At 01:17 on the same day, emergency service was called. At 01:24, the emergency service team arrived at the facility, and then arrived at a hospital at 01:39 where cardiopulmonary resuscitation was started. At 02:17, the patient''s death was confirmed. She was treated by a different physician (of a different hospital from the reporter''s) on duty. It was not reported if an autopsy was performed. The reporting physician commented as follows: since the patient had diabetes mellitus (DM), when developing acute myocardial infarction (AMI), symptoms would be difficult to be noticed and so it was impossible to evaluate. Before the vaccination, there had not been any changes in the patient''s physical condition. But after the vaccination, her condition suddenly changed. Given those facts, the causal relationship with bnt162b2 could be suspected. The reporting physician classified the event as serious (fatal outcome).; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1380435 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure measurement, Body temperature, Electrocardiogram, Hypertension, Neck pain, Oxygen saturation, Respiratory rate, Sinus rhythm
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   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: ACETYLSALICYLIC ACID; OMEPRAZOLE; ALLOPURINOL; ALCOHOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse; Chronic kidney disease (chronic kidney damage); Gout; Hypercholesterolaemia; Hypertension; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210518; Test Name: RR (Riva-Rocci blood pressure); Result Unstructured Data: Test Result:170/110 mmHg; Comments: patient was known to have high blood pressure, but his medication was stopped due to his chronic kidney damage; Test Date: 20210518; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Test Date: 20210518; Test Name: ECG; Result Unstructured Data: Test Result:ST depression, but ECG has not changed in comparis; Comments: ST depression, but ECG has not changed in comparison to an earlier ECG ECG ST depression / cardiologist has assessed that, ECG has not changed from previous ECG; Test Date: 20210518; Test Name: sat; Test Result: 97 %; Test Name: respiratory rate; Result Unstructured Data: Test Result:20/ min; Test Date: 20210518; Test Name: SR; Result Unstructured Data: Test Result:90/ min
CDC Split Type: NLPFIZER INC2021590920

Write-up: Neck pain/ Patient had an increase of pain in his shoulders and neck on the day of vaccination; Pain in the joints; hypertension 170/110./ patient was known to have high blood pressure, but his medication was stopped due to his chronic kidney damage; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00547128. A 77-years-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: Unknown) via an unspecified route of administration on 18May2021 (at the age of 77 years) as 2nd single dose for COVID-19 immunisation and morfine (MORFINE, Lot number: Unknown), subcutaneous from 18May2021 to 18May2021, as once 5 mg subcutaneously for an unspecified indication. Patient medical history included hypertension, hypercholesterolaemia, chronic kidney disease, alcohol abuse, gout, obesity. Concomitant medications included some EH (units) of alcohol, omeprazole capsule gastroresistant 20mg, allopurinol tablet 100mg, acetylsalicylic acid tablet 80mg. Patient previously received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date as 0.3ml 1st single dose for COVID-19 immunisation. Patient had no previous COVID-19 infection. On 18May2021, the patient experienced an increase of pain in his shoulders and neck on the day of vaccination, he had no chest pain or radiating pain, non vegatative. Patient already used 1000mg for his pain and now got a single administration of morphine to help with his pain. Patient had already had some alcohol. The patient recognizes the complaints as wear of cervical vertebrae. the pain cannot be induced by pressing or moving the neck. He had used 1000 mg paractamol twice without effect. Patient indicates that high tension is known to him, medication has been stopped due to kidney damage. Patient lives alone and he has used some EH (units) of alcohol, now ask for help for the pain complaints because paracetamol does not help. The patient underwent lab tests and procedures which included oxygen saturation 97%, SR (sinus rhythm) 90/min, RR (Riva-Rocci blood pressure) 170/110 (patient was known to have high blood pressure, but his medication was stopped due to his chronic kidney damage), ECG showed ST depression, but this was also seen in an older ECG, body temperature 36.1 on 18May2021 and respiratory rate 20/min. The action taken with morfine was not applicable. The patient received 1000 mg paractamol twice and single administration of morfine 5mg subcutaneous as therapeutic measure for event generalized joint pain, neck pain and shoulder pain. The patient died on 19May2021. It was not reported if an autopsy was performed and reported caused of death was unknown. The outcome of events was fatal. Reporter Comment increasing pain on the shoulders / neck since this morning. no pob (chest pain), no radiation, Non vegatative, sat 97%, AF (respiratory rate) 20 / min, SR 90 per min, RR (Riva-Rocci blood pressure) 170/110, ECG ST depression / cardiologist assessed that, ECG has not changed compared to previous ECG, T36.1 , the patient recognizes the complaints as wear of cervical vertebrae. the pain cannot be induced by pressing or moving the neck. he has used 1000 mg paractamol twice without effect. Patient indicates that high tension is known to him, medication has been stopped due to kidney damage? Patient lives alone and he has used some EH (units) of alcohol, now ask for help for the pain complaints because paracetamol does not help. BSN available: yes. confounding factors: Hypertension, hypercholesterolaemia, chronic kidney damage, alcohol abuse, gout, obesity. Previous COVID-19 infection: No. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: Summary of reporter''s comments: increasing pain on the shoulders / neck, sat 97%, AF 20 / min, SR 90 per min, RR 170/110, ECG ST depression, T36.1. Patient indicates that high tension is known to him. Patient lives alone and he has used some EH of alcohol. confounding factors: Hypertension, hypercholesterolaemia, chronic kidney damage, alcohol abuse, gout, obesity Previous COVID-19 infection: No.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1380440 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis
SMQs:, Haemorrhage terms (excl laboratory terms) (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, 27 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity (BMI 30.1)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021629612

Write-up: waking up every morning with nosebleed since vaccination nose keeps bleeding for a long time; This is a spontaneous report from a contactable consumer from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00548748. A 57-year-old male patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 17May2021 as single dose for covid-19 immunisation. Medical history included obesity from an unknown date and unknown if ongoing, BMI 30.1. The patient''s concomitant medications were none and he was perfectly healthy until vaccination. On 18May2021 nosebleed occurred. The patient waking up every morning with nosebleed since vaccination and nose kept bleeding for a long time. Nosebleed was treated with Tissues. The patient was not recovered from nosebleed. The patient was hospitalized for the event and the patient died on an unspecified date. It was not reported if an autopsy was performed. Previous COVID-19 infection: No No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Epistaxis


VAERS ID: 1380442 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-05-07
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METOPROLOL TARTRATE; SIMVASTATINE; OXAZEPAM; CITALOPRAM HYDROBROMIDE; LOSARTAN; PANTOPRAZOLE; LERCANIDIPINE; ASCAL BRISPER CARDIO NEURO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021627820

Write-up: less than 2 months after 2nd vaccination my mother suddenly experienced worsening heart failure; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00554091. A 95-years-old female patient received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: unknown) via unspecified route of administration on 16Mar2021 as single dose for COVID-19 immunization. Medical history included heart failure from an unknown date and unknown if ongoing. Concomitant medication(s) included metoprolol tartrate, simvastatine film-coated tablet 10mg, oxazepam, citalopram hydrobromide, losartan film-coated tablet 25mg, pantoprazole gastro-resistant tablet 20mg, lercanidipine coated tablet 10mg, carbasalate calcium (ASCAL BRISPER CARDIO NEURO) effervescent tablet 100mg. The patient previously received first dose of Comirnaty via an unspecified route of administration on an unspecified date as 0.3 ml single for COVID-19 immunization. On 07May2021, less than 2 months after 2nd vaccination, the patient suddenly got worsening heart failure. The patient died on 15May2021. It was not reported if an autopsy was performed. It was reported that there was no evidence for side effect vaccination, but still wanted to report it for the statistics. The patient had no previous COVID-19 infection. The clinical outcome of the event was fatal. No follow-up attempts possible. No further information expected. Batch/LOT number cannot be obtained. ; Reported Cause(s) of Death: sudden worsening of heart failure


VAERS ID: 1380443 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Body temperature, Body temperature decreased, Chills, Death, Hyperpyrexia, Malaise, Myalgia, Nervousness, Pain in extremity, Poor quality sleep, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRAMADOL; METOPROLOL; CALCI CHEW; PANTOPRAZOLE; FLUOXETINE; LOSARTAN; IBEROGAST; METOCLOPRAMIDE; DIAZEPAM
Current Illness: Smoker (patient smoked a lot)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210512; Test Name: Body temperature; Result Unstructured Data: Test Result:35.4; Test Date: 20210515; Test Name: Body temperature; Result Unstructured Data: Test Result:40.5-42 Centigrade
CDC Split Type: NLPFIZER INC2021628348

Write-up: Death; Cold shivers; Feeling unwell; Fever: 40.5 to 42 degrees Celcius; Muscle pain; Vomiting; pain in the abdomen after vomiting; left arm pain; sleeping badly; Temperature 35.4 weak; Shaky; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00555741. A 60-year-old female patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 11May2021 (Batch/Lot number was not reported) as 0.3 mL single dose for COVID-19 immunisation. Medical history included ongoing smoker (patient smoked a lot). The patient did not experienced COVID-19 prior vaccination. Concomitant medications included tramadol (formulation: capsule, strength: 50 mg); metoprolol (formulation: modified-release tablet, strength: 50 mg); calcium carbonate (CALCI CHEW, formulation: chewable tablet, strength: 1.25 g); pantoprazole (formulation: gastro-resistant tablet, strength: 40 mg); fluoxetine (formulation: dispersible tablet, strength: 20 mg); losartan (formulation: film-coated tablet, strength: 50 mg); angelica archangelica root/carum carvi fruit/chelidonium majus herb/glycyrrhiza glabra root/iberis amara/matricaria recutita flower/melissa officinalis leaf/mentha x piperita leaf/silybum marianum fruit (IBEROGAST); metoclopramide (formulation: tablet) and diazepam (formulation: tablet, strength: 10 mg), all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient experienced cold shivers on 15May2021, shaky on 12May2021, feeling unwell on 15May2021, temperature 35.4 weak on 12May2021, muscle pain on 15May2021, vomiting, fever: 40.5 to 42 degrees Celsius on 15May2021, pain in the abdomen after vomiting on 12May2021, all with fatal outcome and left arm pain, sleeping badly both on 12May2021 with outcome of unknown. The patient died on 25May2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Batch/Lot number cannot be obtained.; Reported Cause(s) of Death: Death; shivers; Shaky; Feeling unwell; Temperature 35.4 weak; Muscle pain; Vomiting; Fever: 40.5 to 42 degrees Celcius; pain in the abdomen after vomiting


VAERS ID: 1380444 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chest discomfort, Hyperventilation, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (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), Eosinophilic pneumonia (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   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: NLPFIZER INC2021627706

Write-up: Cardiac arrest; Feeling unwell; Chest pressure; Hyperventilation; This is a spontaneous report from a contactable consumer or other non-healthcare professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00556173. A 75-year-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number and expiration date not reported), second dose via an unspecified route of administration on 08May2021 as 2nd dose, 0.3 ml single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY, Formulation: Solution for injection), first dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. The patient did not have COVID-19 prior to vaccination. The patient experienced on 09May2021 (1 day after 2nd vaccination) chest pressure and hyperventilation. On 10May2021 (2 days after vaccination), had malaise and the patient had cardiac arrest resulted in death 2nd day following administration of COVID-19 vaccine Pfizer injection fluid. Chest pressure was treated with breathing exercises, hyperventilation was treated with breathing exercises and malaise was treated with breathing exercises. The reporter assessed the case as serious. It was not reported if an autopsy was performed. The outcome of chest pressure, hyperventilation and malaise was unknown, and for cardiac arrest fatal on 10May2021. Reporter Comment: Hyperventilation chest pressure, Additional information adverse drug reaction: Day after 2nd vaccination, Citizen service number available: yes, Previous COVID-19 infection: No, diagnostic procedures: N/A Reporting party Comment: I find it annoying that when I report that my father has died, questions are asked again about side effects when you have died, only the next of kin have any side effects, very much sadness and anger from disbelief, I miss daddy. No follow-up attempts possible. No further information expected. Batch/LOT number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1380467 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PEPFIZER INC2021630284

Write-up: COVID; This is a spontaneous report received from a contactable consumer or other non HCP. A 70-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as unknown, single for for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient developed COVID six days after vaccination and died on the eighth day of illness (two days after being hospitalized). The patient died on an unspecified date. It was not reported if an autopsy was performed. The reported cause of death was COVID. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: COVID


VAERS ID: 1380472 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30004272L / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute kidney injury, Alanine aminotransferase, Aspartate aminotransferase, Autopsy, Base excess, Basophil percentage, Blood bicarbonate, Blood bilirubin, Blood creatinine, Blood culture, Blood glucose, Blood osmolarity, Blood potassium, Blood sodium, Blood thyroid stimulating hormone, Blood urea, Blood uric acid, Body temperature, C-reactive protein, Dyspnoea, Electrocardiogram, Embolism, Eosinophil percentage, Escherichia sepsis, Fibrin D dimer, Gallbladder enlargement, General physical health deterioration, Haematocrit, Haemoglobin, Hyperuricaemia, International normalised ratio, Left ventricular hypertrophy, Leukopenia, Liver injury, Lymphocyte percentage, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Monocyte percentage, Neutrophil percentage, Oxygen saturation, PCO2, PO2, Physical examination, Platelet count, Platelet distribution width, Platelet-large cell ratio, Procalcitonin, Prothrombin time, Pyrexia, Red blood cell count, Red cell distribution width, Renal cyst, Respiratory failure, SARS-CoV-2 test, Troponin T, White blood cell count, pH body fluid
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Gallbladder related disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   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: Atherosclerosis generalised (High-grade); Chronic cystitis; Chronic obstructive pulmonary disease; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve calcification; Left ventricular hypertrophy; Lung neoplasm; Mediastinum neoplasm; Prostatic hyperplasia; Tobacco abuse
Allergies:
Diagnostic Lab Data: Test Date: 20210224; Test Name: Autopsy; Test Result: Inconclusive ; Result Unstructured Data: Initial diagnosis: a lardaceous tumor of the hilus and lower lobe of the right lung, 7x70 cm in size and surrounded by satellite nodules of various sizes. Metastases to the lymph nodes of the right hilum of the lung and to the lymph nodes of the tracheal bifurcation. The entire right lung, except for the tumor, is gray, poppy and disintegrates when touched. Left lung with signs of hyperemia and emphysema. High-grade generalized atherosclerosis. Left ventricular hypertrophy. Aortic valve calcification. Significant enlargement of the gallbladder. Small cysts of the kidney cortex (0.5 cm in diameter). Chronic cystitis. Prostatic hypertrophy.; Test Date: 20210220; Test Name: Base excess; Test Result: Inconclusive ; Result Unstructured Data: -7.9 mmol/l; Test Date: 20210220; Test Name: Basophil percentage; Test Result: Inconclusive ; Result Unstructured Data: 0; Test Date: 20210220; Test Name: Blood bicarbonate; Test Result: Inconclusive ; Result Unstructured Data: 16; Test Date: 20210220; Test Name: Bilirubin total; Test Result: Inconclusive ; Result Unstructured Data: 0.6; Test Date: 20210220; Test Name: Blood creatinine; Test Result: Inconclusive ; Result Unstructured Data: 2.4; Test Date: 20210221; Test Name: Blood culture; Test Result: Inconclusive ; Result Unstructured Data: Investigation was terminated on 24-Feb-2021. E. coli was grown in anaerobic culture Amoxicillin/clavulanic acid R (MIC $g=32.0) Cefuroxime I (MIC4.0) Piperacillin / Tazobactam S (MIC <=4.0) Ceftazidime S (MIC <= 0.12) Cefotaxime S (MIC <= 0.25) Cefepim S (MIC <= 0.12) Imipenem S (MIC <= 0.25) Meropenem S (MIC <= 0.25) Gentamycyna S (MIC <= 1.0) Amikacin S (MIC <= 2.0) Ciprofloxacin S (MIC <= 0.25) Trimethoprim / Sulfamethoxazole S (MIC <= 20.0); Test Date: 20210221; Test Name: Blood culture; Test Result: Inconclusive ; Result Unstructured Data: Investigation was terminated on 24-Feb-2021. E. coli was grown in aerobic culture Amoxicillin/clavulanic acid R (MIC $g=32.0) Cefuroxime I (MIC4.0) Piperacillin / Tazobactam S (MIC <=4.0) Ceftazidime S (MIC <= 0.12) Cefotaxime S (MIC <= 0.25) Cefepim S (MIC <= 0.12) Imipenem S (MIC <= 0.25) Meropenem S (MIC <= 0.25) Gentamycyna S (MIC <= 1.0) Amikacin S (MIC <= 2.0) Ciprofloxacin S (MIC <= 0.25) Trimethoprim / Sulfamethoxazole S (MIC <= 20.0); Test Date: 20210220; Test Name: Blood glucose; Test Result: Inconclusive ; Result Unstructured Data: 120; Test Date: 20210221; Test Name: Glucose; Test Result: Inconclusive ; Result Unstructured Data: 7 am: 107mg% 5 pm: 82 mg%; Comments: glycemic profile; Test Date: 20210220; Test Name: Osmolality; Test Result: Inconclusive ; Result Unstructured Data: 269; Test Date: 20210220; Test Name: Blood potassium; Test Result: Inconclusive ; Result Unstructured Data: 4.2; Test Date: 20210220; Test Name: Blood sodium; Test Result: Inconclusive ; Result Unstructured Data: 137; Test Date: 20210220; Test Name: TSH; Test Result: Inconclusive ; Result Unstructured Data: 1.57; Comments: CRPL2; Test Date: 20210220; Test Name: Blood urea; Test Result: Inconclusive ; Result Unstructured Data: 91.6; Test Date: 20210220; Test Name: Blood uric acid; Test Result: Inconclusive ; Result Unstructured Data: 8.88; Test Date: 20210219; Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: up to 39 Celsius degrees; Test Date: 20210220; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: 439; Comments: CRPL2; Test Date: 20210220; Test Name: Electrocardiogram; Test Result: Inconclusive ; Result Unstructured Data: sinus rhythm accompanied by tachycardia, single ventricular beats; Test Date: 20210220; Test Name: Eosinophil percentage; Test Result: Inconclusive ; Result Unstructured Data: 0; Test Date: 20210220; Test Name: Fibrin D dimer; Test Result: Inconclusive ; Result Unstructured Data: 1731; Test Date: 20210220; Test Name: Hematocrit; Test Result: Inconclusive ; Result Unstructured Data: 35.9; Test Date: 20210220; Test Name: Haemoglobin; Test Result: Inconclusive ; Result Unstructured Data: 12.1; Test Date: 20210220; Test Name: INR; Test Result: Inconclusive ; Result Unstructured Data: 1.4; Test Date: 20210220; Test Name: Lymphocyte percentage; Test Result: Inconclusive ; Result Unstructured Data: 19.2; Test Date: 20210220; Test Name: MCH; Test Result: Inconclusive ; Result Unstructured Data: 31.7; Test Date: 20210220; Test Name: MCHC; Test Result: Inconclusive ; Result Unstructured Data: 33.7; Test Date: 20210220; Test Name: MCV; Test Result: Inconclusive ; Result Unstructured Data: 94,m5; Test Date: 20210220; Test Name: Mean platelet volume; Test Result: Inconclusive ; Result Unstructured Data: 10.8; Test Date: 20210220; Test Name: Monocyte percentage; Test Result: Inconclusive ; Result Unstructured Data: 12; Test Date: 20210220; Test Name: Neutrophil percentage; Test Result: Inconclusive ; Result Unstructured Data: 68.8; Test Date: 20210220; Test Name: Oxygen saturation; Test Result: Inconclusive ; Result Unstructured Data: 88; Test Date: 20210220; Test Name: Partial pressure CO2; Test Result: Inconclusive ; Result Unstructured Data: 28.4; Test Date: 20210220; Test Name: pH; Test Result: Inconclusive ; Result Unstructured Data: 7.370; Test Date: 20210220; Test Name: Physical examination; Test Result: Inconclusive ; Result Unstructured Data: Acute alveolar respiratory murmur over the lung fields, rales in the interscapular region on both sides, more to the right.; Test Date: 20210220; Test Name: Platelet count; Test Result: Inconclusive ; Result Unstructured Data: 225; Test Date: 20210220; Test Name: Platelet distribution width; Test Result: Inconclusive ; Result Unstructured Data: 12.7; Test Date: 20210220; Test Name: Platelet-large cell ratio; Test Result: Inconclusive ; Result Unstructured Data: 32.1 %; Test Date: 20210220; Test Name: Partial pressure O2; Test Result: Inconclusive ; Result Unstructured Data: 58.3; Test Date: 20210220; Test Name: Procalcitonin; Test Result: Inconclusive ; Result Unstructured Data: 0.2 %; Test Date: 20210220; Test Name: Prothrombin time; Test Result: Inconclusive ; Result Unstructured Data: 62 %; Test Date: 20210220; Test Name: RBC count; Test Result: Inconclusive ; Result Unstructured Data: 3.82; Test Date: 20210220; Test Name: Red cell distribution width; Test Result: Inconclusive ; Result Unstructured Data: RDW-SD 47.4 fl RDW-CV 13.6 %; Test Date: 20210220; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210220; Test Name: Troponin T; Test Result: Inconclusive ; Result Unstructured Data: 14.17; Test Date: 20210220; Test Name: WBC; Test Result: Inconclusive ; Result Unstructured Data: 2.92; Test Date: 20210220; Test Name: APTT; Test Result: Inconclusive ; Result Unstructured Data: 40; Test Date: 20210220; Test Name: Alanine aminotransferase; Test Result: Inconclusive ; Result Unstructured Data: 62.9; Test Date: 20210220; Test Name: Aspartate aminotransferase; Test Result: Inconclusive ; Result Unstructured Data: 62.6
CDC Split Type: PLMODERNATX, INC.MOD20211

Write-up: Escherishia coli sepsis; Suspicion of embolism; Small kidney cysts; Liver damage; Respiratory failure; Gallbladder enlargement; Left ventricular of heart hypertrophy; Hyperuricemia; Leukopenia; Deterioration of general condition; Dyspnoea; Acute renal failure; Fever; This regulatory authority case was reported by a physician and describes the occurrence of ESCHERICHIA SEPSIS (Escherishia coli sepsis), EMBOLISM (Suspicion of embolism), RENAL CYST (Small kidney cysts), LIVER INJURY (Liver damage), RESPIRATORY FAILURE (Respiratory failure), GALLBLADDER ENLARGEMENT (Gallbladder enlargement), LEFT VENTRICULAR HYPERTROPHY (Left ventricular of heart hypertrophy), HYPERURICAEMIA (Hyperuricemia), LEUKOPENIA (Leukopenia), GENERAL PHYSICAL HEALTH DETERIORATION (Deterioration of general condition), DYSPNOEA (Dyspnoea), ACUTE KIDNEY INJURY (Acute renal failure) and PYREXIA (Fever) in a 72-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 30004272L) for COVID-19 vaccination. The patient''s past medical history included Tobacco abuse, Lung neoplasm, Aortic valve calcification, Aortic valve calcification, Prostatic hyperplasia, Left ventricular hypertrophy and Mediastinum neoplasm. Concurrent medical conditions included Chronic cystitis, Type 2 diabetes mellitus, Chronic obstructive pulmonary disease and Atherosclerosis generalised (High-grade). On 18-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced ESCHERICHIA SEPSIS (Escherishia coli sepsis) (seriousness criterion death), EMBOLISM (Suspicion of embolism) (seriousness criterion death), RENAL CYST (Small kidney cysts) (seriousness criterion death), LIVER INJURY (Liver damage) (seriousness criterion death), RESPIRATORY FAILURE (Respiratory failure) (seriousness criterion death), GALLBLADDER ENLARGEMENT (Gallbladder enlargement) (seriousness criterion death), LEFT VENTRICULAR HYPERTROPHY (Left ventricular of heart hypertrophy) (seriousness criterion death), HYPERURICAEMIA (Hyperuricemia) (seriousness criterion death), LEUKOPENIA (Leukopenia) (seriousness criterion death), GENERAL PHYSICAL HEALTH DETERIORATION (Deterioration of general condition) (seriousness criterion death), DYSPNOEA (Dyspnoea) (seriousness criterion death), ACUTE KIDNEY INJURY (Acute renal failure) (seriousness criteria death and medically significant) and PYREXIA (Fever) (seriousness criterion death). The patient died on 22-Feb-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Body temperature: upto 39 (Inconclusive) up to 39 Celsius degrees. On 20-Feb-2021, Activated partial thromboplastin time: 40 (Inconclusive) 40. On 20-Feb-2021, Alanine aminotransferase: 62.9 (Inconclusive) 62.9. On 20-Feb-2021, Aspartate aminotransferase: 62.6 (Inconclusive) 62.6. On 20-Feb-2021, Base excess: -7.9 (Inconclusive) -7.9 mmol/l. On 20-Feb-2021, Basophil percentage: 0 (Inconclusive) 0. On 20-Feb-2021, Blood bicarbonate: 16 (Inconclusive) 16. On 20-Feb-2021, Blood bilirubin: 0.6 (Inconclusive) 0.6. On 20-Feb-2021, Blood creatinine: 2.4 (Inconclusive) 2.4. On 20-Feb-2021, Blood glucose: 120 (Inconclusive) 120. On 20-Feb-2021, Blood osmolarity: 269 (Inconclusive) 269. On 20-Feb-2021, Blood potassium: 4.2 (Inconclusive) 4.2. On 20-Feb-2021, Blood sodium: 137 (Inconclusive) 137. On 20-Feb-2021, Blood thyroid stimulating hormone: 1.57 (Inconclusive) 1.57. On 20-Feb-2021, Blood urea: 91.6 (Inconclusive) 91.6. On 20-Feb-2021, Blood uric acid: 8.88 (Inconclusive) 8.88. On 20-Feb-2021, C-reactive protein: 439 (Inconclusive) 439. On 20-Feb-2021, Electrocardiogram: unknown (Inconclusive) sinus rhythm accompanied by tachycardia, single ventricular beats. On 20-Feb-2021, Eosinophil percentage: 0 (Inconclusive) 0. On 20-Feb-2021, Fibrin D dimer: 1731 (Inconclusive) 1731. On 20-Feb-2021, Haematocrit: 35.9 (Inconclusive) 35.9. On 20-Feb-2021, Haemoglobin: 12.1 (Inconclusive) 12.1. On 20-Feb-2021, International normalised ratio: 1.4 (Inconclusive) 1.4. On 20-Feb-2021, Lymphocyte percentage: 19.2 (Inconclusive) 19.2. On 20-Feb-2021, Mean cell haemoglobin: 31.7 (Inconclusive) 31.7. On 20-Feb-2021, Mean cell haemoglobin concentration: 33.7 (Inconclusive) 33.7. On 20-Feb-2021, Mean cell volume: 94 (Inconclusive) 94,m5. On 20-Feb-2021, Mean platelet volume: 10.8 (Inconclusive) 10.8. On 20-Feb-2021, Monocyte percentage: 12 (Inconclusive) 12. On 20-Feb-2021, Neutrophil percentage: 68.8 (Inconclusive) 68.8. On 20-Feb-2021, Oxygen saturation: 88 (Inconclusive) 88. On 20-Feb-2021, PCO2: 28.4 (Inconclusive) 28.4. On 20-Feb-2021, PO2: 58.3 (Inconclusive) 58.3. On 20-Feb-2021, Physical examination: abnormal (Inconclusive) Acute alveolar respiratory murmur over the lung fields, rales in the interscapular region on both sides, more to the right.. On 20-Feb-2021, Platelet count: 225 (Inconclusive) 225. On 20-Feb-2021, Platelet distribution width: 12.7 (Inconclusive) 12.7. On 20-Feb-2021, Platelet-large cell ratio: 32.1 (Inconclusive) 32.1 %. On 20-Feb-2021, Procalcitonin: 0.2% (Inconclusive) 0.2 %. On 20-Feb-2021, Prothrombin time: 62% (Inconclusive) 62 %. On 20-Feb-2021, Red blood cell count: 3.82 (Inconclusive) 3.82. On 20-Feb-2021, Red cell distribution width: 47.4 (Inconclusive) RDW-SD 47.4 fl RDW-CV 13.6 %. On 20-Feb-2021, SARS-CoV-2 test: negative (Negative) negative. On 20-Feb-2021, Troponin T: 14.17 (Inconclusive) 14.17. On 20-Feb-2021, White blood cell count: 2.92 (Inconclusive) 2.92. On 20-Feb-2021, pH body fluid: 7.370 (Inconclusive) 7.370. On 21-Feb-2021, Blood culture: unknown (Inconclusive) Investigation was terminated on 24-Feb-2021. E. coli was grown in anaerobic culture Amoxicillin/clavulanic acid R (MIC $g=32.0) Cefuroxime I (MIC4.0) Piperacillin / Tazobactam S (MIC <=4.0) Ceftazidime S (MIC <= 0.12) Cefotaxime S (MIC <= 0.25) Cefepim S (MIC <= 0.12) Imipenem S (MIC <= 0.25) Meropenem S (MIC <= 0.25) Gentamycyna S (MIC <= 1.0) Amikacin S (MIC <= 2.0) Ciprofloxacin S (MIC <= 0.25) Trimethoprim / Sulfamethoxazole S (MIC <= 20.0) and unknown (Inconclusive) Investigation was terminated on 24-Feb-2021. E. coli was grown in aerobic culture Amoxicillin/clavulanic acid R (MIC $g=32.0) Cefuroxime I (MIC4.0) Piperacillin / Tazobactam S (MIC <=4.0) Ceftazidime S (MIC <= 0.12) Cefotaxime S (MIC <= 0.25) Cefepim S (MIC <= 0.12) Imipenem S (MIC <= 0.25) Meropenem S (MIC <= 0.25) Gentamycyna S (MIC <= 1.0) Amikacin S (MIC <= 2.0) Ciprofloxacin S (MIC <= 0.25) Trimethoprim / Sulfamethoxazole S (MIC <= 20.0). On 21-Feb-2021, Blood glucose: 107 (Inconclusive) 7 am: 107mg% 5 pm: 82 mg%. On 24-Feb-2021, Autopsy: abnormal (Inconclusive) Initial diagnosis: a lardaceous tumor of the hilus and lower lobe of the right lung, 7x70 cm in size and surrounded by satellite nodules of various sizes. Metastases to the lymph nodes of the right hilum of the lung and to the lymph nodes of the tracheal bifurcation. The entire right lung, except for the tumor, is gray, poppy and disintegrates when touched. Left lung with signs of hyperemia and emphysema. High-grade generalized atherosclerosis. Left ventricular hypertrophy. Aortic valve calcification. Significant enlargement of the gallbladder. Small cysts of the kidney cortex (0.5 cm in diameter). Chronic cystitis. Prostatic hypertrophy.. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DYSPNOEA (Dyspnoea), ACUTE KIDNEY INJURY (Acute renal failure) and PYREXIA (Fever) to be probably related and ESCHERICHIA SEPSIS (Escherishia coli sepsis), EMBOLISM (Suspicion of embolism), RENAL CYST (Small kidney cysts), LIVER INJURY (Liver damage), RESPIRATORY FAILURE (Respiratory failure), GALLBLADDER ENLARGEMENT (Gallbladder enlargement), LEFT VENTRICULAR HYPERTROPHY (Left ventricular of heart hypertrophy), HYPERURICAEMIA (Hyperuricemia), LEUKOPENIA (Leukopenia) and GENERAL PHYSICAL HEALTH DETERIORATION (Deterioration of general condition) to be possibly related. Additional medical history details included a tumor of the mediastinum and hilum of the right lung - in an ambulatory chest CT scan with contrast (09-Feb-2021), pathological infiltrative-nodal mass, also described peripherally from the tumor in the upper lobe at the apex of the segment 6 GGO density of atelectatic-inflammatory nature with accompanying fibrosis. For this reason, the patient was consulted by an oncologist and then referred to a thoracic surgeon - where after consultation, the date of bronchoscopy was scheduled and laboratory tests were ordered Concomitant product details were not provided. Treatment information not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Translation Document received on 26-MAY-2021.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1380474 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-20
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   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: Heart disease, unspecified (The patient was taking heart medications); Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20211

Write-up: Possibly thrombosis; This regulatory authority case was reported by a consumer and describes the occurrence of THROMBOSIS (Possibly thrombosis) in a 63-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Heart disease, unspecified (The patient was taking heart medications). On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced THROMBOSIS (Possibly thrombosis) (seriousness criteria death and medically significant). The patient died on 20-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was reported as heart medications (not otherwise specified). Treatment information was not provided. Very limited information regarding this event has been provided at this time. Further information cannot be requested.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information cannot be requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1380510 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-03-01
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 2021-03-01
   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: Hypertension (controlled with medication)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021627927

Write-up: Cerebral haemorrhage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB [Regulatory Authority number SE-MPA-2021-038656], Safety Report Unique Identifier SE-VISMA-1620984232169. This is the first of two reports for the same patient, and pertains to the 2nd dose administered. A 94-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, on 10Feb2021, as single dose, for COVID-19 immunisation. Medical history included ongoing hypertension (controlled with medication). Concomitant medications were not reported. Previously the patient received the 1st dose of Comirnaty on 22Jan2021 and experienced dizziness and sick; earlier vaccinations with influenza vaccine (unknown manufacturer) for immunisation. The patient experienced cerebral haemorrhage (death) in Mar2021 with fatal outcome in Mar2021. The patient died in Mar2021 due to cerebral haemorrhage and dizziness. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : SE-PFIZER INC-2021632027 Same patient, different dose/events; Reported Cause(s) of Death: Cerebral haemorrhage; Dizziness


VAERS ID: 1380528 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Illness
SMQs:, Anticholinergic syndrome (broad), Vestibular 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: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021632027

Write-up: Dizziness; Sick; This is a spontaneous case from a contactable consumer. This is the 2nd of 2 cases. The first case was downloaded from the Regulatory Authority-WEB [SE-MPA-2021-038656]. A 94-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, on 22Jan2021, as single dose, for COVID-19 immunisation. Medical history included ongoing hypertension. The patient previously received vaccinations with influenza vaccine (unknown manufacturer) for immunisation. The patient experienced dizziness (death) in 2021 with fatal outcome on unspecified date and sick (non serious) in 2021 with outcome of unknown. The patient felt sick, dizzy, dazed already after the first dose and said several times that it started after the first dose. She did not think she felt that way when she received vaccinations earlier for seasonal flu. The patient died in 2021 due to dizziness and cerebral bleeding. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : SE-PFIZER INC-2021627927 Same patient, different dose/events; Reported Cause(s) of Death: Cerebral bleeding; Dizziness


VAERS ID: 1380531 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW5279 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Death, Oxygen saturation, Oxygen saturation decreased
SMQs:, Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), 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: 2021-04-24
   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: KVENTIAX; CONCOR COR; LASIX [FUROSEMIDE SODIUM]; LEKADOL; PLIVIT D3; PANTOPRAZOL TEVA; TRAJENTA; ANALGIN [METAMIZOLE SODIUM MONOHYDRATE]
Current Illness: Illness; Immobile; Oxygen therapy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210423; Test Name: Body temperature; Result Unstructured Data: Test Result:38.4 Centigrade; Test Date: 20210424; Test Name: Oxygen saturation; Test Result: 77 %
CDC Split Type: SIPFIZER INC2021630085

Write-up: Death; Oxygen saturation decreased; Body temperature increased 38,4?C; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the Regulatory Authority-WEB (regulatory authority number SI-JAZMP-NCPHV-2021SI0612_0612). A 90-year-old male patient received the second dose of bnt162b2 (COMIRNATY) intramuscular on 23Apr2021 11:00 (at the age of 90-year-old) (Batch/Lot Number: EW5279; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Relevant medical history included ongoing immobile, ongoing chronically ill and ongoing permanent oxygen therapy at home. Concomitant medications included quetiapine fumarate (KVENTIAX) taken for an unspecified indication from 13Mar2021 to an unspecified stop date; bisoprolol fumarate (CONCOR COR) taken for an unspecified indication from 17Mar2021 to an unspecified stop date; furosemide sodium (LASIX) taken for an unspecified indication from 17Mar2021 to an unspecified stop date; paracetamol (LEKADOL) taken for an unspecified indication from 17Mar2021 to an unspecified stop date; colecalciferol (PLIVIT D3) taken for an unspecified indication from 17Mar2021 to an unspecified stop date; pantoprazole sodium sesquihydrate (PANTOPRAZOL TEVA) taken for an unspecified indication from 27Mar2021 to an unspecified stop date; linagliptin (TRAJENTA) taken for an unspecified indication from 17Mar2021 to an unspecified stop date; metamizole sodium monohydrate (ANALGIN) taken for an unspecified indication from 26Mar2021 to an unspecified stop date. On 23Apr2021 at 3pm, the patient experienced increased body temperature 38.4?C (lasted one day) and had an increased need for oxygen (already on permanent oxygen therapy at home). On 24Apr2021 at 6 p.m., oxygen saturation dropped to 77%, and despite the arrival of emergency general medical care, the patient died at 7:05 p.m. The patient was not newly ill for at least one week before vaccination. The patient was immobile, chronically ill and on permanent oxygen therapy at home. The cause of death was unknown. It was not reported if an autopsy was performed. This case report was assessed as medically significant. No additional data arrived in the initial case report. Additional information was requested. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1380533 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Bradycardia, C-reactive protein, Cardiac arrest, Cardiopulmonary failure, Computerised tomogram, Cyanosis, Hyperglycaemia, Hypotension, Laboratory test, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, Oxygen saturation decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (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), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   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: Arterial hypertension; Dementia Alzheimer''s type; Diabetes mellitus (on treatment with oral antidiabetics (not specified)); Dysarthria; Hypoacusis; Obesity; Popliteal vein thrombosis; Schizo-affective type of psychosis; Stroke (acute stroke (in 2004, 2018)); Vein disorder (chronic venous disease of lower extremities)
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: hypotension; Result Unstructured Data: Test Result:hypotension; Test Date: 20210203; Test Name: CT scan of brain, chest, abdomen findingd; Result Unstructured Data: Test Result:ischemia parietooccipital; Comments: ischemia parietooccipital on the right side of the brain, vascular ileus, suspect bronchopneumonia bilateral; Test Date: 20210203; Test Name: C-reactive protein; Result Unstructured Data: Test Result:increased; Test Date: 20210203; Test Name: cardiac specific markers; Result Unstructured Data: Test Result:increased (not otherwise specified); Test Date: 20210203; Test Name: NT-proBNP; Result Unstructured Data: Test Result:Positive; Test Date: 20210203; Test Name: hyposaturation; Result Unstructured Data: Test Result:hyposaturation
CDC Split Type: SKPFIZER INC2021588337

Write-up: Cardiopulmonary failure; central and peripheral cyanosis; hyperglycaemia; hypotension; hyposaturation; asystolia; bradycardia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB SK-SUKLSK-20210604. An 83-year-old female patient received bnt162b2 (COMIRNATY), intramuscularly on 02Feb2021 (Batch/Lot Number: Unknown) as unknown, 0.3ml single for covid-19 immunisation. Medical history included diabetes mellitus on treatment with oral antidiabetics (not specified), state after acute stroke (in 2004, 2018) with dysarthria and hypoacusis, dementia Alzheimer''s type, schizo-affective type of psychosis, chronic venous disease of lower extremities, popliteal vein thrombosis, arterial hypertension, obesity. The patient''s concomitant medications were not reported. The patient experienced cardiopulmonary failure with a fatal outcome of reaction on 03Feb2021. The patient was vaccinated on 02Feb2021 with bnt162b2. On the next day (03Feb2021) the patient visited emergency department because of central and peripheral cyanosis, hyperglycaemia (unmeasurable), hypotension, hyposaturation. Laboratory tests were performed on 03Feb2021: C-reactive protein increased, NT-proBNP positive, cardiac specific markers increased (not otherwise specified). The physician performed toilet of respiratory airways with a plegic content. During the transport for CT scan investigation the patient experienced bradycardia and asystolia. It was needed cardiopulmonary resuscitation and adrenalin administration with good response, the heart rhythm was restored. CT scan of brain, chest, abdomen findings on 03Feb2021: ischemia parieto-occipital on the right side of the brain, vascular ileus, suspect bronchopneumonia bilateral. After CT scan preformation, the patient experienced asystolia repeatedly without any response to treatment. On 03Feb2021 at 03:43 a.m. it was stated exitus letalis. Cardiopulmonary failure is suspected as the immediate cause of death. The physician recommended an autopsy. Therapeutic measures were taken as a result of asystolia and bradycardia. The patient died on 03Feb2021 at 03:43 a.m. It was not reported if an autopsy was performed. Reporter Comment: Cardiopulmonary failure is suspected as the immediate cause of death. The causality was not confirmed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Cardiopulmonary failure is suspected as the immediate cause of death. The causality was not confirmed.; Reported Cause(s) of Death: Cardiopulmonary failure


VAERS ID: 1380534 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Dysstasia, Gait disturbance, Muscular weakness, Vital signs measurement
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   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: Medical History/Concurrent Conditions: Cardiac disorder NOS; Movement disorder (The patient has had problems with movement in the past); Pacemaker insertion (cardiac); Renal disorder NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210423; Test Name: vital signs; Result Unstructured Data: Test Result:without vital signs; Comments: at 14:40 the patient was found without vital signs by her family
CDC Split Type: SKPFIZER INC2021617868

Write-up: unknown cause of death; Lower extremities weakness of; unable to stand up; problem with walking; This is a spontaneous report received from a contactable consumer (patient daughter) downloaded from the Regulatory Authority-WEB. Regulatory authority number SK-SUKLSK-20214137. A 90-year-old female patient received the second dose of BNT162B2 (COMIRNATY; lot EX0893, expiry date Jul2021) intramuscular, on 22Apr2021, at 14:17, for COVID-19 immunisation. Medical history included pacemaker insertion (cardiac) from an unknown date and unknown if ongoing, movement disorder not ongoing (the patient has had problems with movement in the past), heart disease NOS from an unknown date and unknown if ongoing and kidney disease NOS. The first dose of Comirnaty was administered on an unspecified date with no adverse effect. Concomitant medications were not reported. Before the second vaccination the patient health condition was stabilised, she was regularly observed by her physician. The patient experienced adverse drug reactions 30 minutes after the second vaccination, on 22Apr2021. The patient experienced weakness of lower extremities, unable to stand up. The problem with walking lasted one hour. The reporter stated that the patient has had problems with movement in the past, but not in that extend. In the morning, on the next day after vaccination, the patient condition was better and she recovered from the previous state. On 23Apr2021 at 14:40 the patient was found without vital signs by her family. Weakness of lower extremities and unable to stand up were reported with fatal outcome. However, cause of death was unknown. Reporter''s comments: The family did not consent to an autopsy. The family consider the causality as possible. Sender Comment: Because of unknown cause of death and missing statement of pathologist, the causal relationship could not be assessed. No follow-up attempts possible. No further information expected.; Reporter''s Comments: The family did not consent to an autopsy. The family consider the causality as possible.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1380535 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Haematoma, Pain in extremity, Pallor
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Limb ischaemia (Chronic lower limb ischaemia); Triple vessel bypass graft; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: SKPFIZER INC2021617816

Write-up: Pallor of skin; haematoma of left arm; Shivering; pain of whole upper left extremity; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number SK-SUKLSK-20214306. An 87-year-old male patient received his first dose of BNT162B2 (COMIRNATY) (tozinameran, Batch/lot number ET6956) intramuscular on 27Apr2021 for Covid-19 immunization. Relevant medical history included triple vessel bypass graft, type 2 diabetes mellitus and chronic lower limb ischaemia. Concomitant medications were not reported. On 28Apr2021 the patient experienced tremor (shivering), pale skin, hematoma of two thirds of the left shoulder, pain of the whole left upper limb. On 30Apr2021 around 16:00 there was an escalation of shoulder pain and patient''s relatives transported him to the hospital, admitted for hospitalization. On 01May2021 at 08:50 a.m. the patient was pronounced as dead. After death the autopsy was not done. The physician has little information on cause of death, "the only available reported information were from inspection of a body after death: Ia: Heart failure, unspecified, Ic: Chronic ischaemic heart disease, II: Poisoning by anticoagulant antagonists (vitamin K)". The outcome of all events was reported as fatal. Sender Comment: Because of insufficient information on this case and missing autopsy, the causal relationship can not be assess. The physician was not able to assess the causality because of little information on this case and missing autopsy. The physician considered the time relationship to vaccine administration. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: pain of whole upper left extremity; pallor of skin; hematoma of left arm; Shivering


VAERS ID: 1380536 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Aspartate aminotransferase, Asthenia, Echocardiogram, Electrocardiogram, Fall, Mobility decreased, N-terminal prohormone brain natriuretic peptide, Troponin, Viral myocarditis
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 30
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: Arterial hypertension; Atherosclerosis (80%); Bladder operation; Carotid endarterectomy; Chronic atrial fibrillation; Chronic kidney disease; Chronic obstructive lung disease; Coronary artery bypass graft; Myocardial infarction; Pulmonary hypertension; Type 2 diabetes mellitus (on treatment with oral antidiabetics (not specified)); Urinary bladder carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:increased; Comments: 5x higher; Test Date: 202102; Test Name: echocardiography; Result Unstructured Data: Test Result:MR II+, Ao R II, TR III+; Test Date: 202102; Test Name: ekg; Test Result: Negative ; Comments: negative T wave; Test Date: 202102; Test Name: NT-proBNP; Result Unstructured Data: Test Result:6500 ng/L; Test Date: 202102; Test Name: Troponin; Result Unstructured Data: Test Result:30 ng/ml; Test Date: 202102; Test Name: Troponin; Result Unstructured Data: Test Result:530 ng/ml; Test Date: 202102; Test Name: Troponin; Result Unstructured Data: Test Result:200 ng/ml; Test Date: 202102; Test Name: virus markers of myocarditis; Test Result: Negative ; Comments: virus markers of myocarditis (not specified. bacterial ethiology: unlikely
CDC Split Type: SKPFIZER INC2021588381

Write-up: falling at home; Acute myocardial infarction/fresh myocardial infarction; progressive weakness; mobility impairment; This is a spontaneous report from two contactable physicians downloaded from the Regulatory Authority-WEB. Regulatory authority report number SK-SUKLSK-20214309. An 87-year-old male patient received BNT162B2 (COMIRNATY), intramuscular on 26Jan2021 (at the age of 87 years old; Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included chronic atrial fibrillation, myocardial infarction, chronic obstructive lung disease, coronary artery bypass graft in 2006, atherosclerosis 80%, arterial hypertension, pulmonary hypertension, Type 2 diabetes mellitus on treatment with oral antidiabetics (not specified), chronic kidney disease, urinary bladder carcinoma, resection of urinary bladder in 2003, reoperation in 2012, and carotid endarterectomy. The patient''s concomitant medications were not reported. The patient was vaccinated with first dose of COMIRNATY on 26Jan2021. After the first dose vaccine administration on 26Jan2021, the patient experienced progressive weakness and mobility impairment. Prior to vaccination, the patient was able to go up the stairs. On 18Feb2021, the patient was hospitalized after the falling at home. Laboratory tests in Feb2021 showed increased troponin with a progression (30 ng/mL; 200ng/mL; 530ng/mL), NT-proBNP (6500 ng/L), increased AST (5x higher). ECG: negative T wave and Echocardiography: MR II+, Ao R II, TR III+ in Feb2021. The patient experienced acute myocardial infarction on unspecified date. The physician assessed the patient''s health state as acute myocarditis with suspect toxic etiology after vaccination. Investigations were performed (not otherwise specified) - virus markers of myocarditis (not specified): negative, bacterial etiology: unlikely. The second dose of vaccine should have been administered on 24Feb2021. Because of suspect acute myocarditis the physician postponed the second dose of vaccine. On 25Feb2021 at 04:35 am, it was stated an exitus letalis. An autopsy was done. The pathologist reported autopsy-determined cause of death as fresh myocardial infarction, very serious atherosclerosis (80%), the state after coronary artery bypass graft (in 2006), the state after urinary bladder resection because of carcinomatosis (in 2003) and reoperation (in 2012). The pathologist excluded myocarditis, an autopsy confirmed fresh ischemic signs of acute myocardial infarction without lymphocytic/plasmocytes cellulisation, which were observed in histological heart samples. The pathologist reported that the death cannot be related to the vaccination. Outcome of fall, progressive weakness, and mobility impairment were unknown. The patient died due to acute myocardial infarction/fresh myocardial infarction on 25Feb2021 at 04:35 am. Sender''s Comment: This case was verified by the physician (pathologist) and the causality was assessed as not related to vaccination (unlikely). Lot/batch no.: unknown Reporter''s comment: 87-year-old polymorbid patient with chronic atrial fibrillation, after myocardial infarction and coronary artery bypass graft, with chronic kidney disease, after carotid endarterectomy 2015, diabetes mellitus type 2 on Peroral Antidiabetic Therapy, chronic obstructive lung disease, pulmonary hypertension, arterial hypertension, brought after the falling at home. 1st dose of anticovid-19 vaccine was administered 26Jan2021. Progressive weakness and mobility impairment (before the vaccination, the patient was able to go up the stairs), 18Feb2021 was hospitalized after the falling at home. Laboratory tests: high troponin with a progression (30; 200; 530), NT-proBNP (6500), 5xAST, ECG negative T wave, echocardiography MR II+, Ao R II, TR III+. Virus markers of myocarditis negative, bacterial etiology unlikely, possible toxic etiology after the vaccine? 2nd dose of the vaccine was planned 24Feb2021 postponed because of acute myocarditis, on 25Feb2021 at 4:35 a. m. it was stated an exitus letalis. Supplement from a doctor (pathology): The patient was necropsied. We didn''t have a mention about the vaccination in documentation. Cause of death as fresh myocardial infarction, very serious atherosclerosis (80% disability), the state after coronary artery bypass graft (2006). The state after urinary bladder resection because of carcinomatosis reoperation (2003, 2021). In the event of the death of (the patient), we exclude of myocarditis presence. Fresh ischemic changes of acute myocardial infarction without increased lympho/plasmocytes cellulisation are present in histological heart samples. The death is not related. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: Acute myocardial infarction/fresh myocardial infarction


VAERS ID: 1380538 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-08
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: 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: TRPFIZER INC2021616675

Write-up: passed away; This is a spontaneous report from a contactable health professional (relative). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient passed away after getting two doses of vaccine on an unspecified date. Another relative of reporter saw that when a magnet was placed on the place where the vaccine was administered, they saw that it sticks. The outcome of event was fatal. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, 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: passed away


VAERS ID: 1381508 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-21
Onset:2021-05-01
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Vaccination failure
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: 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: IBRUTINIB;OBINUTUZUMAB
Current Illness: Extranodal marginal zone B-cell lymphoma (MALT type) stage IV (according to Ann Arbor: ongoing chemotherapy with 2021 obinutuzumab and ibrutinib)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021627610

Write-up: Covid, severe disease on 01May2021; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-28994. A 62-years-old male patient received BNT162B2 (COMIRNATY; Solution for injection; Batch/Lot number was not reported), dose 2 intramuscular on 21Mar2021 as single dose and dose 1 via an unspecified route of administration on 21Feb2021 as single dose for covid-19 immunisation. Medical history included ongoing extranodal marginal zone B-cell lymphoma (MALT type) stage IV (according to (city name): ongoing chemotherapy with 2021 obinutuzumab and ibrutinib). Concomitant medication(s) included ibrutinib; obinutuzumab (IBRUTINIB;OBINUTUZUMAB) for chemotherapy from 2021. The patient experienced vaccination failure, other, Covid, severe disease on 01May2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. This serious spontaneous report was received from a physician. The outcome for events vaccination failure and Covid, severe disease on 01May2021 was fatal. Sender Comment: The report is for a patient. No mail was sent to reporters! No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Sender''s Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. 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.; Reported Cause(s) of Death: Covid, severe disease on 01May2021


VAERS ID: 1381535 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-07
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Concomitant disease progression
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: AUPFIZER INC2021631622

Write-up: Concomitant disease progression; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority. Regulatory authority number 557262. A 68 years old female patient received BNT162B2 (COMIRNATY) on an unknown date, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if she was pregnant. On 07May2021 the patient experienced concomitant disease progression (no further details provided). The patient died on an unspecified date in 2021 due to concomitant disease progression. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Concomitant disease progression


VAERS ID: 1381536 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-24
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Concomitant disease progression
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   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: AUPFIZER INC2021634807

Write-up: Concomitant disease progression; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 557543. A 65-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient''s concomitant medications were not reported. The patient died on 24Mar2021 of a Concomitant disease progression. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Concomitant disease progression


VAERS ID: 1381537 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-27
Submitted: 0000-00-00
Entered: 2021-06-08
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: 2021-04-27
   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: AUPFIZER INC2021634809

Write-up: unknown cause of death; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 557543. A 95-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient''s concomitant medications were not reported. The patient died on 27Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1381538 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-27
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Concomitant disease progression
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: AUPFIZER INC2021634810

Write-up: Concomitant disease progression; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory Authority report number is 557868. An 89-year-old male patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (unknown if first or second dose) for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 27Apr2021, the patient experienced concomitant disease progression with fatal outcome on an unspecified date in 2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Concomitant disease progression


VAERS ID: 1381539 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-22
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 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: AUPFIZER INC2021634811

Write-up: Adverse event following immunisation; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory Authority report number is 557967. An 87-year-old female patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (unknown if first or second dose) for COVID-19 immunisation and influenza vaccine inact split 3v (FLUARIX) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for immunisation. Relevant medical history and concomitant medications were not reported. On 22May2021, the patient experienced adverse event following immunisation with fatal outcome. The patient died on an unspecified date in 2021. The cause of death was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Adverse event following immunisation


VAERS ID: 1381540 (history)  
Form: Version 2.0  
Age: 99.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021634812

Write-up: Cardiac failure; Pulmonary oedema; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 558047. A 99-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at the age of 99-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cardiac failure (death) and, pulmonary oedema (death) on an unspecified date. The autocoem of events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac failure; Pulmonary oedema


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