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

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

Government Disclaimer on use of this data



Case Details

This is page 194 out of 222

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VAERS ID: 1777214 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Mechanical ventilation, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-19
   Days after onset: 79
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: B-cell lymphoma; Diabetes mellitus; Sarcoidosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101313666

Write-up: Somnolence; Invasive mechanical ventilation; This is a spontaneous report from a non-contactable physician downloaded from the WEB, regulatory authority number DE-DCGMA-21193155. Safety Report Unique Identifier DE-PEI-202100199193. A 60-year-old male patient received bnt162b2 (COMIRNATY), via intramuscular on 24Jun2021 (at the age of 60-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included diabetes mellitus, sarcoidosis, b-cell lymphoma that all from unknown date and unknown if ongoing. Concomitant medications were not provided. On Jun2021 the patient experienced somnolence. On 2021 the patient experienced invasive mechanical ventilation. Patient died on 19Aug2021. No autopsy done. Outcome of events was fatal. This report was assessed by the reporting physician as serious of death. Relatedness of the drug to the events: Somnolence, Invasive mechanical ventilation was reported as D: unclassifiable by the regulatory authority (PEI). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Somnolence; invasive mechanical ventilation


VAERS ID: 1777215 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-19
   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: Cerebral haemorrhage; Hemiparesis; Immune-mediated meningoencephalitis; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101313194

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the WEB DE-DCGMA-21193395. Safety Report Unique Identifier: DE-PEI-202100195038. A 63-years-old female patient received bnt162b2 (COMIRNATY 0.3ml), dose 2 intramuscular on 17Aug2021 at her 63-years-old (Batch/Lot Number: SCRW2) as dose 2, single for covid-19 immunisation . Medical history included Immune-mediated meningoencephalitis from an unknown date and not ongoing , Smoker from an unknown date and unknown if ongoing , cerebral haemorrhage from 2014 and not ongoing , hemiparesis from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Historical Vaccine included first dose bnt162b2 (COMIRNATY, 1st dose, batch/lot number: FE7011) for COVID-19 immunisation on 15Jul2021. On 19Aug2021 the patient experienced death(unknown cause of death). The patient''s outcome was fatal for death. The patient died on 19Aug2021. It was not reported if an autopsy was performed. This report is serious - death. Comirnaty/Death/PEI/C. Inconsistent causal association to immunization. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1777252 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-06-10
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   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: DEPFIZER INC202101323094

Write-up: Acute heart failure; This is a spontaneous report from a non-contactable physician downloaded from the WEB, regulatory authority number DE-PEI-202100201561. An 85-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: EW8904) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation (at the age of 84-year-old). The patient medical history and concomitant medications were not reported. The patient experienced acute heart failure (death, hospitalization) on 10Jun2021. The patient died on 10Jun2021 with cause of cardiac failure left. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac failure left


VAERS ID: 1777300 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-25
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous thrombosis, Circulatory collapse, Death, Haemorrhage subcutaneous, Pain, Petechiae, Rash, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-15
   Days after onset: 174
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: Rheumatism
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101272500

Write-up: thrombosis in the head/Thrombosis cerebral vein; death; Circulatory failure; Skin rash; Subcutaneous bleeding; Pain; Vomiting; Petechiae; This is a spontaneous report from a non-contactable consumer downloaded from the WEB DE-PEI-CADR2021180454, Safety Report Unique Identifier DE-PEI-202100191863. A 76-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 03Mar2021 (Lot Number: ER9470) as dose number unknown, single for COVID-19 immunisation. Medical history included rheumatism from an unknown date. No relevant medical history reported. The patient''s concomitant medications were not reported. This report is serious due to hospitalization. The patient''s weight was 38 kg, and height was 160 cm. On 25Mar2021, the patient experienced vomiting, pain, skin rash, petechiae (also reported as subcutaneous bleeding), thrombosis cerebral vein (also reported as thrombosis in the head), circulatory failure. On 15Sep2021, the patient experienced unknown cause of death. The event thrombosis in the head caused hospitalization. The patient died on 15Sep2021. An autopsy was not performed. The outcome of death was fatal, outcome of event thrombosis in the head/Thrombosis cerebral vein, circulatory failure, skin rash, subcutaneous bleeding, pain, vomiting, petechiae was not recovered. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? no information on risk factors or previous illnesses rheumatism, Relatedness of drug to reaction/event for all events was unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1777380 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-22
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101313265

Write-up: Malaise; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021185289. Safety Report Unique Identifier DE-PEI-202100199645. A 47-year-old female patient received BNT162B2 (COMIRNATY, lot number: EP9598) via an unspecified route of administration on 09Sep2021 as dose number unknown, 0.3ml single for COVID-19 immunisation. Medical history and concomitant medications were unknown. On 16Sep2021 the patient experienced malaise. The patient died on 22Sep2021. It was unknown if autopsy was performed. Outcome of the event was fatal. This report is serious - death. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: malaise


VAERS ID: 1777381 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-03-12
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Plasmacytoma
SMQs:, Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101314114

Write-up: Plasmacytoma; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority number DE--CADR2021185962.Safety Report Unique Identifier DE--202100200412. A 82-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 08Feb2021 (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Mar2021 the patient experienced Plasmacytoma.The patient''s outcome was fatal for Plasmacytoma. This report is serious as death.Relatedness of the drug to the event: Plasmacytoma was reported as D: unclassifiable by the regulatory authority (PEI).Sender Comment: Are you or the person concerned known of any allergies? If yes, which? no. Information on risk factors or previous illnesses: none / B On 20Apr2021 diagnosis: plasmacytoma The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Reported Cause(s) of Death: Plasmacytoma


VAERS ID: 1777397 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral thrombosis
SMQs:, Ischaemic 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: DEPFIZER INC202101323243

Write-up: blood clot in his brain; This is a spontaneous report from a contactable consumer (patient child) based on information received by Pfizer from Biontech [manufacturer control number: 91118], license party for Comirnaty. A male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced blood clot in his brain on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.The reporter stated that their father was dying from a blood clot in his brain, not from covid, but from a side effect of the vaccine. And all the doctors say this vaccine does stroke. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: blood clot in his brain


VAERS ID: 1777475 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD3909 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Extra dose administered, Off label use
SMQs:, Anaphylactic reaction (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), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-25
   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:
CDC Split Type: ESPFIZER INC202101313942

Write-up: off label use; booster; Acute dyspnea/ Acute respiratory failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-1016910. An 88-years-old female patient received bnt162b2 (COMIRNATY), dose 3 intramuscular on 24Sep2021 (Lot Number: FD3909) as DOSE 3 (BOOSTER), 0.3 ML SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced acute dyspnea on 25Sep2021. The patient died on 25Sep2021. It was not reported if an autopsy was performed. The cause of death reported as Acute respiratory failure. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute dyspnea/ Acute respiratory failure


VAERS ID: 1777531 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Antiacetylcholine receptor antibody, Eyelid ptosis, Fall, Femoral neck fracture, Femur fracture, Myasthenia gravis, Oxygen saturation decreased, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   Days after onset: 26
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: Cognitive disorder; Fall; Fracture of humerus; Myasthenia gravis; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: acetylcholine antibody; Test Result: Positive
CDC Split Type: FRPFIZER INC202101313535

Write-up: fracture of the femur; fall; femoral neck fracture; respiratory distress with desaturation; respiratory distress with desaturation; myasthenia gravis; eyelid ptosis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-BR20213205. A 90-year-old female patient received the second dose of bnt162b2 (COMIRNATY), via intramuscular on 10Feb2021 (lot number: EJ6789) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included patient with a level of autonomy GIR 4 (as reported); multiple of falls and cognitive disorders; diagnosed with myasthenia gravis in Dec2020; osteoporosis, humerus fracture. Concomitant medications were not provided. On 18Feb2021, the patient experienced myasthenia gravis with eyelid ptosis and acetylcholine antibody positive. Ophthalmological consultation. Patient deceased. File not very informative. Additional information requested twice without response from the declarant on 13Aug2021. It was reported that patient fell from its height on 16Mar2021 femoral neck fracture, transfer to hospital by helicopter. The patient death on 17Mar2021 in a table of respiratory distress with desaturation without fever, undocumented etiology. Death probably related to a complication of the fracture of the femur. Events myasthenia gravis, eyelid ptosis reported as medically significant. Event femoral neck fracture reported as medically significant, hospitalized on 16Mar2021, death. Lab data included acetylcholine antibody was positive in Feb2021. Outcome of events myasthenia gravis, eyelid ptosis was unknown, while of the other events was fatal. No autopsy done.; Reported Cause(s) of Death: fall; fracture of the femur; respiratory distress with desaturation; respiratory distress with desaturation; femoral neck fracture


VAERS ID: 1777632 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-12
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101317815

Write-up: Adverse event following immunisation; Dyspnoea; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 635499. An 84-year-old male patient received BNT162B2 (COMIRNATY) on unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient experienced Adverse event following immunization and Dyspnoea on 12Sep2021. The patient died of Adverse event following immunization and Dyspnoea on unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Adverse event following immunisation; Dyspnoea


VAERS ID: 1777635 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-21
Onset:2021-09-27
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCKT8 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-27
   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: Apoplexy; COPD; Coronary disease; Nicotine dependence
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101314108

Write-up: Found dead (cause undetermined); This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority number DE-PEI-202100200932. A 63-year-old female patient received BNT162B2 (COMIRNATY), on 21Sep2021 at age of 63-year-old as DOSE NUMBER UNKNOWN, SINGLE (Lot number: SCKT8) for COVID-19 immunisation. Medical history included Coronary disease, COPD, Apoplexy, Nicotine dependence. No concomitant medication reported. On 27Sep2021, the patient experienced found dead (cause undetermined). No autopsy was done. Outcome of the event was fatal. Relatedness of drug to reactions/events Comirnaty / Found dead (cause undetermined) / PEI / D. Unclassifiable.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1777645 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-09-01
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Fatigue, Neck pain
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-25
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thrombosis venous (leg vein thrombosis about 5 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101323099

Write-up: Sinus vein thrombosis; tiredness; neck pain; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority number DE-PEI-CADR2021186260, Safety Report Unique Identifier DE-PEI-202100201266. A 59-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 15Jul2021 as dose 2, single for covid-19 immunisation. Medical history included leg vein thrombosis about 5 years ago. There is no known of any allergies. The patient''s concomitant medications were not reported. The patient died on 25Sep2021 due to sinus vein thrombosis/ 8 weeks following second vaccination, 2 weeks earlier onset of tiredness and neck pain (in Sep2021). The patient also experienced thrombosis of venous sinuses in Sep2021. 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: Sinus vein thrombosis


VAERS ID: 1777647 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-19
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3716 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Coronary artery occlusion, Coronary artery thrombosis, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-09-19
   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: PRENESSA
Current Illness: Alcoholism; Non-insulin-dependent diabetes mellitus; Renal failure
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarction
Allergies:
Diagnostic Lab Data: Test Name: Coronary angiography; Result Unstructured Data: Test Result:right coronary occlusion with thrombus 20 mm,; Comments: dissection
CDC Split Type: EEPFIZER INC202101314359

Write-up: right coronary occlusion with thrombus 20 mm; right coronary occlusion with thrombus 20 mm; sudden cardiac death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number EE-SAM-517021092010. A 47-year-old male patient received first dose of BNT162B2(COMIRNATY, Lot Number: FG3716), intramuscular on 09Sep2021 at 0.3ml single dose for covid-19 immunisation. Medical history included ongoing non-insulin-dependent diabetes mellitus, ongoing renal failure, ongoing alcoholism, myocardial infarction from 2015 to 2015. Concomitant medication included perindopril erbumine (PRENESSA). On 19Sep2021, at about 11.30, a sudden cardiac death occurred. Coronary angiography with right coronary occlusion with thrombus 20 mm, dissection. Revasculation failed. The event was reported as serious: death, hospitalization, life threatening. The outcome of events was fatal. The patient died on 19Sep2021 17: 15. It was not reported if an autopsy was performed. Sender Comment: The temporal relationship exists. A causal relationship cannot be assessed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden cardiac death; right coronary occlusion with thrombus 20 mm; right coronary occlusion with thrombus 20 mm


VAERS ID: 1777654 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-29
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiomegaly, Deep vein thrombosis, Inappropriate schedule of product administration, Pulmonary embolism
SMQs:, Cardiac failure (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   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: Acne rosacea (summer of 2020)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101322522

Write-up: Inappropriate schedule of vaccine administered; Pulmonary embolism; Thrombosis of leg deep venous; Cardiomegaly; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number FI--20215093. A 71-year-old female patient received the second dose of Comirnaty at single dose for COVID-19 immunisation on 02Jul2021. The patient was previously healthy and not on regular medication. In the summer of 2020, he developed rosacea of the right lower limb. Concomitant drugs were not reported. The patient previously received the first dose of Comirnaty for COVID-19 immunisation on 09Apr2021. The patient was found dead in the morning of 29Jul2021 in the yard of a private house by a garbage truck driver. An autopsy revealed a venous thrombus in the right calf and pulmonary thrombi. The heart was enlarged. Underlying cause of death was reported as Cardiomegaly / enlarged heart. Intermediate cause(s) of death was reported as Thrombosis venae cruris dextri / venous thrombosis of the right calf. Immediate cause of death (does not imply the final cause of death) was reported as Embolism pulmonis / Pulmonary embolism. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolism; Autopsy-determined Cause(s) of Death: venous thrombus in the right calf; pulmonary thrombi; enlarged heart


VAERS ID: 1777661 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Chest discomfort, Chest pain, Death
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METHADONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Addiction to drugs; Ex-alcohol user
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101313508

Write-up: Death unexplained; Chest pain; Chest tightness; tightness potentially related to anxiety; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority WEB FR-AFSSAPS-BR20213562. A 36-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 03Aug2021 (Batch/Lot Number: FE7051) as dose 1, single at the age of 36 year old for covid-19 immunisation. Medical history included ex-alcohol user, Addiction to drugs. Concomitant medication(s) included methadone taken for an unspecified indication, start and stop date were not reported. The patient experienced death unexplained on 14Aug2021.In the aftermath, he felt very bad (to the point of not wanting to take the 2nd dose) with chest pain and tightness potentially related to anxiety, according to the declaring doctor.The patient died on 14Aug2021. An autopsy was performed and results were not provided. Outcome of death unexplained was fatal, of others was not recovered. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1777734 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-05
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COVID-19; Pernicious anaemia NOS; Prostatic disorder
Preexisting Conditions: Comments: Biermer''s anemia
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive
CDC Split Type: FRJNJFOC20211013523

Write-up: VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority ( Vaccines, FR-AFSSAPS-NT20214480) on 07-OCT-2021 and concerned an 86 year old male of unspecified race and ethnic origin. The patient''s weight was 82 kilograms and height was not reported. The patient''s concurrent conditions included: covid-19, pernicious anaemia nos, and prostatic disorder, and other pre-existing medical conditions included: Biermer''s anemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) 1 dosage form, 1 total, administered on 01-JUL-2021 for sars-cov-2 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 05-AUG-2021, the patient experienced vaccination failure. Laboratory data included: SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) test (NR: not provided) Positive. On an unspecified date, the patient died from vaccination failure. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Vaccination failure was fatal. This report was serious (Death). This report was associated with a product quality complaint.; Reported Cause(s) of Death: VACCINATION FAILURE


VAERS ID: 1777761 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-08-25
   Days after vaccination:112
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine, C-reactive protein, COVID-19, Oxygen saturation, SARS-CoV-2 test, 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TACROLIMUS [TACROLIMUS MONOHYDRATE]; MYCOPHENOLATE MOFETIL; EVEROLIMUS; PREDNISOLONE; SULFAMETHOXAZOLE AND TRIMETHOPRIM; ZOPICLONE; EZETIMIBE; LANSOPRAZOLE; INSULIN; CLOPIDOGREL; AMLODIPINE; PREGABALIN
Current Illness: Arterial hypertension; Diabetes mellitus insulin-dependent; Diabetic nephropathy
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholism; Angioplasty; Cardiac transplant; Ischemic cardiomyopathy; Retinopathy; Stent placement
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: Creatinemia; Result Unstructured Data: Test Result:206 umol/l; Test Date: 202109; Test Name: CRP; Result Unstructured Data: Test Result:157 mg/l; Test Date: 202109; Test Name: spO2; Test Result: 50 %; Test Date: 20210825; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101313428

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority WEB FR-AFSSAPS-PP20211457. A 62-year-old male patient received BNT162B2 (COMIRNATY), via Intramuscular on 08Apr2021 (Lot EW2239) as dose 1, single, via Intramuscular on 05May2021 at dose 2, single for COVID-19 immunisation. D3 planned but not realized. Medical history included Angioplasty and stent in Jul2020, not ongoing, ongoing Insulin-requiring diabetes with diabetic nephropathy and retinopathy, ongoing Diabetes mellitus insulin-dependent, ongoing Arterial hypertension, Cardiac transplant for dilated and rhythmic ischemic cardiomyopathy (in 2019), Weaned alcoholism not ongoing. History of COVID: no. Concomitant medications included tacrolimus monohydrate (TACROLIMUS [TACROLIMUS MONOHYDRATE]) at 2 mg / day, mycophenolate mofetil at 1.5 g, daily, everolimus at 0.75 mg / day, prednisolone 7.5 mg / day, sulfamethoxazole and trimethoprim, zopiclone, ezetimibe, lansoprazole, insulin, clopidogrel, amlodipine, pregabalin. Details of the COVID infection, On 25Aug2021: cough, sputum and fever with positive COVID PCR/ COVID-19 confirmed by positive COVID-19 test. On 03Sep2021: worsening of symptoms, in particular respiratory symptoms, prompting a visit to the emergency room on 04Sep2021 then hospitalization in pulmonology unit. Clinically: respiratory distress with 50% spO2 in Sep2021. Signs of cardiac decompensation prompting the introduction of furosemide. No suspected rejection, no suspicion of myocarditis. Lab tests in Sep2021: Creatinemia at 206 umol / L and CRP at 157 mg / L. Infections: suspected bacterial superinfection with Streptococcus and Haemophilus pneumonia. Treatment with ceftriaxone. On 15Sep2021: Aggravation with repeated episodes of desaturations under high flow oxygenation motivating a transfer to intensive care on 16Sep2021. On 19Sep2021: Intubation before a major hypoxemia, state of vasoplegic shock. Prone position. New worsening during the night of 22 to 23Sep with an increase in the multiple organ failure. Prone position that does not improve breathing. Death on 24Sep2021. All in all, fatal COVID-19 infection in a patient who received a complete vaccination schedule: proven vaccine failure, probably favored by immunosuppression in connection with his anti-transplant rejection treatment. Outcome of the event was fatal. It is unknown if autopsy was done. No follow-up attempts are possible; information about 1 dose lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Covid-19; Vaccination failure


VAERS ID: 1777781 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-06-21
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Creutzfeldt-Jakob disease
SMQs:, Dementia (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-09-07
   Days after onset: 78
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: Hypercholesterolaemia; Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: MALADIE DE CREUTZFELD-JAKOB; This case was received (Reference number: FR-AFSSAPS-TO20217545) on 04-Oct-2021 and was forwarded to Moderna on 04-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of in an 87-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3001653 and 3000493) for COVID-19 vaccination. Concurrent medical conditions included Hypertension arterial and Hypercholesterolaemia. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jun-2021, after starting mRNA-1273 (Spikevax), the patient experienced (seriousness criteria death, hospitalization, medically significant and life threatening). The patient died on 07-Sep-2021. The reported cause of death was maladie de creutzfeld-jakob. An autopsy was not performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were mentioned. No treatment medication details were reported. Company comment: This case concerns a 87-year-old male patient, with reported medical history of hypertension arterial and hypercholesterolaemia, who experienced the unexpected fatal event of Creutzfeld-Jacob disease. The event occurred 27 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) and fatal outcome resulted 4 months 14 days post second dose. The rechallenge was not applicable as event developed after the second dose and had a fatal outcome. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) not affected by this report. Event seriousness assessed serious per Regulatory authority based on fatal outcome. Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Translation received on 06-Oct-2021 as live follow up and updated with Dosage text.; Sender''s Comments: This case concerns a 87-year-old male patient, with reported medical history of hypertension arterial and hypercholesterolaemia, who experienced the unexpected fatal event of Creutzfeld-Jacob disease. The event occurred 27 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) and fatal outcome resulted 4 months 14 days post second dose. The rechallenge was not applicable as event developed after the second dose and had a fatal outcome. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) not affected by this report. Event seriousness assessed serious per Regulatory authority based on fatal outcome.; Reported Cause(s) of Death:


VAERS ID: 1777795 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-18
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-18
   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: End stage cardiac failure; Implantable defibrillator user; Vascular dementia
Preexisting Conditions: Medical History/Concurrent Conditions: Living in residential institution
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101322698

Write-up: Acute decompensated heart failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-TO20218285. An 84-year-old male patient received 2nd dose of BNT162B2 (COMIRNATY, lot number FG7387) at single dose intramuscular in right arm on 14Sep2021 for COVID-19 immunisation. Medical history included ongoing implantable defibrillator since 2009, ongoing end-stage heart failure, ongoing vascular dementia. Patient was accommodation facility for dependent elderly people resident. Concomitant drug was not provided. Historical vaccine included 1st dose of BNT162B2 (COMIRNATY, lot number FG6273) intramuscular in left arm on 24Aug2021 for COVID-19 immunisation. Patient experienced acute decompensated heart failure on 18Sep2021. Time Interval between Beginning / Last Dose of Drug Administration and Start of Reaction / Event was reported as "5 days". Outcome of the event was fatal. Patient died at day 4 of vaccination. No autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: acute decompensated heart failure


VAERS ID: 1777828 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-26
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: 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 INC202101317791

Write-up: Cardiac arrest; This is a spontaneous report from a contactable other health professional via the Regulatory authority report number is 632340. An 80-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cardiac arrest (death) on 26Sep2021. 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 arrest


VAERS ID: 1777845 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Cyanosis, Hyperhidrosis, Loss of consciousness, Malaise, Pain in extremity, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-27
   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: Delivery (third child); Loin pain
Allergies:
Diagnostic Lab Data: Test Name: covid; Test Result: Negative
CDC Split Type: FRPFIZER INC202101322966

Write-up: unconsciousness; cyanosis; pain in the left arm; sweating; malaise; Arrest cardiac; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority report number FR-AFSSAPS-NT20214390. A 31-year-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular on 24Sep2021 (Batch/Lot Number: unknown) as single dose for COVID-19 immunisation. Medical history included loin pain and delivery third child on 20Sep2021. The patient''s concomitant medications were not reported. Cardiac arrest resulting in death in patient with no prior history at Day 3 (27Sep2021) of a BNT162B2 administration and Day 7 of a delivery. On 27Sep2021, family called of the EMERGENCY Service for pain in the left arm with sweating around 16:00 with malaise. Call back around 16:15 because still unconscious and cyanosis: beginning of cardiac massage by the husband and the father-in-law. At the arrival of the firemen then of the Emergency Service: shockable rhythm. Failure of the specialized resuscitation at 17:15. Patient had no complaint before 27Sep2021 16:00. Evolution: Death on 27Sep2021. Autopsy performed: first results of the autopsy: no obvious cause of death to date. No massive emboli. Distinct patches of pulmonary necrosis but autopsy at Day 3 post-mortem so to be interpreted with caution. COVID negative. Note: delivery 3 days after expected term date so hypercoagulable situation. Investigations were still in progress. Outcome of arrest cardiac was fatal. Outcome of other events was unknown. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Arrest cardiac; Autopsy-determined Cause(s) of Death: Initial autopsy results: no obvious cause of death at this time. No massive emboli. Distinct patches of pulmonary necrosis but autopsy at D3 post-mortem so interpret with caution. COVID negative


VAERS ID: 1777867 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-28
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 2 - / 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: 2021-03-29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DOXAZOSIN; LATANOPROST; ASPIRIN [ACETYLSALICYLIC ACID]; CANDESARTAN
Current Illness: Duodenal ulcer; Ischaemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Gastrointestinal bleed (Admitted to hospital 4th-19th March.); Hospitalisation; Hypertension; Intraocular pressure increased; Myocardial ischaemia; Comments: As I said I am reporting just because he had his 2nd vaccination the day before his death.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101317043

Write-up: Myocardial infarction; This is a spontaneous report from a contactable physician received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-ADR 26004027. A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER1741), dose 2 intramuscular on 28Mar2021 as single dose for covid-19 immunisation. Medical history included ongoing Ischaemic heart disease, ongoing duodenal ulcer, gastrointestinal haemorrhage which admitted to hospital from 04Mar2021 to 19Mar2021, allergy, hypertension, intraocular pressure increased and myocardial ischaemia. Concomitant medications included doxazosin taken for hypertension from Aug2015 to an unspecified stop date; latanoprost taken for intraocular pressure increased from Jan2014 to an unspecified stop date; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for myocardial ischaemia from Aug1996 to an unspecified stop date; candesartan taken for hypertension from Mar2007 to an unspecified stop date. Historical vaccine included 1st dose of BNT162B2 for COVID-19 immunisation. The patient experienced myocardial infarction. The patient died on 29Mar2021. It was not reported if an autopsy was performed. Clinical course was reported that patient died the next day, certificate issued after discussion with coroner as myocardial infarction (MI), ischaemic heart disease (IHD) and part 2, duodenal ulcer. Patient was admitted with gastrointestinal (GI) bleed 4th-19th March. But not sure if related to vaccine, reporter felt they should report. Outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1778152 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-12
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: 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: GBPFIZER INC202101324919

Write-up: Pfizer''s vaccines killed three of his family members; This is a spontaneous report from a non-contactable consumer via a Medical Information Team. This consumer reported same event for 3 patients. This is 1st of three reports. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 concomitant medications were not reported. The customer called to report Pfizer''s vaccines killed three of his family members on an unspecified date. 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. ; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101339837 same reporter, same drug/event, different patient;GB-PFIZER INC-202101339838 same reporter, same drug/event, different patient; Reported Cause(s) of Death: Pfizer''s vaccines killed three of his family members


VAERS ID: 1778155 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-12
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: 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: GBPFIZER INC202101339837

Write-up: Pfizer''s vaccines killed three of his family members; This is a spontaneous report from a non-contactable consumer via a Medical Information Team. This consumer reported same event for 3 patients. This is 2nd of three reports. A patient of an 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 single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The customer called to report Pfizer''s vaccines killed three of his family members on an unspecified date. 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.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101324919 same reporter, same drug/event, different patient;GB-PFIZER INC-202101339838 same reporter, same drug/event, different patient; Reported Cause(s) of Death: Pfizer''s vaccines killed three of his family members


VAERS ID: 1778156 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-12
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: 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: GBPFIZER INC202101339838

Write-up: Pfizer''s vaccines killed three of his family members; This is a spontaneous report from a non-contactable consumer via a Medical Information Team. This consumer reported same event for 3 patients. This is 3rd of three reports. A patient of an 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 single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The customer called to report Pfizer''s vaccines killed three of his family members on an unspecified date. 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.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101324919 same reporter, same drug/event, different patient;GB-PFIZER INC-202101339837 same reporter, same drug/event, different patient; Reported Cause(s) of Death: Pfizer''s vaccines killed three of his family members


VAERS ID: 1778160 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-06
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aneurysm, Headache
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-18
   Days after onset: 135
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: Ex-smoker (INTERRUPTED 2 YEARS AGO)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202101312870

Write-up: Aneurysm; INTENSE HEADACHE; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the WEB, regulatory authority number GR-GREOF-202108481. A 74-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunisation. Medical history included Ex-smoker (interrupted 2 years ago). The patient''s concomitant medications were not reported. The patient experienced intense headache (death, medically significant) on 06May2021. The patient died on 18Sep2021. It was not reported if an autopsy was performed. Reported Cause(s) of Death was Aneurysm. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: INTENSE HEADACHE; Aneurysm


VAERS ID: 1778161 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-09-21
   Days after vaccination:172
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hemiplegia, Ischaemic stroke
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), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-25
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EDARBI; LADOSE; THYROHORMONE; PRESIDIN
Current Illness: Arterial hypertension; Depression; Dysfunction thyroid
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202101314200

Write-up: Hemiplegia (right); Ischaemic stroke; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number GR-GREOF-202108568. An 83-years-old female patient received bnt162b2 (COMIRNATY), the second dose via an unspecified route of administration on 02Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included ongoing depression, ongoing arterial hypertension, ongoing dysfunction thyroid. Concomitant medications included azilsartan kamedoxomil (EDARBI) taken for an unspecified indication, start and stop date were not reported; fluoxetine hydrochloride (LADOSE) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (THYROHORMONE) taken for an unspecified indication, start and stop date were not reported; manidipine hydrochloride (PRESIDIN) taken for an unspecified indication, start and stop date were not reported. On 21sep2021 patient experienced ischaemic stroke with right hemiplegia. On 25Sep2021 the patient died. It was unknown if an autopsy was performed. The events were reported as serious due to death. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Ischaemic stroke; Hemiplegia (right)


VAERS ID: 1778191 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202101340151

Write-up: UNKNOWN CAUSE OF DEATH; This is a spontaneous report from a non-contactable other health care professional via Regulatory Authority (regulatory authority number: Not Applicable), based on information received by Pfizer. (manufacturer control number: HK-Fosun-2021FOS003711), license party for bnt162be (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. In the preceding week till 11:59 pm on 26-Sep-2021, RA received one death reports involving an individual who had received COVID-19 vaccination within 14 days before passing away. A 57-year-old male patient started to receive COVID-19 vaccine on unspecified date via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. There was no clinical evidence that the incident arose from vaccination. The event unknown cause of death met the seriousness criterion of death. The action taken for COVID-19 vaccine regarding the event was not applicable. Patient died on an unknown date. It was unknown if the autopsy was done and the reported cause of death was unknown. Initial report was received on 30-Sep-2021. This is one of two reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS003711 (master case) and 2021FOS003712. This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities. Follow-up closed, no further information is possible. BioNTech SE Comment: The medical review comments of PV Department on the report of "unknown cause of death" as follows: The seriousness of "unknown cause of death" was: death, serious. The event "unknown cause of death" is not a common adverse event in the package insert of tozinameran(COMIRNATY), so its expectedness is: unexpected.Given the limited information available to date, it is difficult to exclude a causal relationship, and the relationships between "unknown cause of death" and tozinameran(COMIRNATY) was considered as possible. 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: 1778196 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Immunisation, Off label use
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-15
   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: SYNCUMAR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deep vein thrombosis; Polycythaemia rubra vera
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC202101314288

Write-up: death; previously received SARS-CoV-2 Vaccine (Vero Cell) first dose on 03Mar2021 and second dose on 31Mar2021/ received bnt162b2 (COMIRNATY) on 06Sep2021; previously received SARS-CoV-2 Vaccine (Vero Cell) first dose on 03Mar2021 and second dose on 31Mar2021/ received bnt162b2 (COMIRNATY) on 06Sep2021; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number HU-OGYI-758021. An 82-years-old male patient received bnt162b2 (COMIRNATY), via intramuscular administered in left arm on 06Sep2021 (Batch/Lot Number: FD6840) as single dose for covid-19 immunisation. Medical history included deep vein thrombosis, polycythaemia rubra vera, both from unspecified date and not ongoing. Concomitant medication included acenocoumarol (SYNCUMAR) taken for an unspecified indication, start and stop date were not reported. The patient previously received SARS-CoV-2 Vaccine (Vero Cell) suspension for injection in a pre-filled syringe (inactivated 19nCoV-CDC-Tan-HB02 strain, first dose on 03Mar2021 and second dose on 31Mar2021 for COVID-19 immunisation. The patient experienced death on 15Sep2021. The patient died on 15Sep2021. An autopsy was performed and results were not provided. The outcome of the event death was fatal. Sender Comment: The patient died 9 days after Comirnaty vaccination. Autopsy was done, further information is expected about the cause of death. The causal relationship between the event and Comirnaty is not assessable due to lack of information. The case is serious due to fatal outcome. No follow up attempts possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1778197 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Interchange of vaccine products, Off label use
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-25
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC202101321542

Write-up: cardiac failure; Before COMIRNATY, the patient was immunised with SINOPHARM vaccine (0.5 ml, inactivated 19nCoV-CDC-Tan-HB02 strain, MAH: 2 consequent doses; Before COMIRNATY, the patient was immunised with SINOPHARM vaccine (0.5 ml, inactivated 19nCoV-CDC-Tan-HB02 strain, MAH:, 2 consequent doses; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number HU-OGYI-772021. An 88-year-old female patient received BNT162B2 (COMIRNATY), dose 3 intramuscular, administered in arm left on 15Sep2021 09:00 (Batch/Lot Number: FD6840) as 0.3ml single for covid-19 immunisation (age at vaccination was 88-year-old). Before BNT162B2, the patient was immunised with SINOPHARM vaccine (0.5 ml, inactivated 19nCoV-CDC-Tan-HB02 strain; batch number: unknown, expiry date: not reported,, 2 consequent doses, date of vaccination was not reported but presumably more than 4 months before BNT162B2. The patient medical history and concomitant medications were not reported. On 25Sep2021, the patient died. Autopsy has not been done. The physician reported that this was an expected event for the patient. Cause of death was determined as cardiac failure. No relationship with vaccination was suspected. Outcome of cardiac failure was fatal. Sender''s comments: Death is not expected for COMIRNATY, it was an expected event based on the patient''s general condition. TTO was 10 days. Based on the above, causality between the event death and COMIRNATY is not related. The case is serious because the patient died. No further information is expected. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: based on the known safety profile of vaccine and the information available the event cardiac failure was considered unrelated to the suspect drug; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1778243 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Off label use, 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: COUMADIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Bone marrow transplant; Cardiac ablation; Myeloma
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC202101303729

Write-up: sudden death; booster dose; booster dose; This is a spontaneous report from a contactable consumer received from the Regulatory Authority via a Pfizer colleague. A male patient in his 70s (reported age group: 75-79) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included myeloma, bone marrow transplant, arrhythmia, and ablation; all from an unknown date and unknown if ongoing. Concomitant medication included warfarin sodium (COUMADIN) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient had a booster dose. On an unspecified date, 7 days after the administration of the vaccine, the patient experienced sudden death. The patient died on an unspecified date. It was not reported if an autopsy was performed. The reporter assessed that there was no causality between the vaccine, BNT162B2, and the event, sudden death. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the limited information provided the causality between the vaccine, BNT162B2 to the reported event sudden death cannot be meaningfully assessed nor excluded. The case will be reassessed once additional information is 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: sudden death


VAERS ID: 1778244 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Immunisation, Off label use
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: ILPFIZER INC202101314256

Write-up: has died; receiving the third Comirnaty vaccine; receiving the third Comirnaty vaccine; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had died after receiving the third bnt162b2 vaccine. Event took place after use of product. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: has died


VAERS ID: 1778245 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Immunisation, Off label use
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: ILPFIZER INC202101314381

Write-up: died 24 hours after receiving the third dose of the Pfizer covid 19 vaccination; receiving the third dose of the Pfizer covid 19 vaccination; receiving the third dose of the Pfizer covid 19 vaccination; This is a spontaneous report from a contactable consumer via company representative. A 75-year-old male patient received bnt162b2 (COMIRNATY), the third dose via unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient died 24 hours after receiving the third dose of the Pfizer covid 19 vaccination. The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died 24 hours after receiving the third dose of the Pfizer covid 19 vaccination


VAERS ID: 1778369 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-09-13
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Injection site pain, Pyrexia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-21
   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: ITMODERNATX, INC.MOD20213

Write-up: Pain injection site; Fever with non-productive cough and respiratory failure; Fever with non-productive cough and respiratory failure; Fever with non-productive cough and respiratory failure; This case was received (Reference number: IT-MINISAL02-792107) on 04-Oct-2021 and was forwarded to Moderna on 04-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of RESPIRATORY FAILURE (Fever with non-productive cough and respiratory failure), COUGH (Fever with non-productive cough and respiratory failure) and PYREXIA (Fever with non-productive cough and respiratory failure) in a 91-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced RESPIRATORY FAILURE (Fever with non-productive cough and respiratory failure) (seriousness criteria death and medically significant), COUGH (Fever with non-productive cough and respiratory failure) (seriousness criterion death) and PYREXIA (Fever with non-productive cough and respiratory failure) (seriousness criterion death). On an unknown date, the patient experienced INJECTION SITE PAIN (Pain injection site). The patient died on 21-Sep-2021. The reported cause of death was Respiration failure, Fever and nonproductive cough. It is unknown if an autopsy was performed. At the time of death, INJECTION SITE PAIN (Pain injection site) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. Company comment: This case concerns a 91-year-old female patient with no relevant medical history, who experienced the serious unexpected events of Respiratory failure, Cough and Pyrexia. The events occurred 5 days after receiving the second dose of Spikevax. The re-challenge was not applicable as the events occurred following the second dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Translation Document received on 6-OCT-2021 that contains No New Information. On 05-Oct-2021: Follow-up received on 05-OCT-2021 that contains updated Suspect 1st dose information and event added of First dose of suspect product.; Sender''s Comments: This case concerns a 91-year-old female patient with no relevant medical history, who experienced the serious unexpected events of Respiratory failure, Cough and Pyrexia. The events occurred 5 days after receiving the second dose of Spikevax. The re-challenge was not applicable as the events occurred following the second dose. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: respiration failure; Fever; nonproductive cough


VAERS ID: 1778380 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Coma, Investigation, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Decompensation cardiac (mild heart failure); Hypertension
Allergies:
Diagnostic Lab Data: Test Name: affected the quality of life; Result Unstructured Data: Test Result:10; Test Name: post portem swabs; Test Result: Negative
CDC Split Type: ITPFIZER INC202101323260

Write-up: coma; cerebral haemorrhage; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency-WEB, regulatory authority number IT-MINISAL02-793711. An 84-years-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular administered in Deltoid Left on 12Jan2021 11:58 (Batch/Lot Number: EL1484) as single dose for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, decompensation cardiac (mild heart failure) from an unknown date and unknown if ongoing. Concomitant medication included apixaban (ELIQUIS). The patient residing in nursing homes underwent the first dose of comirnaty vaccine on 12Jan2021 at 11:58, left deltoid. On 14Jan2021 appearance of cerebral haemorrhage followed by coma in the patient. The patient was hospitalized following the haemorrhage. The patient died on 16Jan2021. The reaction lasted 2 days and affected the quality of life with a score of 10. The outcome of the events was fatal. It was not reported if an autopsy was performed. Reporter comment: The reporter was contacted and stated that post portem swabs were all negative. the death certificate is attached. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: The reporter was contacted and stated that post portem swabs were all negative. the death certificate is attached.; Reported Cause(s) of Death: coma; cerebral haemorrhage


VAERS ID: 1778381 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-09-16
   Days after vaccination:125
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7065 / 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: 2021-09-19
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: SARS-CoV-2 RT-PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101330250

Write-up: INIFFECTIVE DRUG; PNEUMONIA COVID 19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-793783. A 61-years-old male patient received second dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Lot number: EY7065), via intramuscular on 14May2021 10:35 as dose 2, 30 ug single, and received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Lot Number: unknown), via an unspecified route of administration on 23Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced vaccination failure and had pneumonia Covid-19. The patient was died due to sars-cov-2 infection on 19Sep2021. The patient underwent lab tests and procedures which included SARS-CoV-2 RT-PCR test resulted positive on 16Sep2021. It was unknown if an autopsy was performed. The lot number of the first dose for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1778382 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 3 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Off label use, 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: 2021-09-29
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerosis; Chronic renal failure; IHD; Immunosuppression (in immunosuppressive therapy since 2004); Polyarteritis nodosa; Renal transplant
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101323185

Write-up: Unexpected death; Booster; Off label use; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number IT-MINISAL02-793903. An 81-year-old male patient received bnt162b2 (COMIRNATY), dose 3 intramuscular, administered in Arm Right on 28Sep2021 10:50 (Batch/Lot Number: FG7387; Expiration Date: 30Nov2021) as dose 3 (booster), 30 ug, single for covid-19 immunisation at the age of 81-year-old. Medical history included arteriosclerosis from 01Jan1983 to an unknown date, ischemic heart disease from 01Jan1984 to an unknown date, renal transplant from 08Mar2004 to an unknown date, immunosuppression from 08Mar2004 to an unknown date (in immunosuppressive therapy since 2004), panvasculopathy, chronic renal failure. On 28Sep2021 the patient underwent 3rd dose of the Comirnaty vaccine and experienced unexpected death on 29Sep2021. Therapeutic measures were taken as a result of unexpected death included cardiopulmonary resuscitation. The patient died on 29Sep2021. It was not reported if an autopsy was performed. Reporter Comment: Patient suffering from ischemic heart disease, panvasculopathy, chronic renal failure, kidney replaced by transplant in immunosuppressive therapy since 2004. On 28Sep2021 underwent 3rd dose of the Comirnaty vaccine (Pfizer / Biontech). No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Patient suffering from ischemic heart disease, panvasculopathy, chronic renal failure, kidney replaced by transplant in immunosuppressive therapy since 2004. On 28Sep2021 underwent 3.dose of the Comirnaty vaccine (Pfizer / Biontech); Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1778434 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-09-15
   Days after vaccination:51
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004217 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-17
   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: Cancer; Thrombosis
Preexisting Conditions: Medical History/Concurrent Conditions: Chemotherapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: Unknown cause of death; This case was received (Reference number: DE-PEI-202100198063) on 04-Oct-2021 and was forwarded to Moderna on 04-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Unknown cause of death) in a 60-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004217) for Prophylactic vaccination. The patient''s past medical history included Chemotherapy. Concurrent medical conditions included Thrombosis and Cancer. On 26-Jul-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on 17-Sep-2021 The patient died on 17-Sep-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant medications were not reported . Treatment information was not provided. Company Comment: This case concerns a 60 year old male with a history of Cancer, Chemotherapy and Thrombosis who experienced the severe unlisted event of Death, cause unknown. The event occurred 51 days after the second dose of Spikevax. Re-challenge is not applicable as the patient could not have experienced the event between first and second doses. The history of Cancer, Chemotherapy and Thrombosis remain confounders as any of these could be a cause for the event. Benefit -risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Translation received on 06-Oct-2021 contains no new information.; Sender''s Comments: This case concerns a 60 year old male with a history of Cancer, Chemotherapy and Thrombosis who experienced the severe unlisted event of Death, cause unknown. The event occurred 51 days after the second dose of Spikevax. Re-challenge is not applicable as the patient could not have experienced the event between first and second doses. The history of Cancer, Chemotherapy and Thrombosis remain confounders as any of these could be a cause for the event. Benefit -risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1778554 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-18
Onset:2021-10-02
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Cardiac failure
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: 2021-10-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101303922

Write-up: Cardiac failure; Cardiac arrest; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 42-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left, at age 42 years (as reported), on 18Sep2021 12:00 (the day of vaccination) (Batch/Lot Number: FF4204; Expiration Date: 31Oct2021) as DOSE 2, SINGLE for COVID-19 immunisation. The patient had no other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient''s concomitant medication was none. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historically received the first dose of COMIRNATY, intramuscular on the arm left, at age 42 years, on 28Aug2021 at 12:00 (Lot number: FF4204, Expiration date 31Oct2021) for COVID-19 immunisation. On 02Oct2021 at 07:00 (also reported as: 14 days after the vaccination), the patient experienced cardiac failure and cardiac arrest. The events resulted in emergency room/department or urgent care, hospitalization in Oct2021 for 1 day, and death. The reported event was as follows: On 02Oct2021, at 07:00 (14 days after the second vaccination), the patient was found to have cardiac arrest in his bed. Although the patient was transferred, he was confirmed to die (due to cardiac failure) in the hospital. It was unknown if treatment was performed. Since the vaccination, it was unknown whether the patient has not been tested for COVID-19. The outcome of the event was fatal. It was unknown if autopsy was performed. The reporting physician assessed the event as serious (death/hospitalization). Cause of death was cardiac failure.; Sender''s Comments: Current information is limited and does not allow a full assessment. No information provided during the period of 14 days after receiving 2nd dose and before events occurrence. Case will be reassessed once receiving additional 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: Cardiac failure


VAERS ID: 1778557 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Malaise, Myocarditis, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-25
   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: Allergy to antibiotic
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: Test Result:35.0 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101314104

Write-up: malaise; queasy; Acute myocarditis; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21128690. The patient was a 72-year and 5-month-old female. Body temperature before vaccination was 35.0 degrees centigrade. The family history was not provided. The patient had medical history of allergy to antibiotic. On 25Aug2021 at 09:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FF9942, Expiration date 30Nov2021) via an unspecified route of administration as DOSE 1, SINGLE for COVID-19 immunization. On 25Aug2021 (the day of the vaccination), the patient died with acute myocarditis. On 25Aug2021, although the patient complained of physical deconditioning while she was waiting after the vaccination, since she recovered, she went home. On 25Aug2021 16:00 (7 hours later), the patient was complained of physical deconditioning to her family member (malaise and queasy), and the family member came to see how the patient was doing. On 26Aug2021, the family member was not in contact with the patient, and when the family member came to see how the patient was doing, the patient was found dead at her home. Based on the results of the administrative autopsy under the act on the investigation of cause of death, severe and acute myocarditis accompanied by microthrombus was observed in the heart of this dead body, and no underlying diseases such as bacteria or virus which generally caused myocarditis were observed. In addition, the time of onset of the event which was assumed from the tissue image was not inconsistent with after the vaccination. Moreover, no other diseases or injuries which could be the causes of death were observed. Thus, it was hard to avoid thinking that the acute myocarditis in this dead body was a side reaction caused by the vaccination. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: As the results of the autopsy, it was hard to avoid thinking that the acute myocarditis in this dead body was a side reaction caused by the vaccination. Outcome of the events malaise and queasy was unknown.; Reported Cause(s) of Death: Acute myocarditis; Autopsy-determined Cause(s) of Death: It was hard to avoid thinking that the acute myocarditis in this dead body was a side reaction caused by the vaccination.


VAERS ID: 1778558 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cognitive disorder, Computerised tomogram, Eating disorder, Fall, Hypoaesthesia, Muscular weakness, Pain in extremity, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-08
   Days after onset: 72
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TRAMCET; CYMBALTA; THYRADIN; ALINAMIN-F [FURSULTIAMINE HYDROCHLORIDE]; FOLIAMIN [FOLIC ACID]; LOXONIN; NEUROTROPIN [RABBIT VACCINIA EXTRACT]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cervical myelopathy; Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 20210628; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Name: CT (head, cervix, chest, and abdomen); Result Unstructured Data: Test Result:no remarkable findings
CDC Split Type: JPPFIZER INC202101314184

Write-up: aggravated cognitive function; fall; muscular weakness of the upper and lower limbs; numbness of the upper and lower limbs; eating disorder; sudden death; pain of both hands; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21129561. The patient was a 77-year-old female. Body temperature before vaccination was 36.5 degrees Centigrade. On 28Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date 30Sep2021) via an unspecified route of administration as a single dose, at age of 77 years of vaccination, for COVID-19 immunization.The patient family history was not reported. The patient had medical history of cervical spondylotic myelopathy and hypothyroidism. The patient had no allergic history. Concomitant medications included paracetamol, tramadol hydrochloride (TRAMCET); duloxetine hydrochloride (CYMBALTA); thyroid (THYRADIN); fursultiamine hydrochloride (ALINAMIN-F); folic acid (FOLIAMIN); loxoprofen sodium (LOXONIN); and rabbit vaccinia extract (NEUROTROPIN); all of which were orally taken on a regular basis for an unspecified indication from an unspecified start date and ongoing.On 07Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number and Expiration date were not reported).On 28Jun2021 (the day of vaccination), the patient experienced muscular weakness of the upper and lower limbs, numbness and aggravated cognitive function. The course of the event was as follows: After the vaccination in Jun2021, pain of both hands and numbness of the upper and lower limbs were aggravated. Although the patient presented to a general hospital, the cause was unknown without improvement. Weakness also worsened, and the patient had fall which made it difficult for her to live at home. On 30Aug2021, the patient was admitted to the reporting physician''s hospital. Computerised tomogram (CT) (head, cervix, chest, and abdomen) revealed no remarkable findings. The patient also had aggravated cognitive function and eating disorder. On 08Sep2021 under treatment with drip infusion and detailed examinations, the patient suddenly died.Outcome of numbness of the upper and lower limbs, pain of both hands was not recovered, of sudden death was fatal, for others was unknown.The reporting physician classified the event as serious (death/hospitalized) 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: It could not be ruled out the possibility that these symptoms were adverse reactions to the vaccine. Causality between the vaccine and her death was unknown. No follow-up attempts are possible. No further information is expected; Reported Cause(s) of Death: sudden death


VAERS ID: 1778559 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-11
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Postmortem CT; Result Unstructured Data: Test Result:unknown results
CDC Split Type: JPPFIZER INC202101318874

Write-up: Death; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21128689. An 80-year and 0-month-old male patient received the first dose of bnt162b2 (COMIRNATY) on 06Jul2021 (lot number: unknown) (at the age of 80-years-old) via unknown route of administration at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Body temperature before vaccination and family history were not reported. It was unknown whether there were 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 06Jul2021 at unknown time (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date not reported) at age of 80 via an unspecified route of administration as a single dose for COVID-19 immunisation. On 11Jul2021 at 10:52 (5 days after the vaccination), the patient experienced death. Lab data included Postmortem CT in Jul2021: unknown results. On 11Jul2021 (5 days after the vaccination), the outcome of the event was fatal. An autopsy was performed on unknown date and the autopsy results were unknown. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases: Circulatory disease such as myocardial infarction could be also cited for differentiation, but the cause was unidentified even on postmortem computerised tomography (CT) and remained unclear. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1778560 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Blood pressure measurement, Body temperature, Heart rate, Investigation
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic aneurysm rupture; Left sided paralysis; Orientation disturbed; Short-term memory impairment; Spatial disorientation (Left side); Subarachnoid haemorrhage
Allergies:
Diagnostic Lab Data: Test Date: 20210930; Test Name: blood pressure; Result Unstructured Data: Test Result:80s; Comments: on palpation; Test Date: 20210928; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210930; Test Name: tachycardia; Result Unstructured Data: Test Result:80s; Test Date: 20210930; Test Name: SAT; Test Result: 86 %
CDC Split Type: JPPFIZER INC202101319474

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician received from the RA and a pharmacist. The regulatory authority report number is v21128744. A 72-year and 11-month-old female patient received the second dose of BNT162b2 (COMIRNATY, solution for injection, Lot number: FG0978, Expiration Date: 30Nov2021) via an unspecified route of administration at single dose on 28Sep2021 at 10:36 at the age of 72-year-old for COVID-19 immunization. Body temperature before vaccination was 36.5 degrees centigrade on 28Sep2021. The first dose was on an unspecified date in 2021. Medical history included subarachnoid haemorrhage from 28Jun2021; rupture of right middle aortic aneurysm from 28Jun2021; left sided paralysis; left side spatial disorientation; orientation disturbed; short-term memory impairment. The family history was not provided. Concomitant medication was not reported. On 30Sep2021 at 13:46 (2 days 3 hrs 10 min after the vaccination), the patient experienced acute myocardial infarction. The course of the event was as follows: On 28Jun2021, a clipping surgery was performed for subarachnoid haemorrhage and right middle cerebral artery aneurysm ruptured which occurred on the same day. After the surgery, mild paralysis of left upper and lower limbs, left sided spatial agnosia, disorientation, and decreased memory persisted. On 04Aug2021, the patient was transferred to the convalescent rehabilitation ward. On 30Sep2021 (one day, 13 hours, and 24 minutes after vaccination), the general condition was favorable until lunch, and the patient could take 100% of lunch. On the same day, at 13:45 (2 days, 3 hours, and 9 minutes after vaccination), since the patient complained of malaise while she was seated in a wheelchair in the day room, she moved to her room. Although the patient could walk approximately 50 m with moderate help until morning on the same day, she could not stand up at that time. As soon as the patient lay down in the bed, she had pallor facial and stertor. The blood pressure was 80s on palpation, the tachycardia was 80s, and the SAT was 86%. No pupil unequal was noted, and the consciousness level was Coma Scale 100. Thus, immediately an intravenous line was established, and the patient was transferred to the general ward. The pressure rising with dopamine and adrenaline was ineffective, and the patient was confirmed to die at 15:37 on 30Sep2021 (2 days after the vaccination). Autopsy was not performed. The outcome of event was fatal. The reporting physician classified the event as serious (death) and 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. The reporting physician commented as follows: The onset date of the event was 2 days after the BNT162B2 vaccination, and 3 months had passed since the surgery for subarachnoid haemorrhage, and the patient was a 72-year-old female with favorable general condition. In the explanation that sudden cardiogenic shock was considerable, the causality between the event and the vaccination was considered, which required a report.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1778562 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-06
   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: Hyperlipidaemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: cholesterol; Result Unstructured Data: Test Result:controlled; Comments: before the vaccination; Test Name: blood pressure; Result Unstructured Data: Test Result:controlled; Comments: before the vaccination; Test Name: triglyceride; Result Unstructured Data: Test Result:controlled; Comments: before the vaccination
CDC Split Type: JPPFIZER INC202101320190

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician (anatomist) received from the Regulatory Agency ). Regulatory authority report number is v21129725. A 52-year-old male the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FF3620, Expiration date 30Nov2021) via an unspecified route of administration as a single dose, for COVID-19 immunization 02Sep2021 (52-year-old at the time of vaccination). Body temperature before vaccination was unknown because the vaccine screening questionnaire could not be obtained. The patient had medical history of hypertension and hyperlipidemia. Relevant concomitant drug was unknown. On 05Sep2021 (3 days after the vaccination), the patient experienced acute myocardial infarction. On 06Sep2021 (4 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 05Sep2021 at around 10:00, the patient''s mother, who lived with the patient, heard a sound from the patient''s room. On the same day at around 15:55, his mother sent an e-mail to the patient telling the lunch was ready, but he did not respond. At around 17:40, when his mother went and saw him in his room, she found that the patient had no breath in bed. She called to request an ambulance. However, postmortem rigidity was observed, and the patient was not transported. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. As for other possible causes of the event such as any other diseases, the patient had hypertension and hyperlipidemia, for which he visited the hospital regularly. The reporting physician commented as follows: The autopsy was performed that revealed thrombus at 9.0 cm distal to the origin of the right coronary artery, and clot filling at the upper part of the thrombus. Hemorrhagic necrosis was observed on the posterior wall of the left ventricle, and myocardial thinning was found at the necrotic site. Based on the above-mentioned findings, the cause of the death was considered acute myocardial infarction. The patient had received oral treatment for hypertension and hyperlipidemia. The blood pressure as well as triglyceride and cholesterol levels on blood testing had been controlled until the vaccination; however, he had a risk factor of myocardial infarction. Although it was difficult to consider a direct relationship with the vaccination, this case was reported with requirement for epidemiologic investigation.; Reported Cause(s) of Death: Acute myocardial infarction; Autopsy-determined Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1778741 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-28
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Pulmonary function test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Asthma; Cardiovascular disorder NOS; Diabetes mellitus; Pain legs (low blood circulation and vascular patency)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: pulmonary check-up; Result Unstructured Data: Test Result:good
CDC Split Type: CZPFIZER INC202101331134

Write-up: ache across chest/chest pain; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number CZ-CZSUKL-21010883. A 74-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 14May2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included ongoing Pain legs (because of insufficient circulation and vascular patency), ongoing asthma, ongoing diabetes mellitus, ongoing Arterial hypertension. Concomitant medications included unspecified medications for high pressure, asthma, diabetes. The patient experienced ache across chest/chest pain (death, medically significant, life threatening) on 28May2021 (also reported as Jun2021). Specialist consultation: all right, she complained of chest pain on 03Jun2021 control at the pulmonary department. The patient experienced no reaction immediately after vaccination, occasional chest pain 14 days after vaccination (28May2021). On 03Jun2021 she had a pulmonary check-up and the outcome was good. The patient died at night from Sunday 06Jun2021 to Monday 07Jun2021. The date of death is 07Jun2021. A cardiology check-up was not performed due to death. Also reported cause of death is not known, an autopsy was not done according to the reporter. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: ache across chest/chest pain


VAERS ID: 1778744 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Ruptured cerebral aneurysm
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Medication errors (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: DEPFIZER INC202101331493

Write-up: Brain aneurysm hemorrhage resulting in death; Inappropriate schedule of vaccine administered; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, company number DE-DCGMA-21193318, Safety Report Unique Identifier DE-PEI-202100200968. A 50-year-old female patient received bnt162b2 (COMIRNATY, mRNA TOZINAMERAN) at the age of 50-year-old , dose 2 intramuscular on 24May2021 (Batch/Lot Number: Unknown) as dose 2, single (0.5) for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY, strength: 0.3 ml) on 12Apr2021 at the age of 50-year-old for covid-19 immunization. The patient experienced brain aneurysm hemorrhage resulting in death on 29Aug2021 with outcome of fatal, inappropriate schedule of vaccine administered on 24May2021 with outcome of unknown. The patient died on an unspecified date. An autopsy was performed and results were not provided. This report is serious - death. Assessment: Comirnaty/ Ruptured cerebral aneurysm/ PEI: D. Unclassifiable. Dosage text: 0.5. Stop date for event: 30Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Ruptured cerebral aneurysm


VAERS ID: 1779780 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-08-30
   Days after vaccination:121
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Cerebral infarction
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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: 2021-09-01
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101330986

Write-up: Hemorrhage intracerebral; Multiple cerebral infarction; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100202662. An 87-year-old male patient received second dose of BNT162B2 (COMIRNATY, strength 0.3 ml) in May2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included first dose of Comirnaty in Apr2021 (at age of 86 years old, Strength: 0.3 mL) at single dose for COVID-19 vaccination. On 30Aug2021 the patient experienced Multiple cerebral infarction, Hemorrhage intracerebral. This report is serious - death. It was unknown if the autopsy was done. Relatedness of the drug to the events: Hemorrhage intracerebral and Multiple cerebral infarction was reported as B: indeterminate by the regulatory authority. No follow-up attempts are possible, information on batch numbers cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Multiple cerebral infarction; Hemorrhage intracerebral


VAERS ID: 1779848 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002620 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
   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: DEMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: DE-PEI-202100197535) on 04-Oct-2021 and was forwarded to Moderna on 04-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (unbekannte todesursache) in a 46-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002620) for Prophylactic vaccination. No Medical History information was reported. On 14-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on 15-Aug-2021 The patient died on 15-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant medications were not provided by the reporter. Treatment information was not provided. Company Comment: This case concerns a 46-year-old, male patient with no relevant medical history. The patient experienced unlisted serious event of Death. Rechallenge is not applicable The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Translation Received on 07-Oct-2021, it contains no new information.; Sender''s Comments: This case concerns a 46-year-old, male patient with no relevant medical history. The patient experienced unlisted serious event of Death. Rechallenge is not applicable The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1779849 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-09-20
   Days after vaccination:114
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, 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: 2021-09-20
   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: Diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: Unknown cause of death; Ventricular fibrillation; This case was received via regulatory authority (Reference number: DE-PEI-202100197821) on 04-Oct-2021 and was forwarded to Moderna on 04-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Unknown cause of death) and VENTRICULAR FIBRILLATION (Ventricular fibrillation) in a 79-year-old male patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. Concurrent medical conditions included Diabetes mellitus. On 29-May-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced DEATH (Unknown cause of death) (seriousness criteria death and medically significant) and VENTRICULAR FIBRILLATION (Ventricular fibrillation) (seriousness criteria death and medically significant). The patient died on 20-Sep-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No relevant concomitant medications were reported. No treatment information was reported. It was reported that patient had pre-existing conditions included diabetes mellitus, arrhythmia requiring resuscitation, ventricular fibrillation, death. Company comment: This fatal case concerns a 79-year-old male patient with a relevant medical history of diabetes mellitus, who experienced the serious unexpected events of Death and Ventricular fibrillation. The events occurred approximately 3 months 23 days after the second dose of Spikevax. Cause of death not reported. The re-challenge was not applicable as the events occurred following the second dose. The medical history of diabetes mellitus is a possible confounder. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Translation document received on 06-Oct-2021 and Sender''s comment was translated.; Sender''s Comments: This fatal case concerns a 79-year-old male patient with a relevant medical history of diabetes mellitus, who experienced the serious unexpected events of Death and Ventricular fibrillation. The events occurred approximately 3 months 23 days after the second dose of Spikevax. Cause of death not reported. The re-challenge was not applicable as the events occurred following the second dose. The medical history of diabetes mellitus is a possible confounder. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1779850 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Fatigue
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? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Disorder lung; Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101330859

Write-up: Coma; tiredness; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021186980. Safety Report Unique Identifier: DE-PEI-202100202316. An 87-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3 ml), via an unspecified route of administration on 15Sep2021 at 87 years old (Batch/Lot Number: Unknown) as single dose for covid-19 immunization. Medical history included heart failure, lung weakness, dementia. The patient''s concomitant medications were not reported. On 15Sep2021 the patient experienced Coma and tiredness. Clinical course details: 2 hours after vaccination extremely tired, went to sleep, did not want to get up in the evening because of tiredness, next morning did not wake up despite loud talking and touching, hospital, death. The patient''s outcome was fatal for Coma, and outcome was unknown for tiredness. The patient died on 17Sep2021 (as reported). An autopsy was not performed. This event coma was serious - death, hospitalization. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? no. Information on risk factors or previous illnesses: Heart failure, lung weakness, dementia, / 2 hrs. after vaccination extremely tired, went to sleep, did not want to get up in the evening because of tiredness, next morning did not wake up despite loud talking and touching, hospital, death. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Coma


VAERS ID: 1779851 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-26
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, C-reactive protein increased, Cholecystitis, Death, Enterovesical fistula, Functional gastrointestinal disorder, Gait disturbance, Hepatic failure, Immobile, Inflammation, Liver function test, Liver function test abnormal, Medical induction of coma, Necrosis, Pyrexia, Renal failure, Syncope, Thrombocytopenia, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Parkinson-like events (broad), Gastrointestinal perforation (narrow), Infectious biliary disorders (narrow), Gallbladder related disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific inflammation (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Arthritis (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-24
   Days after onset: 121
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: MDS (with optimal medication and almost without complications adjusted); Rheumatism (with optimal medication and almost without complications adjusted)
Allergies:
Diagnostic Lab Data: Test Name: CRP; Result Unstructured Data: Test Result:unexplained high levels of inflammation; Test Date: 20210526; Test Name: Liver function test; Result Unstructured Data: Test Result:abnormal
CDC Split Type: DEPFIZER INC202101330857

Write-up: intestinal-bladder-fistula; Unknown cause of death; Thrombocytopenia; Liver function test abnormal; hip necrosis; collapsed under strongest pain; gallbladder inflammation; liver failure; renal failure (dialysis); arm immobility for approx. 5 days; fever; directly very strong pain injection site, arm immobility for approx. 5 days; permeable bowel; unexplained high levels of inflammation (CRP)/unfathomable inflammatory foci; walking uncertainties; increasing hip pain; artificial coma; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021187116. Safety Report Unique Identifier: DE-PEI-202100202454. A 68-year-old male patient received bnt162b2 (COMIRNATY) (strength: 0.3 ml), dose 2 via an unspecified route of administration on 20May2021 (Batch/Lot Number: EX3599) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included rheumatism and MDS, both with optimal medication and almost without complications adjusted. No known allergies. The patient''s concomitant medications were not reported. On 26May2021 the patient experienced Thrombocytopenia, Liver function test abnormal. On 24Sep2021 the patient experienced unknown cause of death. The patient experienced gallbladder inflammation, liver failure, renal failure, fever, unexplained high levels of inflammation (CRP)/unfathomable inflammatory foci, permeable bowel on an unspecified date. Week20 directly very strong pain injection site, arm immobility for approx. 5 days; since week 21 walking uncertainties, increasing hip pain; week26 inpatient, diagnosis hip necrosis / discharge after 4 days with prospect for hip surgery in week28; week27 collapsed under strongest pain / by ambulance to emergency department and inpatient admission under Corona-suspicion quarantine for 2 days (unconfirmed) despite double vaccination protection since week 20; Week 28 intestinal surgery (intestinal-bladder-fistula, stoma, intensive care unit and, although the lungs are and although the lung was always free of complications and findings, artificially ventilated and most of the time most of the time in an artificial coma; Weeks 29-38 Due to unfathomable inflammatory foci and correspondingly high further operations (e.g. removal of gall bladder, removal of femoral head, tracheotomy, etc.), removal of femoral head, tracheotomy, PEG) and various treatment attempts of different of various kinds (e.g. dialysis) were initiated - without any success or discernible recognizable success; week 38 death occurred. The patient underwent lab tests and procedures which included CRP: unexplained high levels of inflammation on an unknown date, liver function test: abnormal on 26May2021. Therapeutic measures were taken as a result of intestinal-bladder-fistula. This event unknown cause of death, thrombocytopenia and liver function test abnormal is serious due to hospitalization. The patient''s outcome was not recovered for thrombocytopenia and liver function test abnormal, fatal for unknown cause of death. The outcome of other event was unknown. The patient died on 24Sep2021. An autopsy was not performed. Comirnaty/Unknown cause of death, Thrombocytopenia, Liver function test abnormal/Regulatory Authority/D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1779852 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-09-28
   Days after vaccination:99
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / UNK - / -

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: 2021-09-28
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101330882

Write-up: sudden death without announcement collapsed and suddenly dead during a walk; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021187320. Safety Report Unique Identifier DE-PEI-202100202580. A 71-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 21Jun2021 (Batch/Lot Number: FD7958) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced sudden death without announcement collapsed and suddenly dead during a walk on 28Sep2021. The patient died on 28Sep2021. An autopsy was not performed. The outcome of the event was fatal. Sender Comment: Do you or the affected person have any allergies? If so, which ones? No! / Without prior notice and pre-illness sudden breakdown during a walk. Collapsed and suddenly dead. Description as reported: Sudden death. Without announcement! Collapsed and suddenly dead. During a walk. Dosage and Relevant Information: Dosage text: 2. Relatedness of the drug to the event: Unknown cause of death was reported as D: unclassifiable by the regulatory authority. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: sudden death without announcement collapsed and suddenly dead during a walk


VAERS ID: 1779952 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-29
Onset:2021-09-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1H048A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Haematemesis, Upper gastrointestinal haemorrhage, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic regurgitation; Arterial hypertension; Heart failure; Mitral regurgitation; Prostate carcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101330195

Write-up: hematin-like vomiting; confusion; Upper gastrointestinal bleeding; Haematemesis; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority WEB DE-PEI-CADR2021186161. Safety Report Unique Identifier: DE-PEI-202100201134. A 96-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 29Sep2021 (Batch/Lot Number: 1H048A) at single dose for COVID-19 immunisation. Medical history included prostate carcinoma, heart failure, aortic regurgitation, mitral regurgitation, and arterial hypertension. The patient''s concomitant medications were not reported. The patient experienced upper gastrointestinal bleeding, and haematemesis on 30Sep2021. In the early morning hours after vaccination the day before, at noon hematin-like vomiting with confusion appeared. Shortly thereafter, the patient died. Outcome of events hematin-like vomiting and confusion was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Haematemesis; Upper gastrointestinal bleeding


VAERS ID: 1780049 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Cardiac arrest, Cardiovascular examination, SARS-CoV-2 test, Sudden death, Syncope
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), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COAPROVEL; RAMIPRIL; RILMENIDINE
Current Illness: Hypertension (treated and balanced)
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary insufficiency (coronary insufficiency in the father (stenting at age 60) + hypertension.); COVID-19; Hypertension (coronary insufficiency in the father (stenting at age 60) + hypertension.); Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 2019; Test Name: CT coronary; Result Unstructured Data: Test Result:normal; Test Date: 2019; Test Name: cardiovascular examination; Result Unstructured Data: Test Result:normal; Test Date: 20210107; Test Name: PCR test; Test Result: Positive ; Test Date: 20210730; Test Name: PCR test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101322582

Write-up: Sudden death; Asystole throughout resuscitation; he collapses suddenly in front of a witness; This is a spontaneous report from a contactable physician downloaded from the regulatory authority report number FR-AFSSAPS-BR20213570. A 45-year-old male patient received first dose of bnt162b2 (COMIRNATY) intramuscular (Lot Number: FE7051) single dose for covid-19 immunisation on 30Jul2021. Medical history included ongoing hypertension arterial/ severe hypertension well balanced on triple therapy (COAPROVEL 300/25 1 in the morning, ramipril 5 mg/d, rilmenidine 2 mg/d), covid-19 from 04Jan2021, non-smoker. The patient performed a cardiological workup in 2019 with normal coronary scanner. COVID-19 infection was on 04Jan2021 (contact case, positive PCR test on 07Jan2021). Family history of coronary insufficiency in the father (stenting at age 60) + hypertension. Concomitant medications included hydrochlorothiazide, irbesartan (COAPROVEL); ramipril; rilmenidine; all for hypertension. The patient experienced sudden death on 01Aug2021. PCR test of 30Jul2021 negative. The next day, while the patient was on a boat at sea, he suddenly collapsed in front of a witness. No warning sign. Call of the SMUR at 13:55. An anesthesiologist on vacation took charge of the patient: almost immediate cardiac massage, injection of 12 mg of adrenaline + ORO-tracheal intubation by the anesthetist. Asystole throughout the resuscitation. The patient was brought back to the beach at 20-25 minutes of cardio-respiratory arrest. Resuscitation stopped at 14:30 with the agreement of the regulation before the arrival of the SMUR. The patient died on 01Aug2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1780050 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3739 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Blood pressure measurement, Cardiopulmonary failure, General physical health deterioration, Heart rate, Immunisation, Off label use, Oxygen saturation
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-30
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute pancreatitis; CVA; Hypertension arterial; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210923; Test Name: blood pressure; Result Unstructured Data: Test Result:100/60 mmHg; Test Date: 20210923; Test Name: heart rate; Result Unstructured Data: Test Result:84; Comments: bpm; Test Date: 20210923; Test Name: oxygen saturation; Test Result: 96 %; Comments: in ambient air
CDC Split Type: FRPFIZER INC202101331232

Write-up: state of health tended to deteriorate/slip syndrome (serious state of physical and psychological destabilization); Respiratory decompensation of heart failure; Acute oedema of lung, unspecified; the booster dose (third dose); the booster dose (third dose); This is a spontaneous report from a contactable physician downloaded from the regulatory authority number FR-AFSSAPS-BR20213585. A 90-year-old female patient received bnt162b2 (COMIRNATY), dose 3 intramuscular on 23Sep2021 (Batch/Lot Number: FG3739) as dose 3 (booster), single for covid-19 immunisation. First dose on 19Jan2021, and second dose on 10Feb2021) for covid-19 immunisation. Medical history included Hypertension arterial/high blood pressure, CVA (cerebrovascular accident), acute pancreatitis and old stroke. No COVID-19 history. The patient''s concomitant medications were not reported. Respiratory decompensation of heart failure occurring 4 days after the booster dose (third dose) of bnt162b2 vaccine (27Sep2021) in the patient. The patient also experienced acute oedema of lung, unspecified on 27Sep2021. This is a patient who presents with the following comorbidities: old stroke, high blood pressure and acute pancreatitis. She was institutionalized in Long-Term Care Unit. Her state of health tended to deteriorate over the past few weeks with slip syndrome (serious state of physical and psychological destabilization), which set in after acute pancreatitis last summer. Nevertheless, she was still very alert, able to discuss, with a favorable clinical examination on 23Sep2021, a favorable hemodynamics (BP = 100/60, HR = 84 bpm, SatO2 in ambient air = 96%), without dyspnea or polypnea. Since 27Sep2021, the patient has deteriorated in her respiratory function (table of decompensated heart failure). She died on 30Sep2021. The doctor wonders about the participation of vaccination in this death. The outcome of event Respiratory decompensation of heart failure and acute oedema of lung, unspecified was fatal. The outcome of other event was unknown. The patient died on 30Sep2021. An autopsy was not performed. No follow-up attempts are possible, no further information is expected.; Reported Cause(s) of Death: Acute oedema of lung, unspecified; Respiratory decompensation of heart failure


VAERS ID: 1780075 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-08-20
   Days after vaccination:184
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Acute respiratory failure, COVID-19, Confusional state, Hyperthermia, Investigation, Pneumococcal bacteraemia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (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: Medical History/Concurrent Conditions: Adenocarcinoma (prostatic adenocarcinoma operated by the upper route in 98); Appendectomy; Cholecystectomy; COVID-19; Hip prosthesis insertion (total right hip prosthesis); Hypertension arterial; Hyperthyroidism; Insufficiency renal (severe); Senile macular degeneration ((age-related macular degeneration))
Allergies:
Diagnostic Lab Data: Test Name: investigation; Result Unstructured Data: Test Result:no values; Comments: ground glass scans lesions with 50% damage to the pulmonary parenchyma; Test Date: 20210820; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: delta variant
CDC Split Type: FRPFIZER INC202101331113

Write-up: pneumococcal bacteremia; confusion; abdominal pain; Vaccination failure; COVID-19; Hyperthermia; signs of acute respiratory failure; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-LL20216386. A 94-year-old male patient received the first dose of bnt162b2 (COMIRNATY) on 21Jan2021 (lot number: EJ6788) Intramuscularly at single dose; the second dose of bnt162b2 (COMIRNATY) on 17Feb2021 (lot number: EM6950) Intramuscularly at single dose for COVID-19 immunisation. Medical history included Senile macular degeneration (age-related macular degeneration); Hip prosthesis insertion (total right hip prosthesis); COVID-19; Hypertension arterial; Appendectomy; Hyperthyroidism; Cholecystectomy; Adenocarcinoma (prostatic adenocarcinoma operated by the upper route in 98); severe Insufficiency renal. Concomitant medications were not reported. Patient experienced Vaccination failure on 20Aug2021; COVID-19 on 20Aug2021; signs of acute respiratory failure on 24Aug2021; pneumococcal bacteremia on unknown date; confusion on unknown date; abdominal pain on unknown date; Hyperthermia on unknown date. Positivity of the COVID PCR test on 20Aug2021 delta variant on systematic screening (admitted to the hospital on the 13th for pneumococcal bacteremia with confusion and abdominal pain). Hyperthermia on 23rd and appearance of signs of acute respiratory failure on 24Aug (ground glass scans lesions with 50% damage to the pulmonary parenchyma). On 20Aug2021, the result of SARS-CoV-2 test was Positive, delta variant. The outcome of the events Vaccination failure; COVID-19; signs of acute respiratory failure was fatal. The outcome of other events was unknown. Patient died on unknown date. And it was unknown reported whether the autopsy was performed. No follow-up attempts are possible, no further information is expected.; Reported Cause(s) of Death: signs of acute respiratory failure; COVID-19; Vaccination failure


VAERS ID: 1780159 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4508 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Coma, Epilepsy, Hypertensive crisis, Inappropriate schedule of product administration, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Generalised convulsive seizures following immunisation (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-26
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 respiratory infection; Dementia; Hypertension; Hyperuricaemia; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: ATPFIZER INC202101339382

Write-up: Coma; Hypertensive crisis; Epileptic fit; Fever over 38 � C; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is AT-BASGAGES-2021-049728. A 92-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FG4508, expiration date: not reported) via intramuscular on 24Aug2021 at 12:00 (at the age of 92-years-old) as dose 2, single for covid-19 immunization. Medical history included Hypertension, Osteoporosis, Hyperuricaemia, Dementia start and stop date was unknown, COVID-19 respiratory infection from Mar2021 to stop date unknown. No concomitant medication reported. Historical vaccine included first dose of BNT162B2 (COMIRNATY; Solution for injection, Lot Number: not reported, expiration date: not reported), via an unspecified route of administration on Feb2021 as a single dose for COVID-19 immunization. On 24Aug2021 at 16:00, patient experienced Coma (death), Hypertensive crisis, Epileptic fit, Fever over 38 � C which was medically significant, Inappropriate schedule of vaccine administered. On 24Aug2021, patient underwent lab tests and procedures which included body temperature was 38 centigrade. The patient died on 26Aug2021. It was not reported if an autopsy was performed. The outcome of event coma was fatal, Epileptic fit was unknown rest all events was not recovered. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1780165 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-10
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Gastrointestinal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (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: Chronic hepatitis C; Laryngeal papillomatosis; Nicotine abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101331498

Write-up: Gastrointestinal haemorrhage; This is a spontaneous report from a physician downloaded from the regulatory authority, regulatory authority number DE-DCGMA-21193322. Safety Report Unique Identifier DE-PEI-202100200969. A 70-year-old male patient received bnt162b2 (COMIRNATY, mRNA TOZINAMERAN), via an unspecified route of administration on 06May2021 (Batch/Lot Number: Unknown) at the age of 70-year-old as dose number unknown, 0.3mL single for covid-19 immunisation. Medical history included tobacco abuse, laryngeal papilloma, chronic hepatitis c. The patient''s concomitant medications were not reported. The patient experienced gastrointestinal haemorrhage on 10May2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event was fatal. This report is serious - death. Relatedness of the drug to the event: Gastrointestinal haemorrhage was reported as D: unclassifiable by the regulatory authority. No follow-up attempts are possible, information on batch numbers cannot be obtained.; Reported Cause(s) of Death: Gastrointestinal bleeding


VAERS ID: 1780169 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 123 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Tumor
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101330183

Write-up: sudden tumor. fast growing after surgery stroke and death; Headache; Accident cerebrovascular; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority DE-PEI-CADR2021186206. Safety Report Unique Identifier: DE-PEI-202100201215. A 74-year-old female patient received BNT162B2 (COMIRNATY, lot number 123) at single dose (reported as "Dosage text: 2") via an unknown route on 01Mar2021 at 74-year-old for COVID-19 immunisation. The patient''s medical history included tumor. Concomitant medication was not reported. Patient had no concerned known allergies. The reported event was "sudden tumor. fast growing after surgery stroke and death", "headache", and "accident cerebrovascular" with onset date of 01Mar2021. Outcome of the event was fatal. This report was serious with seriousness criteria of death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Headache; Accident cerebrovascular; sudden tumor. fast growing after surgery stroke and death


VAERS ID: 1780170 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-01
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Loss of consciousness, Multiple organ dysfunction syndrome, Off label use, Pancreatitis
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (narrow), Hyperglycaemia/new onset diabetes mellitus (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) (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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-10-03
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101330867

Write-up: 19Sep2021 collapsed at home, intubated 7 days later, died 7 days later; first pancreatitis up to multi-organ failure, within 14 days after third vaccination; first pancreatitis up to multi-organ failure, within 14 days after third vaccination; Booster; Booster; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority DE-PEI-CADR2021187338. Safety Report Unique Identifier: DE-PEI-202100202584. A 90-year-old male patient received BNT162B2(COMIRNATY, Batch/Lot Number: Unknown), dose 3 via an unspecified route of administration at the age of 90-year-old on 16Sep2021 as dose 3 (booster), single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 19Sep2021 collapsed at home, intubated 7 days later, died 7 days later. First pancreatitis up to multi-organ failure, within 14 days after third vaccination (in Sep2021). This report was reported as serious as death, hospitalization. The outcome of event Booster was unknown and other events was fatal. The patient died on 03Oct2021. An autopsy was not performed. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? No No information on risk factors or previous diseases No none / first pancreatitis up to multi-organ failure, within 14 days after third vaccination Relatedness of drug to reaction(s)/event(s) Source of assessment Result of Assessment - D. Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: first pancreatitis up to multi-organ failure, within 14 days after third vaccination; 19Sep2021 collapsed at home, intubated 7 days later, died 7 days later; first pancreatitis up to multi-organ failure, within 14 days after third vaccination


VAERS ID: 1780171 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-12
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: 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: DEPFIZER INC202101332345

Write-up: cerebral bleeding; This is a spontaneous report from a non-contactable physician based on information received by Pfizer [91486], license party for [Comirnaty]. A female patient of unspecified age received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient previously received the first dose of bnt162b2 (COMIRNATY) for COVID-19 immunisation. The patient died after the second vaccination. Five hours after the vaccination the patient was admitted to the hospital and a cerebral bleeding was detected. In addition, the physician reported about other deceased rather young patients. For reasons of time, no further information was provided. Because of the incident, the physician no longer vaccinated. It was unknown if autopsy was performed. Outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Cerebral haemorrhage (Fatal) and 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 bleeding


VAERS ID: 1780176 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-05-03
   Days after vaccination:67
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / 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: 2021-05-13
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101339227

Write-up: Infarct myocardial/ massive myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-BR20213589. A 79-years-old male patient received second dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: EP2166), via intramuscular route of administration on 25Feb2021 as dose 2, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: EK9788), via on 04Feb2021 as dose 1, single for covid-19 immunization. On 03May2021, the patient experienced infarct myocardial/ massive myocardial infarction. It was experienced about 2 months after a 2nd injection of COMIRNATY. The patient was hospitalized for infarct myocardial/ massive myocardial infarction from 03May2021 to an unknown date in intensive cardiological care. The patient died on 13May2021 (Fatal evolution 10 days later) and cause of death reported as Infarct myocardial/ massive myocardial infarction. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Infarct myocardial/ massive myocardial infarction


VAERS ID: 1780177 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-07-01
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Neoplasm progression, Positron emission tomogram, Therapeutic response decreased
SMQs:, Lack of efficacy/effect (narrow), Malignancy related conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-31
   Days after onset: 61
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PACLITAXEL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer (Hormone-dependent, Breast removal); Mastectomy; Metastasis (radiotherapy and chemotherapy); Metastasis (Liver metastasis in 2016? -2017? -2018?); Penicillin allergy
Allergies:
Diagnostic Lab Data: Test Name: PET scan; Result Unstructured Data: Test Result:the disease has progressed; Comments: "in routine" at the end of July: therapeutic escape, the disease has progressed
CDC Split Type: FRPFIZER INC202101331226

Write-up: Therapeutic response decreased after vaccination; Therapeutic response decreased/therapeutic escape, the disease has progressed/condition deteriorated very quickly; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-CF20212811. A 61-year-old female patient received BNT162B2 (COMIRNATY) second dose Intramuscular on right arm in May2021 at single dose for COVID-19 immunisation. Medical history included Penicillin allergy, breast cancer (Hormone-dependent, Breast removal) from 2005, Breast removal, Sternum + bone metastasis from 2012 (radiotherapy and chemotherapy), Liver metastasis in 2016? -2017? -2018?. Concomitant medications included paclitaxel. Treatment with Paclitaxel since PET Scan "in routine" at the end of Jul2021: therapeutic escape, the disease has progressed. Before the vaccination, patient reacted very favorably to her treatment, her condition deteriorated very quickly after the vaccination. Therapeutic response decreased after vaccination. Patient died on 31Aug2021. It was unknown if autopsy was done. No follow-up attempts are possible, no further information is expected. Batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Therapeutic response decreased/therapeutic escape, the disease has progressed/condition deteriorated very quickly


VAERS ID: 1780180 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Respiratory disorder, SARS-CoV-2 test
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 38
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: 20210406; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210415; Test Name: COVID-19 virus test; Test Result: Positive ; Test Date: 20210430; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101331191

Write-up: covid infection/ covid-19 respiratory infection; breathing problems; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-LL20216567. A 93-years-old male patient received bnt162b2 (COMIRNATY), the first dose via intramuscular on 08Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced covid infection/ covid-19 respiratory infection on 13Apr2021. Clinical summary: The patient was tested on 06Apr2021: negative. He was vaccinated on 08Apr2021. Tested on 15Apr2021: positive. He had breathing problems, he was tested again on 30Apr and he was negative. He would die on 09May2021 (as reported). The patient died on 09May2021. It was not reported if an autopsy was performed. The outcome of the event covid infection/ covid-19 respiratory infection was fatal, while the other events were unknown. No follow-up attempts are possible, no further information is expected.; Reported Cause(s) of Death: covid infection/ covid-19 respiratory infection


VAERS ID: 1780209 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-30
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Coma scale, Ruptured cerebral aneurysm
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   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: EXFORGE; LAMICTAL; TAHOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cerebral aneurysm (unruptured) (diagnosed in 2017); Epilepsy; Road traffic accident (pedestrian car road accident); TIA
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: glasgow; Result Unstructured Data: Test Result:3
CDC Split Type: FRPFIZER INC202101322977

Write-up: Ruptured cerebral aneurysm; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority report number FR-AFSSAPS-NC20214522. A 72-year-old male patient received second dose of bnt162b2 (COMIRNATY) intramuscular on 20Apr2021 (Lot Number: EW4815) single dose for covid-19 immunisation; acetylsalicylate lysine (KARDEGIC) oral 75 mg daily for atherothrombosis prophylaxis from an unspecified date to 30Apr2021. Medical history included: arterial hypertension, TIA, epilepsy, cerebral aneurysm diagnosed in 2017, pedestrian car road accident. Concomitant medications included amlodipine besilate, valsartan (EXFORGE); lamotrigine (LAMICTAL); atorvastatin calcium (TAHOR). The patient previously received first dose of bnt162b2 (COMIRNATY) for covid-19 immunisation on 23Mar2021. The patient experienced ruptured cerebral aneurysm (death) on 30Apr2021. On 30Apr2021, the patient was discomfort while driving with otorrhagia, transported to the emergency room, glasgow 3. Diagnosis was cerebral aneurysm rupture. The action taken for acetylsalicylate lysine was not applicable. The patient died on 30Apr2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Ruptured cerebral aneurysm


VAERS ID: 1780281 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-18
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardio-respiratory arrest, 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: 2021-09-18
   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: Renal transplant
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Infarct myocardial; Cardio-respiratory arrest; This case was received via a regulatory authority (Reference number: FR-AFSSAPS-RS20213021) on 04-Oct-2021 and was forwarded to Moderna on 04-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDIAL INFARCTION (Infarct myocardial) and CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) in a 63-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Renal transplant. On 14-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 18-Sep-2021, the patient experienced MYOCARDIAL INFARCTION (Infarct myocardial) (seriousness criteria death and medically significant) and CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria death and medically significant). The patient died on 18-Sep-2021. The reported cause of death was Infarct myocardial and Cardio-respiratory arrest. An autopsy was not performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drug information provided. No treatment information was reported. Action taken with mRNA-1273 (Spikevax) was Not applicable. Company Comment: This case concerns a 54-year-old, male with medical history of Renal transplant, who experienced the unexpected serious (death and AESI) events of myocardial Infarction and cardiopulmonary arrest. The events occurred approximately 5 days after the second dose of mRNA-1273 Moderna vaccine (Spikevax). The rechallenge was considered not applicable because the events were fatal. The patient expired on 09-18- 2021 on the same day of events of myocardial Infarction and cardiopulmonary arrest. The autopsy was not done. The medical history of renal transplant is a confounder for the events and the outcome of the case. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Translation document received on 06-Oct-2021 and included no new information.; Sender''s Comments: This case concerns a 54-year-old, male with medical history of Renal transplant, who experienced the unexpected serious (death and AESI) events of myocardial Infarction and cardiopulmonary arrest. The events occurred approximately 5 days after the second dose of mRNA-1273 Moderna vaccine (Spikevax). The rechallenge was considered not applicable because the events were fatal. The patient expired on 09-18- 2021 on the same day of events of myocardial Infarction and cardiopulmonary arrest. The autopsy was not done. The medical history of renal transplant is a confounder for the events and the outcome of the case. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.; Reported Cause(s) of Death: Infarct myocardial; Cardio-respiratory arrest


VAERS ID: 1780290 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-09-02
   Days after vaccination:156
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19 pneumonia, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-28
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN; DIAMICRON; RESITUNE; ZOPLICONE; REVINTY ELLIPTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchitis chronic; Calculus pancreatitis; Facial palsy; Malignant otitis externa; Thalassaemia; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210902; Test Name: Body temperature; Result Unstructured Data: Test Result:Fever; Test Date: 20210908; Test Name: SARS-CoV-2 serology; Result Unstructured Data: Test Result:IgG: 57.8 (limit) (IgG anti-SARS-CoV-2 targeting; Comments: IgG: 57.8 (limit) (IgG anti-SARS-CoV-2 targeting protein S) IgM: 0.68 (negative) conclusion: natural or vaccine immunity uncert; Test Date: 20210902; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20210907; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant with L452R mutation (probable delta variant).
CDC Split Type: FRPFIZER INC202101322717

Write-up: Vaccination failure; SARS-CoV-2 pneumonia; Fever; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-SE20212535. An 82-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 30Mar2021 (Batch/Lot Number: ER9470) as dose 2, single, dose 1 intramuscular on 02Mar2021 (Batch/Lot Number: EP2166) as dose 1, single for covid-19 immunisation. Medical history included obstructive pancreatitis from 2017, type 2 diabetes mellitus, facial paralysis from 2019, otitis externa from 2019, thalassaemia, bronchitis chronic. Concomitant medications included metformin; gliclazide (DIAMICRON); acetylsalicylic acid (RESITUNE); zopiclone (ZOPLICONE); fluticasone furoate, vilanterol trifenatate (REVINTY ELLIPTA). The patient experienced vaccination failure on 02Sep2021, sars-cov-2 pneumonia on 02Sep2021, fever on 02Sep2021. The outcome of the events was fatal. Seriousness criteria of the events was death.The patient underwent lab tests and procedures which included body temperature: fever on 02Sep2021, sars-cov-2 antibody test: igg: 57.8 (limit) (igg anti-sars-cov-2 targeting on 08Sep2021 IgG: 57.8 (limit) (IgG anti-SARS-CoV-2 targeting protein S) IgM: 0.68 (negative) conclusion: natural or vaccine immunity uncert, sars-cov-2 test: positive on 02Sep2021, sars-cov-2 test: positive on 07Sep2021 Variant with L452R mutation (probable delta variant). The patient died on 28Sep2021. An autopsy was not performed. The clinical course was reported as follows: Case summary: This serious case, of the type Spontaneous Notification, received by the Ministry Portal - SAS, was notified by an anaesthesiologist-resuscitator. It concerns a man aged 82 years. Reported history:- Diabetes mellitus type 2, - Facial paralysis (2019), - Malignant external otitis (2019), - Lithiasis pancreatitis (2017), - Thalassemia, - Chronic bronchitis. Personal treatment: Metformin 1g 1-0-1, Diamicron 60 mg 1.5 -0-0, Resitune 75 mg 1/day, Zoplicone 7.5 0-0-0-1. Revinty ellipta. Suspected drugs :- COMIRNATY : Dose 1 LOT EP2166 completed on 02Mar2021, Dose 2 LOT ER9470 completed on 30Mar2021. Adverse reactions:- 02Sep2021: vaccine failure. Current history: 02Sep2021: episode of fever. Positive PCR test. 07Sep2021: hospitalisation for deterioration of general condition with repeated downfall in the context of SARS-CoV-2 pneumonia. Initiation of dexamethasone. 09Sep2021: transfer to intensive care. The patient s general condition, particularly from a respiratory point of view, continues to worsen and it is decided after an ethical meeting to implement therapeutic limitation or cessation due to the patient s age and lack of improvement. 28Sep2021: death in the presence of his family from a still active SARS COV-2 pneumopathy. Further investigations: 07Sep2021, SARS-CoV-2 test: Positive (highly contagious patient). Variant with L452R mutation (probable delta variant). 08Sep2021: SARS-CoV-2 serology: IgG: 57.8 (limit) (IgG anti-SARS-CoV-2 targeting protein S), IgM: 0.68 (negative). conclusion: natural or vaccine immunity uncertain. Conclusion: Vaccine failure at 5 months of COMIRNATY Dose 2, in an 82 year old patient infected with the delta variant, with fatal evolution. Note.: Imputability without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable procedures of compensation. Therapie 1985;40:111-8. For event: Time Interval between Beginning of Drug Administration and Start of Reaction / Event: 185 days. Time Interval between Last Dose of Drug and Start of Reaction / Event: 157 days. Did reaction recur on readministration?: no rechallenge was done, recurrence is not applicable. Stop date of vaccination failure 28Sep2021. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Severe SARS COVID-19 lung disease


VAERS ID: 1780310 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pancreatic carcinoma
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-31
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: FRPFIZER INC202101332737

Write-up: PANCREAS CANCER; This is a spontaneous report received from a contactable consumer or non HCP reporting for her sister. A 74-year-old female patient received the 1st dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient was diagnosed with pancreas cancer after her first injection: despite a 1st cycle of chemotherapy, the patient died on 31Aug2021. It was unknown if autopsy was performed. Outcome of the event was fatal.; Reported Cause(s) of Death: Pancreas cancer


VAERS ID: 1780653 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-10
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Movement disorder, Pneumonia, Pulmonary embolism
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Accidents and injuries (narrow), 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: 2021-07-24
   Days after onset: 44
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: Thrombosis NOS (HOSPITALIZATION 2-3 YEARS AGO.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202101314097

Write-up: Pneumonia; PULMONARY EMBOLISM; Movement disorder-SHUFFLE HER LEG; BRUISES OF ARM AND LEG; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority, regulatory authority number GR-GREOF-20218441. An 87-year-old female patient received second dose of bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 01Jun2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included thrombosis from an unknown date and unknown if ongoing (hospitalization 2-3years ago). The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY) for covid-19 immunization. The patient experienced pneumonia on 12Jul2021, movement disorder-shuffle her leg on 12Jul2021, bruises of arm and leg on 10Jun2021, pulmonary embolism on an unspecified date with outcome of unknown. The patient was hospitalized for pneumonia (pneumonia) from 19Jul2021 to an unknown date. Therapeutic measures were taken as a result of pneumonia, movement disorder-shuffle her leg, bruises of arm and leg, pulmonary embolism. The patient died on 24Jul2021. It was not reported if an autopsy was performed. Seriousness criteria of the event pneumonia was death, hospitalization, medically significant. Seriousness criteria of the events movement disorder-shuffle her leg and bruises of arm and leg was death, medically significant. Seriousness criteria of the event pulmonary embolism was medically significant. Important part of narrative from source document: at night she presented pulmonary embolism. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1782154 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-23
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7206 / 1 - / OT

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

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-09-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MULTIVITAMIN FOR WOMEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101359925

Write-up: Congenital anomaly; At the time of my injection I was 5 weeks pregnant.; This is a spontaneous report. This consumer reported for both the mother and baby case. This is the baby case. A fetus patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 transplacental on 10Sep2021 13:45 (Batch/Lot Number: FD7206) as DOSE 1, SINGLE for covid-19 immunisation. The mother at 32-years-old received the vaccine on 10Sep2021 in the Arm Right. The last menstrual period 06Aug2021 pregnancy due date is on 13May2022. The mother also did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No history of pregnancy complications, bleeding, spotting, and no history of miscarriage. 4 healthy, successful pregnancies. The patient medical history was not reported. Concomitant medication included ascorbic acid, biotin, calcium carbonate, calcium pantothenate, chromium nicotinate, colecalciferol, cupric oxide, cyanocobalamin, ferrous fumarate, folic acid, magnesium hydroxide, manganese gluconate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, selenomethionine, sodium molybdate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTIVITAMIN FOR WOMEN) taken for an unspecified indication, start and stop date were not reported. It was reported that the patient experienced Congenital anomaly/birth defect (reported as Congenital anomaly/birth defect: YES). The mother reported that: "At the time of my injection I was 5 weeks pregnant. I miscarried 13 days later (also reported as 23Sep2021 12:00). I have no history of pregnancy complications, bleeding, spotting, and no history of miscarriage. I have had 4 healthy, successful pregnancies. I have no reason to believe this pregnancy would have been any different if not for receiving this vaccine which doesn''t have adequate testing on pregnant women" The patient died on 23Sep2021. It was not reported if an autopsy was performed.; Sender''s Comments: Linked Report(s) : CA-PFIZER INC-202101281587 Maternal case; Reported Cause(s) of Death: congenital anomaly


VAERS ID: 1782174 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-09-24
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: METFORMINA [METFORMIN]; GLIBENCLAMIDA; ASPIRINA; VYMADA; FORXIGA; ROVARTAL; CORENTEL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Diabetes; Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: CRPFIZER INC202101350904

Write-up: acute myocardial infarction; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Aug2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included diabetes, heart failure, high blood pressure. Concomitant medication(s) included metformin (METFORMINA); glibenclamida; acetylsalicylic acid (ASPIRINA); sacubitril, valsartan (VYMADA); dapagliflozin propanediol monohydrate (FORXIGA); rosuvastatin calcium (ROVARTAL); bisoprolol fumarate (CORENTEL). The patient experienced acute myocardial infarction on 24Sep2021. The outcome was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. The lot number for BNT162B2, was not provided and will be requested during follow up; Reported Cause(s) of Death: acute myocardial infarction


VAERS ID: 1782188 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-09-04
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 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: 2021-09-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction; Arterial hypertension; Coronary artery disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101339800

Write-up: Death sudden; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-DCGMA-21193352. A 56-year-old male patient received bnt162b2 (COMIRNATY) strength: 0.3 ml, intramuscularly on 23Aug2021 (Batch/Lot Number: Unknown) as dose number unknown, single for covid-19 immunisation at age of 56-year-old. Medical history included coronary artery disease which was unknown if ongoing, arterial hypertension which was unknown if ongoing, and acute myocardial infarction which was recovered. The patient''s concomitant medications were not reported. The patient experienced death sudden on 04Sep2021. It was not reported if an autopsy was performed. This report is serious - death. Result of assessment (source: Regulatory Authority) unclassifiable. No follow-up activities possible. No further information expected. Batch/LOT number cannot be obtained. ; Reported Cause(s) of Death: Death sudden


VAERS ID: 1783269 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-23
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCJU6 / 2 - / -

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: 2021-09-24
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: Apoplexy; Arterial occlusive disease; COPD; Coronary disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101339487

Write-up: Sudden death unexplained; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100203282 and concerns about a 66-Year-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection, lot No: SCJU6 and Expiration date was not reported), via an unspecified route of administration on 23Sep2021 (Age at Vaccination was 66 years) as dose2, single for COVID-19 immunization. The patient''s medical history and concurrent conditions included Arterial occlusive disease, COPD(chronic obstructive pulmonary disease), Coronary disease and Apoplexy. The patient concomitant medication were not reported. Historical vaccine included first dose of bnt162b2 (COMIRNATY, Solution for injection, lot no. and expiry date were not reported) on 26Aug2021, as dose 1, 0.3 ml single for COVID-19 immunization. On an unspecified date, the patient Sudden death unexplained. The patient died on 24Sep2021. It was not reported if an autopsy was performed. This report was serious - death. The outcome of event was fatal. Event assessment : Comirnaty/ event /Regulatory Authority /Result of Assessment : B. Indeterminate No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1783271 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-07
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Palpitations, Panic disorder, Sinus tachycardia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101339807

Write-up: Found dead/ Sudden death, cause unknown; Sinus tachycardia; Heart racing; Panic disorder; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100203403. A 27-year-old male patient received bnt162b2 (COMIRNATY, mRNA TOZINAMERAN, Lot Number: FE6975), via an unspecified route of administration on 30Jun2021 (27-year-old at time of vaccination) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced sinus tachycardia, heart racing, and panic disorder on 07Jul2021; "found dead/ Sudden death, cause unknown" on 27Jul2021. This report is serious - death. The patient died on 27Jul2021. The outcome of the events sinus tachycardia, heart racing, and panic disorder was unknown. The cause of death was "found dead/ Sudden death, cause unknown". An autopsy was not performed. Relatedness of drug to events Sinus tachycardia, Heart racing, Found dead, Panic disorder was assessed by Regulatory Authority as "C. Inconsistent causal association to immunization" per Glob. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Found dead/ Sudden death, cause unknown


VAERS ID: 1783275 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-06
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20211022687

Write-up: Vaccination failure; COVID-19; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, DE-PEI-202100204687) on 12-OCT-2021 and concerned a 79 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 dosage forms, 1 total administered on 30-AUG-2021 for an unspecified indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 06-OCT-2021, the patient experienced vaccination failure, and was hospitalized (date unspecified). On 06-OCT-2021, the patient experienced covid-19. On an unspecified date, the patient died from vaccination failure, and covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: G.S.SARS-CoV-2-positivetive PCR Test am 06 10 2021.; Reported Cause(s) of Death: VACCINATION FAILURE; COVID-19


VAERS ID: 1783330 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-15
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac death, Exercise tolerance decreased, Vasculitis
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Guillain-Barre syndrome (broad), Vasculitis (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 18
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 INC202101339539

Write-up: Cardiac death; vasculitis of the heart vessels; Significantly reduced resilience after vaccination; weakness; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB [DE-PEI-CADR2021187510], Sender''s (Case) Safety Report Unique Identifier is DE-PEI-202100203236. A 30-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Strength: 0.3 ml) at single dose on 30Apr2021 for COVID-19 immunisation. Medical history, concurrent conditions and concomitant medications were not reported. On 15May2021, the patient experienced exercise tolerance decreased and weakness; described as significantly reduced resilience after vaccination, weakness. On 02Jun2021, the patient experienced cardiac death and died the same day. The autopsy was done and autopsy result was available: cause of death after autopsy was vasculitis of the heart vessels. The outcome of events cardiac death and vasculitis of the heart vessels was fatal. The outcome of events exercise tolerance decreased and weakness was not recovered. This report was serious - death. Sender Comment: Information on risk factors or underlying diseases. No known underlying diseases. Father died of sudden cardiac death the year before. Received the first dose of Biontech vaccine on 30Apr2021. Found dead on 02Jun2021. Significantly reduced resilience and feeling of weakness in the days before. Cause of death after autopsy: vasculitis of the heart vessels. The Regulatory Authority assessment for cardiac death and exercise tolerance decreased with the suspect product Comirnaty is D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: vasculitis of the heart vessels; Cardiac death; Autopsy-determined Cause(s) of Death: vasculitis of the heart vessels


VAERS ID: 1783331 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1010A / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspiration, Constipation, Ileus, Immunisation, Malaise, Nausea, Off label use, Urinary tract infection
SMQs:, Acute pancreatitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-10-03
   Days after onset: 5
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; Atrial fibrillation; Bloody discharge (Before vaccination); Constipation; Decreased appetite (Before vaccination); Tricuspid insufficiency (II degree)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101339556

Write-up: Constipation in ileus; Constipation in ileus; Presumably due to aspiration in case of ileus; Urinary tract infection; Malaise; Nausea; Booster; Off-label use; This is a spontaneous report received from a non-contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-CADR2021187571. Safety Report Unique Identifier DE-PEI-202100203146. A 90-year-old female patient received the third dose of BNT162B2 (COMIRNATY) at 90-year-old, via an unspecified route of administration on 28Sep2021 (Batch/Lot Number: 1F1010a) at single dose (booster) for COVID-19 immunisation. Medical history included tricuspid insufficiency II degree, atrial fibrillation, and arterial hypertension. Patient noticed loss of appetite and bloody discharge already before vaccination. Already no bowel movement before vaccination (probably since 25Sep2021). Stable pre-existing conditions, independent, active woman. No known allergies. The patient''s concomitant medications were not reported. The patient experienced constipation in ileus on an unspecified date, malaise on 29Sep2021, urinary tract infection on 29Sep2021, and nausea on 29Sep2021. On 29Sep2021 and 02Oct2021 presentation in the emergency department and ambulatory in each case with worsening of all symptoms. On 03Oct2021 presumably due to aspiration in case of ileus died. This report was serious - death. Outcome of events malaise, urinary tract infection, and nausea was not resolved. The patient died on 03Oct2021. It was not reported if an autopsy was performed. Relatedness Assessment: Malaise, Urinary tract infection, Obstipation, Nausea: D. Unclassifiable. Source of assessment: Regulatory Authority. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Constipation in ileus; Constipation in ileus


VAERS ID: 1783332 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-07-18
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Oropharyngeal pain, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-15
   Days after onset: 59
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: Dementia (Onset of dementia/absence); Depression; Palpitations
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101339531

Write-up: Lung edema; Pain pharynx; Fatigue; Dyspnoea; This is a spontaneous report from a non-contactable consumer or other non HCP downloaded from the Regulatory Authority-WEB [DE-PEI-CADR2021187631], Safety Report Unique Identifier [DE-PEI-202100203100]. An 83 years old female patient received BNT162B2 (COMIRNATY) 0.3ml single dose on 09Jun2021 for COVID-19 immunisation. Medical history included dementia/absence, depression, heart palpitations and concomitant drugs were not provided. On 18Jul2021 the patient experienced Fatigue. On 18Jul2021 the patient experienced Pain pharynx, Dyspnoea. On 01Aug2021 the patient experienced Lung edema. This was serious - death, hospitalization. The patient was unable to bear weight, sore throat, water in the legs, shortness of breath, pulmonary edema. Outcome of event fatigue, pain pharynx and dyspnoea was not resolved, outcome of lung edema was fatal. The patient died on 15Sep2021. Event assessment for events Pain pharynx, Fatigue, Lung edema, Dyspnoea by Regulatory Authority: D. Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Lung edema


VAERS ID: 1783333 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-04-25
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness, Cerebral infarction, General physical health deterioration
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Accident cerebrovascular
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101339549

Write-up: Stroke, or several minor strokes; Blindness or impaired vision; General poor health; This is a spontaneous report from a non-contactable consumer or other non HCP downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021187678. A 76-year-old patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 25Apr2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. The patient medical history included ongoing accident cerebrovascular. The patient had no known allergy. The patient''s concomitant medications were not reported. The patient had stroke, or several minor strokes. Blindness or impaired vision. General poor health. Onset date was reported "17Apr2021". This report is serious - death. Autopsy was not done. Cause of death was reported Multiple cerebral infarction. The outcome of the other events was unknown. Regulatory Authority assessed the relatedness of drug to the event was unclassifiable. Sender''s comments: Are you or the person concerned known of any allergies? If yes, which? no. Information on risk factors or previous illnesses Stroke / hospitalization Death. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. ; Reported Cause(s) of Death: Multiple cerebral infarction


VAERS ID: 1783349 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Chronic lymphocytic leukemia
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: Test Result:No significant antibody
CDC Split Type: DEPFIZER INC202101340130

Write-up: Covid-19 after the second vaccination; Covid-19 after the second vaccination; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 91708], license party for bnt162b2 (COMIRNATY). A contactable physician reported a male patient in his 70s received bnt162b2 (Lot number: unknown), dose 1 and dose2, both via an unspecified route of administration on an unspecified date, single for COVID-19 immunization. Medical history included chronic lymphocytic leukemia. The patient''s concomitant medications were not reported. The patient experienced COVID-19 after his second vaccination and died 2 months after the second vaccination, the seriousness of which was fatal. Despite vaccinations, the patient had no significant antibody. The outcome of COVID-19 was fatal. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of events covid19 and drug ineffective cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1783508 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-01
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7911 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood bicarbonate, Blood bilirubin, Blood creatinine, Blood glucose, Blood pH, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, Breath sounds abnormal, C-reactive protein, Cardiac failure, Circulatory collapse, Coma, Coma scale, Dehydration, Disturbance in attention, Glomerular filtration rate, Haematocrit, Haemoglobin, Heart rate, Heart sounds, Heart sounds abnormal, Hypopnoea, Hypotension, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Oxygen saturation, PCO2, PO2, Platelet count, Pneumonia, Prothrombin time, Tachypnoea, Troponin, White blood cell count
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LERCAN; ESIDREX; MIRTAZAPINE; ALPRAZOLAM; VALPROMIDE; PANTOPRAZOLE; FOLIC ACID; PARACETAMOL; LACTULOSE; ZYMAD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (without more precision (?)); Atrioventricular block; Bipolar disorder; Cardiac pacemaker insertion (Pace Maker on Atrioventricular block); Cardiovascular disease, unspecified; Cognitive disorder (recent worsening); Decompensation cardiac; Dyslipidaemia; General physical health deterioration; Hypertension arterial; NIDDM
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: ALT; Result Unstructured Data: Test Result:17.8 mol/L; Test Date: 202109; Test Name: ASAT; Result Unstructured Data: Test Result:36 mol/L; Test Date: 202109; Test Name: Bicarbonates; Result Unstructured Data: Test Result:12.1 mmol/L; Test Date: 202109; Test Name: Total bilirubin; Result Unstructured Data: Test Result:32.9 umol/l; Test Date: 202109; Test Name: Ceratinine; Result Unstructured Data: Test Result:505 umol/l; Test Date: 202109; Test Name: Glucose; Result Unstructured Data: Test Result:2.3 g/l; Test Date: 202109; Test Name: Blood gas with a PH of; Result Unstructured Data: Test Result:7.14; Test Date: 202109; Test Name: K+; Result Unstructured Data: Test Result:5.2 mmol/L; Test Date: 202109; Test Name: blood pressure; Result Unstructured Data: Test Result:45/20 mmHg; Test Date: 20210916; Test Name: BP; Result Unstructured Data: Test Result:13/7; Comments: before vaccination; Test Date: 20210917; Test Name: BP; Result Unstructured Data: Test Result:12.5/7; Test Date: 20210919; Test Name: BP; Result Unstructured Data: Test Result:10/5; Comments: in the afternoon; Test Date: 20210919; Test Name: BP; Result Unstructured Data: Test Result:8; Comments: Around 6:15 p.m; Test Date: 202109; Test Name: Na+; Result Unstructured Data: Test Result:152 mmol/L; Test Date: 202109; Test Name: Urea; Result Unstructured Data: Test Result:49 mmol/L; Test Date: 20210917; Test Name: temperature; Result Unstructured Data: Test Result:37.6; Test Date: 20210919; Test Name: temperature; Result Unstructured Data: Test Result:37; Comments: in the morning; Test Date: 202109; Test Name: coma scale; Result Unstructured Data: Test Result:5; Test Date: 202109; Test Name: CRP; Result Unstructured Data: Test Result:496 mg/l; Test Date: 202109; Test Name: GFR; Result Unstructured Data: Test Result:6; Comments: ml / min / 1.73 m2; Test Date: 202109; Test Name: hematocrit; Test Result: 54.5 %; Test Date: 202109; Test Name: Hb; Result Unstructured Data: Test Result:17.1 g/dl; Test Date: 202109; Test Name: heart rate; Result Unstructured Data: Test Result:128; Comments: bpm; Test Date: 202109; Test Name: Heart sounds; Result Unstructured Data: Test Result:irregular; Test Date: 202109; Test Name: Polunuclear Neutrophils; Result Unstructured Data: Test Result:20.9 x10 9/l; Test Date: 202109; Test Name: NT-pro BNP; Result Unstructured Data: Test Result:24146 ng/L; Test Date: 202109; Test Name: O2 saturation; Test Result: 84.8 %; Test Date: 20210916; Test Name: O2 saturation; Test Result: 93 %; Comments: before vaccination; Test Date: 20210917; Test Name: O2 saturation; Result Unstructured Data: Test Result:93 to 94 %; Test Date: 202109; Test Name: PCO2; Result Unstructured Data: Test Result:36.7 mmHg; Test Date: 202109; Test Name: Platelets; Result Unstructured Data: Test Result:301 x10 9/l; Test Date: 202109; Test Name: pO2; Result Unstructured Data: Test Result:69.5 mmHg; Test Date: 202109; Test Name: prothrombin time; Test Result: 26 %; Test Date: 202109; Test Name: Troponin; Result Unstructured Data: Test Result:433 ng/L; Test Date: 202109; Test Name: Leukocyte count; Result Unstructured Data: Test Result:23 x10 9/l
CDC Split Type: FRPFIZER INC202101339766

Write-up: Decompensation cardiac/cardiac decompensation/sudden cardiac failure; a false route (swallowing pneumonia?); rapid onset of collapse; vigilance disorder; Polypnea; shallow breathing; skin dehydration; bronchial rales in both pulmonary fields; Glagow 5 coma; Heart sounds are irregular; blood pressure at 45/20 mmHg; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-DJ20213852. An 84-year-old female patient received bnt162b2 (COMIRNATY), dose 3 intramuscular on 16Sep2021 (Batch/Lot Number: FG7911) as dose 3 (booster), single for covid-19 immunisation. The person is considered to be at risk of developing a severe form of the disease COVID-19: yes (cardiovascular pathologies). Dose 1 on 19Mar2021, Left arm, Intramuscular injection, Lot No.: ET3620; Dose 2 on 12May2021, Left arm, Intramuscular injection, Lot number: FA5831. Medical history included cardiac pacemaker insertion (Pace Maker on Atrioventricular block), dyslipidaemia, cognitive disorder (recent worsening), Bipolar disorder/Bipolarity, Decompensation cardiac/Cardiac decompensation, allergy (without more precision (?)), Hypertension arterial, non-insulinodependant diabetes (NIDDM), atrioventricular block, cardiovascular disease, and refusal to eat, failure to thrive syndrome (syndrome de glissement)/ slip syndrome. No Covid history. Concomitant medications included lercanidipine hydrochloride (LERCAN); hydrochlorothiazide (ESIDREX); mirtazapine; alprazolam; valpromide; pantoprazole; folic acid; paracetamol; lactulose; and colecalciferol (ZYMAD), all taken for an unspecified indication, start and stop date were not reported. Side effects: 19Sep2021: occurrence of cardiac decompensation with evolution: death. Clinical summary: Patient entered the nursing home since May or June 2021. Patient in a wheelchair. 16Sep2021: 3rd injection of bnt162b2. Before the vaccination on 16Sep2021: BP at 13/7; 93% saturation. 17Sep2021, ie the day after vaccination: BP at 12.5 / 7; 93 or 94% saturation; temperature to 37.6 degrees. 18Sep2021: nothing relevant, the patient ate a little. 19Sep2021, i.e. on Day4 of the vaccination: in the morning temperature at 37degrees 1, BP not taken. In the afternoon BP at 10/5. Around 6:15 p.m. the doctor was called because the patient''s condition suddenly deteriorated with the appearance of vigilance disorders, a BP of 8 and impregnable saturation. On clinical examination: Polypnea, bronchial rales in both pulmonary fields, very shallow breathing, skin dehydration which appeared during the day. The declaring physician reports the onset of sudden cardiac failure with rapid onset of collapse. Call 15 and the patient is hospitalized. In the emergency room (Sep2021): Notion of deterioration of general condition for 3 weeks. The patient presented with a coma score of 5 with a difficult neurological examination. Heart sounds are irregular with blood pressure at 45/20 mmHg and heart rate at 128 bpm. The patient is seen under oxygen with a high concentration mask at 85% saturation. The lungs are free. There is a skin fold. Biology: Hb at 17.1 g / dl; hematocrit 54.5%; Leukocytes at 23 x10 9/l including polynuclear neutrophil 20.9 x10 9/l; Platelets at 301 x10 9/l; prothrombin time 26% (70-100); Na + at 152 mmol / l; K + at 5.2 mmol / l; Urea at 49 mmol / l; Creatinine at 505 umol / l; GFR at 6 ml / min / 1.73 m2; Glucose at 2.30 g / l; ASAT at 36 mol/L; ALT at 17.8 mol/L; Total bilirubin at 32.9 umol / l; Troponin at 433 ng / l (less than45); NT-pro BNP at 24146 ng / l (less than 450); CRP at 496 mg / l (less than 10); Blood gas with a PH of 7.14 (7.35-7.45); PCO2 at 36.7 mmHg (35-45); PO2 at 69.5 mmHg (80-100); Bicarbonates at 12.1 mmol / l with 84.8% saturation. High concentration oxygen with placement of a urinary catheter and hydration. Brain scan is not possible due to the patient''s respiratory and neurological condition. The family was informed, no futile medical care. The patient was declared dead on 17Sep2021 at 1 a.m. (as reported). In the emergency report, it is mentioned as the main short-term hospitalization unit diagnosis: "Death occurring less than 24 hours after the onset of symptoms, without further explanation". The reporting physician reported this patient''s case due to the timeline with vaccination 4 days prior to onset of symptoms. It evokes two hypotheses: cardiac decompensation or a false route (swallowing pneumonia?). In total, an 84-year-old patient with a history of cardiovascular disease with recent worsening cognitive disorders and slip syndrome, who presented with sudden cardiac failure with onset of collapse on D4 of the 3rd dose of the bnt162b2 vaccine. Evolution towards death on Day5. The hypotheses of a cardiac decompensation or a false route were raised by the declaring physician. Therapeutic measures were taken as a result of events. The outcome of event Decompensation cardiac/cardiac decompensation/sudden cardiac failure, and a false route (swallowing pneumonia?) was fatal. The outcome of other event was unknown. The patient died on Sep2021. It was not reported if an autopsy was performed. NB: A drug is coded in substance when the specialty name is not known.; Reported Cause(s) of Death: Decompensation cardiac/cardiac decompensation/sudden cardiac failure; a false route (swallowing pneumonia?)


VAERS ID: 1783514 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-09-11
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-24
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: PCR; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC202101340047

Write-up: Vaccination failure; Suspected Covid-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-LL20216633. A 79-year-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscularly on 06Apr2021 (Batch/Lot Number: Unknown) and second dose of bnt162b2 (COMIRNATY), intramuscularly on May2021 (Batch/Lot Number: Unknown), as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 11Sep2021, cough and fever occurred. The patient experienced vaccination failure on 11Sep2021. PCR performed on 11Sep2021 (result not provided). Patient hospitalized from 11Sep2021 and died on 24Sep2021. An autopsy was not performed. The case was reported as serious due to medically significant, hospitalized and fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vaccination failure; Suspected Covid-19


VAERS ID: 1783541 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-22
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001653 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Foetal death, Foetal growth restriction, Foetal hypokinesia, Microbiology test, Placental infarction, Ultrasound Doppler, Ultrasound scan
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug hypersensitivity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210505; Test Name: Fetal study; Test Result: Positive ; Result Unstructured Data: Macroscopic data: female fetus. Signs of recent retention Intrauterine growth delay without externally or internally visualized malformation. Major placental hypotrophy (less than 8.5 weeks since LMP ) with vascular changes. Samples taken for bacteriological and frozen sample studies. Histological data : ongoing. comment: subject to the state of the fetus. Pregnancy reported at 26.5 since LMP. Biometric characteristics usually consistent with 25th week post-amnenorrhea development; Test Date: 20210505; Test Name: Microbiological lung examination; Test Result: Negative ; Result Unstructured Data: No flora, aerobic bacteria study negative at 5 days. Anaerobic bacteria study negative at 5 days.; Test Date: 20210505; Test Name: Microbiology placenta/cord/membrane examination; Test Result: Positive ; Result Unstructured Data: Some gram-positive bacilli. Aerobic bacteria study: Positive Isolation of Enterococcus faecalis (fair number of colonies) and Proteus mirabilis (fewcolonies).; Test Date: 20210423; Test Name: doppler scan; Result Unstructured Data: Regular fetal heartbeat at 150bpm; Test Date: 20210331; Test Name: Ecography; Test Result: Negative ; Result Unstructured Data: ultrasound of the fetus and its organs that did not reveal any abnormalities. Fetal size consistent with term. Monitoring of morphology and maturation was planned between 26 and 28 weeks since LMP.; Test Date: 20210430; Test Name: Ecography; Test Result: Positive ; Result Unstructured Data: Recent fetal death a few days ago. Multiple placental infarction
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Intrauterine growth retardation; Death intrauterine; Placental infarction; Foetal movements decreased; This case was initially received (Reference number: FR-AFSSAPS-NY20210941) on 04-Oct-2021. The most recent information was received on 04-Oct-2021 and was forwarded to Moderna on 06-Oct-2021. This regulatory authority prospective pregnancy case was reported by a physician and describes the occurrence of FOETAL GROWTH RESTRICTION (Intrauterine growth retardation), FOETAL DEATH (Death intrauterine), PLACENTAL INFARCTION (Placental infarction) and FOETAL HYPOKINESIA (Foetal movements decreased) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3001653) for COVID-19 vaccination. Concurrent medical conditions included Drug hypersensitivity. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. The patient''s last menstrual period was on 15-Oct-2020 and the estimated date of delivery was 22-Jul-2021. On 22-Apr-2021, after starting mRNA-1273 (Spikevax), the patient experienced FOETAL HYPOKINESIA (Foetal movements decreased) (seriousness criteria hospitalization and medically significant). On 30-Apr-2021, the patient experienced FOETAL GROWTH RESTRICTION (Intrauterine growth retardation) (seriousness criteria hospitalization and medically significant), FOETAL DEATH (Death intrauterine) (seriousness criteria death, hospitalization and medically significant) and PLACENTAL INFARCTION (Placental infarction) (seriousness criterion hospitalization). The patient received mRNA-1273 (Spikevax) beginning around the twenty-sixth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Intrauterine death. For foetus 1, The outcome was reported as Stillbirth NOS. On 02-May-2021, FOETAL GROWTH RESTRICTION (Intrauterine growth retardation) had not resolved. The patient died on an unknown date. It is unknown if an autopsy was performed. At the time of death, PLACENTAL INFARCTION (Placental infarction) and FOETAL HYPOKINESIA (Foetal movements decreased) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Ultrasound scan: negative (Negative) ultrasound of the fetus and its organs that did not reveal any abnormalities. Fetal size consistent with term. Monitoring of morphology and maturation was planned between 26 and 28 weeks since LMP.. On 23-Apr-2021, Ultrasound Doppler: normal (normal) Regular fetal heartbeat at 150bpm. On 30-Apr-2021, Ultrasound scan: positive (Positive) Recent fetal death a few days ago. Multiple placental infarction. On 05-May-2021, Autopsy: positive (Positive) Macroscopic data: female fetus. Signs of recent retention Intrauterine growth delay without externally or internally visualized malformation. Major placental hypotrophy (less than 8.5 weeks since LMP ) with vascular changes. Samples taken for bacteriological and frozen sample studies. Histological data : ongoing. comment: subject to the state of the fetus. Pregnancy reported at 26.5 since LMP. Biometric characteristics usually consistent with 25th week post-amnenorrhea development. On 05-May-2021, Microbiology test: negative (Negative) No flora, aerobic bacteria study negative at 5 days. Anaerobic bacteria study negative at 5 days. and positive (Positive) Some gram-positive bacilli. Aerobic bacteria study: Positive Isolation of Enterococcus faecalis (fair number of colonies) and Proteus mirabilis (fewcolonies).. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications listed. No treatment information provided. Company Comment: This case of fetal death/maternal exposure during pregnancy, concerns a 28-year-old female patient (gestational age at the time of exposure to vaccine was 24-26 based on LMP) with no relevant medical history, who experienced the unexpected serious events of placental infarction, fetal hypokinesia, intrauterine growth restriction and fetal death. The events occurred 2 weeks after receiving the Moderna mRNA-1273 vaccine (Spikevax). The rechallenge is not applicable. The benefit-risk relationship of mRNA vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Translation received 06-Oct-21: Updated all lab data.; Sender''s Comments: This case of fetal death/maternal exposure during pregnancy, concerns a 28-year-old female patient (gestational age at the time of exposure to vaccine was 24-26 based on LMP) with no relevant medical history, who experienced the unexpected serious events of placental infarction, fetal hypokinesia, intrauterine growth restriction and fetal death. The events occurred 2 weeks after receiving the Moderna mRNA-1273 vaccine (Spikevax). The rechallenge is not applicable. The benefit-risk relationship of mRNA vaccine is not affected by this report.


VAERS ID: 1783857 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101317067

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; died related to other illnesses; This is a spontaneous report from a contactable physician received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110041730363100-MBWX5, Safety Report Unique Identifier number is (GB-MHRA-ADR 26033970) An elderly male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 24Dec2020 (Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. Patient previously has not had symptoms associated with COVID-19. The patient medical history and concomitant medications were not reported. The patient experienced died related to other illnesses on 2021, sars-cov-2 infection (hospitalization, life threatening) on 03Aug2021. Patient was caught hospital acquired covid in August 2021 but recovered. Has subsequently died related to other illnesses. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test. The outcome of the event unknown cause of death was fatal, others was recovered in 2021. The patient died on 2021. 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: died related to other illnesses


VAERS ID: 1783871 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-09-15
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cleft lip and palate, Dysmorphism, Eye disorder, Foetal damage, Maternal exposure during pregnancy, Scan
SMQs:, Congenital, familial and genetic disorders (narrow), Corneal disorders (broad), Retinal disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-09-26
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; INFANRIX IPV HIB
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: scans; Result Unstructured Data: Test Result:Foetal abnormalities were found including facial c; Comments: Foetal abnormalities were found including facial cleft, cleft lip, cleft palate, underdeveloped eye, more results pending, and will follow after autopsy
CDC Split Type: GBPFIZER INC202101355068

Write-up: Maternal exposure during pregnancy, 1 Trimester; Foetal damage; Cleft lip and palate; facial cleft; underdeveloped eye; This is the second of 2 reports. The first report is a report downloaded from the WEB, regulatory authority number GB-MHRA-WEBCOVID-202110071735531460-SFBTE. A contactable consumer reported information for both mother and fetus/baby. This is a fetus report. A 32-year-old mother received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH), dose 1 via (Transplacental for fetus) on 09Jun2021 (Batch/Lot Number: EW3143) as DOSE 1, SINGLE, dose 2 (Transplacental for fetus) on 31Jul2021 (Batch/Lot Number: FD8813) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported; diphtheria vaccine toxoid, hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (INFANRIX IPV HIB) taken for an unspecified indication, start and stop date were not reported. Mother medical history included allergy, past drug event included erythromycin and hayfever and experienced allergy. Gestation Period at Exposure was 1 Trimester. The patient experienced maternal exposure during pregnancy on an unknown date; foetal damage on 15Sep2021 with fatal outcome, facial cleft, cleft lip, cleft palate, underdeveloped eye on 15Sep2021 with outcome of not recovered serious due to Congenital Anomaly. The patient died on 26Sep2021. The pregnancy was subsequently lost in the second trimester. Details of scans or investigations on 15Sep2021: Foetal abnormalities were found including facial cleft, cleft lip, cleft palate, underdeveloped eye, more results pending, and will follow after autopsy. An autopsy is being carried out. Autopsy Results not available. No follow-up attempts are possible. No further information is expected ; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101341902 mom case; Reported Cause(s) of Death: Foetal damage; Maternal exposure during pregnancy


VAERS ID: 1783895 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8235 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Extra dose administered, Interchange of vaccine products, Off label use, Seizure
SMQs:, Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-18
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASA KRKA; VIDONORM; VIDOTIN; MILURIT; BISOPROLOL SANDOZ; ATORVA TEVA; FURON [FUROSEMIDE]; VEROSPIRON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic alcoholism; COPD; Dilated cardiomyopathy; Facial paresis; Generalised arteriosclerosis; Liver fatty degeneration; Myocardial infarction; Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC202101348232

Write-up: Acute myocardial infarction; seizure; off label use; Interchange of vaccine products; Extra dose administered; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number HU-OGYI-759721. A 56-years-old female patient received bnt162b2 (COMIRNATY), dose 3 intramuscular, administered in Arm Left on 16Sep2021 (Batch/Lot Number: FF8235) as BOOSTER DOSE (INITIAL PFIZER DOSE), 0.3 ML SINGLE for covid-19 immunisation. Medical history included COPD (not ongoing), liver fatty degeneration (not ongoing), myocardial infarction (not ongoing), pneumonia (not ongoing), chronic alcoholism (not ongoing), dilated cardiomyopathy (not ongoing), generalised arteriosclerosis (not ongoing) and facial paresis between 15Jul2018 and 17Jul2018. She previously received Vaxzevria (COVID-19 VACCINE Astrazeneca (ChAdOx1 nCoV-19), first dose batch number: ABV3025 on 11Feb2021 and second dose batch number: ABV6096 on 11Mar2021 for COVID-19 immunisation. Concomitant medications included acetylsalicylic acid (ASA KRKA, 100 mg gastro-resistant tablet (once daily, orally)) from 12Dec2018 to 16Sep2021; amlodipine besilate, perindopril erbumine (VIDONORM, 8/5 mg tablet (once daily, orally)) taken from 12Dec2018 to 16Sep2021; perindopril erbumine (VIDOTIN, 4 mg tablet (orally)) taken from 12Dec2018 to 16Sep2021; allopurinol (MILURIT, 300 mg tablet (once daily, orally)) taken from 12Dec2018 to 16Sep2021; bisoprolol fumarate (BISOPROLOL SANDOZ, 5 mg film-coated tablet (once daily, orally) taken from 12Dec2018 to 16Sep2021; atorvastatin calcium (ATORVA TEVA, 20 mg film-coated tablet (once daily, orally)) taken for hyperlipidaemia from 12Dec2018 to 16Sep2021; furosemide (FURON [FUROSEMIDE], 40 mg tablet (once daily, orally)) taken from 12Dec2018 to 16Sep2021; spironolactone (VEROSPIRON, tablet (once daily, orally) taken for an unspecified indication from 12Dec2018 to 16Sep2021. The patient experienced seizure on 17Sep2021 with outcome unknown, acute myocardial infarction on 17Sep2021 with fatal outcome, off label use, interchange of vaccine products, Extra dose administered on 16Sep2021 with outcome of unknown. Therapeutic measures were taken as a result of acute myocardial infarction. The patient died on 18Sep2021 at 6:24 a.m. An autopsy was performed that revealed acute myocardial infarction. Additional information: On 17Sep2021, the patient felt unwell at home starting with a seizure, which lasted for about 10 minutes, after which her breathing and circulation stopped, according to the paramedics. Her husband began resuscitation under direction. After about 10 minutes of resuscitation, ambulance crew took over the resuscitation, no shocking rhythm was found, and endotracheal intubation and then a mechanical chest compression device were applied. Circulation returned after 3 ampoules of Tonogen 1 mg/ml solution for injection (epinephrine), and the patient was transported to the hospital. A predisposition to bradycardia was observed with PEA (Pulseless Electrical Activity) in the hospital, therefore 1 ampoule of atropin was started with cardiac massage, and 2 ampoules of Tonogen were given again. Due to hypotension, a pressoramine pump was started. To compensate for the observed major acidosis, NaHCO3 administration was initiated, with which oxygen saturation gradually improved. Severe tachycardia developed for which amiodaron infusion was given. Acceptable oxygenation was achieved with relatively high volumes of positive exspiratory pressure (PEP) and 100% FiO2 during ventilation. The patient was placed in the Intensive Care Unit for further care and therapy. The patient was unconscious, with bilateral wide pupils, areflexia, and lack of spontaneous breathing. Central vein provision, mechanical respiration support, and circulatory support were used. Her condition remained critical despite treatment, hypotension deepened, and her anuria persisted. A few hours after admission, the patient circulation collapsed, and the patient died on 18Sep2021 at 6:24 a.m. Stop date of event: Acute myocardial infarction as reported: 18Sep2021 (as reported). Sender Comment: Acute myocardial infarction occurred 1 day after Comirnaty vaccination. Based on the patient''s medical history, the causal relationship between the event and Comirnaty is considered unlikely. The case is serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Autopsy-determined Cause(s) of Death: Acute myocardial infarction; Acute myocardial infarction


VAERS ID: 1784171 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-01-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Nasopharyngitis, Pain in extremity, Sneezing, Sudden death, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dialysis; Heart disease, unspecified
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101330256

Write-up: sudden death; Immediately strong pain in the arm; fatigue/exhaustion; tremors; continuous sneezing; cold; This is a spontaneous report received from a contactable consumer downloaded from the WEB. The regulatory authority report number is IT-MINISAL02-793804. A 60 years old male patient received 1st dose of BNT162B2 (COMIRNATY, COVID 19 COMIRNATY VACCINE (PFIZER), at the age of 60 years old, on 17Jan2021 at single dose for covid-19 immunization. Medical history was Dialyzed, cardiopathic disorder. Concomitant drug was not reported. Immediately strong pain in the arm, tremors, cold with continuous sneezing, fatigue, exhaustion, lasted until 17. 45 of the day 19Jan2021 time of the sudden death. Outcome of other events were unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reporter''s Comments: Dialyzed, cardiopathic; Reported Cause(s) of Death: sudden death


VAERS ID: 1784173 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-05-23
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Coma, Ruptured cerebral aneurysm
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm cerebral; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101330205

Write-up: irreversible coma due to cerebral aneurysm burst; irreversible coma due to cerebral aneurysm burst; This is a spontaneous report from a contactable consumer downloaded from the WEB [IT-MINISAL02-794134]. An 83-year-old female patient received BNT162B2 (COMIRNATY) via intramuscular at single dose on 13Apr2021 for covid-19 immunisation. Medical history included aneurysm cerebral and hypertension, but monitored and with therapies. Concomitant medications were not reported. The patient experienced irreversible coma due to cerebral aneurysm burst on 23May2021. The patient died on 23May2021. It was not reported if an autopsy was performed. The outcome of events was unknown. Sender''s comments Required lots, concomitant therapy, report. irreversible coma due to cerebral aneurysm burst Description as reported: irreversible coma due to cerebral aneurysm burst No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Coma; Ruptured cerebral aneurysm


VAERS ID: 1784174 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3739 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Malaise, Pulmonary embolism, Vomiting
SMQs:, Acute pancreatitis (broad), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-12
   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: SLE
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101330220

Write-up: Sunday evening a pulmonary embolism caused death.; feeling sick; Vomiting; Weakness; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-794172. A 68-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot number FG3739) intramuscularly at the right shoulder (Deltoid) at single dose for COVID-19 immunisation on 09Sep2021. Relevant history included SLE (Systemic Lupus Erythematosus). Relevant concomitant drugs were unknown. On Thursday morning, 09Sep2021, the patient had been carried out the second dose of BNT162B2, on Saturday evening (11Sep2021), the patient started feeling sick, vomiting, and weakness. On Sunday evening (12Sep2021), the patient had a pulmonary embolism which caused death on 12Sep2021. Treatment therapy included cardiac massage and epinephrine. Impact on quality of life reported as 10/10. It was unknown if autopsy performed or not. The outcome of events feeling sick, vomiting, and weakness was unknown. Reporter''s comments: SLE (Systemic Lupus Erythematosus). Sender''s comments: Already requested additional information. I will try to listen to the GP for the clinical report. No follow-up attempts possible. No further information expected.; Reporter''s Comments: SLE (Systemic Lupus Erythematosus); Reported Cause(s) of Death: pulmonary embolism


VAERS ID: 1784190 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-09-11
   Days after vaccination:66
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19 pneumonia, Chest scan, Diarrhoea, Drug ineffective, Dyspnoea, Inappropriate schedule of product administration, Investigation, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Medication errors (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-21
   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: AFib (previous AF treated with DC shock); Cachexia; Cardioversion; Chronic ischemic heart disease, unspecified; COPD; Emphysema pulmonary; Malnutrition; Movements reduced; Oxygen therapy (severe O2 therapy 24 h (O2 1.5 l/min)); Squamous cell carcinoma; Subendocardial myocardial infarction
Allergies:
Diagnostic Lab Data: Test Name: chest ct scan; Result Unstructured Data: Test Result:posterobasal consolidations bilaterally; Comments: showed posterobasal consolidations bilaterally in a diffuse picture. bilaterally in a picture of diffuse emphysema with large bubbles; Test Date: 20210911; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20210921; Test Name: Rx thorax; Result Unstructured Data: Test Result:parenchymal thickening with gr; Comments: showing bilateral mid-basal parenchymal thickening with gr.
CDC Split Type: ITPFIZER INC202101339629

Write-up: COVID-19 PCR test positive; COVID-19 PCR test positive; Sars-Cov 2 pneumonia; infection characterized by asthenia, dyspnoea and diarrhea; Sars-Cov 2 pneumonia; infection characterized by asthenia, dyspnoea and diarrhea; Sars-Cov 2 pneumonia; infection characterized by asthenia, dyspnoea and diarrhea; Sars-Cov 2 pneumonia; infection characterized by asthenia, dyspnoea and diarrhea; Dose 1 on 26May2021 and dose 2 on 07Jul2021; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-794966. An 81-years-old female patient received BNT162B2 (COMIRNATY), dose 2 intramuscular on 07Jul2021 (Batch/Lot Number: fe2707) as 0.3 ML SINGLE, dose 1 intramuscular on 26May2021 (Batch/Lot Number: fc3558) as 0.3 ML SINGLE for COVID-19 immunisation. Medical history included cardioversion from 07Sep2018 to 10Sep2018, subendocardial myocardial infarction from 28Aug2017 to 05Sep2017, emphysema pulmonary, chronic obstructive pulmonary disease (COPD), atrial fibrillation (AFIB, previous AF treated with DC shock), squamous cell carcinoma, chronic ischemic heart disease, severe protein-calorie malnutrition, cachexia, severe O2 therapy 24 h (O2 1.5 l/min) and reduced physical capacity (bed-sitting). The patient''s concomitant medications were not reported. The patient experienced COVID-19 PCR test positive, sars-cov-2 pneumonia, infection characterized by asthenia, dyspnoea and diarrhea, all on 11Sep2021. Patient underwent lab tests included chest CT scan (unknown date): showed posterobasal consolidations bilaterally in a diffuse picture, bilaterally in a picture of diffuse emphysema with large bubbles, Rx thorax (21Sep2021): showing bilateral mid-basal parenchymal thickening with GR, COVID-19 PCR test (11Sep2021): positive. The patient died on 21Sep2021. It was not reported if an autopsy was performed. Outcome of the events was fatal.; Reported Cause(s) of Death: Sars-Cov 2 pneumonia; COVID-19 PCR test positive; COVID-19 PCR test positive; asthenia; dyspnoea; diarrhea


VAERS ID: 1784197 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-20
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident
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: Medical History/Concurrent Conditions: Arterial hypertension; Bypass surgery; Cardiovascular disorder; Epilepsy; Ischemic heart disease; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101337542

Write-up: stroke; This is a spontaneous report from a contactable consumer. This is the second of two reports. The first report is a report downloaded from the Regulatory Authority WEB IT-MINISAL02-794451. An elderly male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in Arm Right on 04May2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes Mellitus 2, ischemic heart disease, 3 bypasses, epilepsy, arterial hypertension, and chronic cerebral vasculopathy. The patient previously received first dose of bnt162b2 (COMIRNATY, Lot number: ER9470) on 29Mar2021, intramuscular, DOSE 1, 0.3 ML SINGLE for COVID-19 immunisation and experienced had a glycemic decompensation that created so many problems. The patient''s concomitant medications were not reported. The patient experienced stroke on 20May2021 after the second dose of Pfizer on 04May2021. 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. No further information is expected.; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-202101330214 same patient, different event for 2nd dose of Comirnaty; Reported Cause(s) of Death: stroke


VAERS ID: 1784362 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-10-01
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident
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: 2021-10-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101311874

Write-up: suspected stroke; This is a spontaneous report from a contactable physician. A 65-year-old male patient received the second single dose of COVID-19 Vaccine (Manufacturer Unknown, Batch/Lot number was not reported) intramuscularly on an unspecified date at end of Jul2021 for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included first single dose COVID-19 Vaccine (Manufacturer Unknown, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date for COVID-19 immunisation. On 01Oct2021 (unknown months and days after the vaccination), the patient experienced suspected stroke. The outcome was fatal. Death date was 01Oct2021. The course of the event was as follows: On 01Oct2021, a contact was received from the patient''s family that the patient was found dead while taking a bath. The reporting physician confirmed her death. The reporting physician stated that, in light of the status, the possibility of stroke was considered to be high. The reporting physician was informed by the patient''s family that she received the second dose of COVID-19 vaccine at the end of Jul2021. However, it was determined that there was no causality between the vaccination and the event. (As for COVID-19 vaccine, it was not clarified which manufacturer''s vaccine the patient received). There was probably no causality, and the vaccine might not be Comirnaty, but this information was given to be safe. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. It was not reported if an autopsy was performed. On 04Oct2021, the same contactable physician reported the following: The reporting physician was not the patient''s primary care physician. The patient died in the bathroom on 01Oct2021. At the request of the Police, this was to be a case of postmortem examination requiring an autopsy. Although it was not confirmed whether a manufacturer was Pfizer, the reporting physician thought that the vaccine was probably made by Pfizer because the patient had been seen by another clinic''s physician. The patient''s family doubted the vaccine as the cause of his death. It was impossible that the patient died of adverse reactions to the vaccine 2 months or more after the vaccination, so this case was submitted as the death from disease in the post-mortem certificate. Examinations such as blood testing could not be conducted, since the patient had already died. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Cerebrovascular accident (Fatal) and 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: Suspected Stroke


VAERS ID: 1784367 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-09-26
   Days after vaccination:193
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101319466

Write-up: GENERAL INVESTIGATION TARGETING THE VACCINES (HEALTH CARE PROVIDERS HCPS) WHO ARE VACCINATED IN EARLY POST-APPROVAL PHASE (FOLLOW-UP STUDY) This is a report from a Non-Interventional Study Source for Protocol C4591006. A subject of unknown age and gender received the second dose of BNT162b2 (COMIRNATY, Lot number and Expiration date were not provided) at 0.3 mL intramuscularly as a single dose for COVID-19 immunisation on 17Mar2021. No information on concomitant medications, medical history or family history was provided. Subject previously received first dose of bnt162b2 intramuscularly on 24Feb2012 at 0.3 ml single dose for COVID-19 immunisation. On 26Sep2021, the subject died. It was not reported if an autopsy was performed. Details regarding the adverse events or the cause of the death were uncertain at present. The reporter classified the event was serious (fatal outcome). Investigator''s causality assessment was not provided. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of unknown cause of death. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: death


VAERS ID: 1784368 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2018 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Arrhythmia, Body temperature, Cardio-respiratory arrest, Headache, Loss of consciousness, Pyrexia, Ventricular fibrillation
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), Ventricular tachyarrhythmias (narrow), 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), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101319537

Write-up: arrhythmia; epigastric pain; cardio-respiratory arrest; Ventricular fibrillation; loss of consciousness; headache; Pyrexia; This is a spontaneous report from a contactable physician. Regulatory authority report number is v21128735. A 38-year and 3-month-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FF2018, Expiration date 31Dec2021), at age of 38 years old, via an unspecified route of administration on 28Sep2021 at 12:04 at single dose for COVID-19 immunization. Body temperature before vaccination was 36.4 degrees centigrade. Medical history was none. There were no points to be considered on the vaccine screening questionnaire. The patient family history was not reported. The patient''s concomitant medications were not reported. On 06Sep2021, the patient previously received the first dose of BNT162B2 (Lot number FF9942, Expiration date 30Nov2021), at age of 38 years old, at single dose for COVID-19 immunization. On 28Sep2021 at 12:04 (the day of vaccination), the patient received the second dose of BNT162B2. On 29Sep2021 at 23:00 (1 day after the vaccination), the patient experienced cardio-respiratory arrest and ventricular fibrillation. On 30Sep2021 at 01:56 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 28Sep2021, the patient received the second dose of the vaccine. On 29Sep2021, the patient had headache and pyrexia, so he orally took over-the-counter analgesic-antipyretic drug. On 29Sep2021 at around 21:00, attack of unconsciousness developed and lasted for 2 minutes. At 23:00, loss of consciousness developed again, and emergency medical services were requested. The patient was in cardiopulmonary arrest (CPA). Ventricular fibrillation was noted. Direct current defibrillation (DC) was performed and adrenaline was administered, but he did not respond to the resuscitation. Although veno-arterial extracorporeal membrane oxygenation (VA-ECMO) was performed, heartbeat did not return. On 30Sep2021 at 01:56, the patient passed away. The reporting physician classified the event as serious (death) and assessed the event as related to BNT162B2. Other possible cause of the event such as any other diseases included a possibility of asymptomatic heart disorder. Outcome of events cardio-respiratory arrest and ventricular fibrillation was fatal. Outcome of other events was unknown. The patient died on 30Sep2021 at 01:56. It was not reported if an autopsy was performed. Reporter''s comment: This was a 38-year-old man who had not had any disease history in the past. Considering that the patient experienced pyrexia after the second vaccination and simultaneously he had arrhythmia, a causal relationship with the vaccine was suspected. However, it was heard that the patient had complained of epigastric pain before. Therefore, the possibility that there was a heart disorder as a background factor could not be denied.; Reporter''s Comments: This was a 38-year-old man who had not had any disease history in the past. Considering that the patient experienced pyrexia after the second vaccination and simultaneously he had arrhythmia, a causal relationship with the vaccine was suspected. However, it was heard that the patient had complained of epigastric pain before. Therefore, the possibility that there was a heart disorder as a background factor could not be denied.; Reported Cause(s) of Death: Ventricular fibrillation; cardio-respiratory arrest


VAERS ID: 1784371 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood potassium, Blood pressure decreased, Blood pressure measurement, Blood sodium, Blood test, Body temperature, Computerised tomogram, Computerised tomogram head, Disease recurrence, Electrocardiogram, Hypernatraemia, Hypokalaemia, Respiratory failure
SMQs:, Anaphylactic reaction (narrow), 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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Dehydration (broad), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-13
   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: BISOPROLOL; FUROSEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder cancer; Chronic respiratory failure; Gastric cancer; Hypertension; Pulmonary thromboembolism
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: potassium; Result Unstructured Data: Test Result:5.0 mEq/l; Test Date: 20210910; Test Name: potassium; Result Unstructured Data: Test Result:1.9 mEq/l; Comments: hypokalaemia; Test Date: 20210910; Test Name: Blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210826; Test Name: sodium; Result Unstructured Data: Test Result:130 mEq/l; Test Date: 20210910; Test Name: sodium; Result Unstructured Data: Test Result:158 mEq/l; Comments: hypernatraemia; Test Date: 20210910; Test Name: blood test; Result Unstructured Data: Test Result:hypernatraemia and hypokalaemia; Comments: hypernatraemia (158 mEq/L) and hypokalaemia (1.9 mEq/L); Test Date: 20210909; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210910; Test Name: thoracoabdominal CT; Result Unstructured Data: Test Result:no findings which suddenly changed; Test Date: 20210910; Test Name: head CT; Result Unstructured Data: Test Result:no findings which suddenly changed; Test Date: 20210910; Test Name: ECG; Result Unstructured Data: Test Result:no findings which suddenly changed
CDC Split Type: JPPFIZER INC202101320099

Write-up: Blood pressure decreased; Respiratory failure; Disease recurrence; Hypokalaemia (1.9 mEq/l); Hypernatraemia (158 mEq/l); This is a spontaneous report from a contactable physician. Regulatory authority report number is v21128788. An 88-year and 8-month-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021), at the age of 88 years old, via intramuscular on 09Sep2021 at 15:30 as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.4 degrees centigrade. Medical history included gastric cancer, bladder cancer, chronic respiratory failure, hypertension and pulmonary thromboembolism. The family history was not provided. The concomitant medications included bisoprolol (adhesive skin patch) at 4 mg via topical, furosemide at 20 mg via intramuscular. On 09Sep2021 at 15:30 (the day of vaccination), the patient received the first dose of BNT162B2. On 10Sep2021 at 02:45 (11 hours 15 minutes after the vaccination), the patient experienced respiratory failure. On 13Sep2021 (4 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 21May2021, although advanced gastric cancer and bladder cancer were found while the patient was being treated for pulmonary thromboembolism, the patient was treated with best supportive care (BSC). On 13Aug2021, the patient was transferred to the reporting hospital for medical treatment. On 26Aug2021, the sodium was 130 mEq/L and the potassium was 5.0 mEq/L. On 09Sep2021 (the day of vaccination), at 15:30, the patient received the first dose of BNT162b2 vaccination via intramuscular. On 10Sep2021, at 07:30 (11 hours and 15 minutes after vaccination), the patient was found to have respiratory failure and blood pressure decreased. The blood test showed hypernatraemia (158 mEq/L) and hypokalaemia (1.9 mEq/L), and treatment such as an intravenous drip was initiated. ECG, head CT, and the thoracoabdominal CT showed no findings which suddenly changed. The reporting physician classified the event as serious (death) and assessed that the events was unrelated to BNT162B2. Other possible causes of the event such as any other diseases were hypernatraemia and hypokalaemia. Outcome of events respiratory failure, hypernatraemia and hypokalaemia was fatal. Outcome of event blood pressure decreased was unknown. The patient died on 13Sep2021. An autopsy was not performed.; Sender''s Comments: Based on the information currently available and currently known drug safety profile, the reported events of respiratory failure, disease recurrence, hypokalaemia, hypernatraemia and blood pressure decreased more likely represented intercurrent illness, but not related 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: Respiratory failure; Hypokalaemia (1.9 mEq/l); Hypernatraemia (158 mEq/l); Disease recurrence


VAERS ID: 1784373 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101321417

Write-up: Death/ died; This is a spontaneous report from a contactable physician via a Pfizer sales representative. An 83-year-old female patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0201, Expiration date 30Sep2021) intramuscular 0.3 mL single on 06Jul2021 for covid-19 immunisation at 83-year-old. The patient medical history was unknown. The patient''s concomitant medications were not reported. On 10Jul2021 (around 4 days after the vaccination), the patient died. The course of the event was as follows: Two days after the first vaccination, when contact was made by phone for the second vaccination, the patient looked well. Four days after the vaccination, the patient''s daughter called the reporting clinic and stated that the patient died. Only her death was informed, and the detailed status including the cause of the death was unspecified. Since the reporting physician was not the patient''s primary care physician and the patient visited the reporting physician''s clinic simply to receive the vaccine, her underlying disease, complication, and others were unknown. In the history taking, the patient did not report any matters to be attended to. The patient died on 10Jul2021. It was unknown if an autopsy was performed. The reporting physician classified the event as serious (death). No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information provided is very limited and does not allow for a complete medical assessment. Based on current convention, the case of death is assessed as related to BNT162b2 until sufficient information is available to confirm an unrelated cause of death. Additional information including concomitant medications and their indications, concurrent medical conditions, medical history, diagnostic test results, treatment done, autopsy report (if done) is needed to better assess this report. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ; Reported Cause(s) of Death: Death/ died


VAERS ID: 1784374 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hemiparesis, Hemiplegia, Interstitial lung disease, Multiple sclerosis
SMQs:, Interstitial lung disease (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101323422

Write-up: Multiple sclerosis; Loss of strength in one side of the body; Hemiplegia; Interstitial pneumonia; This is a spontaneous report from a contactable consumer received via Medical information group. The patient was 73-year-old female (reporter''s mother). On an unknown date in Jul2021 (reported as possibly at the beginning of Jul2021) (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not reported, Expiration date not reported) via an unspecified route of administration as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not reported, Expiration date not reported) at unspecified age via an unspecified route of administration for COVID-19 immunization. On an unknown date (in Jul2021), the patient experienced hemiplegia, loss of strength in one side of the body, and multiple sclerosis. On an unknown date in Aug or Sep2021, the patient experienced interstitial pneumonia. The reported verbatim was as follows: About a week after the vaccination, the patient had felt unwell consistently. Later, she really lost her energy in a moment and end up in hemiplegia and loss of strength in one side of the body. For example, when both hands were extended in front of her, the one would fall. That was her condition. Since it was unusual, the patient immediately consulted a physician just in case. At first, she was told a diagnosis of neuromyelitis optica, an autoimmune disease designated as intractable diseases. As these occurred after the vaccination, the reporter thought that the possible trigger was the vaccine. As one criteria for neuromyelitis optica was not met, the final diagnosis for the reporter''s mother was multiple sclerosis which was also designated as intractable diseases. Since then, the patient was initially treated with steroids for about a month. She previously could not bend her fingers after the vaccination but was now able to do so thanks to the effect of steroids. However, although the reporter had no reason to complain because the drugs were prescribed by the physician, the patient had taken quite many doses of the prescribed steroids also at home after being discharged. The patient took a lot of drugs and said that she hoped their numbers would decrease quickly. Three weeks (thought to be less than a month) after discharge, while recuperating at home, the patient developed interstitial pneumonia possibly because of the effect of steroids and was admitted to the hospital on 8th in August or September2021, after which she died in 2 weeks. The seriousness, and causality of the events were not reported. The outcome of interstitial pneumonia was fatal, of other events was unknown. The patient died in 2021. It was not reported whether autopsy was done. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Interstitial pneumonia


VAERS ID: 1784375 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Cerebral infarction, Computerised tomogram head, Headache, Nausea, Platelet count, Platelet count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: REVOLADE; MOSAPRIDE CITRATE; PREGABALIN; ALFACALCIDOL; SHAKUYAKUKANZOTO; BAYASPIRIN; MAGNESIUM OXIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autoimmune hepatitis; Autoimmune thrombocytopenia; Cellulitis of leg (admitted to the hospital)
Allergies:
Diagnostic Lab Data: Test Date: 20210707; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210710; Test Name: head CT; Result Unstructured Data: Test Result:only findings of old lacunar infarction; Test Date: 2008; Test Name: platelet count; Result Unstructured Data: Test Result:10000 to 100000; Test Date: 20210719; Test Name: platelet count; Result Unstructured Data: Test Result:898000; Comments: platelet count increased to 898000
CDC Split Type: JPPFIZER INC202101325968

Write-up: cardio-respiratory arrest; Platelets increased; Cerebral infarction/lacunar infarction; queasy; headache; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21128791. A 84-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 07Jul2021 10:10 (Batch/Lot Number: EY3860; Expiration Date: 31Aug2021) at the age of 84-years-old as SINGLE DOSE for covid-19 immunisation. Medical history included autoimmune hepatitis, autoimmune thrombocytopenia, cellulitis of leg, all in 2008. Concomitant medications included eltrombopag olamine (REVOLADE) taken for autoimmune thrombocytopenia, from an unknown date to 19Jul2021; mosapride citrate taken for an unspecified indication, start and stop date were not reported; pregabalin taken for an unspecified indication, start and stop date were not reported; alfacalcidol taken for an unspecified indication, start and stop date were not reported; glycyrrhiza spp. root, paeonia lactiflora root (SHAKUYAKUKANZOTO) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (BAYASPIRIN) taken for an unspecified indication, start and stop date were not reported; magnesium oxide taken for an unspecified indication, start and stop date were not reported. The patient was an 84-year-old female. Body temperature before vaccination was 36.8 degrees centigrade. The patient had no particular family history. The patient had underlying diseases of autoimmune hepatitis, autoimmune thrombocytopenia, and cellulitis. She had no allergic history. The patient did not receive any other vaccination within one month. The patient orally took eltrombopag olamine (REVOLADE), mosapride citrate hydrate (manufacture name not provided), pregabalin (manufacture name not provided), alfacalcidol (manufacture name not provided), SHAKUYAKUKANZOTO, acetylsalicylic acid (BAYASPIRIN), and magnesium oxide (manufacture name not provided). The patient had no history of adverse drug reaction in the past. In 2008, the patient was diagnosed with autoimmune hepatitis, and oral administration of eltrombopag olamine was continued for autoimmune thrombocytopenia. The course was observed with the platelet count of 10000 to 100000. The patient was admitted to the hospital for cellulitis of leg. On 07Jul2021 at 10:10 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On the same date after the first vaccination, she had headache and queasy. On 10Jul2021 (3 days after vaccination), head CT showed only findings of old lacunar infarction. As of 12Jul2021 (5 days after vaccination), the symptoms of the old lacunar infarction were resolving. On 19Jul2021 (12days after vaccination), since the blood test revealed that the platelet count increased to 898000, administration of eltrombopag olamine was discontinued. On 26Jul2021 (19 days after vaccination), immediately after the breakfast at 08:00, the patient had cardio-respiratory arrest. Although cardiopulmonary resuscitation was performed, the patient did not recover and died. No pathological autopsy and autopsy imaging (AI) was performed. According to the course of the symptoms, the direct cause of death was diagnosed as cerebral infarction. The reporting physician classified the events as serious (death) and assessed that the events were related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Oral administration of eltrombopag olamine was continued for autoimmune thrombocytopenia, and the course was observed with the platelet count of 10000 to 100000. However, it was considered that the platelet count rapidly increased after the vaccination, and the patient had cerebral infarction and died. Since there was no factor of platelets increased other than the vaccination, the causality between the events and the vaccination could not be ruled out. The outcome of the events Cerebral infarction, Platelets increased, and Cardio-respiratory arrest was fatal, the outcome of the events Queasy and Headache was unknown.; Reported Cause(s) of Death: cardio-respiratory arrest; Platelets increased; Cerebral infarction


VAERS ID: 1784377 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-05
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-10-05
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101326005

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21128805. A 67-year-old male patient received the second dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) on an unknown date for covid-19 immunisation. The patient experienced acute myocardial infarction on 05Oct2021 17:30 with outcome of fatal. Therapeutic measures were taken as a result of acute myocardial infarction. The patient died on 05Oct2021. It was not reported if an autopsy was performed. The course of the event was as follows: On 05Oct2021 around 17:30 (after an unknown time gap from the vaccination), the patient was found lying down in front of the pachinko parlor. At contact with the emergency squad, the patient was in cardiac arrest. After arrival at the hospital, percutaneous cardiopulmonary support (PCPS) was introduced. The cause of cardiac arrest was acute myocardial infarction. The reporting physician classified the event as serious (fatal) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported whether there were other possible causes of the event such as any other diseases. The reporting physician commented as follows: There was little relation.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1784379 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-26
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Brain compression, Haemorrhage intracranial, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-27
   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: Atrial fibrillation; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101326685

Write-up: Respiratory arrest due to brainstem compression; Respiratory arrest due to brainstem compression; Haemorrhage intracranial; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. An adult male patient received bnt162b2 (COMIRNATY; solution for injection, lot number FF9942; expiration date: 30Nov2021) via intramuscular, on 10Sep2021, at dose 2, single for covid-19 immunization. Medical history included hypertension, diabetes mellitus and atrial fibrillation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received any medications within 2 weeks of vaccination. Historical vaccine included bnt162b2 (COMIRNATY; solution for injection, lot number FF4204; expiration date: 31Oct2021) via intramuscular, on 20Aug2021, at dose 1, single for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested with covid-19 since the vaccination. The patient had no allergies to medications, food, or other products. On 26Sep2021 (16 days after the vaccination), the patient experienced hemorrhage intracranial. The event resulted in Emergency room/department or urgent care and death. The reporting physician assessed the event as serious (death). No treatment was received for the event hemorrhage intracranial. The outcome of the event was fatal. The patient died on 27Sep2021. The cause of death was respiratory arrest due to brainstem compression on an unspecified date and Haemorrhage intracranial. An autopsy was not performed.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events haemorrhage intracranial, respiratory arrest and brain compression and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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: Respiratory arrest due to brainstem compression; Haemorrhage intracranial; Respiratory arrest due to brainstem compression


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