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

Found 17,128 cases where Vaccine targets COVID-19 (COVID19) and Patient Died



Case Details

This is page 103 out of 172

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VAERS ID: 1187707 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385729

Write-up: vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of an unspecified age and gender received the first and second doses of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN); both via unspecified routes of administration on unspecified dates as single doses for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the second dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 12 reported cases, the average date of onset of COVID-19 was 10 days after the second dose with the average days to death of 14 days. The Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19; Drug ineffective


VAERS ID: 1187708 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385730

Write-up: vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of an unspecified age and gender received the first and second doses of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN); both via unspecified routes of administration on unspecified dates as single doses for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the second dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 12 reported cases, the average date of onset of COVID-19 was 10 days after the second dose with the average days to death of 14 days. The Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19; Drug ineffective


VAERS ID: 1187709 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385731

Write-up: vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of an unspecified age and gender received the first and second doses of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN); both via unspecified routes of administration on unspecified dates as single doses for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the second dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 12 reported cases, the average date of onset of COVID-19 was 10 days after the second dose with the average days to death of 14 days. Institute assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19; Drug ineffective


VAERS ID: 1187710 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385732

Write-up: vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of an unspecified age and gender received the first and second doses of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN); both via unspecified routes of administration on unspecified dates as single doses for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the second dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 12 reported cases, the average date of onset of COVID-19 was 10 days after the second dose with the average days to death of 14 days. The Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19; Drug ineffective


VAERS ID: 1187711 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385733

Write-up: vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of an unspecified age and gender received the first and second doses of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN); both via unspecified routes of administration on unspecified dates as single doses for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the second dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 12 reported cases, the average date of onset of COVID-19 was 10 days after the second dose with the average days to death of 14 days. Health Authority (HA) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19; Drug ineffective


VAERS ID: 1187712 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385734

Write-up: vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; vaccinated with the second dose died on an average at 14 days after administration of the booster, and the diagnosis of COVID was established on an average at 10 days after the second dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of an unspecified age and gender received the first and second doses of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN); both via unspecified routes of administration on unspecified dates as single doses for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the second dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 12 reported cases, the average date of onset of COVID-19 was 10 days after the second dose with the average days to death of 14 days. The Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021329830 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19; Drug ineffective


VAERS ID: 1187716 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / -

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021363356

Write-up: massive stroke; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority number is SE-MPA-2021-019476. A 91-year-old female patient received her first dose of BNT162B2 (COMIRNATY, lot number: ER7812), via an unspecified route of administration on Mar2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced massive stroke 3 days after the vaccination on Mar2021. She was admitted to a hospital and died 6 days after her first vaccination on an unspecified date in 2021. The cause of death was massive stroke. It was unknown if an autopsy was performed. The Regulatory Authority has required more information. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: massive stroke


VAERS ID: 1187717 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood potassium, Blood potassium increased, C-reactive protein, C-reactive protein increased, Computerised tomogram, Encephalitis, Erythema, Generalised tonic-clonic seizure, Lumbar puncture, Meningism, Pneumonia aspiration, Post stroke epilepsy
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METFORMIN; CANODERM; CLOZAPINE; INOTYOL [ICHTHAMMOL;TITANIUM DIOXIDE;ZINC OXIDE]; CORTIMYK; OVESTERIN; ZOPICLONE; ABASAGLAR; CILAXORAL; JANUVIA [SITAGLIPTIN PHOSPHATE]; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aspiration pneumonia; Bladder cancer; Parkinson''s disease; Schizoaffective disorder; Stroke; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: p-potassium; Result Unstructured Data: Test Result:6.2 mmol/L; Comments: slight elevation; Test Date: 202102; Test Name: CT; Result Unstructured Data: Test Result:Nothing new; Test Date: 202102; Test Name: CRP; Result Unstructured Data: Test Result:102; Comments: elevated CRP without pronounced leukocytosis of unknown origin; Test Date: 202102; Test Name: lumbar puncture; Result Unstructured Data: Test Result:No cells; Comments: lkc poly and mono were both 0
CDC Split Type: SEPFIZER INC2021363373

Write-up: Cramp (Generalised tonic-clonic seizure); severe redness on the arm where the vaccination was given; meningoencephalitis; aspiration pneumonia; post stroke epilepsy; elevated CRP; light elevation in potassium of 6.2 mmol/L for unknown reason (reference value P-Potassium: 3.5-5.0 mmol/L); possible meningitis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA), regulatory authority number SE-MPA-2021-019661. An 88-year-old female patient received bnt162b2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on Feb2021 (batch/lot number and expiry date not reported) as single dose for covid-19 immunization. Medical history included bladder cancer, aspiration pneumonia, stroke; all not ongoing, and type 2 diabetes mellitus, schizoaffective disorder, Parkinson''s disease; all unknown if ongoing. Concomitant medications included metformin; urea (CANODERM); clozapine; ichthammol, titanium dioxide, zinc oxide (INOTYOL [ICHTHAMMOL;TITANIUM DIOXIDE;ZINC OXIDE]); hydrocortisone, miconazole nitrate (CORTIMYK); estriol (OVESTERIN); zopiclone; insulin glargine (ABASAGLAR); sodium picosulfate (CILAXORAL); sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]); macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]); sodium fluoride (DENTAN); acetylcysteine; carbomer (VISCOTEARS); mometasone; carbidopa, levodopa (SINEMET); all from unspecified date for unspecified indication. The patient previously took pneumococcal vaccine and influenza vaccine; both from unspecified date for immunization and without adverse events. The patient''s vaccination with dose 1 (COMIRNATY) was on 20Jan2021 and after the vaccination the patient experienced increasing redness at the vaccination site. On 26Jan2021, the patient experienced severe redness on the arm where the vaccination was given (erythema of extremities). The reporter informed that the patient experienced extensive redness, some swelling and warmth on the vaccinated arm. The affected area was from the medial part of the upper arm, laterally to the armpit. The patient was treated with antihistamine and hydrocortisone and improved after about a day. On Feb2021, the patient experienced possible meningitis (meningitis-like reaction), cramp (generalised tonic-clonic seizure). The patient experienced severe redness on the arm where the vaccination was given (erythema of extremities) (unspecified date). The patient vaccination with dose 2 was in Feb2021 and 8 days later, the patient had a generalised tonic-clonic seizure, duration 10 minutes, and was hospitalized. The physician informed that suspected adverse events were erythema of arm, generalised tonic-clonic seizure and possibly meningitis. According to the reporter, suspicion of serious meningoencephalitis or aspiration pneumonia. The reporter informed that according to the medical journal from the hospital (Feb2021), lumbar puncture showed no cells (Lkc Poly and mono were both 0), CRP was 102 and the woman didn''t have a fever. The previously initiated treatments with aciclovir, cefotaxim, ampicillin and betametason were withdrawn. The CT showed nothing new. It was considered post stroke epilepsy and treatment was started with levetiracetam 250 mg x 2. Due to elevated CRP without pronounced leukocytosis of unknown origin and previous history of aspiration pneumonias, the woman was treated with amoxicillin, clavulanic acid 500 mg/125 mg x 3 for 7 days. It was also noted a slight elevation in potassium of 6.2 mmol/L for unknown reason (reference value P-Potassium: 3.5-5.0 mmol/L), the woman was treated with a single dose of resonium 30 g. The reporter informed that due to a previous decision made in Apr2020 that the woman should be cared for in her nursing home during end of life, the woman was transferred back to the nursing home for palliative care. The woman died 10 days later. Therapeutic measures were taken as a result of the events. The reporter informed that the outcome was fatal, and the report was assessed as serious, death. 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.; Reported Cause(s) of Death: meningoencephalitis; aspiration pneumonia; post stroke epilepsy; elevated CRP; light elevation in potassium of 6.2 mmol/L for unknown reason (reference value P-Potassium: 3.5-5.0 mmol/L); Cramp (Generalised tonic-clonic seizure); severe redness on th


VAERS ID: 1187719 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, Chest X-ray, Confusional state, Cyanosis, Fall, Pneumonia, Urinary tract infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FURIX [FUROSEMIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Hypertension; Mucus discharge
Allergies:
Diagnostic Lab Data: Test Name: Chest x-ray; Result Unstructured Data: Test Result:lung infiltration; Test Name: CRP; Result Unstructured Data: Test Result:81; Comments: elevated
CDC Split Type: SEPFIZER INC2021363343

Write-up: cause of death was pneumonia/wheezing and saturated poorly/chest X-ray showed lung infiltration; confused; falls twice; cold cyanotic; elevated CRP of 81; positive urinary tract infection; This is a spontaneous report downloaded from the Regulatory Authority-WEB, Regulatory authority number SE-MPA-2021-020836. A contactable physician reported that a 101-year-old female patient received the second dose of bnt162b2 (COMIRNATY, lot number: EP2163), via an unspecified route of administration on Mar2021 as a single dose for COVID-19 immunization. Medical history included hypertension and cardiac failure both from an unknown date and unknow if ongoing. Before the vaccine, the patient had some problems with mucus. Concomitant medication included furosemide (FURIX) taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (COMIRNATY) on an unspecified date for COVID-19 immunization. On an unspecified date in Mar2021, six days after the vaccination, the patient appears confused and falls twice. The patient was deteriorated and becomes cold cyanotic. Decisions were made to provide palliative care. The patient had an elevated CRP of 81. The patient was wheezing and saturated poorly. A chest X-ray showed lung infiltration and the patient had a positive urinary tract infection and was started on Bactrim. The patient died on Mar2021, 12 days after the second dose of bnt162b2. The cause of death was pneumonia. No autopsy was performed. The outcome of the other events was unknown. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: cause of death was pneumonia/wheezing and saturated poorly/chest X-ray showed lung infiltration; cause of death was pneumonia/wheezing and saturated poorly/chest X-ray showed lung infiltration


VAERS ID: 1187726 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TROMBYL; PREDNISOLONE; METOPROLOL; CANDESARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic ischemic heart disease, unspecified; Hyperlipidaemia; Hypertension; Ulcerative colitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021363359

Write-up: SUDDEN DEATH; collapsed outdoors due to cardiac arrest; collapsed outdoors due to cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number SE-MPA-2021-021651. An 86-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on Mar2021 (Batch/Lot Number: EP2166) as single dose for covid-19 immunisation. Medical history included hypertension, ulcerative colitis, chronic ischemic heart disease, unspecified, and hyperlipidaemia. Concomitant medications included acetylsalicylic acid (TROMBYL), prednisolone for ulcerative colitis, metoprolol, and candesartan. The patient experienced sudden death on Mar2021. The patient was at the outpatient care center for dressing a wound, good healing after light trauma and he was unaffected and well during the visit. Later, a relative reported that the day after the vaccination (Mar2021), the patient had collapsed outdoors due to cardiac arrest. An ambulance was called but the man''s life could not be saved. The patient died on Mar2021 due to sudden death. The outcome of the other events was unknown. No autopsy will be performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1187731 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac assistance device user; Cardiac dysrhythmia, unspecified; Chronic obstructive pulmonary disease
Preexisting Conditions: Medical History/Concurrent Conditions: CPAP; Heart insufficiency; Overweight; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021363365

Write-up: Suspected death due to Covid-19 vaccine, breathlessness; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-023213. A 64-year-old female patient received the second dose of BNT162B2 (COMIRNATY; lot number: EL0725), via an unspecified route of administration on Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history included ongoing cardiac assistance device user, ongoing chronic obstructive pulmonary disease, stroke, heart insufficiency, ongoing cardiac dysrhythmia, unspecified, overweight, and continuous positive airway pressure (CPAP). The patient''s concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (COMIRNATY) on an unspecified date for COVID-19 immunization. The reported suspect adverse event was breathlessness on an unspecified date in Feb2021. Onset date of breathlessness was unclear, but 11 days after the vaccination, the woman was in contact with her outpatient pulmonology clinic regarding deterioration after vaccination with dose 2, had become more breathless than usual and slightly warm. Green sputum. The patient thought she needed antibiotics and prednisolone. She was booked for a oxygenation check. 14 days after the vaccination, the woman was found unresponsive with respiratory arrest. CPR was started by a relative and ambulance was called. The woman was defibrillated and treated with adrenaline before attempts at resuscitation were aborted. In the days preceding the death, the woman had felt that her breathing became increasingly more labored and breathless. She had not had a fever, though she had discolored nasal discharge. According to the reporter, the woman was very ill and correlation to vaccination was not certain. The patient died due to breathlessness on an unspecified date. Report assessed as serious, death. 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: Suspected death due to Covid-19 vaccine, breathlessness


VAERS ID: 1187734 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Acute respiratory failure, Cardiac failure congestive, Decreased appetite, Dehydration, Diarrhoea, Malaise, Pneumonia viral, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (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), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   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: Medical History/Concurrent Conditions: No adverse event (No reported medical history.)
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 20210212; Test Name: SARS-CoV-2 trapid test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: SIMODERNATX, INC.MOD20210

Write-up: Viral pneumonia; Acute renal failure; Congestive heart failure; Dehydration; Acute respiratory failure; Fever; DIARRHEA; Significant general malaise; Inappetence; A regulatory authority report was received from a physician concerning a 92-years-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced viral pneumonia, diarrhea, significant general malaise/malaise, acute renal failure/acute kidney injury, fever/pyrexia, congestive heart failure/cardiac failure congestive, dehydration, acute respiratory failure and inappetence/decreased appetite. The patient''s medical history was not provided. No relevant concomitant medications were reported. On 11 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 300042698) intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient experienced inappetence, diarrhea and significant general malaise. On 12 Feb 2021, the patient experienced fever and tested positive for COVID-19 PCR test and COVID-19 virus test. On 14 Feb 2021, the patient experienced viral pneumonia, acute renal failure, congestive heart failure, acute respiratory failure and dehydration. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, viral pneumonia, diarrhea, significant general malaise, acute renal failure, fever, congestive heart failure, dehydration, acute respiratory failure and inappetence, were reported as fatal. The patient died on 24 Feb 2021. The cause of death was reported as viral pneumonia. Plans for an autopsy were not provided.; Sender''s Comments: This is a case of death in a 92-year-old male subject with unknown medical history, who died 13 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Viral pneumonia


VAERS ID: 1188877 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-11
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021377359

Write-up: Pneumonia; This is a spontaneous report from a contactable other hcp. This is a line listing report received from the Regulatory authority report number 528113. A 93-year-old male patient received bnt162b2 (COMIRNATY) (Lot number was not reported), via an unspecified route of administration at single dose on an unspecified date for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 11Mar2021, the patient experienced pneumonia with fatat outcome. 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: Pneumonia


VAERS ID: 1188878 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-19
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021377626

Write-up: Vomiting; This is a spontaneous report received from an Other HCP through the Regulatory authority, (Regulatory authority number 529053). An 86-year-old female patient received BNT162b2 (COMIRNATY, Lot # not provided) via an unspecified route of administration on an unspecified date, at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced vomiting on 19Mar2021. The event was reported as fatal. It was unknown whether an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reported Cause(s) of Death: Vomiting


VAERS ID: 1188879 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-27
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021377627

Write-up: death; This is a spontaneous report received from a contactable HCP form the Regulatory authority, (Regulatory authority number 529201). An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On 27Mar2021, the patient died. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: death


VAERS ID: 1188895 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-02-25
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30042723 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   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: AMLODIPINE MESILATE; VORTIOXETINE HYDROBROMIDE; MELATONIN; COLECALCIFEROL; GLYCOPYRRONIUM BROMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial carcinoma cell type unspecified stage III; COPD; Depression; Hypertension; Sleep disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Patient collapsed and died while out walking; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Patient collapsed and died while out walking) in an 80-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 30042723 and 30042723) for COVID-19 vaccination. The patient''s past medical history included Bronchial carcinoma cell type unspecified stage III in 2011, Hypertension, Depression, Sleep disorder and COPD. Concomitant products included AMLODIPINE MESILATE, VORTIOXETINE HYDROBROMIDE, MELATONIN, COLECALCIFEROL and GLYCOPYRRONIUM BROMIDE for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. Death occurred on 25-Feb-2021 The patient died on 25-Feb-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown Route), the reporter considered DEATH (Patient collapsed and died while out walking) to be unlikely related. Concomitant medications were amlodipine mesilate, vortioxetine hydrobromide, melatonin, colecalciferol, gycopyronnium bromide. This is a case of death in a 80-year-old male subject with a medical history of bronchial carcinoma cell type unspecified stage III in 2011, hypertension, depression, sleep disorder and COPD, who died 6 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 80-year-old male subject with a medical history of bronchial carcinoma cell type unspecified stage III in 2011, hypertension, depression, sleep disorder and COPD, who died 6 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1188930 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-12
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 2275575 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021370679

Write-up: Exitus letalis; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB. An 84-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 04Jan2021 (Batch/Lot Number: 2275575) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced exitus letalis (death) on 12Jan2021. The cause of death was unknown. It was not reported if an autopsy was performed. COMIRNATY causality with death by regulatory authority was unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Exitus letalis


VAERS ID: 1188932 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Discomfort, Disturbance in attention, Dizziness, Fall, Skin haemorrhage, Splenic haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-07
   Days after onset: 34
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: XARELTO
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021369761

Write-up: shortly after vaccination he develpoed diarrhoea; shortly after vaccination he became dizzy; Shortly after vaccination he could not concentrate; shortly after vaccination he develpoed discomfort; fall at home, twice; bleeding on the spleen after second fall at home; Skin haemorrhage, severe after fall at home; This is a spontaneous report from contactable consumers downloaded from the regulatory authority number DK-DKMA-ADR 24962112. This is a spontaneous case, received on 15Mar2021 from a relative to the patient for an 81-year-old male patient, vaccinated with COMIRNATY (tozinameran). Concurrent conditions included ongoing hypertension, he was in thrombosis prophylaxis treatment. Concomitant medication included rivaroxaban (XARELTO) from 2018 for thrombosis prophylaxis. On 23Feb2021 the patient was vaccinated with first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/lot number: EP9598, expiration date: 30Jun2021) at single dose for COVID-19 immunisation. Shortly after he vaccination (unspecified date in Feb2021) the patient developed Discomfort, Diarrhoea, he became dizzy, he could not concentrate. At an unknown date in 2021 the patient developed Skin haemorrhage, severe after fall at home and bleeding on the spleen after second fall at home. As a consequence of dizziness the patient experienced the following consequences: fall at home, twice (in 2021). After the first fall at home, the family could not get in touch with him for a few days, and he was subsequently hospitalized. He came home after a week, but two days later he fell again. The ADRs were by the relative to the patient reported as being Fatal (events Splenic haemorrhage, Discomfort, fall) and all events resulting in hospitalization (twice, but dates are unknown). The outcome of Dizziness, Diarrhoea, Concentration impaired and Skin haemorrhage was unknown. Outcome of Splenic haemorrhage, Discomfort, fall was fatal. The patient died on 07Mar2021. It was unknown if an Autopsy was performed. No treatment due to the ADRs or medical procedure was reported. Causality: The relative of the patient does not know if there is a connection between the death and the vaccine, but it is striking, even though he was 81 years old he was mentally ok. He was very conscious of not wanting the second dose of the vaccine. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: shortly after vaccination he develpoed discomfort; fall at home, twice; bleeding on the spleen after second fall at home


VAERS ID: 1188935 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-28
Onset:2021-02-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Depressed level of consciousness, General physical health deterioration, Systemic immune activation
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUCITHALMIC; OPHTHA; MOVICOL; MICROLAX; PAMOL
Current Illness: Atrial fibrillation; Cachexia (Caused by Dementia Alzheimer''s type and Atrial Fibrillation); Dementia Alzheimer''s type; Depression; Living in nursing home; Multiple sclerosis
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Eye infection; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021370064

Write-up: Death; The patient is described as being distant and dying; The patient gets very weak 7 days after the vaccination; Overactivation of the immune system; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority, Regulatory Authority number DK-DKMA-WBS-0058364, Safety Report Unique Identifier DK-DKMA-ADR 24995455. A 94-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot Number: ER2659; Expiration Date: 30Jun2021), via an unspecified route of administration on 28Feb2021 (at the age of 94-year-old) as single dose for COVID-19 immunization. Medical history included living in nursing home, dementia alzheimer''s type, Multiple sclerosis, Atrial fibrillation, depression and cachexia (caused by Dementia Alzheimer''s type and Atrial Fibrillation); all were ongoing. The patient also had a history of constipation, eye infection and pain. Concomitant medications included fusidic acid (FUCITHALMIC) taken for eye infection from 17Nov2020; dorzolamide hydrochloride, timolol maleate (OPHTHA) taken for eye lubrication therapy from 26Nov2020; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) taken for constipation from 07Nov2017; macrogol, sodium citrate, sodium lauryl sulfate, sorbic acid (MICROLAX) taken for constipation from 07Sep2020; paracetamol (PAMOL) taken for pain from 20Sep2017. The patient experienced death on 17Mar2021, General physical health deterioration (The patient gets very weak 7 days after the vaccination) on 07Mar2021, Consciousness decreased (The patient is described as being distant and dying) on 07Mar2021 and Systemic immune activation (Overactivation of the immune system) on 28Feb2021. Course of events as follows: On 28Feb2021 the patient was vaccinated with first dose of bnt162b2. On 28Feb2021 the patient developed Systemic immune activation. On 07Mar2021 the patient developed General physical health deterioration and Consciousness decreased. On 17Mar2021 the patient died. The adverse events were reported by the physician as being fatal. The patient was treated with Furosemide, Midazolam, MORPHINHYDROCHLORID (trihydrate) and SERENASE (HALOPERIDOLUM) on 17Mar2021. The reported cause of death were cachexia, systemic immune activation, death, the patient is described as being distant and dying/Consciousness decreased and the patient gets very weak 7 days after the vaccination/General physical health deterioration. An autopsy was not performed. Causality: The physician has stated that there is a causality between the vaccine and the death. The case has not been reported to the police, the doctor has been informed of the Health Act and the section but refuses as he believes it is a presumed death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cachexia; Systemic immune activation; Death; the patient is described as being distant and dying/Consciousness decreased; The patient gets very weak 7 days after the vaccination/General physical health deterioration


VAERS ID: 1188954 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-15
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021370611

Write-up: Acute myocardial infarction; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is ES-AEMPS-813104. A 62-year-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection, lot: EK9788), intramuscular on 02Feb2021 as 0.3 mL, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had no history of COVID19. It was reported that two weeks later (on 15Feb2021), he suffered an acute myocardial infarction. The patient died due to acute myocardial infarction on 15Feb2021. It was unknown if autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1188965 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-03-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   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: FRPFIZER INC2021370683

Write-up: Oedema lung; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-BR20211034. A 78-year-old female patient received second of the BNT162B2 (COMIRNATY, Solution for injection and Lot number: ER9470) via intramuscularly to left arm on 27Mar2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 28Mar2021, the patient had pulmonary edema with cardio-respiratory arrest and death. Outcome of event was fatal. Further follow-up attempts are not possible. No further information expected.; Reported Cause(s) of Death: Oedema lung


VAERS ID: 1188970 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Death, Glomerular filtration rate, Investigation, Neutrophil count, Oxygen saturation, White blood cell count
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   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: BACLOFENE; BISOPROLOL QUIVER; ALPRAZOLAM ARROW; VALACICLOVIR ARROW; WELLVONE; PREGABALINE MYLAN; VFEND; ZOPICLONE; SKENAN; AMIODARONE ARROW; INNOHEP
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aspergillus infection; Atrial fibrillation (context of fluid overload and acute lung edema); Bronchial congestion; Cardioversion (Failure of cardioversion with amiodarone, addition of bisopprolol from 08Mar2021.); Coughing blood (requiring an increase in oxygen therapy from 2 to 4L); Hypotension (Probabilistic antibiotic therapy with amikacin and meropenem ineffective.); Insomnia (12:50AM, alprazolam 0.25 mg administered); Kidney failure acute; Klebsiella pneumonia; Leukemia (treated with chemotherapy); Lung edema; Phlebitis lower limb; Polypnea (requiring an increase in oxygen therapy from 2 to 4L); Sepsis (Probabilistic antibiotic therapy with amikacin and meropenem ineffective.); Septic shock (caused by klebsielle pneumoniae); Tetraparesis; Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: urinary tract infection with klebsiella penumoniae, Start Date Format: 102, Start Date: 20210218
Allergies:
Diagnostic Lab Data: Test Date: 20210319; Test Name: CRP; Result Unstructured Data: Test Result:58.42 mg/l; Test Date: 20210319; Test Name: DFG; Result Unstructured Data: Test Result:84 ml/min; Test Date: 20210322; Test Name: investigation; Result Unstructured Data: Test Result:no fever, no chills, persistent bronchial congesti; Comments: no fever, no chills, persistent bronchial congestion; Test Date: 20210319; Test Name: GB; Result Unstructured Data: Test Result:7.9 g/l; Test Date: 20210319; Test Name: PNN; Result Unstructured Data: Test Result:6.96 x10 9/l; Test Date: 20210324; Test Name: Oxygen saturation; Test Result: 72 %
CDC Split Type: FRPFIZER INC2021369854

Write-up: Death NOS; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority number is FR-AFSSAPS-BX20212551. A 67-year-old male patient received the first dose of bnt162b2 (COMIRNATY), intramuscular, administered in the left arm on 24Mar2021 (Batch/Lot Number: ET3620) as a single dose for covid-19 immunization. Medical history included tetraparesis in 2011, Phlebitis lower limb in Sep2020, Acute plasmacytoid dendritic cell leukemia (treated with chemotherapy) in Feb2021, urinary tract infection with Klebsiella penumoniae on 18Feb2021, septic shock (caused by klebsiella pneumoniae) in 2021, febrile episode on 04Mar2021 with sepsis and hypotension (Probabilistic antibiotic therapy with amikacin and meropenem ineffective), aspergillus infection with positive PCR and failure of cardioversion with amiodarone, addition of bisopprolol from 08Mar2021; coughing up blood (requiring an increase in oxygen therapy from 2 to 4L), polypnea and atrial fibrillation in a context of fluid overload and acute lung edema on 01Mar2021; persistent bronchial congestion on 22Mar2021, insomnia on 25Mar2021 at 12:50AM (alprazolam 0.25 mg administered) and kidney failure on unknown date. Concomitant medications included baclofene; bisoprolol fumarate (BISOPROLOL QUIVER); alprazolam (ALPRAZOLAM ARROW); valaciclovir hydrochloride (VALACICLOVIR ARROW) taken; atovaquone (WELLVONE); pregabalin (PREGABALINE MYLAN); voriconazole (VFEND); zopiclone; morphine sulfate (SKENAN); amiodarone hydrochloride (AMIODARONE ARROW) from Mar2021; and tinzaparin sodium (INNOHEP). On 25Mar2021, about 17 hours after the vaccination, in the early morning, death NOS of the patient (observation at 5:40 a.m.). It was further reported as Death within 24 hours after 1st dose of Comirnaty, in a patient with polymorbidity including acute leucemia treated with chemotherapy 1 month previously, aspergillus infection with positive PCR, tetraparesis after public road accident and self-catheterization. Patient did not have Covid-19, no test was performed. Chemotherapy from 23Feb2021 with idarubicin (12 mg / m2), methotrexate, intrathecal cytarabine, dexamethasone, pegaspargase. ARI post chemotherapy with methotrexate with overload syndrome. Change to atrial fibrillation in a context of fluid overload and acute lung edema on 01Mar2021. Failure of cardioversion with amiodarone, addition of bisopprolol from 08Mar2021. Urinary tract infection with Klebsiella pneumoniae since 18Feb2021. New febrile episode on 04Mar2021 with sepsis and hypotension. Probabilistic antibiotic therapy with amikacin and meropenem ineffective. Aspergillus antigenemia on 08Mar2021 positive. Transfer of the patient. Relative clinical improvement of the patient from 17Mar2021 allowing transfer to continuing care hospitalization. On 19Mar2021, biology were DFG (CKD) 84 ml / min, GB 7.9 G / L, PNN 6.96 G / L, CRP 58.42 mg / L. On 22Mar2021, no fever, no chills, persistent bronchial congestion. According to nurses notes, patient with coughing up blood from 21Mar2021, polypnea requiring an increase in oxygen therapy from 2 to 4L. On the day of vaccination, before administration, saturation under 4L of 72% oxygen measured at 9:22 am, with no apparent clinical signs. Administration of the vaccine at 10:45 a.m., no immediate adverse effect observed. About 17 hours after the vaccination, in the early morning, death of the patient (observation at 5:40 a.m.), cognitively competent patient, last contact at 12:50 a.m. of 25Mar in front of insomnia, alprazolam 0.25 mg was administered. The patient died on 25Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number already obtained.; Reported Cause(s) of Death: death NOS


VAERS ID: 1188988 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   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: COVERSYL AM; KARDEGIC; CORTANCYL; FENTANYL
Current Illness: Arterial hypertension; Atherosclerosis; Rhizomelic pseudopolyarthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Hip prosthesis insertion; Knee arthroplasty; Polymyalgia rheumatica
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021369754

Write-up: Sudden death; cardiorespiratory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number, FR-AFSSAPS-MP20210901. An 88-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Lot Number: ET3620), intramuscular, administered in left arm on 18Mar2021 as single dose for COVID-19 immunization. Medical history included rhizomelic pseudopolyarthritis, atherosclerosis, arterial hypertension; all were ongoing. The patient also had a history of polymyalgia rheumatica, knee arthroplasty and hip prosthesis. Concomitant medications included amlodipine besilate, perindopril erbumine (COVERSYL AM); acetylsalicylate lysine (KARDEGIC); prednisone (CORTANCYL); and fentanyl. The patient previously received the first dose of bnt162b2 (COMIRNATY) on unspecified date for COVID-19 immunization. The patient is living alone at home. She had no history of COVID-19. On 20Mar2021, the patient was found dead at home (reported as sudden death), the emergency services indicate that the cause of death is a cardiorespiratory arrest on 20Mar2021. The patient died on 20Mar2021. An autopsy was not performed. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest; sudden death


VAERS ID: 1189018 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Hemiplegia, Ischaemic stroke, Magnetic resonance imaging
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, 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? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE; AMLOR; KARDEGIC; FUROSEMIDE; EUPRESSYL [URAPIDIL]; TARDYFERON; SIMVASTATINE; ALDACTONE [SPIRONOLACTONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolemia; Hypertension; Prosthesis implantation; Valvular heart disease NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210210; Test Name: MRI; Result Unstructured Data: Test Result:sylvic ischemic attack made up posterior right and; Comments: sylvic ischemic attack made up posterior right and a thrombus of the middle cerebral artery in M2 on the right
CDC Split Type: FRPFIZER INC2021369708

Write-up: left hemiplegia; Ischemic stroke; Haemorrhage cerebral/massive hemorrhagic transformation of the whole of the right posterior sylvian territory; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory Authority Report Number : FR-AFSSAPS-TO20212237. An 83-year-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscularly on 08Feb2021 as single dose for COVID-19 immunisation. Medical history included valvular heart disease treated with aortic bioprosthesis, hypertension and hypercholesterolaemia. Concomitant medications included pantoprazole (PANTOPRAZOLE), amlodipine besilate (AMLOR), acetylsalicylate lysine (KARDEGIC), furosemide (FUROSEMIDE), urapidil (EUPRESSYL), ferrous sulfate (TARDYFERON), simvastatine (SIMVASTATINE) and spironolactone (ALDACTONE). The patient previously took rivaroxaban (XARELTO) for embologenic rhythm disorder and experienced gastrointestinal bleeding. On 10Feb2021 at 8am, patient was hospitalized for left hemiplegia noted at 6am the same day. At the hospital, patient had ischemic stroke which magnetic resonance imaging showed as a sylvic ischemic attack made up posterior right and a thrombus of the middle cerebral artery in M2 on the right. The patient was treated by performing intravenous thrombolysis by ACTILYSE. It was then reported that the patient experienced haemorrhage cerebral; further reported as a massive hemorrhagic transformation of the whole of the right posterior sylvian territory. A decision of palliative care was made and the patient died on 11Feb2021 in the morning. 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: Ischemic stroke; Haemorrhage cerebral/massive hemorrhagic transformation of the whole of the right posterior sylvian territory; left hemiplegia


VAERS ID: 1189116 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-13
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0668 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 68
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: Stroke
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021371436

Write-up: Stroke; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202104031010296190, safety Report Unique Identifier GB-MHRA-ADR 25079388. A 97-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ej0668, expiry date: unknown), via an unspecified route of administration on 05Jan2021 (at the age of 97 years old) at a single dose for covid-19 immunisation. Medical history included stroke. Patient has not had symptoms associated with COVID-19 and is not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 15Dec2020 (Lot Number: ej0553) at a single dose for covid-19 immunisation. The patient experienced stroke on 13Jan2021. It was further reported that the patient suffered a minor stroke 8 days after his second vaccine while in hospital he suffered a major stroke. The patient underwent lab tests and procedures which included covid-19 virus test: no - negative covid-19 test on unspecified date. It was reported that the patient died on 23Mar2021 due to stroke. It was unknown whether an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Stroke


VAERS ID: 1189214 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-03
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Foot operation NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021380936

Write-up: Death; This is a spontaneous report from a contactable consumer. A 50-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021; first dose on 02Mar2021 (Batch/Lot number was not reported) via an unspecified route of administration, both as single dose for Covid-19 immunisation. Medical history included foot operation on 11Mar2021. The patient'' concomitant medications were not reported. The patient died on 03Apr2021. An autopsy was performed that revealed unknown at this time. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. The following information on the batch/lot number has been requested.; Reported Cause(s) of Death: unknown at this time; Autopsy-determined Cause(s) of Death: unknown at this time


VAERS ID: 1189253 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Malaise, Myalgia, Nausea, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021370997

Write-up: Vomiting/vomited; Nausea; Fatigue; malaise/Feeling unwell/feeling sick in the morning; Generalized joint pain; Myalgia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority NL-LRB-00490505. An 89-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot: ER7812), via an unspecified route of administration on 25Mar2021 as single dose for covid-19 immunisation. Medical history included atrial fibrillation. The patient''s concomitant medications were not reported. The patient had no previous COVID-19 infection. On 26Mar2021 (reported as 1 day after start), the patient experienced fatigue, malaise, generalized joint pain and myalgia. On 29Mar2021 (reported as 4 days after start), the patient experienced nausea. On 30Mar2021 (reported as 5 days after start), the patient experienced vomiting and feeling unwell. The patient was feeling sick in the morning, vomiting, without fever. There were no diagnostic procedures. The events were considered serious by the reporting physician. On the morning of the day the patient died, she felt unwell and vomited, no fever. The patient died on 30Mar2021 due to fatigue, malaise, arthralgia, myalgia, nausea and vomiting. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Myalgia; Not feeling well/Feeling unwell; Fatigue; Vomiting; Generalized joint pain; Nausea


VAERS ID: 1189254 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD; Interstitial lung disease (Was waiting for a lung transplantation); Pulmonary hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: Echocardiography; Result Unstructured Data: good left ventricle function, dilated right ventricle
CDC Split Type: NOMODERNATX, INC.MOD20210

Write-up: Dyspnoea; Feeling unwell; NAUSEA; Cardiac arrest; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Cardiac arrest), DYSPNOEA (Dyspnoea), MALAISE (Feeling unwell) and NAUSEA (NAUSEA) in a 62-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. Concurrent medical conditions included Interstitial lung disease (Was waiting for a lung transplantation), COPD and Pulmonary hypertension. On 10-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DYSPNOEA (Dyspnoea) (seriousness criterion hospitalization), MALAISE (Feeling unwell) (seriousness criterion hospitalization) and NAUSEA (NAUSEA) (seriousness criterion hospitalization). On 16-Mar-2021, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criterion death). The patient died on 16-Mar-2021. The reported cause of death was Cardiac arrest. An autopsy was performed, but no results were provided. At the time of death, DYSPNOEA (Dyspnoea), MALAISE (Feeling unwell) and NAUSEA (NAUSEA) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Echocardiogram: dilated right ventricle (abnormal) good left ventricle function, dilated right ventricle. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1189259 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Incorrect route of product administration, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021370249

Write-up: Fever; administration subcutaneously; This is as spontaneous report received from a contactable consumer downloaded from the Agency Regulatory Authority WEB. The regulatory authority report number is PL-URPL-DML-MLP.4401.2.154.2021. A 74-year-old male patient received bnt162b2 (COMIRNATY, lot number and expiration date not provided), subcutaneous on 24Feb2021 at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Feb2021, after vaccination the patient developed a fever. There was a visit to the doctor. The patient stayed home due to the elevated temperature. On 14Mar2021, the patient died. An autopsy was not performed. Senders comments: Pyrexia is an expected adverse reaction listed in Comirnaty Summary of Product Characteristics. Due to the time of its onset (2-3 days after vaccination), the relationship was assessed as possible. Due to insufficient information, the relationship between the administration of the vaccine and the occurrence of death has not been established. There is a time relationship between the administration of the vaccine and the occurrence of the reaction. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Fever


VAERS ID: 1189262 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Decreased appetite, Dyspnoea, Fatigue, Oedema peripheral, Speech disorder
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021381829

Write-up: Cardio-respiratory arrest; Difficulty breathing and speaking; Extreme tiredness; Appetite loss; Difficulty breathing and speaking; Swollen legs; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 24Feb2021 (Lot Number: EP2166) at 0.3 mL, single for covid-19 immunisation. The vaccine was administered at a Clinic. The patient''s medical history and concomitant medications were not reported. According to the reporting consumer, the patient was healthy without any known diagnosed pathologies. It was unknown if the patient had an allergies to medications, food, or other products. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 25Feb2021, the patient experienced extreme tiredness, appetite loss, difficulty breathing and speaking and swollen legs. No treatment was received for the adverse events. On 25Mar2021, the patient was deceased. The reported cause of death was cardio-respiratory arrest, tiredness, appetite loss, difficulty breathing and speaking and swollen legs. The patient died on 25Mar2021. An autopsy was not performed.; Reported Cause(s) of Death: Difficulty breathing and speaking; Cardio-respiratory arrest; Extreme tiredness; Appetite loss; Difficulty breathing and speaking; Swollen legs


VAERS ID: 1189268 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021376163

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. National Institute of Public Health (INSP) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021385938 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385939 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385940 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385941 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385942 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385943 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385944 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385945 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385946 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385947 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385948 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385949 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385950 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385951 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385952 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385953 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385954 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385955 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385956 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385957 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385958 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385959 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385960 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385961 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385962 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385963 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385964 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385965 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021385966 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189269 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385893

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Regulatory authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189270 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385894

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189271 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385897

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189272 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385900

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. National Institute of Public Health (INSP) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189273 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385903

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. National Institute of Public Health (INSP) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189274 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385904

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. National Institute of Public Health (INSP) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189275 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385905

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189276 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385906

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. National Institute of Public Health (INSP) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189277 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385907

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. National Institute of Public Health (INSP) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189278 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385908

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189279 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385910

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189280 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385912

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. National Institute of Public Health (INSP) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189281 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385913

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189282 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385914

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Public health assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189283 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385915

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. National Institute of Public Health (INSP) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189284 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385916

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Institute of Public Health assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189285 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385918

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Public Health assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189286 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385922

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Public Health assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189287 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385923

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Public Health assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189288 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385926

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. National Institute of Public Health (INSP) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189289 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385928

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189290 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385929

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. National Institute of Public Health (INSP) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189291 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385931

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189292 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385932

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189293 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385934

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. National Institute of Public Health (INSP) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189294 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385935

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189295 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385936

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. National Institute of Public Health (INSP) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189296 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385937

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. National Institute of Public Health (INSP) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189297 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385945

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. National Institute of Public Health (INSP) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189298 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385948

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189299 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385950

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189300 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385951

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. National Institute of Public Health (INSP) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189301 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385952

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189302 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385954

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Regulatory authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189303 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385957

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. National Institute of Public Health (INSP) assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189304 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385960

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189305 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385962

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Public Health assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189306 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385965

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189311 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP 2166 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardiac failure, Heart rate
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FURADANTIN; OMEPRAZOL SANDOZ [OMEPRAZOLE]; NITROLINGUAL; ALVEDON; UREA; IMPUGAN [FUROSEMIDE]; ENALAPRIL SANDOZ; BISOPROLOL SANDOZ; OXASCAND; ISONOVA; ALLOPURINOL SANDOZ; WARAN; ZOPICLONE ACTAVIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure
Allergies:
Diagnostic Lab Data: Test Date: 20210312; Test Name: blood pressure; Result Unstructured Data: Test Result:without remark; Test Date: 20210312; Test Name: pulse; Result Unstructured Data: Test Result:without remark
CDC Split Type: SEPFIZER INC2021371022

Write-up: death/Cause of death: cardiac failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority SE-MPA-2021-020843, Safety Report Unique Identifier SE-MPA-1615988685350. A 92-year-old female patient received bnt162b2 (COMIRNATY, lot number EP 2166 and expiration date not provided), intramuscular, administered in Arm Right second dose on 12Mar2021 at 0.3 mL, single for covid-19 immunisation. The patient''s medical history included atrial fibrillation and cardiac failure. The patient''s concomitant medications included nitrofurantoin (FURADANTIN) from 13Aug2020 at 150 mg, 1x/day; omeprazole (OMEPRAZOL SANDOZ [OMEPRAZOLE]) from 22Jun2020 at 20 mg, 1x/day; glyceryl trinitrate (NITROLINGUAL) from 22Jun2020 at 0.4 mg, as needed; paracetamol (ALVEDON) at 1000 mg, as needed; urea from 16Jul2020 at Lubricate as needed; furosemide (IMPUGAN [FUROSEMIDE]) from 16Jul2020 at 80 mg, 1x/day; enalapril maleate (ENALAPRIL SANDOZ) from 22Jun2020 at 10 mg, 1x/day; bisoprolol fumarate (BISOPROLOL SANDOZ) from 22Jun2020 at 5 mg, 1x/day; oxazepam (OXASCAND) from 22Jun2020 at 5 mg, 1x/day; isosorbide mononitrate (ISONOVA) from 22Jun2020 at 30 mg, 1x/day; allopurinol (ALLOPURINOL SANDOZ) from 07May2020 at 300 mg, 1x/day; warfarin sodium (WARAN) from 07May2020 at according to special prescription; and zopiclone (ZOPICLONE ACTAVIS) from 22Jun2020 at 5 mg, 1x/day. The patient historical vaccine includes bnt162b2 (COMIRNATY) first dose on Jan2021 for COVID-19 immunization. It was reported that patient received the second dose on 12Mar2021, the patient appeared to be as usual. No fever. Pulse and blood pressure without remark. The next day on 13Mar2021, the patient was found dead in her bed. The cause of death was cardiac failure. The patient died on 13Mar2021. An autopsy was not performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: death/Cause of death: cardiac failure


VAERS ID: 1189370 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-22
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Respiratory rate increased
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 INC2021377625

Write-up: Dyspnoea; Respiratory rate increased; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority (Regulatory authority number 529039). A 94 years male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for Covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 22Mar2021 the patient experienced dyspnoea and respiratory rate increased.The outcome of both events was reported as fatal. 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: Dyspnoea; Respiratory rate increased


VAERS ID: 1189371 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-11
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EMO477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Diagnostic procedure, Laboratory test, Multimorbidity, Pulmonary embolism, Respiratory failure, SARS-CoV-2 test
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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 17
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: TOILAX; IMOVANE; FURIX; KALIUMKLORID; ASCORBIC ACID; QUETIAPIN ACCORD; LACTULOSE ORIFARM; BETOLVEX; APOVIT B COMBIN; AMITRIPTYLIN "DAK"; OXYNORM; MOVICOL; SIMVASTATIN KRKA; MIRTAZAPIN "ACTAVIS"; TRADOLAN; CALCIUM + VIT D; TOUJEO; FOLIMET; B
Current Illness: Bipolar disorder; Cardiac disorder; Constipation; COVID-19 (A few days before vaccination, routinely testet. One day after vaccination, test result positive.); Depression; Edema; Kidney failure; Living in nursing home; Multimorbidity (Severe co-morbidity); Pain; Skin infection (Exit site); Sleeplessness; Type 2 diabetes mellitus; Vitamin B12 deficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Diagnostic procedure; Result Unstructured Data: Test Result:Unspecified diagnostic imaging, unknown results; Comments: Unspecified diagnostic imaging, unknown results; Test Date: 202101; Test Name: Laboratory test; Result Unstructured Data: Test Result:Unspecified, unknown results; Test Date: 20210108; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Positive
CDC Split Type: DKPFIZER INC2021370082

Write-up: Developed lung embolisms and respiratory failure, and died of the complications.; Lung embolisms; COVID-19; multimorbidity; This is a spontaneous report from a contactable Physician downloaded from the Regulatory Authority-WEB DK-DKMA-WBS-0059241. This is a spontaneous case, received on 23Mar2021 from a physician (Internal ID: XMO-A09DA4056C6C4C3A8199155E969CD535) and a requested follow-up received on 26Mar2021 from the same physician, which describes the occurrence of Embolism lung (Lung embolisms) and Respiratory failure (Developed lung embolisms and respiratory failure, and died of the complications) in a 57 years old female patient vaccinated with COMIRNATY (tozinameran). A 57-year-old female patient received BNT162b2 (COMIRNATY, Lot #EMO477) via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included severe multimorbidity/co-morbidity and living in nursing home, both ongoing. Patient concurrent conditions included: depression, skin infection (exit site), vitamin B12 deficiency, cardiac disorder, edema caused by kidney failure, sleeplessness, constipation, pain, bipolar disorder and type 2 diabetes mellitus. Concomitant medications included oral bisacodyl (TOILAX) taken for constipation from 23Jul2020 at 10mg 1x/day; oral zopiclone (IMOVANE) taken for insomnia from 26Jun2020 at 7.5mg 1x/day; oral cefuroxime (FURIX) taken for oedema from 05Jan2021 at 250mg 1x/day; oral kaliumklorid taken for potassium supplementation from 05Jan2021 at 2 tablets morning and 1 tablet evening; oral ascorbic acid taken for vitamin supplementation from 01Sep2020 at 80 mg, 1x/day; oral quetiapine fumarate (QUETIAPIN ACCORD) taken for bipolar disorder from 25Jun2020 400 mg, 1x/day; oral lactulose (LACTULOSE ORIFARM) taken for constipation from 14Jun2018 15 mL, 1x/day; oral cyanocobalamin zinc tannate (BETOLVEX) taken for vitamin B12 deficiency at 1 mg, 1x/day; oral calcium pantothenate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (APOVIT B COMBIN) taken for vitamin supplementation from 01Sep2020 at 1 DF, 1x/day; oral amitriptyline hydrochloride (AMITRIPTYLIN "DAK") taken for depression from 02Aug2018 at 100 mg, 1x/day; oral oxycodone hydrochloride (OXYNORM) taken for pain from 30Dec2020 to 13Jan2021 at 10 mg, 1x/day; oral macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) taken for constipation from 07Oct2020; oral simvastatin (SIMVASTATIN KRKA) taken for cardiovascular disorder from 06Jun2019 at 10 mg, 1x/day; oral mirtazapine (MIRTAZAPIN "ACTAVIS") taken for depression from 26Jun2020 at 30 mg, 1x/day; oral tramadol hydrochloride (TRADOLAN) taken for pain from 26Jun2018 at 50 mg, as needed; oral calcium carbonate, vitamin D NOS (CALCIUM + VIT D) taken for calcium supplementation from 07Dec2020 at 2 DF, 1x/day; subcutaneous insulin glargine (TOUJEO) taken for diabetes mellitus from 28Aug2018 at 20 DF, 1x/day; oral folic acid (FOLIMET) taken for vitamin supplementation from 02Sep2020 at 15 mg, weekly; cutaneous mupirocin calcium (BACTROBAN) taken for skin infection from 11Nov2020 at 2 DF, 1x/day; oral carvedilol (CARVEDILOL HEXAL) taken for cardiac disorder from 26Mar2013 at 25 mg, 1x/day; oral paracetamol (PANODIL) taken for pain from 07Dec2020 at 4000 mg, 1x/day; oral linagliptin (TRAJENTA) taken for type 2 diabetes mellitus from 07Jun2015 at 5 mg, 1x/day. The patient was routinely tested for COVID-19 a few days before vaccination and one day after vaccination, on 08Jan2021, test result was positive. On 11Jan2021 the patient developed embolism lung (onset first dose day 4). On 28Jan2021 the patient developed respiratory failure (onset first dose day 21). The ADRs were reported as being life threatening, resulting in hospitalisation, and being fatal (28Jan2021). No treatment or medical procedure due to the ADRs were reported. No autopsy was performed. Reported cause of death was respiratory failure, lung embolism, COVID-19, multimorbidity (severe co-morbidity). Only normal confirmation of death was performed post-mortem, findings unknown. Test results included SARS-CoV-2 test, 08Jan2021, positive; laboratory test, Jan2021, unspecified, unknown results; diagnostic procedure, Jan2021, unspecified diagnostic imaging, unknown results. It was unknown if the death was reported to the police since the reporting physician has not conducted the confirmation of death. The physician does not wish to report the death to the police. Causality: The physician comments that she originally hadn''t reported the ADRs on her own initiative and believed the COVID-19 infection compared with severe co-morbidity is cause of the patient''s death. The reason for the late report is that the patient''s daughter has contacted her after the cases regarding thrombosis and AstraZeneca (ChAdOx1 nCoV-19) was announced in the media, and requested of having the case reported - despite the patient was vaccinated with Comirnaty. The physician comments furthermore that she despite of her not believing the vaccine is the cause of death, she cannot rule it out due to the timeframe from given vaccination to the lung embolisms and the death occurs. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19; Respiratory failure; Lung embolism; Multimorbidity


VAERS ID: 1189375 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dysarthria, Lethargy, 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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EFFOX; CLAVIX [CLOPIDOGREL BISULFATE]; POLPRIL; PRADAXA; NONPRES; TRIMEDUCTAN; IPP [OMEPRAZOLE]; TORSEMED; ATORIS; METFORMAX; BISOCARD; GENSULIN
Current Illness: Arterial hypertension; Atherosclerosis; Atrial fibrillation; Diabetes; Ischaemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Drug-eluting stent placement (anti-proliferative drug-eluting stents;); Heart attack (3 x myocardial infarction)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021370939

Write-up: Sudden death - SCA - on the 5th day after vaccination with the 2nd dose of Pfizer vaccine/asystole; Slurred speech; fainted/swoon; depressed/mopey/lethargic; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is PL-URPL-3-469-2021. A contactable physician reported that an 89-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Batch/Lot Number: ET3674; Expiration Date: 31Jul2021), intramuscular, administered in the left arm on 18Mar2021 19:18 as 0.3 mL, single for COVID-19 immunization. Medical history included arterial hypertension, diabetes, ischemic heart disease, atherosclerosis, atrial fibrillation all from an unknown date and ongoing. The patient had stents implanted with antiproliferative drugs in 01Nov2020. The patient also had three heart attacks on unspecified dates. No allergies were found. Concomitant medications included isosorbide mononitrate (EFFOX); clopidogrel bisulfate (CLAVIX [CLOPIDOGREL BISULFATE]); ramipril (POLPRIL); dabigatran etexilate mesilate (PRADAXA); eplerenone (NONPRES); trimetazidine hydrochloride (TRIMEDUCTAN); omeprazole (IPP [OMEPRAZOLE]); torasemide (TORSEMED); atorvastatin calcium (ATORIS); metformin hydrochloride (METFORMAX); bisoprolol fumarate (BISOCARD); insulin human (GENSULIN), all taken for an unspecified indication, start and stop date were not reported. On 23Mar2021, on the fifth day after the second vaccination, at 2.30 PM, the patient experienced sudden death/sudden cardiac arrest. There was no hospitalization due to a post-vaccination reaction. Before cardiac arrest, which was the cause of death, the patient was depressed/mopey/lethargic and had slurred speech, and also fainted/swoon. The emergency medical team recognized asystole and started CPR. The wife who lived with the patient, was also vaccinated on the same days with many chronic diseases, feels well now. The patient had no symptoms after receiving the first dose of bnt162b2. The doctor diagnosed an adverse vaccine reaction due to the time frame after vaccination. All the events were reported as fatal. The patient died on 23Mar2021. An autopsy will not be performed. Reporter comment: Sudden cardiac arrest, asystole, lethargy, slurred speech, and fainting are unexpected symptoms following the administration of COMIRNATY. Until 30Mar2021, the Agency Regulatory Authority database reported cases of cardiac arrest, speech disorder, depressed mood, syncope. An autopsy was not performed. In the assessment, URPL took into account information about the patient''s health, chronic diseases and the opinion of a doctor who linked death with vaccination due to the existing time relationship. Taking into account the patient''s medical history and the doctor''s opinion, it cannot be stated whether the vaccine had an impact on the patient''s death. There is a time relationship between the administration of the vaccine and the occurrence of side effects. The person reporting Adverse event following immunization (AEFI) qualified it as serious. Due to the qualification of the reporting person and the health result of the death, Regulatory Authority assessed the AEFI as serious. Relatedness of drug to all events assessed by Agency Regulatory Authority as Possible (WHO scale-assessment method). No follow-up attempts possible. No further information expected.; Reporter''s Comments: Sudden cardiac arrest, asystole, lethargy, slurred speech, and fainting are unexpected symptoms following the administration of COMIRNATY. Until 30Mar2021, the Agency Regulatory Authority database reported cases of cardiac arrest, speech disorder, depressed mood, syncope. An autopsy was not performed. In the assessment, Regulatory Authority took into account information about the patient''s health, chronic diseases and the opinion of a doctor who linked death with vaccination due to the existing time relationship. Taking into account the patient''s medical history and the doctor''s opinion, it cannot be stated whether the vaccine had an impact on the patient''s death. There is a time relationship between the administration of the vaccine and the occurrence of side effects. The person reporting Adverse event following immunization (AEFI) qualified it as serious. Due to the qualification of the reporting person and the health result of the death, Regulatory Authority assessed the AEFI as serious.; Reported Cause(s) of Death: Slurred speech; depressed/mopey/lethargic; fainted/swoon; Sudden death - SCA - on the 5th day after vaccination with the 2nd dose of Pfizer vaccine/asystole


VAERS ID: 1189630 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-30
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021377622

Write-up: Cardiac arrest; Vomiting; This is a spontaneous report from a contactable other hcp. This is a report received from the regulatory authority. Regulatory authority report number 529382. An 89 female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cardiac arrest and vomiting on 30Mar2021. The events were fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest; Vomiting


VAERS ID: 1189631 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-30
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021377629

Write-up: Anxiety; Cardiac arrest; Hyperhidrosis; Vomiting; This is a spontaneous report received from a contactable other health professional via the Regulatory Authority. Regulatory authority number is 529947. A 89-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 30Mar2021 the patient experienced anxiety on 30Mar2021, cardiac arrest, hyperhidrosis and vomiting The outcome for all events was reported as fatal. 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: Anxiety; Cardiac arrest; Hyperhidrosis; Vomiting


VAERS ID: 1189633 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-14
Onset:2021-02-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Carotid artery occlusion, Cerebrovascular accident, Embolism, Hemiparesis, Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Itching (occasionally slight itching on the skin, not definable); Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021370526

Write-up: Ischemic stroke; Occlusion d. Internal carotid due to embolism, stroke, left medial syndrome with aphasia, right hemiparesis.; Occlusion d. Internal carotid due to embolism, stroke, left medial syndrome with aphasia, right hemiparesis.; Occlusion d. Internal carotid due to embolism, stroke, left medial syndrome with aphasia, right hemiparesis.; Occlusion d. Internal carotid due to embolism, stroke, left medial syndrome with aphasia, right hemiparesis.; Occlusion d. Internal carotid due to embolism, stroke, left medial syndrome with aphasia, right hemiparesis.; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB [DE-PEI-CADR2021040265]. Other case identifier number DE-PEI-202100027957. A 91-year-old female patient received bnt162b2 (COMIRNATY), first dose intramuscular on 14Feb2021 (Batch/Lot Number: EL8723) as single dose for covid-19 immunisation. Medical history included Idiopathic Parkinson''s Syndrome, arterial hypertension, occasionally slight itching on the skin, not definable from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced ischemic stroke, occlusion d. internal carotid due to embolism, stroke (apoplectic fit; Plaque build-up in the intra- and extracranial vessels), left medial syndrome with aphasia, right hemiparesis on 19Feb2021. The patient was hospitalized due to the events from 19Feb2021 to 01Mar2021. The patient died on 05Mar2021 due to ischemic stroke. An autopsy was not performed. The outcome of ischemic stroke was fatal while the patient did not recover from the remaining events. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Ischemic stroke


VAERS ID: 1190688 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021377624

Write-up: Unresponsive to stimuli; This is a spontaneous report from a contactable other health professional received from the Regulatory Authority. Regulatory authority report number 529022. A 97-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was unresponsive to stimuli on an unspecified date with fatal outcome. The patient died on an unspecified date. 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: Unresponsive to stimuli


VAERS ID: 1190689 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-27
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021377628

Write-up: Malaise; This is a spontaneous report received from the Regulatory Authority (RA) (Regulatory authority number 529418). The reporter type to the RA was reported as a HCP. This is a line listing report. A 91 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 27Mar2021 the patient experienced malaise which led to patient death on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained; Reported Cause(s) of Death: Malaise


VAERS ID: 1190714 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021372976

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; The first report downloaded from the Regulatory Authority GB-MHRA-WEBCOVID-202101261748200590, Safety Report Unique Identifier GB-MHRA-ADR 24651574. This is the seventh of eight reports. A contactable physician reported for a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sars-cov-2 infection on an unspecified date. The clinical course was reported as follows: This lady''s cause of death was Covid-19. This lady was one of 8 patients in the nursing home who died of Covid-19 within a month of receiving the same vaccine. I did not complete a yellow card for all of them. The events were assessed as results in death and medically significant. 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. Amendment: This follow-up report is being submitted to amend previously reported information: Updated the labelling for the events SARS-CoV-2 infection (COVID-19 and Drug ineffective) from listed to unlisted.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1193825 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021377623

Write-up: Pneumonia; This is a spontaneous report from a contactable Healthcare Professional received from the Agency Regulatory Authority (Regulatory authority number 528392). This is a line listing report. A 92-year-old female patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date the patient experienced pneumonia, which was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1193830 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-03-12
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Cardiogenic shock, Confusional state, Dyspnoea, Electrocardiogram, Hypotension, Sinus tachycardia, Syncope, Troponin
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   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: ASPIRIN CARDIO; CONCOR; JANUVIA [SITAGLIPTIN PHOSPHATE]; EUTHYROX; NITRODERM; CITALOPRAM MEPHA; PANTOZOL CONTROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hashimoto''s thyroiditis; Ischaemic cardiomyopathy; Metabolic syndrome; Terminal renal insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210312; Test Name: blood pressure; Result Unstructured Data: 80/60 mmHg, hypovolemic shock; Test Date: 20210313; Test Name: ECG; Result Unstructured Data: revealed sinus tachycardia, ST elevation to limits, non-specific T-wave alterations and baseline instability on leads I,III,aVL,V1,V2; Test Date: 20210313; Test Name: troponin; Result Unstructured Data: ng/L; Test Date: 20210314; Test Name: troponin; Result Unstructured Data: ng/L
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: cardiogenic shock; dyspnoeic; confused; syncope; sinus tachycardia; low blood pressure (80/60); Asthenia; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIOGENIC SHOCK (cardiogenic shock), HYPOTENSION (low blood pressure (80/60)), ASTHENIA (Asthenia), SYNCOPE (syncope), SINUS TACHYCARDIA (sinus tachycardia), DYSPNOEA (dyspnoeic) and CONFUSIONAL STATE (confused) in a 93-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Ischaemic cardiomyopathy in 2017, Terminal renal insufficiency and Metabolic syndrome. Concurrent medical conditions included Diabetes mellitus in 1981 and Hashimoto''s thyroiditis. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO), BISOPROLOL FUMARATE (CONCOR), SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), LEVOTHYROXINE SODIUM (EUTHYROX), GLYCERYL TRINITRATE (NITRODERM), CITALOPRAM HYDROBROMIDE (CITALOPRAM MEPHA) and PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOZOL CONTROL) for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced HYPOTENSION (low blood pressure (80/60)) (seriousness criteria hospitalization and medically significant) and ASTHENIA (Asthenia) (seriousness criterion hospitalization). On 13-Mar-2021, the patient experienced SYNCOPE (syncope) (seriousness criteria hospitalization and medically significant) and SINUS TACHYCARDIA (sinus tachycardia) (seriousness criterion hospitalization). On 14-Mar-2021, the patient experienced CARDIOGENIC SHOCK (cardiogenic shock) (seriousness criteria death, hospitalization and medically significant), DYSPNOEA (dyspnoeic) (seriousness criterion hospitalization) and CONFUSIONAL STATE (confused) (seriousness criterion hospitalization). The patient was hospitalized on 12-Mar-2021 due to ASTHENIA, CARDIOGENIC SHOCK, CONFUSIONAL STATE, DYSPNOEA, HYPOTENSION, SINUS TACHYCARDIA and SYNCOPE. The patient died on 14-Mar-2021. The reported cause of death was Cardiogenic shock. An autopsy was not performed. At the time of death, HYPOTENSION (low blood pressure (80/60)), ASTHENIA (Asthenia), SYNCOPE (syncope), SINUS TACHYCARDIA (sinus tachycardia), DYSPNOEA (dyspnoeic) and CONFUSIONAL STATE (confused) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Blood pressure measurement: 80/60 mmhg 80/60 mmHg, hypovolemic shock. On 12-Mar-2021, Electrocardiogram: Inconclusive. On 13-Mar-2021, Electrocardiogram: abnormal revealed sinus tachycardia, ST elevation to limits, non-specific T-wave alterations and baseline instability on leads I,III,aVL,V1,V2. On 13-Mar-2021, Troponin increased: 1889 ng/L. On 14-Mar-2021, Troponin increased: 8175 ng/L. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered CARDIOGENIC SHOCK (cardiogenic shock) to be unlikely related. No further causality assessments were provided for HYPOTENSION (low blood pressure (80/60)), ASTHENIA (Asthenia), SYNCOPE (syncope), SINUS TACHYCARDIA (sinus tachycardia), DYSPNOEA (dyspnoeic) and CONFUSIONAL STATE (confused). On 13/03/2021, during her usual hemodialysis session, after approx. 1 h 30 min from the start of dialysis, presented with marked low blood pressure with an episode of syncope lasting approximately 10-15 minutes, fluctuate with unstable haemodynamic Treatment medication include "Noradrenaline and Dobutamine support" and also gradually reduce the catecholamine therapy in progress and to accompany this with palliative care. The patient died on 14/03/2021 at 12:48 with her family present. Reason for death: cardiogenic shock following acute STEMI-type coronary syndrome in a context of ischemic-hypertensive heart disease. Company comment:Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Cardiogenic shock


VAERS ID: 1193833 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   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: No adverse event (No reported medical history.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Apr-2021 and was forwarded to Moderna on 03-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (death) in an 88-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history.). On 03-Mar-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 05-Mar-2021 The patient died on 05-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (death) to be unlikely related. Reporter did not allow further contact; Sender''s Comments: This case refers to an 88 year-old elderly female patient who died 48 hours after receiving the mRNA-1273 vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1193836 (history)  
Form: Version 2.0  
Age: 101.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 722 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Immobilization prolonged; Weakness
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20210

Write-up: Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021. This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA and PYREXIA (Fever) in a 101-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 722) for COVID-19 vaccination. The patient''s past medical history included Immobilization prolonged, Cardiac failure and Weakness. On 05-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced DYSPNOEA (seriousness criterion death) and PYREXIA (Fever) (seriousness criterion death). The patient died on 08-Mar-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was provided. This is a case of death in a 101-year-old male subject with unknown medical history of cardiac failure and prolonged immobilization, who died 3 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow-up is possible. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 101-year-old male subject with unknown medical history of cardiac failure and prolonged immobilization, who died 3 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow-up is possible.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1193970 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   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: PLPFIZER INC2021370947

Write-up: Vomiting; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number PL-URPL-3-467-2021. An 83-year-old patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 25Mar2021 09:57 (Batch/Lot Number: ET3674; Expiration Date: 28Mar2021) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Mar2021 04:15, the patient experienced vomiting. The patient died on 26Mar2021. An autopsy was performed and results were not provided. Sender comment: Comirnaty- vaccine against COVID-19 (mRNA). Nausea is mentioned as an expected effect in the SmPC, therefore it cannot be excluded that vomiting was caused by the vaccination. The direct cause of death is unknown, an autopsy will be performed, URPL has requested additional information. There is a time relationship between vaccination and death. The reporting person qualified AEFI as severe. URPL assessed the AEFI as severe. Vomiting: Source of assessment NCA, Method of assessment WHO scale, Result of Assessment Possible. No follow-up attempts possible. No further information expected. Information on lot# already obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1193971 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-20
Onset:2021-03-03
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, COVID-19, Dizziness, Feeling hot, Myalgia, Respiratory failure
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (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), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   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: Spinal disorder (Degeneration of the spine)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20210

Write-up: Respiratory failure; Dizziness; Feeling hot; Weakness generalized; Muscle pain; COVID-19; This regulatory authority case was reported by a non-health professional and describes the occurrence of RESPIRATORY FAILURE (Respiratory failure) and COVID-19 (COVID-19) in a 74-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042721) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Spinal disorder (Degeneration of the spine). On 20-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizziness), FEELING HOT (Feeling hot), ASTHENIA (Weakness generalized) and MYALGIA (Muscle pain). On 05-Mar-2021, the patient experienced RESPIRATORY FAILURE (Respiratory failure) (seriousness criterion death) and COVID-19 (COVID-19) (seriousness criterion death). The patient died on 05-Mar-2021. The reported cause of death was Respiratory failure and covid-19, virus identified. It is unknown if an autopsy was performed. At the time of death, DIZZINESS (Dizziness), FEELING HOT (Feeling hot), ASTHENIA (Weakness generalized) and MYALGIA (Muscle pain) outcome was unknown. Concomitant product use was not provided. Treatment information was not provided. The reporter''s contact information was not provided. Reporter did not allow further contact; Reported Cause(s) of Death: Respiratory failure; COVID-19, virus identified


VAERS ID: 1193975 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385843

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193976 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385895

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193977 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385896

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193978 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385898

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193979 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385899

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193980 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385901

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193981 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385902

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193982 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385909

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193983 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385911

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193984 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385917

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193985 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385919

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193986 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385920

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193987 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385921

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193988 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385924

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193989 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385925

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. 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.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


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