National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

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 150 out of 172

Result pages: prev   51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172   next


VAERS ID: 1555440 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-03-23
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: sars-cov-2 PCR test; Test Result: Positive; Comments: B.1.1.7, N501Y.
CDC Split Type: ATPFIZER INC202101016143

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB with regulatory authority number AT-BASGAGES-2021-39214. An 86-year-old male patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: EJ6796) via an unspecified route of administration on 13Jan2021 as dose 1, single and received BNT162b2 (COMIRNATY, Solution for injection, Lot Number: EJ6134) via an unspecified route of administration on 03Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On 23Mar2021 the patient experienced vaccination failure, Sars-cov-2 infection (COVID-19). The patient underwent lab tests and procedures which included Sars-cov-2 test (B.1.1.7, N501Y) with result as positive. The patient died on an unspecified date. It was not reported if an autopsy was performed. As of 10Aug2021, QC investigation results for batch EJ6796 and EJ6134 received from PQC team. Investigation summary from PQC conclusion included that the investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6796. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6134. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555441 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-19
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Sars-cov-2 test; Test Result: Positive; Comments: PCR variant based B.1.1.7; N501Y positive.
CDC Split Type: ATPFIZER INC202101016147

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-39215. A 92-year-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EJ6134, Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location, with unknown dosage on 04Feb2021 as single dose and first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EJ6797, Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location, with unknown dosage on 14Jan2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was stated that, on 19Feb2021, the patient developed sars-cov-2 infection and the patient died on an unspecified date in 2021 due to this. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (PCR variant based B.1.1.7; N501Y positive). The outcome for the event sars-cov-2 infection was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sars-cov-2 infection


VAERS ID: 1555442 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-03-26
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result: positive.
CDC Split Type: ATPFIZER INC202101016159

Write-up: SARS-CoV-2 infection/variant sequenced B.1.1.7; N501Y positive; vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-39216. A 81-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number: EJ6797), via an unspecified route of administration on 04Feb2021 as dose 2, single dose and BNT162B2 (COMIRNATY, Solution for injection, Lot number: EJ6796), via an unspecified route of administration on 14Jan2021 as dose 1, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Mar2021, patient experienced SARS-CoV-2 infection, variant sequenced B.1.1.7; N501Y positive and vaccination failure. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Mar2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection.


VAERS ID: 1555443 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-03-23
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101016162

Write-up: SARS-CoV-2 infection; drug ineffective; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number AT-BASGAGES-2021-39217. A 96-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection), second dose via an unspecified route of administration on 09Feb2021 (Batch/Lot Number: EJ6136), as a single, first dose via an unspecified route of administration on 15Jan2021 (Batch/Lot Number: EJ6797), as a single for COVID-19 immunisation. No medical history and concomitant medications were reported. On 23Mar2021, the patient experienced Sars-Cov-2 infection. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555444 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-04-10
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210410; Test Name: SARS-CoV-2; Result Unstructured Data: Test Result: Positive.
CDC Split Type: ATPFIZER INC202101016154

Write-up: SARS-CoV-2 infection; drug ineffective; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-39218. A 83-year-old female patient received bnt162b2 (COMIRNATY; Solution for Injection, Batch/Lot Number: EK9788), via an unspecified route of administration on 10Feb2021, as DOSE 2, SINGLE, dose 1 intramuscular on 19Jan2021 (COMIRNATY; Solution for Injection, Batch/Lot Number: EJ6797) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and patient''s concomitant medications were not reported. The patient experienced Sars-COV-2 infection, Vaccination failure on 10Apr2021.The patient underwent lab tests and procedures which included covid-19: positive on 10Apr2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2.


VAERS ID: 1555445 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-03-28
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:positive
CDC Split Type: ATPFIZER INC202101016166

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is AT-BASGAGES-2021-39219. A 86-years-old male patient received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EJ6134 and Expiration date was not reported), via an unspecified route of administration on 09Feb2021 as dose 2, single and first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EL1491 and Expiration date was not reported), via an unspecified route of administration on 19Jan2021 as dose 1, single for covid-19 immunization. The patient''s medical history and concurrent conditions was reported as no. The patient''s concomitant medications were not reported. On 28Mar2021 the patient experienced vaccination failure, sars-cov-2 infection. The patient underwent lab tests and procedures which included sars-cov-2 test positive on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1555446 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-04-30
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: SARS-CoV-2 test PCR; Test Result: Positive ; Comments: Variant PCR based B.1.1.7; N501Y positive
CDC Split Type: ATPFIZER INC202101016193

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable Physician from Regulatory Authority. An 82-years-old female patient received first dose of BNT162B2 (COMIRNATY, Formulation: solution for injection, lot number: EL1491, expiry date: unknown) via unspecified route of administration on 21Jan2021 as dose 1, single and second dose of BNT162B2 (COMIRNATY, Formulation: solution for injection, lot number: EJ6134, expiry date: unknown) via unspecified route of administration on 11Feb2021 as dose 2, single for Covid-19 immunisation. No relevant medical history and no concomitant medications were reported. On 30Apr2021, patient experienced SARS-CoV-2 infection and vaccination failure. The patient underwent lab test which included SARS-CoV-2 PCR test, with positive results (Verbatim: Variant PCR based B.1.1.7; N501Y positive) on 30Apr2021. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555447 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-04-07
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210407; Test Name: SARS-COV-2; Result Unstructured Data: Test Result:N501Y positive
CDC Split Type: ATPFIZER INC202101016198

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number AT-BASGAGES-2021-39228. A 85-years-old male patient received bnt162b2 (COMIRNATY, Solution for Injection), dose 2 via an unspecified route of administration on 11Feb2021 (Lot Number: EJ6790) as dose 2, single and dose 1 via an unspecified route of administration on 21Jan2021 (Lot Number: EJ6134) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 07Apr2021, the patient was diagnosed with SARS-COV-2 infection i.e. SARS-COV-2 test showed N501Y positive and he was died due to same. On an unknown date vaccination failure was noted. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555448 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-05-05
   Days after vaccination:83
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: ATPFIZER INC202101016187

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable Physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-39229. A 95-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: EK9788, Expiration Date was not reported) via an unspecified route of administration on 11Feb2021 as dose 2, single and received first dose (Batch/Lot number: EL1491, Expiration Date was not reported) via an unspecified route of administration on 21Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, On 05May2021, it was reported that vaccination failure and patient experienced SARS-CoV-2 infection. DE: N501Y positive.The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed and reported cause of death was SARS-CoV-2 infection and vaccination failure. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1555449 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-03-10
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: SARS-CoV-2 infection; Result Unstructured Data: Test Result:SARS-CoV-2 infection
CDC Split Type: ATPFIZER INC202101016185

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-39230. A 94-year-old male patient received BNT162B2 (COMIRNATY, Formulation: solution for injection, Batch/Lot Number: EJ6134), via an unspecified route of administration on 26Jan2021 as dose 1, single and again received BNT162B2 (COMIRNATY, Formulation: solution for injection, Batch/Lot Number: EJ6790), via an unspecified route of administration on 16Feb2021 as dose 2, single for COVID-19 immunization. No medical history and concomitant medications were reported. On 10Mar2021, the patient experienced vaccination failure following a SARS-CoV-2 infection. The patient underwent lab tests which included SARS-CoV-2 test: Positive (SARS-CoV-2 infection) on an unspecified date in 2021. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1555450 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-04-26
   Days after vaccination:68
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR; Result Unstructured Data: Test Result:DE: variant PCR based B.1.1.7; N501Y positive; Comments: DE: variant PCR based B.1.1.7; N501Y positive
CDC Split Type: ATPFIZER INC202101016210

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-39231. A 69-year-old male patient received second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number- EJ6790) via an unspecified route of administration on 17Feb2021 as dose 2 single and received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number- EJ6134) via an unspecified route of administration on 27Jan2021 as dose 1 single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 26Apr2021 the patient experienced SARS-CoV-2 infection, vaccination failure. On an unspecified date, DE: variant PCR based B.1.1.7; N501Y positive. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555451 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-04-15
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101016212

Write-up: SARS-CoV-2 infection; Drug ineffective; This is a spontaneous report from a contactable physician from Austria downloaded from the regulatory authority, regulatory authority number AT-BASGAGES-2021-39236. A 74-year-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot Number: EP2163; Batch no: not reported) via an unspecified route of administration on 18Feb2021 as dose 2 and BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot Number: EJ6134; Batch no: not reported) via an unspecified route of administration on 28Jan2021 as dose 1 both as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 15Apr2021 the patient experienced SARS-COV-2 infection (Covid-19) with drug ineffective. The patient died on an unspecified date. The cause of death was SARS-COV-2 infection. It was not reported if an autopsy was performed. No sequencing of the virus variant was available. No follow-up attempts is possible. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555452 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-04-11
   Days after vaccination:51
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Test Result: Positive ; Comments: N501Y positive
CDC Split Type: ATPFIZER INC202101016220

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-39237. An 81-years-old male patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EP2163), via an unspecified route of administration on 19Feb2021 as dose 2, single and first dose via an unspecified route of administration on 29Jan2021 (Batch/Lot Number: EJ6136) as dose 1, Single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 11Apr2021 the patient experienced Vaccination failure, other, SARS-CoV-2 infection. The patient underwent lab tests and procedures which included COVID-19 test: positive on N501Y positive. The patient died on an unspecified date. It was not reported if an autopsy was performed. Cause of death was unknown. The outcome for event SARS-CoV-2 infection was fatal. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1555453 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-04-03
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210403; Test Name: Sars-cov-2 test; Test Result: Positive ; Comments: No sequencing of the virus variety available
CDC Split Type: ATPFIZER INC202101016223

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-39238. An 86-years-old male patient received second dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot number: ET1831), via an unspecified route of administration on 15Mar2021 as dose 2, single and first dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot number: EP2163), via an unspecified route of administration on 22Feb2021 as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. It was stated that, on 03Apr2021, the patient developed Vaccination failure, sars-cov-2 infection and the patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures on 03Apr2021 which included sars-cov-2 test: positive (No sequencing of the virus variety available). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555454 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-11
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101016227

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority AT-BASGAGES-2021-39239. A 71-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot number EJ6790) at single dose for COVID-19 immunisation on 24Feb2021, and the second dose of BNT162B2 (COMIRNATY, Lot number ET1831) at single dose for COVID-19 immunisation on 17Mar2021. No relevant medical history was reported. Relevant concomitant drug was not reported. On 11Apr2021 the patient experienced Vaccination failure, and SARS-CoV-2 infection. The patient died due to the event on unknown date. No sequencing of the virus variant was available. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1555455 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-07-10
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101016230

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-39262. A 77-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot number ET7205) at single dose for COVID-19 immunisation on 02Apr2021, and the second dose of BNT162B2 (COMIRNATY, Lot number EX0893) at single dose for COVID-19 immunisation on 23Apr2021. No relevant medical history was reported. Relevant concomitant drug was not reported. On 10Jul2021 the patient experienced Vaccination failure, and SARS-CoV-2 infection. The patient died due to the events on unknown date. No sequencing of the virus variant was available. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1555489 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9309 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Platelet count
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety (of work); Chronic gingivitis; Cigarette smoker (4-5 a day); Fibula fracture; Lymphadenopathy (left cervical x3, Axillary: 1 on each side, less than 1 cm, Inguinal: 1 on each side); Migraine without aura; Pollen allergy; Surgery (Surgical History included tibia and fibula fracture (ski).); Thrombocytosis (Thrombocytosis (936x103 / uL) of unknown origin, for 1 year); Tibia fracture
Allergies:
Diagnostic Lab Data: Test Name: Thrombocytosis; Result Unstructured Data: Test Result:936; Comments: 10*3/ul
CDC Split Type: ESPFIZER INC202101003487

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority WEB ES-AEMPS-962569. A 34-year-old male patient received first dose of BNT162B2 (COMIRNATY), via intramuscular route on 23Jul2021 (Batch/Lot Number: FD9309), as single dose for COVID-19 immunisation. Medical history included chronic gingivitis (2014), Episodes of anxiety (work), Migraine without aura under occasional treatment with naproxen (since February he has not picked up any containers at the pharmacy, which suggests that he has not suffered many episodes in recent months), Pollen allergy. Surgical History included tibia and fibula fracture (ski). Activity information included a lot of mountain and bicycle. Toxic habits included Tobacco 4 to 5 cigarettes a day. The patient was under study for Thrombocytosis (936x103 / uL) of unknown origin, for 1 year. At the last Hematology consultation (17Jun2021), a body CT scan and molecular study of thrombocythemia are requested. Lymphadenopathy: left cervical x3, Axillary: 1 on each side, less than 1 cm, Inguinal: 1 on each side, harder; but mobile and not painful. Concomitant medications were not reported. On 24Jul2021, the patient was found dead in his house. After notification to the emergency room, he is transferred to carry out a judicial autopsy. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1555601 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fatigue, Pneumonia, Pyrexia, Thrombosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: body temperature; Result Unstructured Data: Test Result:fever
CDC Split Type: GRPFIZER INC202101004131

Write-up: Thrombosis NOS; Fatigue; Pneumonia; Fever; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number GR-GREOF-20216286. An 83-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 30Apr2021 (Batch/Lot Number: Unknown) as DOSE 2, single for covid-19 immunization. The patient medical history was not reported. The patient received the first single dose of Comirnaty on 09Apr2021 intramuscular for covid-19 immunization. The patient''s concomitant medications were not reported. The patient presented fever, fatigue and pneumonia on the first days of May and he was admitted to hospital (9 days hospitalization). The patient experienced thrombosis nos on 28May2021. All the events were fatal, medical significant and causality hospitalization. The patient died on 28May2021. 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: Thrombosis NOS; fatigue; fever; pneumonia


VAERS ID: 1555628 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101016117

Write-up: Vaccination carried out in the afternoon. In the evening onset of convulsions and loss of consciousness. Called 118 and rushed to hospital.; Vaccination carried out in the afternoon. In the evening onset of convulsions and loss of consciousness. Called 118 and rushed to hospital.; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority:IT-MINISAL02-767116. An 86-year-old female patient received second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, lot number: unknown) via intramuscular route of administration on 01Jun2021 (at the age of 86 years old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 01Jun2021, the patient''s vaccination carried out in the afternoon, in the evening onset of convulsions and loss of consciousness, called 118 and rushed to hospital. The patient died on an unspecified date in 2021. The death was due to convulsions and loss of consciousness. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information was expected.; Reporter''s Comments: It should be noted that the patient, despite her age, did not have heart or hypertensive pathologies, nor had she ever suffered from convulsions, was independent and in general good health.; Reported Cause(s) of Death: Vaccination carried out in the afternoon. In the evening onset of convulsions and loss of consciousness. Called 118 and rushed to hospital.; Vaccination carried out in the afternoon. In the evening onset of convulsions and loss of consciousness. Call


VAERS ID: 1555662 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Body temperature, Cardio-respiratory arrest, Computerised tomogram, Shock
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), 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), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:35.4 Centigrade; Comments: Before vaccination; Test Date: 20210603; Test Name: CT; Result Unstructured Data: Test Result:thoracoabdominal aortic dissection
CDC Split Type: JPPFIZER INC202101002522

Write-up: Thoracoabdominal aortic dissection; Cardio-respiratory arrest; shock; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122525. A 79-year-old female patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021), via an unspecified route of administration on 01Jun2021 at 10:30 at single dose for COVID-19 immunization. Body temperature before vaccination was 35.4 degrees centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Medical history and concomitant medications were not reported. On 03Jun2021 (2 day after the vaccination), the patient experienced thoracoabdominal aortic dissection and cardio-respiratory arrest. On 03Jun2021 (2 days after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 03Jun2021, 08:30 (one day and 22 hours after vaccination), the patient suddenly had back pain. At 10:05 (one day, 23 hours, and 35 minutes after vaccination), the patient visited the emergency outpatient department of the reporting hospital. CT showed thoracoabdominal aortic dissection. Although the patient was tried to be transferred to another hospital, several minutes later, the patient had shock and cardiopulmonary arrest (CPA). Resuscitation was continued, and the patient was admitted to the reporting hospital. Eventually, on the same day, at 12:59 (2 days, 2 hours, and 29 minutes after vaccination), the patient was confirmed to die. On 03Jun2021 (2 days after the vaccination), the outcome of the events was fatal. The reporting physician classified the events as serious (death) and assessed that the events was unrelated to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Nothing particular.; Sender''s Comments: Based on close temporal association the role of the usage of the vaccine BNT162B2 in contributing/triggering the events thoracoabdominal aortic dissection, cardiopulmonary arrest and shock cannot be excluded. The case will be reassessed once additional information regarding patients medical history and concomitant medications are reported.; Reported Cause(s) of Death: Thoracoabdominal aortic dissection; Cardio-respiratory arrest


VAERS ID: 1555664 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Blood test, Body temperature, Cardio-respiratory arrest, Chest pain, Dyspnoea, Electrocardiogram abnormal, Glycosylated haemoglobin, Loss of consciousness, Respiratory disorder, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   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: MEDROL [METHYLPREDNISOLONE]; THYRADIN S
Current Illness: Hypothyroidism; Rheumatoid arthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes steroid-induced; Type 2 diabetes mellitus.
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: blood test; Result Unstructured Data: Test Result: no increased cardiac-related enzyme and; Comments: no increased cardiac-related enzyme and negative troponin T; Test Date: 20210729; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination; Test Date: 20210802; Test Name: ECG; Result Unstructured Data: Test Result: no obvious findings of ACS; Comments: no obvious findings of ACS but monitor showed ventricular fibrillation; Test Date: 2021; Test Name: HbA1c; Result Unstructured Data: Test Result:7.4 to 7.6 %.
CDC Split Type: JPPFIZER INC202101023480

Write-up: Respiratory discomfort; Chest pain; Dyspnoea; Ventricular fibrillation; cardio-respiratory arrest; arrhythmia; Loss of consciousness; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21123274. A 60-year and 5-month-old female patient received the second dose of BNT162b2 (COMIRNATY, solution for injection, Lot number FD1945, Expiration date 31Oct2021), via an unspecified route of administration on 29Jul2021 at 13:30 (the day of vaccination), as Dose 2, single for COVID-19 immunization. Body temperature before vaccination was 36.1 degrees centigrade, on 29Jul2021. Patient''s relevant medical history included rheumatoid arthritis, hypothyroidism, type 2 diabetes mellitus, and diabetes steroid- induced, all from an unspecified date to an unspecified date. The patient (historical vaccine) previously received the first dose of BNT162b2 (COMIRNATY, solution for injection, Lot: EW0203, Expiration date 30Sep2021), via an unspecified route of administration, on 08Jul2021, for COVID-19 immunisation. Concomitant medications included ongoing methylprednisolone (MEDROL) 2mg, from an unspecified date, via an unspecified route of administration for rheumatoid arthritis and ongoing levothyroxine sodium (Thyradin S) 75 mcg, from an unspecified date, via an unspecified route of administration, for hypothyroidism. On 02Aug2021 at 14:30 (4 days/1 hour after the vaccination), the patient experienced chest pain. The course of the event was as follows: The patient was prescribed methylprednisolone (MEDROL) 2 mg for rheumatoid arthritis at her nearby hospital, and levothyroxine sodium hydrate (THYRADIN-S) 75 mcg was supplemented for hypothyroidism at the reporting hospital. Thus, the thyroid function was shifted favourably at least. Since the patient had underlying diseases such as type 2 diabetes mellitus or diabetes steroid-induced, the HbA1c level was approximately 7.4 to 7.6 percent, on an unspecified date in 2021. On 29Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 02Aug2021, at 14:30 (4 days and 1 hour after vaccination), the patient visited the reporting hospital for chest pain, respiratory discomfort, and Dyspnoea. The blood examination showed no increased cardiac-related enzyme and negative troponin T. Although ECG showed no obvious findings of ACS, after the examinations, the patient had loss of consciousness, and a hurry call was made in the hospital. On the same date, the monitor showed ventricular fibrillation (VF), and a countershock and cardiopulmonary resuscitation were tried with administration of adrenaline (BOSMIN) and sodium bicarbonate (MEYLON); however, normal sinus rhythm was not achieved. At 16:00 (4 days, 2 hours, and 30 minutes after vaccination), the patient was emergently transferred to the emergency medical care centre of the university hospital. At the same hospital, on the same date, V-A ECMO (extracorporeal membrane oxygenation) was tried; however, VF did not resolve, and the patient had arrhythmia and cardio-respiratory arrest. On the same day, at 21:59 (4 days, 8 hours, and 29 minutes after vaccination), the patient died. On 02Aug2021 (4 days after the vaccination), the outcome of the events ''ventricular fibrillation, cardio-respiratory arrest, arrhythmia'' was fatal, while the outcome for the rest of the events were unknown. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was arrhythmia. The reporting physician commented as follows: The causality between the event and BNT162b2 vaccination was unknown. Based on the clinical course and the laboratory data, the cause of death could not be regarded as acute coronary syndrome or myocarditis. As of this date, the cause of death was considered as arrhythmia. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardio-respiratory arrest; arrhythmia; Ventricular fibrillation.


VAERS ID: 1555687 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood calcium, Blood chloride, Blood creatinine, Blood glucose, Blood osmolarity, Blood phosphorus, Blood potassium, Blood sodium, Blood urea, Body temperature, C-reactive protein, COVID-19, COVID-19 pneumonia, Cardiac failure congestive, Chest X-ray, Dyspnoea, Eosinophil count, Fibrin D dimer, Glomerular filtration rate, Granulocyte count, Haematocrit, Haemoglobin, Hypoxia, Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Monocyte count, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Oxygen saturation, Platelet count, Red blood cell count, Red blood cell nucleated morphology, Renal failure, SARS-CoV-2 test, Tachypnoea, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
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: ALLOPURINOL; AMLODIPINE; ASPIRIN BAYER; BURINEX; DIPYRIDAMOLE; GLICLAZIDE; PREDNISOLONE; SIMVASTATIN; GOSERELIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident; Chronic kidney disease; Congestive heart failure; Diabetes; Gout; Hypertension; Non-smoker (Not a current smoker. Unknown whether previous smoker.); Prostate carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: calcium; Result Unstructured Data: Test Result:2.12 mmol/L; Test Date: 20210712; Test Name: serum chloride; Result Unstructured Data: Test Result:108.3 mmol/L; Test Date: 20210713; Test Name: serum chloride; Result Unstructured Data: Test Result:109.8 mmol/L; Test Date: 20210723; Test Name: serum chloride; Result Unstructured Data: Test Result:114.7 mmol/L; Test Date: 20210712; Test Name: serum creatinine; Result Unstructured Data: Test Result:199 umol/l; Test Date: 20210713; Test Name: serum creatinine; Result Unstructured Data: Test Result:187 umol/l; Test Date: 20210715; Test Name: serum creatinine; Result Unstructured Data: Test Result:211 umol/l; Test Date: 20210716; Test Name: serum creatinine; Result Unstructured Data: Test Result:210 umol/l; Test Date: 20210718; Test Name: serum creatinine; Result Unstructured Data: Test Result:242 umol/l; Test Date: 20210719; Test Name: serum creatinine; Result Unstructured Data: Test Result:258 umol/l; Test Date: 20210721; Test Name: serum creatinine; Result Unstructured Data: Test Result:247 umol/l; Test Date: 20210723; Test Name: serum creatinine; Result Unstructured Data: Test Result:242 umol/l; Test Date: 20210712; Test Name: glucose (random); Result Unstructured Data: Test Result:11.33 mmol/L; Test Date: 20210712; Test Name: osmolality calculated; Result Unstructured Data: Test Result:313 mosm/kg; Test Date: 20210719; Test Name: phsophate; Result Unstructured Data: Test Result:1.69 mmol/L; Test Date: 20210719; Test Name: potassium; Result Unstructured Data: Test Result:3.22 mmol/L; Test Date: 20210721; Test Name: sodium; Result Unstructured Data: Test Result:147 mmol/L; Test Date: 20210723; Test Name: sodium; Result Unstructured Data: Test Result:150 mmol/L; Test Date: 20210712; Test Name: urea; Result Unstructured Data: Test Result:17.2 mmol/L; Test Date: 20210713; Test Name: urea; Result Unstructured Data: Test Result:16.8 mmol/L; Test Date: 20210715; Test Name: urea; Result Unstructured Data: Test Result:16 mmol/L; Test Date: 20210716; Test Name: urea; Result Unstructured Data: Test Result:16.1 mmol/L; Test Date: 20210718; Test Name: urea; Result Unstructured Data: Test Result:20.8 mmol/L; Test Date: 20210719; Test Name: urea; Result Unstructured Data: Test Result:22.2 mmol/L; Test Date: 20210721; Test Name: urea; Result Unstructured Data: Test Result:23.5 mmol/L; Test Date: 20210723; Test Name: urea; Result Unstructured Data: Test Result:26.1 mmol/L; Test Date: 20210712; Test Name: body temperature; Result Unstructured Data: Test Result:38.2; Test Date: 20210712; Test Name: chest X-Ray; Result Unstructured Data: Test Result:clear; Test Date: 20210719; Test Name: chest X-Ray; Result Unstructured Data: Test Result:Bilateral increased interstitial markings and righ; Comments: Bilateral increased interstitial markings and right sided pleural effusion in keeping with an element of pulmonary venous congestion. New confluent air space shadowing in left lower lung zone which in the clinical context is suggestive of a consolidation; Test Date: 20210715; Test Name: C-reactive protein; Result Unstructured Data: Test Result:64.1 mg/l; Test Date: 20210716; Test Name: C-reactive protein; Result Unstructured Data: Test Result:91.4 mg/l; Test Date: 20210718; Test Name: C-reactive protein; Result Unstructured Data: Test Result:91.2 mg/l; Test Date: 20210719; Test Name: C-reactive protein; Result Unstructured Data: Test Result:104.2 mg/l; Test Date: 20210721; Test Name: C-reactive protein; Result Unstructured Data: Test Result:180.3 mg/l; Test Date: 20210723; Test Name: C-reactive protein; Result Unstructured Data: Test Result:127 mg/l; Test Date: 20210712; Test Name: eosinophils; Result Unstructured Data: Test Result:0.03 x10 9/l; Test Date: 20210715; Test Name: eosinophils; Result Unstructured Data: Test Result:0.01 x10 9/l; Test Date: 20210718; Test Name: eosinophils; Result Unstructured Data: Test Result:0.00 x10 9/l; Test Date: 20210719; Test Name: eosinophils; Result Unstructured Data: Test Result:0.00 x10 9/l; Test Date: 20210721; Test Name: eosinophils; Result Unstructured Data: Test Result:0.00 x10 9/l; Test Date: 20210723; Test Name: eosinophils; Result Unstructured Data: Test Result:0.00 x10 9/l; Test Date: 20210713; Test Name: D-Dimer; Result Unstructured Data: Test Result:582 ng/ml; Test Name: eGFR; Result Unstructured Data: Test Result:32; Comments: eGFR fell from 32 on the 13/7 to 22 on 19/7 and 24 on 23/7; Test Name: eGFR; Result Unstructured Data: Test Result:22; Comments: eGFR fell from 32 on the 13/7 to 22 on 19/7 and 24 on 23/7; Test Name: eGFR; Result Unstructured Data: Test Result:24; Comments: eGFR fell from 32 on the 13/7 to 22 on 19/7 and 24 on 23/7; Test Date: 20210723; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.16 x10 9/l; Test Date: 20210712; Test Name: haematocrit; Test Result: 31.8 %; Test Date: 20210715; Test Name: haematocrit; Test Result: 35.2 %; Test Date: 20210718; Test Name: haematocrit; Test Result: 28.9 %; Test Date: 20210719; Test Name: haematocrit; Test Result: 29.6 %; Test Date: 20210721; Test Name: haematocrit; Test Result: 33.9 %; Test Date: 20210723; Test Name: haematocrit; Test Result: 32.4 %; Test Date: 20210712; Test Name: haemoglobin; Result Unstructured Data: Test Result:11 g/dl; Test Date: 20210715; Test Name: haemoglobin; Result Unstructured Data: Test Result:12.1 g/dl; Test Date: 20210718; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.4 g/dl; Test Date: 20210719; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.5 g/dl; Test Date: 20210721; Test Name: haemoglobin; Result Unstructured Data: Test Result:11.1 g/dl; Test Date: 20210723; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.9 g/dl; Test Date: 20210712; Test Name: lymphocytes Abs; Result Unstructured Data: Test Result:0.75 x10 9/l; Test Date: 20210715; Test Name: lymphocytes Abs; Result Unstructured Data: Test Result:1.04 x10 9/l; Test Date: 20210718; Test Name: lymphocytes Abs; Result Unstructured Data: Test Result:0.36 x10 9/l; Test Date: 20210719; Test Name: lymphocytes Abs; Result Unstructured Data: Test Result:0.39 x10 9/l; Test Date: 20210721; Test Name: lymphocytes Abs; Result Unstructured Data: Test Result:0.46 x10 9/l; Test Date: 20210723; Test Name: lymphocytes Abs; Result Unstructured Data: Test Result:0.27 x10 9/l; Test Date: 20210715; Test Name: mean cell Hb; Test Result: 32.2 pg; Test Date: 20210718; Test Name: mean cell Hb; Test Result: 32.5 pg; Test Date: 20210719; Test Name: mean cell Hb; Test Result: 32.3 pg; Test Date: 20210721; Test Name: mean cell Hb conc; Result Unstructured Data: Test Result:32.7 g/dl; Test Date: 20210715; Test Name: mean cell volume; Result Unstructured Data: Test Result:93.6; Test Date: 20210721; Test Name: mean cell volume; Result Unstructured Data: Test Result:94.7; Test Date: 20210723; Test Name: mean cell volume; Result Unstructured Data: Test Result:93.1; Test Date: 20210715; Test Name: monocytes Abs; Result Unstructured Data: Test Result:0.36 x10 9/l; Test Date: 20210718; Test Name: monocytes Abs; Result Unstructured Data: Test Result:0.17 x10 9/l; Test Date: 20210719; Test Name: monocytes Abs; Result Unstructured Data: Test Result:0.21 x10 9/l; Test Date: 20210721; Test Name: monocytes Abs; Result Unstructured Data: Test Result:0.18 x10 9/l; Test Date: 20210723; Test Name: monocytes Abs; Result Unstructured Data: Test Result:0.35 x10 9/l; Test Date: 20210723; Test Name: neutrophils Abs; Result Unstructured Data: Test Result:10.02 x10 9/l; Test Date: 20210712; Test Name: NT-proBNP; Result Unstructured Data: Test Result:1127 pg/mL; Test Date: 20210721; Test Name: NT-proBNP; Result Unstructured Data: Test Result:1649 pg/mL; Test Date: 20210712; Test Name: SpO2; Test Result: 97 %; Test Date: 20210723; Test Name: platelets; Result Unstructured Data: Test Result:348 x10 9/l; Test Date: 20210712; Test Name: red cell count; Result Unstructured Data: Test Result:3.48 x10 12/l; Test Date: 20210715; Test Name: red cell count; Result Unstructured Data: Test Result:3.76 x10 12/l; Test Date: 20210718; Test Name: red cell count; Result Unstructured Data: Test Result:3.20 x10 12/l; Test Date: 20210719; Test Name: red cell count; Result Unstructured Data: Test Result:3.25 x10 12/l; Test Date: 20210721; Test Name: red cell count; Result Unstructured Data: Test Result:3.58 x10 12/l; Test Date: 20210723; Test Name: red cell count; Result Unstructured Data: Test Result:3.48 x10 12/l; Test Date: 20210721; Test Name: nucleated red blood cells; Result Unstructured Data: Test Result:0.02 x10 9/l; Test Date: 20210723; Test Name: nucleated red blood cells; Result Unstructured Data: Test Result:0.05 x10 9/l; Test Name: Sars-cov-2 RT-PCR test; Result Unstructured Data: Test Result:positive; Test Date: 20210712; Test Name: Sars-cov-2 RT-PCR test; Result Unstructured Data: Test Result:positive; Comments: CT 15; Test Date: 20210726; Test Name: Sars-cov-2 RT-PCR test; Result Unstructured Data: Test Result:positive; Comments: CT 27
CDC Split Type: MTPFIZER INC202101005064

Write-up: positive for Covid-19 on RT-PCR test; positive for Covid-19 on RT-PCR test; covid-19 pneumonia; Congestive heart failure worsened; dyspnea; tachypnea; hypoxemia; Renal failure; This is a spontaneous report from a contactable physician. An 86-years-old male patient received BNT162B2 (COMIRNATY; Solution for injection; Lot Number: EJ6788; Expiration date was not reported), second dose via intramuscular route, administered in Arm Left on 05Feb2021 as DOSE 2, single, first dose via intramuscular route on 15Jan2021 (Batch/Lot Number: EJ6796) as DOSE 1, single for covid-19 immunisation. Medical history included hypertension from an unknown date, diabetes mellitus, congestive heart failure, chronic kidney disease (eGFR fell from 32 on the 13/7 to 22 on 19/7 and 24 on 23/7), prostate carcinoma, gout, cerebrovascular accident, non-smoker (Not a current smoker. Unknown whether previous smoker) from an unknown date and unknown if ongoing. Concomitant medications included allopurinol (ALLOPURINOL); amlodipine (AMLODIPINE); acetylsalicylic acid (ASPIRIN BAYER); bumetanide (BURINEX); dipyridamole (DIPYRIDAMOLE); gliclazide (GLICLAZIDE); prednisolone (PREDNISOLONE); simvastatin (SIMVASTATIN); goserelin (GOSERELIN) implant taken for an unspecified indication, start and stop date were not reported. The patient experienced positive for covid-19 on RT-PCR test, covid-19 pneumonia, congestive heart failure worsened, dyspnea, tachypnea, hypoxenmia, renal failure on an unspecified date. The patient was hospitalized from 12Jul2021 to an unknown date due to the events. Therapeutic measures were taken as a result of the events. On admission, fever 38.2 and SpO2 97% on RA. However, oxygen supplementation requirements increased throughout inpatient stay with SpO2 90% on RA on a background of congestive heart failure. The patient received additional therapies for COVID-19 that included 6mg dexamethasone daily on 21Jul2021 and Co-amoxiclav on 24Jul2021. Progression of tachypnoea and desaturation led to initiation of dexamethasone. On admission patient was maintaining SpO2 97% RA. The patient underwent lab tests and procedures which included: Sars-cov-2 test: positive on unspecified date. EGFR was 32, 22, 24 on unspecified dates (eGFR fell from 32 on the 13/7 to 22 on 19/7 and 24 on 23/7). On 12Jul2021 body temperature: 38.2, chest x-ray: clear, oxygen saturation: 97 %, sars-cov-2 test: positive CT 15, lymphocytes Abs: 0.75 x10^9/L, eosinophils abs 0.03 x10^9/L, red cell count: 3.48 x10^12/L, haemoglobin 11 g/dl, haematocrit 31.8%, urea (serum) 17.2 mmol/l, creatinine (serum) 199 umol/l, chloride (serum) 108.3 mmol/l, glucose (random) 11.33 mmol/l, NT-proBNP 1127 pg/ml, osmolality calculated 313 mosm/kg. On 13Jul2021, D-Dimer 582 ng/ml, urea (serum) 16.8 mmol/l, creatinine (serum) 187 umol/l, chloride (serum) 109.8 mmol/l. On 15Jul2021 lymphocytes Abs: 1.04 x10^9/L, eosinophils abs 0.01 x10^9/L, monocytes abs 0.36 x10^9/L, red cell count: 3.76 x10^12/L, haemoglobin 12.1 g/dl, haematocrit 35.2%, mean cell volume 93.6 fL, mean cell Hb 32.2 pg, urea (serum) 16 mmol/l, creatinine (serum) 211 umol/l, C-reactive protein 64.1 mg/L. On 16Jul2021 urea (serum) 16.1 mmol/l, creatinine (serum) 210 umol/l, C-reactive protein 91.4 mg/L. On 18Jul2021 lymphocytes Abs: 0.36 x10^9/L, Eosinophils Abs 0.00 x10^9/L, Monocytes Abs 0.17 x10^9/L, red cell count: 3.20 x10^12/L, haemoglobin 10.4 g/dl, haematocrit 28.9%, Mean cell Hb 32.5 pg, urea (serum) 20.8 mmol/l, creatinine (serum) 242 umol/l, C-reactive protein 91.2 mg/L. On 19Jul2021, chest x-ray: bilateral increased interstitial markings and right sided pleural effusion in keeping with an element of pulmonary venous congestion. New confluent air space shadowing in left lower lung zone which in the clinical context is suggestive of a consolidation; lymphocytes abs: 0.39 x10^9/L, eosinophils abs 0.00 x10^9/L, monocytes abs 0.21 x10^9/L, red cell count: 3.25 x10^12/L, haemoglobin 10.5 g/dl, haematocrit 29.6 %, mean cell Hb 32.3 pg, urea (serum) 22.2 mmol/l, creatinine (serum) 258 umol/l, C-reactive protein 104.2 mg/L, potassium 3.22 mmol/l, calcium 2.12 mmol/l, phosphate 1.69 mmol/l. On 21Jul2021 lymphocytes abs: 0.46 x10^9/L, eosinophils abs 0.00 x10^9/L, monocytes abs 0.18 x10^9/L, red cell count: 3.58 x10^12/L, haemoglobin 11.1 g/dl, haematocrit 33.9 %, mean cell volume 94.7 fL, mean cell Hb conc 32.7 g/dl, nucleated red blood cells 0.02 x10^9/L, urea (serum) 23.5 mmol/l, creatinine (serum) 247 umol/l, sodium 147 mmol/l, C-reactive protein 180.3 mg/L, NT-proBNP 1649 pg/ml. On 23Jul2021 lymphocytes abs: 0.27 x10^9/L, eosinophils abs 0.00 x10^9/L, monocytes abs 0.35 x10^9/L, red cell count: 3.48 x10^12/L, haemoglobin 10.9 g/dl, haematocrit 32.4 %, mean cell volume 93.1 fL, nucleated red blood cells 0.05 x10^9/L, platelets 348 x10^9/L, immature granulocytes 0.16 x10^9/L, neutrophils abs 10.02 x10^9/L, urea (serum) 26.1 mmol/l, creatinine (serum) 242 umol/l, sodium 150 mmol/l, chloride 114.7 mmol/l, C-reactive protein 127 mg/L. Sars-cov-2 test: positive, CT 27 on 26Jul2021. The patient died on 27Jul2021. Clinical outcome of the events positive for covid-19 on RT-PCR test, covid-19 pneumonia, congestive heart failure was fatal, and the outcome of other events was unknown. An autopsy was not performed. Follow-up activities completed. No further information expected.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure, Covid 19, Covid 19 pneumonia, dyspnoea, hypoxia, tachypnoea and the suspect drug BNT162B2.Also the temporal association between event cardiac failure and renal failure and drug BNT162B2 cannot be excluded though also to consider contributory factor patients medical history of congestive cardiac failure and chronic kidney disease. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: covid-19 pneumonia; Congestive Heart Failure; positive for Covid-19 on RT-PCR test


VAERS ID: 1555696 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA3082 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CRESTOR; LISINOPRIL; ACETYLSALICYLIC ACID; HYDROCHLOROTHIAZIDE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101004135

Write-up: According to the municipal coroner patient died approximately on 25May2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number NL-LRB-00646841. A 77-year-old female patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 19May2021 (Lot Number: FA3082) as single dose for COVID-19 immunization. Medical history was not reported. Previous COVID-19 infection was none. Concomitant medication included rosuvastatin calcium (CRESTOR), lisinopril, acetylsalicylic acid hydrochlorothiazide. The patient received the first dose of BNT162B2 via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunization and no side effect reported. Patient''s body was found on 31May2021, 12 days after vaccination. According to the municipal coroner patient died approximately on 25May2021, 6 days after vaccination. Unfortunately, no autopsy performed. Other diagnostic procedure was none. No obduction was done, so cause of death remains unknown. The outcome of event was fatal. No follow-up attempts possible. No further information expected.; Reporter''s Comments: -BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 4/14/2021 - May 31, body find Additional information ADR: wrsch death around May 25 according to municipal coroner, unfortunately no autopsy performed - COVID-19 Previous COVID-19 infection: No - Other diagnostic procedures: no; Reported Cause(s) of Death: unknown


VAERS ID: 1555697 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 17
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: Arrhythmia (Family history: false); Heart failure (Family history: false).
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101016233

Write-up: Epileptic insults; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00654539. An 81-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number- unknown) via an unspecified route of administration on 05Mar2021 as dose 2, 0.3ml single for COVID-19 immunization. Medical history included heart failure, arrhythmia. Patient had no previous COVID-19 infection. Concomitant medications were not reported. Historical vaccine included BNT162b2 (COMIRNATY, Solution for injection, Lot number- unknown) via an unspecified route of administration on 18Feb2021 as dose 1, 0.3ml single for COVID-19 immunization and no adverse reaction with first dose. On 19Mar2021, patient experienced epileptic insults, then slightly recovered. It was reported that Monday 22Mar2021 a serious 45 minute seizure, which became fatal to her 23Mar2021. It was unknown autopsy was done. Reporter comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Adverse Drug reactions: No Date: 18Feb2021 Epileptic insults Additional information Adverse Drug Reaction: First 19Mar 3, then slightly recovered, Monday 22Mar a serious 45 minute seizure, which became fatal to her 23 Mar. She had heart failure and arrhythmia, but was not known to have epilepsy. Previous COVID-19 infection: No No follow-up attempts possible. No further information expected. Batch/LOT number cannot be obtained.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Adverse Drug reactions: No Date: 18Feb2021 Epileptic insults Additional information Adverse Drug Reaction: First 19Mar 3, then slightly recovered, Monday 22Mar a serious 45 minute seizure, which became fatal to her 23 Mar. She had heart failure and arrhythmia, but was not known to have epilepsy. Previous COVID-19 infection: No; Reported Cause(s) of Death: Epileptic insults


VAERS ID: 1555698 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101011663

Write-up: Brain hemorrhage leading to death; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB NL-LRB-00646770. This consumer reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced brain hemorrhage leading to death on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101004145 same reporter/drug/event, different patient; Reported Cause(s) of Death: Brain hemorrhage leading to death


VAERS ID: 1555724 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain (admitted at a hospital last 12Jul2021); Dyspnea (admitted at a hospital last 12Jul2021)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101007719

Write-up: difficulty of breathing; chest pain; fever; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300094461. A 77-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 16Jul2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included the patient was admitted at a hospital last 12Jul2021 due to on and off dyspnea and chest pain. The patient''s concomitant medications were not reported. On 17Jul2021 the patient had fever; On 26Jul2021, she experienced again dyspnea and chest pain and brought to a hospital. The patient died on 26Jul2021. 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: difficulty of breathing; chest pain


VAERS ID: 1555725 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Haematemesis, Malaise, Pyrexia
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101007721

Write-up: Cough; Hematemesis; Fever; body malaise; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300095356. A 66-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 20Jul2021 (Batch/Lot Number: FD5996) as dose number unknown, single for covid-19 immunisation at the age of 66-year-old. The patient medical history and concomitant medications were not reported. The patient experienced fever on 20Jul2021, body malaise on 20Jul2021, cough on 24Jul2021, hematemesis on 24Jul2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of all events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fever; body malaise; Hematemesis; Cough


VAERS ID: 1555737 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-29
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Drug ineffective, Pneumonia bacterial, Polymerase chain reaction, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Guillain-Barre syndrome (broad), Infective pneumonia (narrow), 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: PANTOPRAZOLE; BACLOFENE; QUETIAPINE; LORAZEPAM; AMLODIPINE; METFORMINE HCL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Debility marked
Allergies:
Diagnostic Lab Data: Test Name: PCR test; Test Result: Positive ; Test Name: SARS-CoV-2; Test Result: Negative ; Test Name: SARS-CoV-2; Test Result: Negative
CDC Split Type: PTPFIZER INC202101016217

Write-up: Reported apparently bacterial pneumonia; Marked weakness; Vaccination failure; SARS-CoV-2 infection; This is a Spontaneous report from a contactable Physician downloaded from the Regulatory authority report number PT-INFARMED-R202107-5351 with Safety Report Unique Identifier PT-INFARMED-R202107-5351. A 77-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via intramuscular route of administration on 27May2021 as DOSE 2, 30 mcg/0.3 ML SINGLE and received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via intramuscular route of administration on an unspecified date as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history was reported as marked debility background. Concomitant medications included pantoprazole; baclofene; quetiapine; lorazepam; amlodipine; metformin hydrochloride. The patient was admitted to hospital for pneumonia, apparently bacterial, marked weakness on an unspecified date. On 29Jul2021, the patient experienced vaccination failure and sars-cov-2 infection. The adverse reaction (ADR) occurred 2 months after the administration of the dose 2 of the suspected drug. The patient underwent lab tests and procedures which included sars-cov-2 test: negative, sars-cov-2 test: negative (two subsequent negative tests, carried out on an unspecified date after contact with a person infected with SARS-CoV-2), PCR test: positive on an unspecified date (on hospital admission). The patient died on an unspecified date. Reported apparently bacterial pneumonia as the cause of death. It was not reported if an autopsy was performed. The reporters assessment of the causal relationship of the event with the suspect product was: relatedness of drug to reaction(s)/event(s): Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: possible. Health authority comment: Concomitant Drug: Pantoprazole, quetiapine, lorazepam, amlodipine, baclofene, metformine. Has a medication error occurred: No. Further information: Admitted to hospital due to pneumonia, apparently bacterial. Marked weakness. Full COVID vaccination scheme. Two subsequent negative tests, performed after contact with a person infected with SARS-CoV-2. Positive PCR test on hospital admission. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: bacterial pneumonia


VAERS ID: 1557886 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-03-02
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: variant sequenced B.1.1.7, N501Y positive; Test Result: Positive.
CDC Split Type: ATPFIZER INC202101016135

Write-up: death; Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [AT-BASGAGES-2021-39208]. A 93-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EJ6796; Expiration Date: 30Apr2021) via an unspecified route of administration on 12Jan2021 as dose 1, single and BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EJ6797; Expiration Date: 30Apr2021) via an unspecified route of administration on 02Feb2021 as dose 2, single both for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure, sars-cov-2 infection on 02Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Investigation report received from product complaint team for Lot: EJ6796, Batch-Expiry Date: 30Apr2021 included conclusion as, the investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6796. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed. and for Lot: EJ6797, Batch-Expiry Date: 30Apr2021 included conclusion as, the investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6797. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed on the reference samples. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1557887 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-03-24
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: SARS-CoV-2 test PCR; Result Unstructured Data: Test Result:N501Y positive
CDC Split Type: ATPFIZER INC202101016167

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number AT-BASGAGES-2021-39221.Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: An 84-years-old female patient received first dose of BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number: EL1491) via intramuscular route of administration on 19Jan2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient received second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number: EJ6134) via an unspecified route of administration on 09Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 24Mar2021, the patient experienced vaccination failure and SARS-CoV-2 infection. The patient underwent lab tests and procedures which included SARS-CoV-2 test with results N501Y positive on an unspecified date in 2021. The patient died on an unspecified date in 2021 due to vaccination failure and SARS-CoV-2 infection. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information was expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1557888 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-04-13
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101016216

Write-up: Drug ineffective; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [AT-BASGAGES-2021-39232]. A 82-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EP2163), via an unspecified route of administration on 18Feb2021 as a dose 2, single and the patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EJ6134), via an unspecified route of administration on 28Jan2021 as a dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 13Apr2021, the patient experienced vaccination failure, other, fatal SARS-CoV-2 infection and resulted in death. No sequencing of the virus variant available. The cause of death was reported as SARS-CoV-2 infection. It was unknown that, autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1557903 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC 8736 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Fatigue, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LITALIR; LOSARTANUM; TORASEMIDUM
Current Illness: Age-related macular degeneration; Auricular fibrillation (diagnosis date unknown, slow auricular fibrillation); Essential thrombocytosis (treated with Litalir); Hypertension (diagnosis date unknown, treated with Losartan and Torasemide); Renal failure (diagnosis date unknown; renal failure with usual Clearance of 30 ml/min); Rotator cuff injury (right shoulder rotator cuff tear right shoulder rotator cuff tear)
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia microcytic (exact diagnosis date unknown); COVID-19; Fall (Exact diagnosis date unknown. Left omalgia after accidental fall.); Macrocytic anemia; Omalgia (Exact diagnosis date unknown. Left omalgia after accidental fall.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101004672

Write-up: found deceased at 4:15 p.m. in front of her TV; not feeling well; very fatigued; This is a spontaneous report received from a contactable pharmacist via Regulatory Authority. Regulatory authority report number CH-SM-2021-17518. A 96-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 31May2021 (Lot Number: FC 8736) (at age of 96-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from Feb2021, not ongoing; essential thrombocythaemia from Jan2017 and ongoing, treated with Litalir; microcytic anaemia from Feb2021, macrocytic deficiency anemia; ongoing hypertension diagnosis date unknown, treated with Losartan and Torasemide; left omalgia after accidental fall in Dec2020, not ongoing; ongoing slow auricular fibrillation diagnosis date unknown; ongoing renal failure with usual Clearance of 30 ml/min diagnosis date unknown; ongoing age-related macular degeneration; right shoulder rotator cuff tear right shoulder rotator cuff tear from 30Sep2013 and ongoing. Concomitant medications included hydroxycarbamide (LITALIR) taken for an unspecified indication from 2017 to an unspecified stop date; losartan (LOSARTANUM) taken for an unspecified indication from 2017 to an unspecified stop date; torasemide (TORASEMIDUM) taken for an unspecified indication from 2017 to an unspecified stop date. On 01Jun2021, patient was not feeling well and very fatigued, the constants were correct and at tea time at 15.30 she did not have any particular problems. At 16.15 she was found dead in front of the television. Autopsy not performed at the behest of her family. We have considered the therapy the one indicated by attending physician doctor (not the one at the discharge from the hospital). The patient died on 01Jun2021. An autopsy was not performed. The outcome of event "At 16.15 she was found dead in front of the television" was fatal, events "not feeling well" and "fatigued" was unknown. A causal relationship between Comirnaty and Death was assessed as unlikely. Medic assessed this case as serious with seriousness criterion Results in death. Reporter comment: Death of 94-year-old patient, the day after vaccination with Comirnaty. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Death of 94-year-old patient, the day after vaccination with Comirnaty.; Sender''s Comments: The reported event of death with unknown cause is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Found dead in front of the TV


VAERS ID: 1557909 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-07
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cardiac failure, Cardiac failure chronic, Circulatory collapse, Dyspnoea
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: L-THYROXIN [LEVOTHYROXINE SODIUM]; RAMIPRIL; TORASEMID; VISMED; ASS; NOVAMINSULFON; AMLODIPINE; AMLODIPINE; METOPROLOL; GABAPENTIN
Current Illness: Lymphoedema (Chronic lymphoedema with ulcer); ulcus cruris (Chronic lymphoedema with ulcer)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Hashimoto''s thyroiditis; Knee prosthesis user; Obesity; Recurrent infection (Known recurrent infections); Sleep apnea syndrome; Type II diabetes mellitus.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101003427

Write-up: Decompensation cardiac; Heart failure NYHA class IV; Dyspnoea; Circulatory collapse; Atrial fibrillation; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB. The number is DE-DCGMA-21191310. Safety report unique identifier DE-PEI-202100133892. An 89 years old female patient received 2nd dose of BNT162B2 (COMIRNATY) intramuscular on 17Mar2021 single dose for COVID-19 immunisation. The patient''s medical history and concurrent conditions included: Arterial hypertension, Obesity, Knee prosthesis user, ongoing Lymphoedema, ongoing Ulcus cruris, Hashimoto''s thyroiditis, Type II diabetes mellitus, Sleep apnea syndrome, Recurrent infection. Concomitant medications included acetylsalicylic acid (ASS), torasemide (TORASEMID), metoprolol, amlodipine, amlodipine, ramipril, levothyroxine sodium (L-THYROXIN), novaminsulfon, gabapentin, hyaluronate sodium (VISMED). On 07Apr2021, the patient experienced Atrial fibrillation, Decompensation cardiac, Heart failure NYHA class IV, Circulatory collapse, Dyspnoea. The event outcome was fatal. The patient died on 13Apr2021. No autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Atrial fibrillation; Decompensation cardiac; Heart failure NYHA class IV; Circulatory collapse; Dyspnoea.


VAERS ID: 1557936 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-04-17
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal neoplasm, Activated partial thromboplastin time, Activated partial thromboplastin time ratio, Alanine aminotransferase, Anion gap, Aspartate aminotransferase, Atrial thrombosis, Base excess, Basophil count, Bicytopenia, Bilirubin conjugated, Blood bicarbonate, Blood bilirubin, Blood chloride, Blood creatinine, Blood culture, Blood fibrinogen, Blood glucose, Blood lactate dehydrogenase, Blood lactic acid, Blood potassium, Blood pressure diastolic, Blood pressure systolic, Blood sodium, Blood urea, Body temperature, C-reactive protein, Chest X-ray, Computerised tomogram abdomen, Computerised tomogram head, Confusional state, Echocardiogram, Eosinophil count, Erythroblast count, Glomerular filtration rate, Glucose urine, Haematocrit, Haemoglobin, Heart rate, Immature granulocyte count, International normalised ratio, Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Monocyte count, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Neutrophil/lymphocyte ratio, Nitrite urine, Oxygen saturation, PCO2, PO2, Platelet count, Platelet distribution width, Polyuria, Positron emission tomogram, Procalcitonin, Protein total, Prothrombin level, Red blood cell count, Red cell distribution width, Respiratory failure, SARS-CoV-2 test, Subclavian vein thrombosis, Urine analysis, Urine ketone body, Urobilinogen urine, White blood cell count, pH body fluid, pH urine
SMQs:, Anaphylactic reaction (broad), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (broad), Myelodysplastic syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Non-haematological tumours of unspecified malignancy (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 4
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: DABIGATRAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Benign prostatic hyperplasia; Cataracts; Gonarthrosis; Ischemic heart disease; Knee prosthesis insertion; Metastatic neoplasm; Pacemaker insertion (cardiac); Spondyloarthrosis; Thyroid nodule
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: Thromboplastin Time; Test Result: 38 s; Test Date: 20210415; Test Name: Thromboplastin Time Ratio; Result Unstructured Data: Test Result:1.46; Test Date: 20210415; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:30 IU/l; Test Date: 20210415; Test Name: Anion gap; Result Unstructured Data: Test Result:9.4 mEq/l; Test Date: 20210415; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:29 IU/l; Test Date: 20210415; Test Name: Base excess; Result Unstructured Data: Test Result:-2.5 mmol/L; Comments: (-3 - 3); Test Date: 20210415; Test Name: Basophils; Result Unstructured Data: Test Result:0.01; Comments: 10*3/ul; Test Date: 20210415; Test Name: Basophils; Test Result: 0.1 %; Test Name: Bicytopenia; Result Unstructured Data: Test Result:observed (normocytic-normochromic anemia...; Comments: ...thrombopenia); Test Date: 20210415; Test Name: Direct bilirubin; Test Result: 1.24 mg/dl; Test Date: 20210415; Test Name: CO3H; Result Unstructured Data: Test Result:22.6 mmol/L; Test Date: 20210415; Test Name: Bilirubin; Test Result: Negative ; Comments: (<1); Test Date: 20210415; Test Name: Bilirubin; Test Result: 2.12 mg/dl; Test Date: 20210415; Test Name: Chlorine; Result Unstructured Data: Test Result:108 mEq/l; Test Date: 20210415; Test Name: Creatinine; Test Result: 1.26 mg/dl; Test Name: blood cultures; Test Result: Negative ; Test Date: 20210415; Test Name: Derived fibrinogen; Test Result: 291 mg/dl; Test Date: 20210415; Test Name: Glucose; Test Result: 106 mg/dl; Test Date: 20210415; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:318 IU/l; Test Date: 20210415; Test Name: Lactate; Result Unstructured Data: Test Result:4.3 mmol/L; Test Date: 20210415; Test Name: Potassium; Result Unstructured Data: Test Result:4.73 mEq/l; Test Date: 20210417; Test Name: Diastolic pressure; Result Unstructured Data: Test Result:72; Test Date: 20210417; Test Name: Systolic pressure; Result Unstructured Data: Test Result:117 mmHg; Test Date: 20210415; Test Name: sodium; Result Unstructured Data: Test Result:140 mEq/l; Test Date: 20210415; Test Name: Urea; Test Result: 134 mg/dl; Test Date: 20210417; Test Name: Temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Test Date: 20210409; Test Name: chest X-ray; Result Unstructured Data: Test Result:with a well-positioned probe and without...; Comments: ...complications; Test Date: 20210415; Test Name: chest X-ray; Result Unstructured Data: Test Result:Study in the supine position did not ...; Comments: ...identify new-onset infiltrates or pleural effusion. 15 mm right hilar pulmonary nodule Unicameral pacemaker with end VI Calcific aortic atheromatosis.; Test Date: 20210415; Test Name: Abdominal CT; Result Unstructured Data: Test Result:Space-occupying hepatic lesion in caudate lobe...; Comments: ...-Floating thrombus in the right atrium -Lung nodule in LID. Findings: Liver of normal size and morphology, a space occupying lesion located in the caudate lobe with centronecrotic and peripheral vascularization is identified. Lymphadenopathy in the hepatic hilum, periduinal. and perihepatic and tail nodular images of the pancreas probably related to implants. 10x14mm LID pulmonary nodule. Floating thrombus of 47x38mm pericateter in the right atrium. Cysts bilateral cortical kidney stones. Diverticulosis in the descending colon and sigmoid without signs of acute diverticulitis Hiatal hernia No free fluid, collections, or pneumoperitoneum are identified. Bilateral pleural effusion and passive atelectasis in both lower lobes.; Test Date: 20210415; Test Name: CT brain; Result Unstructured Data: Test Result:- Signs of small vessel arteriopathy...; Comments: ...Findings: No evidence of acute intra- or extra-axial bleeding. No space-occupying lesions that condition displacement of intracranial structures are observed. Centered midline. Signs of small vessel artery disease. Dilated ventricular system related to degree of cortical atrophy. Posterior fossa and cisternae of the base without alterations.; Test Date: 20210415; Test Name: C Reactive Protein; Result Unstructured Data: Test Result:22.3 mg/l; Test Name: Bedside echocardiogram.; Result Unstructured Data: Test Result:LV not dilated, slightly hypertrophic...; Comments: ...normofunctioning. Lead in right cavities with image at the proximal level (RA) of 4x5cm spheroidal morphology compatible with thrombus. Thrombus-free IVC as well as distal RV lead regions; Test Name: echocardiogram; Result Unstructured Data: Test Result:moderate dilatation of the left atrium...; Comments: ...and undilated left ventricle with good global and segmental systolic function, Aortic sclerosis, Insufficiencies light mitral and tricuspid; Test Date: 20210415; Test Name: Eosinophils; Result Unstructured Data: Test Result:0; Comments: 10*3/ul; Test Date: 20210415; Test Name: Eosinophils; Test Result: 0 %; Test Date: 20210415; Test Name: Erythroblasts; Result Unstructured Data: Test Result:0.05; Comments: 10*3/ul; Test Date: 20210415; Test Name: Erythroblasts; Test Result: 0.5 %; Test Date: 20210415; Test Name: Glomerular filtration estimate; Result Unstructured Data: Test Result:50.60 ml/min; Comments: Multiply by 1,159 if black race.; Test Date: 20210415; Test Name: Glucose; Test Result: Negative ; Comments: (15); Test Date: 20210415; Test Name: Hematocrit; Test Result: 33.9 %; Test Date: 20210415; Test Name: Hemoglobin; Result Unstructured Data: Test Result:10.9 g/dl; Test Date: 20210417; Test Name: Heart rate; Result Unstructured Data: Test Result:103; Comments: beats/min; Test Date: 20210415; Test Name: Immature granulocytes; Result Unstructured Data: Test Result:0.11; Comments: 10*3/ul; Test Date: 20210415; Test Name: Immature granulocytes; Test Result: 1.1 %; Test Date: 20210415; Test Name: INR; Result Unstructured Data: Test Result:2.11; Test Date: 20210415; Test Name: Lymphocytes; Result Unstructured Data: Test Result:1.85; Comments: 10*3/ul; Test Date: 20210415; Test Name: Lymphocytes; Test Result: 19 %; Test Date: 20210415; Test Name: MCH; Test Result: 29.5 pg; Test Date: 20210415; Test Name: MCHC; Result Unstructured Data: Test Result:32.2 g/dl; Test Date: 20210415; Test Name: MCV; Result Unstructured Data: Test Result:91.9; Comments: fL; Test Date: 20210415; Test Name: Mean platelet volume; Result Unstructured Data: Test Result:13.3; Comments: fl; Test Date: 20210415; Test Name: Monocytes; Result Unstructured Data: Test Result:0.95; Comments: 10*3/ul; Test Date: 20210415; Test Name: Monocytes; Test Result: 9.8 %; Test Date: 20210415; Test Name: Neutrophils; Result Unstructured Data: Test Result:6.82; Comments: 10*3 /ul; Test Date: 20210415; Test Name: Neutrophils; Test Result: 70 %; Test Date: 20210415; Test Name: Neutrophil / Lymphocyte Ratio; Result Unstructured Data: Test Result:3.7; Test Date: 20210415; Test Name: Nitrites; Test Result: Negative ; Test Date: 20210415; Test Name: NTpro Natriuretic Peptide B; Result Unstructured Data: Test Result:4825 pg/mL; Test Date: 20210417; Test Name: Oxygen saturation; Test Result: 94 %; Comments: basal; Test Date: 20210415; Test Name: SatO2; Test Result: 54.6 %; Test Date: 20210415; Test Name: pCO2; Result Unstructured Data: Test Result:38.2 mmHg; Test Date: 20210415; Test Name: pH; Result Unstructured Data: Test Result:7.38; Test Date: 20210415; Test Name: urine pH; Result Unstructured Data: Test Result:5.5; Test Date: 20210415; Test Name: Platelet; Result Unstructured Data: Test Result:65; Comments: 10*3/ul; Test Date: 20210415; Test Name: Platelet cell distribution width; Test Result: 18.4 %; Test Date: 20210415; Test Name: po2; Result Unstructured Data: Test Result:33.8 mmHg; Test Date: 20210417; Test Name: Diuresis; Result Unstructured Data: Test Result:900; Test Date: 2000; Test Name: Positron emission tomography; Result Unstructured Data: Test Result:unknown; Test Date: 20210415; Test Name: Procalcitonin; Result Unstructured Data: Test Result:0.26 ng/ml; Test Date: 20210415; Test Name: Protein; Test Result: 15 mg/dl; Comments: (25); Test Date: 20210415; Test Name: Prothrombin Activity; Test Result: 29.9 %; Test Date: 20210415; Test Name: Erythrocytes; Result Unstructured Data: Test Result:12; Comments: /field; Test Date: 20210415; Test Name: Erythrocytes; Result Unstructured Data: Test Result:67; Comments: /ul; Test Date: 20210415; Test Name: Red blood cells; Result Unstructured Data: Test Result:2+; Comments: /ul; Test Date: 20210415; Test Name: Red blood cells; Result Unstructured Data: Test Result:3.69 10*6/uL; Test Date: 20210415; Test Name: RDW-CV; Test Result: 18.7 %; Test Date: 20210415; Test Name: RDW-SD; Result Unstructured Data: Test Result:56.6; Test Date: 20210415; Test Name: PCR SARS-CoV-2; Test Result: Negative ; Test Date: 20210415; Test Name: density; Result Unstructured Data: Test Result:1027; Test Date: 20210415; Test Name: Methyl ketone; Test Result: Negative ; Comments: (5); Test Date: 20210415; Test Name: Urobilinogen; Test Result: 2 mg/dl; Comments: (1); Test Date: 20210415; Test Name: Leukocytes; Test Result: Negative ; Comments: /ul; Test Date: 20210415; Test Name: Leukocytes; Result Unstructured Data: Test Result:2; Comments: /field; Test Date: 20210415; Test Name: Leukocytes; Result Unstructured Data: Test Result:11; Comments: /ul; Test Date: 20210415; Test Name: Leukocytes; Result Unstructured Data: Test Result:9.74; Comments: 10*3/ul
CDC Split Type: ESPFIZER INC202100996569

Write-up: intracardiac floating thrombosis; Subclavian vein thrombosis; acute confusional syndrome; Probable intra abdominal neoplasm with liver and lung spread; respiratory failure requiring oxygen therapy; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority ES-AEMPS-960203. An 88-yrs-old male patient (pt) received 2nd dose of bnt162b2 (COMIRNATY; Solution injection; Batch/Lot:ET1831), IM on 16Mar2021 as single dose for covid-19 immunization. Medical hist. included metastatic neoplasm, cardiac pacemaker insertion, AF, myocardial ischaemia, cataract, osteoarthritis, spinal osteoarthritis, benign prostatic hyperplasia, thyroid mass & knee arthroplasty. Conc medication: dabigatran for AF. Pt previously took clopidogrel, digoxin, atenolol & pantoprazole. On 17Apr2021, pt had intracardiac floating thrombosis & subclavian vein thrombosis. Pt was admitted to the hospital due to the presence of a recent onset intracardiac thrombus in the R atrium of 47mmm in a pt with recent pacemaker placement. ECG done during his previous admi. a mnth ago did nt reveal the existence of thrombosis. Pt also had thrombopenia. Cardiology ruled out a surgical approach. Also had impaired edema with filling of the left U limb, possibly related to subclavian vein thrombosis. Pt evolved unfavorably. Thoraco-Abd CT scan performed with lesions suggestive of intra-Abd neoplasia with implants close to the bile duct & metastatic liver & lung lesions. On admission, presented due to general discomfort with a mnth of asthenia, dizziness & chest discomfort. Went to a hospital finding AF of uncertain chronology, cardioverting after IV digoxin &ended up coming to center after an episode of loss of consciousness of the syncope profile (seconds complete & spontaneous recovery, short duration). Exits from AF with bradycardia at 30-45bpm with hypotensive bumps were described, so it implanted. A pacemaker on 08Apr2021. Cranial CT scan done without findings. As an incidence during admission, self-limited febrile picture without focus & -ve HCx2, however empirical ATB administered (Amox/Clav from 5Apr-12Apr). Brought to the hospital for an episode of loss of consciousness. HD with BP over 100/50mmhg. HR:50bpm in own rhythm. SatO2 96% baseline. Image compatible with thrombus at the level of the RA surrounding the pacemaker lead. Lesion occupying the hepatic space & pulmonary nodule in the L R lobe. It points to an imp prothrombotic situation since all this occurs in the context of an anticoagulated pt for about 10-15 days with a DOAC. The pt''s symptoms not very suggestive of massive PE, the low level of consciousness intermittent without being accompanied by other data such as marked respiratory failure or hypotension significant enough to lead to unconsciousness. However, to consider looking for embolic phenomena in the pulmonary arterial territory. From a thrombus point of view, it was recommended switching from DOAC to UFH. Evolution & comments: Admission due to the presence of generalized deterioration associated with the presence of a 47 mmm R atrial thrombus of recent appearance, in a pt with recent pacemaker placement. Hematology was consulted who recommended management with low mole. Wt. heparin at therapeutic doses & cardiology ruled out a surgical approach. In admi., he had deterioration of renal function & edema with filling of the L U limb, possibly related to subclavian vein thrombosis. The pt evolved unfavorably developing respiratory failure requiring O2 therapy & acute confusional syndrome with brain CT without relevant findings & without initially justifying laboratory abnormalities. In an emergency, thoracic Abd CT scan performed with lesions suggestive of intra-Abd neoplasia with implants close to the bile duct & metastatic liver & lung lesions with pathological adenopathy. Given the existence of acute thrombosis & thrombopenia, it was not possible at the time of admission to take biopsies for diagnosis. Given the serious situation of the pt & the possible disseminated neoplasm origin, the presence of intracardiac thrombosis was chosen once agreed with the family & given the impossibility of offering curative alternatives for a conservative management maintaining the anticoagulant treatment. Lab tests included on 15Apr2021 Sys urine showed pH: 5.5 Density:1027 Leukocytes: -ve num/ul, RBC: 2+ num/uL Nitrites:-ve uarb Protein:15mg dL;Glucose: -vemg/dL; Methyl ketone: -ve mg/dL;Urobilinogen: 2.0mg/dL; Bilirubin:-vemg/dL. Urinary sediment Erythrocytes /ul: 67 Erythrocytes /field: 12 Leukocytes /ul: 11 Leukocytes /field: 2 Glucose:106 mg/dL;Cr:1.26 mg/dL;CKD-EPI: 50.60 mL/min. Multiply by 1159 if black race.Urea:134 mg/dL;Na: 140 mEq/L;K: 4.73 mEq/L; Anion gap: 9.4 mEq/L:Cl:108mEq/L; GOT/AST: 29 U / L, Ritis R AST/ALT:0.97;Lactate dehydrogenase:318U/L;Bilirubin:2.12mg/dL;D. bilirubin:1.24mg/dL;CReactive Protein:22.3mg/L;rocalcitonin:0.26ng/mL;NTpro Natriuretic Peptide B:4825pg/mL.Venous blood gasespH:7.38;pCO2:38.2mmHg;pO2:33.8mmHg;CO3H:22.6mmol/L;Base excess:-2.5mmol/L;SO2:54.6%, Lactate:4.30mmol/L;Leukocytes:9.74 10 E 3/uL;RBC:3.69 10 E 6/uL ;Hb:10.9g/dL;Hematocrit:33.9%; MCV:91.9fL;MCH:29.5pg;MCHC:32.2 g/dL;RDW-CV:18.7%;RDW-SD:56.6;Plat:65 10 E 3/uL;VPM:13.3 fL; PDW:18.4%;Erythroblasts:0.05 10 E 3/uL;Erythroblasts:0.50;Neutrophils:6.82 10 E 3/uL; Lymphocytes:1.85 10 E 3/uL;Monocytes:0.95 10 E 3/Ul;Eosinophils:0.00 10 E 3/uL;Basophils:0.01 10 E 3/uL;Granulocytesimmature:0.11 10 E 3/uL; Neutrophils:70.0%; Lymphocytes:19.0%;Monocytes:9.8%;Eosinophils:0.0%;Basophils:0.1%;Immaturegranulocytes:1.1%; Neutrophil/Lymphocyte Ratio:3.7,Prothrombin Activity:29.90%;INR:2.11,Thromboplastin Time: 38.00 s; Thromboplastin Time Ratio:1.46; Derived fibrinogen:291 mg/dL. Chest x-ray in the supine position did not identify new-onset infiltrates or pleural effusion, 15 mm R hilar pulmonary nodule & unicameral pacemaker with end VI calcific aortic atheromatosis. Abd CT: Space-occupying hepatic lesion in caudate lobe, floating thrombus in the R atrium & pulmonary nodule in R L lobe. Liver of normal size &morphology, a space occupying lesion located in the caudate lobe with centronecrotic &peripheral vascularization identified. Lymphadenopathy in the hepatic hilum, periduinal, perihepatic &tail nodular images of the pancreas probably related to implants. 10x14mm LID pulmonary nodule. Floating thrombus of 47x38mm pericateter in the R atrium. Cysts bilateral cortical kidney stones. Diverticulosis in the descending colon &sigmoid without signs of acute diverticulitis Hiatal hernia, collections, or pneumoperitoneum are identified. B/L pleural effusion &passive atelectasis in both L lobes. CT brain: signs of small vessel arteriopathy. Centered midline. Signs of small vessel artery disease. Dilated ventricular system related to degree of cortical atrophy. Posterior fossa &cisternae of the base without alterations. Activated partial thromboplastin time: 38s. Activated PT time ratio:1.46, ALT:30iu/l, AST:29 iu/l, anion gap:9.4meq/l, bicytopenia: observed (normocytic-normochromic anemia thrombopenia), bilirubin conjugated:1.24 mg/dl, blood bicarbonate:22.6 mmol/l, blood bilirubin:-Ve and 2.12 mg/dl, blood Cl:108meq/l &blood Cr:1.26mg/dl. On 17Apr2021, Physical exploration: Input 1300 diuresis 900 Systolic pressure (mmHg):117, Diastolic pressure (mm Hg):72, Temp:37.1,HR:103bpm, O2Sat: 94 Basal, base excess: -2.5mmol/l, basophil count:0.01 10 3/ul, basophil count:0.1%. Patient died on 21Apr2021. It was not reported if an autopsy was performed. No FU-up attempts possible. No further information expected.; Reported Cause(s) of Death: intracardiac floating thrombosis; Subclavian vein thrombosis


VAERS ID: 1558007 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CARDIOASPIRIN; QUETIAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ischemic stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101003966

Write-up: Covid Pfizer vaccine was performed in the morning, access to the emergency room in the evening for pulmonary embolism susp; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority IT-MINISAL02-765349. A 93-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 23Jun2021 (Lot Number: FC5089) as SINGLE for covid-19 immunisation; quetiapine, via an unspecified route of administration from an unspecified date to an unspecified date for an unspecified indication. Medical history included ischaemic stroke from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid (CARDIOASPIRIN) taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of bnt162b2 (COMIRNATY, lot: EY7065) on 19May2021 for covid-19 immunisation. The patient experienced covid pfizer vaccine was performed in the morning, access to the emergency room in the evening for pulmonary embolism susp on 26Jun2021. The action taken in response to the event for quetiapine was not applicable. The patient died on 12Jul2021. 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: Embolism lung


VAERS ID: 1558709 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Inappropriate schedule of product administration
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), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101004264

Write-up: first dose of bnt162b2 (COMIRNATY) on 20May2021 / second dose of bnt162b2 (COMIRNATY) on 30Jul2021; Death: Cardiac Arrest; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB and received via Regulatory Authority NL-LRB-00647001. A 61-years-old male patient received second dose of bnt162b2 (COMIRNATY), at the age of 61-years-old via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no previous COVID-19 infection. The patient previous took first dose of bnt162b2 (COMIRNATY) on 20May2021 as 0.3 ml single dose for covid-19 immunisation. The patient experienced cardiac arrest (death) on 30Jul2021. The patient died on 30Jul2021. The outcome of cardiac arrest was fatal. It was not reported if an autopsy was performed. Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty): Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 20May2021 COVID19 : Previous COVID-19 infection: No No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty): Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 20May2021 COVID19 : Previous COVID-19 infection: No; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1558710 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-30
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebellar infarction
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101004166

Write-up: Cerebellar infarction; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00648160. A 43-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 23Jul2021 (Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. Patient previously took the first dose of vaccine on an unknown date at dose 1 single for covid-19 immunization with no adverse reaction. Patient previously didn''t experience COVID-19 infection. The patient medical history and concomitant medications were not reported. The patient experienced cerebellar infarction (death, hospitalization, life threatening) on 30Jul2021. Cerebellar infarction was treated with posterior cranial fossa decompression left. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. Reporter comment: Past drug therapy Pfizer/BioNTech: yes. ADR: no. Date unknown. Cerebellar infarction. Additional information ADR: Cerebellum Infarction. Previous COVID-19 infection: No. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: Past drug therapy Pfizer/BioNTech: yes. ADR: no. Date unknown. Cerebellar infarction Additional information ADR: Cerebellum Infarction COVID-19 Previous COVID-19 infection: No; Reported Cause(s) of Death: Cerebellar infarction


VAERS ID: 1558719 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PEPFIZER INC202101007494

Write-up: This is a spontaneous report from a contactable physician. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single and first dose via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient death was reported. It was not reported if an autopsy was performed. Outcome of the event was fatal. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the limited information, a causal association between the reported event death and suspect drug bnt162b2 cannot be excluded. The case will be re-assessed once further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1565992 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-07-19
   Days after vaccination:150
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? Yes
Died? Yes
   Date died: 2021-07-24
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.); Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101005881

Write-up: Maternal exposure during pregnancy; Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority. Regulatory authority report number (GB-MHRA-WEBCOVID-202108042255110690-DRTHG). Safety Report Unique Identifier (GB-MHRA-ADR 25756910). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included pregnancy, Lactation decreased, Pregnancy (Patient no longer pregnant at the time of reporting.) Patient has not had symptoms associated with COVID-19 Patient is not currently breastfeeding. Concomitant medication(s) included folic acid taken for Folic acid supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy (death, hospitalization, medically significant, life threatening, congenital anomaly) on an unspecified date, miscarriage of pregnancy (death, hospitalization, medically significant, life threatening, congenital anomaly) on 19Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: yes - positive covid-19 test on an unknown date. The outcome of events were fatal. It was not reported if an autopsy was performed. Patient died on 24-JUL-2021. Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. Did the medicine have an adverse effect on any aspect of the pregnancy: Yes Pregnancy adverse effects details: 18 week miscarriage. Details of previous pregnancies: All 4 live birth no problems. Patient was exposed to the medicine Before pregnancy. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: miscarriage of pregnancy; Maternal exposure during pregnancy


VAERS ID: 1571139 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: died after first dose Moderna; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died after first dose Moderna) in a male patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant product information was provided by the reporter. No treatment information was provided by the reporter. Very limited information regarding this event has been provided at this time. Further information is not expected as there is no contact information. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up does not contain any new information.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information is not expected as there is no contact information.; Reported Cause(s) of Death: Unknown cause of Death


VAERS ID: 1571239 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-12
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, 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: 2021-07-31
   Days after onset: 49
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: DEJNJFOC20210819528

Write-up: DEATH, UNKNOWN; SHORTNESS OF BREATH; This spontaneous report received from a consumer via a Regulatory Authority [DE-PEI-CADR2021155652] concerned a 69 year old male, race and ethnicity unknown. The patient''s weight was 90 kilograms, and height was 172 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD975 expiry: Unknown) frequency one total, dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the patient experienced dyspnoea, and was hospitalized (date unspecified). On 31-JUL-2021, the patient died due to unknown cause of death. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death, unknown and shortness of breath on 31-JUL-2021. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210819528 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Death, unknown and Shortness of breath. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1571286 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-19
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214004 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial; Osteoporosis
Preexisting Conditions: Medical History/Concurrent Conditions: Inflammation; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Sudden death, cause unknown; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death, cause unknown) in a 62-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 214004) for COVID-19 vaccination. The patient''s past medical history included Obesity and Inflammation. Concurrent medical conditions included Osteoporosis and Hypertension arterial. On 09-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 19-Jul-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 did not provide any causality assessments. No concomitant medications are reported. No treatment medications are reported. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-TO20216066. Company Comment: Very Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Sender''s Comments: Very Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1571450 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-15
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP067947

Write-up: Subarachnoid hemorrhage; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SUBARACHNOID HAEMORRHAGE (Subarachnoid hemorrhage) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion death). On 24-Jul-2021, the patient experienced SUBARACHNOID HAEMORRHAGE (Subarachnoid hemorrhage) (seriousness criteria death and medically significant). The patient died on 24-Jul-2021. The reported cause of death was Headache and Subarachnoid haemorrhage. It is unknown if an autopsy was performed. Patient was experienced mild headache on 15-Jul-2021, headache was exacerbated On 20-Jul-2021, headache subsided On 23-Jul-2021. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Company comment: Very limited information regarding these events has been provided at this time. However, more information is required for further assessment.; Sender''s Comments: This case concerns a female of unknown age who experienced a serious unexpected event of death 22 days after receiving her 1st dose of mRNA-1273. Very limited information regarding these events has been provided at this time. However, more information is required for further assessment.; Reported Cause(s) of Death: Headache; Subarachnoid haemorrhage


VAERS ID: 1573433 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-04-23
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210423; Test Name: PCR; Test Result: Positive ; Comments: variant PCR based B.1.1.7; N501Y positive
CDC Split Type: ATPFIZER INC202101016251

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number AT-BASGAGES-2021-39240. A 93-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: EP2166), via an unspecified route of administration on 27Feb2021 as dose 1, single and BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: ET1831), via an unspecified route of administration on 20Mar2021 as dose 2, single, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sars-cov-2 infection on 23Apr2021. The patient underwent lab tests and procedures which included polymerase chain reaction: variant PCR based b.1.1.7; n501y positive on an 23Apr2021 variant PCR based B.1.1.7; N501Y positive. The patient died on an unspecified date in 2021, due to COVID-19 and vaccination failure. It was not reported if an autopsy was performed. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: COVID-19; Vaccination Failure


VAERS ID: 1573434 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-05-12
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Investigation
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: Test Name: Investigation; Result Unstructured Data: Test Result:Variant sequenced B.1.1.7; N501Y positive
CDC Split Type: ATPFIZER INC202101016236

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number AT-BASGAGES-2021-39241. A 94-year-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 23Mar2021 (Batch/Lot Number: ET1831) as single dose, dose 1 via an unspecified route of administration on 03Mar2021 (Batch/Lot Number: EP2166) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced SARS-COV-2 infection on 12May2021. The patient underwent lab test which included investigation: variant sequenced b.1.1.7; n501y positive on unknown date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of SARS-COV-2 infection was fatal. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; SARS-CoV-2 infection


VAERS ID: 1573435 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-04-11
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR TEST; Test Result: Positive ; Comments: PCR variant based B.1.1.7; N501Y positive
CDC Split Type: ATPFIZER INC202101016232

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number AT-BASGAGES-2021-39246. An 82 years old male patient received 1st dose of BNT162B2 (COMIRNATY; lot EP2163) on 03Mar2021 and 2nd dose (lot EP2163) on 24Mar2021 for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant drugs were not provided. On 11Apr2021 the patient experienced Vaccination failure, other, SARS-CoV-2 infection. PCR variant based B.1.1.7; N501Y positive. Event outcome was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1573436 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-06-23
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101016239

Write-up: Drug ineffective; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Report number: AT-BASGAGES-2021-39250. An 86-year-old male patient received the BNT162B2 (COMIRNATY), dose 1 via unspecified route on 09Mar2021 as single dose (Batch/Lot Number: ET 1831), dose 2 via unspecified route on 30Mar2021 as single dose (Batch/Lot Number: ET3620), for COVID-19 immunisation. No relevant medical history reported. No concomitant medication reported. On 23Jun2021, the patient experienced vaccination failure, other. On 30Jun2021, the patient experienced SARS-CoV-2 infection death. The patient''s outcome was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: vaccination failure; SARS-CoV-2 infection


VAERS ID: 1573437 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-21
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: PCR test; Test Result: Positive ; Comments: PCR
CDC Split Type: ATPFIZER INC202101016106

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB, regulatory authority number AT-BASGAGES-2021-39251. A 95-year-old male patient received second dose of BNT162B2(COMIRNATY), via an unspecified route of administration on 01Apr2021, as single dose (Lot Number: ET7205; Expiration Date: 31Jul2021) and received first dose of BNT162B2(COMIRNATY), via an unspecified route of administration on 12Mar2021, as single dose (Lot Number: ET1831; Expiration Date: 30Jun2021) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure and sars-cov-2 infection on 21Apr2021. The patient underwent lab tests and procedures which included polymerase chain reaction(PCR): positive on an unspecified date. The outcome was fatal. It was not reported if an autopsy was performed. This case was reported as serious due to medically significant and fatal outcome. New information provided from Product Complaint Team, included: Investigation conclusion for lot ET1831: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ''ET1831''. A complaint sample was not returned. No related quality issues were identified during the investigation.There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Investigation conclusion for lot ET7205:The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ET7205.A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1573464 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Activated partial thromboplastin time, Asthenia, Atrial fibrillation, Bacterial test, Base excess, Bladder catheter permanent, Blood bicarbonate, Blood bilirubin, Blood creatinine, Blood glucose, Blood pH, Blood pressure systolic, Blood urea, C-reactive protein, COVID-19 pneumonia, Chest X-ray, Chest pain, Cholelithiasis, Differential white blood cell count, Echocardiogram, Haemophilus test, Headache, Hypotension, Oxygen saturation, PCO2, PO2, Platelet count, Procalcitonin, Prothrombin time, Red blood cell count, Respiratory failure, SARS-CoV-2 test, Septic shock, Staphylococcus test, Stress cardiomyopathy, Ultrasound scan, White blood cell count
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (narrow), Other ischaemic heart disease (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LOKREN; STACYL; EUTHYROX
Current Illness: Decreased appetite; Dizziness; Epigastric pain; Ex-smoker (3 daily formerly); Hypertension arterial (on betablocators); Thyroid disorder (substitution)
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract operation; Hysterectomy; Varicose vein operation
Allergies:
Diagnostic Lab Data: Test Date: 20210228; Test Name: APTT; Test Result: 66.4 s; Test Date: 20210226; Test Name: Bacteria stool test; Result Unstructured Data: Test Result:Staphylococcus aureus; Comments: Staphylococcus aureus; Test Date: 20210226; Test Name: Bacteria urine; Result Unstructured Data: Test Result:legionella and pneumococcus negative; Comments: legionella and pneumococcus negative; Test Date: 20210228; Test Name: Base excess; Result Unstructured Data: Test Result:-8.1 mmol/L; Comments: -8.1 mmol/l; Test Date: 20210226; Test Name: Bladder catheter permanent; Result Unstructured Data: Test Result:Escherichia coli; Comments: Escherichia coli 10*5/ml extended spectrum beta-lactamases; Test Date: 20210228; Test Name: Bicarbonate; Result Unstructured Data: Test Result:21.1 mmol/L; Comments: actual; Test Date: 20210228; Test Name: Bicarbonate; Result Unstructured Data: Test Result:17.7 mmol/L; Comments: standard; Test Date: 20210228; Test Name: Bilirubin; Result Unstructured Data: Test Result:43.3 mmol/L; Test Date: 20210228; Test Name: Creatinine; Result Unstructured Data: Test Result:355 umol/l; Test Date: 20210228; Test Name: Serum glucose; Result Unstructured Data: Test Result:11.8 mmol/L; Test Date: 20210228; Test Name: Blood pH; Result Unstructured Data: Test Result:7.177; Test Date: 20210220; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:90 mmHg; Test Date: 20210228; Test Name: Urea; Result Unstructured Data: Test Result:19.2 umol/l; Test Date: 20210224; Test Name: CXR; Result Unstructured Data: Test Result:infiltrates; Comments: infiltrates corresponding to bilateral viral pneumonia; Test Date: 20210225; Test Name: CXR; Result Unstructured Data: Test Result:developed interstitial syndrome; Comments: developed interstitial syndrome without effusion, progression obvious; Test Date: 20210228; Test Name: C-reactive protein; Result Unstructured Data: Test Result:274.9 mg/l; Test Date: 20210228; Test Name: Differential WBC count; Result Unstructured Data: Test Result:92.4 ; 2.9 %; Comments: neutrofils 92.4 %, lymphocytes 2.9 %; Test Date: 20210221; Test Name: Echocardiography; Result Unstructured Data: Test Result:significant left atrium dilatation; Comments: significant left atrium dilatation, left ventricle ejction fraction 35 %; Test Date: 20210226; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:stress cardiomyopathy; Comments: stress cardiomyopathy very suspected, severe systolic dysfunction, left ventricle ejection fraction 35-30 %, apical akinesia, midventricular hypokinesa anteroseptal. Without signs of low cardiac output, now 5-5.4 l/min cardiac output, without severe valve defects or right-sided dilatation; Test Date: 20210226; Test Name: Haemophilus test; Result Unstructured Data: Test Result:upper respiratory ways; Comments: upper respiratory ways; Test Date: 20210221; Test Name: Oxygen saturation; Test Result: 94 %; Test Date: 20210228; Test Name: Partial pressure CO2; Result Unstructured Data: Test Result:7.58; Comments: 7.58 kPa; Test Date: 20210228; Test Name: Platelet count; Result Unstructured Data: Test Result:112; Comments: 112/nL; Test Date: 20210228; Test Name: Partial pressure O2; Result Unstructured Data: Test Result:7.8; Comments: 7.8:kPa; Test Date: 20210228; Test Name: Procalcitonin; Result Unstructured Data: Test Result:107.93 umol/l; Test Date: 20210228; Test Name: Quick''s test; Result Unstructured Data: Test Result:2.17; Comments: INR 2.17; Test Date: 20210228; Test Name: RBC count; Result Unstructured Data: Test Result:3.51; Comments: 3.51/pL; Test Date: 20210221; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210226; Test Name: COVID-19 antigen test; Test Result: Negative ; Test Date: 20210226; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20210226; Test Name: Staphylococcus aureus; Result Unstructured Data: Test Result:Staphylococcus aureus; Test Date: 20210219; Test Name: Echography; Result Unstructured Data: Test Result:cholecystolithiasis; Comments: cholecystolithiasis; Test Date: 20210228; Test Name: WBC count; Result Unstructured Data: Test Result:17.65; Comments: 17.65/nL
CDC Split Type: CZPFIZER INC202101003447

Write-up: septic shock; stress cardiomyopathy; respiratory failure; SARS-CoV-2 pneumonia/breathlessness progresssion, due to pulmonary infiltrates high-flow nasal oxygen 30l oxygen fraction 83 %; hypotension/lowered blood pressure; atrial fibrillation; progressive weakness; abdominal pains; chest pain - sternum and nape region; strong pain of the back of the head; cholecystolithiasis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number CZ-CZSUKL-21008826. A 76-year-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular on 19Feb2021 (Batch/Lot Number: unknown) as single dose for COVID-19 immunisation. Patient age at vaccination was 76-year-old. Medical history included arterial hypertension on betablocators from 1990 and ongoing, varices surgery in 1995, hysterectomy in 2004, thyreopathy on substitution from 2010 and ongoing, cataract surgery in 2016 and 2018, abuses: ex-smoker for 20 years, 3 daily formerly. Patient was preceded by epigastrium pain, lack of appetite, dizziness since 12Feb2021. Concomitant medications included betaxolol hydrochloride (LOKREN), acetylsalicylic acid (STACYL) and levothyroxine sodium (EUTHYROX), all taken for an unspecified indication, start and stop date were not reported. Patient was preceded by epigastrium pain, lack of appetite, dizziness since 12Feb2021 and followed by strong pain of rear side of head on 19Feb2021 after the vaccination. Since 20Feb2021 progressive weakness, abdominal pain, chest pain of sternum and nape, lowered blood pressure, beta-blocators were withdrawn. On 21Feb2021 she was admissed to internal department, antigen SARS-CoV-2 positive. Atrial fibrillation appeared, anticoagulated by low-molecular weight heparin, beta-blocator administered, ejection fraction of left ventricle decreased to 35 %, persistent fast response of ventricles. On 24Feb2021 amiodaron, breathlessness progresssion, due to pulmonary infiltrates high-flow nasal oxygen 30l oxygen fraction 83 %, at first saturation satisfactory, then with hyposaturation, oxygen saturation max 85 %, Remdesivir (since 25Feb), corticoids (since 21Feb), C-reactive protein increased to 250 mg/l, procalcitonine 32 umol/l, lactate (6.6 mmol/l) metabolic acidosis, anuria. On 25Feb2021 non improving status on high-flow nasal oxygen, ad noninvasive ventilation with minimal or transient improvement intermitently sinus only, otherwise atrial tachyfibrillation on antiarythmic therapy of amiodarone continually by perfusor. On 26Feb admissed to intensive care unit due to pulmonary finding progression, sinus rhythm after electro-cardioversion, bolus opiates, oxygen saturation does not go over 85 %, oliguria lasts in spite of bolus and continual administration of Furosemid and dobutamin - combined vasopresoric support, severe interstitial pulmonary process (acute respiratory distress syndrome), stress/posttachycardic cardiomyopathy diagnosed at the same time. After drug administration adequate cardiac output and organ perfusion restored, patient with a good response to ventilation in pronation position. In spite of adequate antibiotic treatment (27Feb - Tazo, Ciphin and 28Feb2021- Mero, Zyvox, Amikacin) there is a ventricular tachycardia 170/min, cardioverted by 1st discharge, then atrial fibrillations repeatedly 140-160/min without reaction to electro-cardioversion or amiodaron, Levosimendan indicated, volumotherapy, septic shock development, procalcitonine 67 umol/l, lactate increase, metabolic acidosis development with continual alcalisation needed. 3 transfusion units of fresh-frozen plasma administered due to coagulopathy, oligo/anuria development, severe vasoparalysis. On 28Feb2021 persisting severe shock status, exitus at 14 o''clock. Patient underwent lab tests which included: 19Feb2021 ultrasonography: cholecystolithiasis, 20Feb2021 blood pressure: 90 mmHg systolic, 21Feb2021 SARS-CoV-2 antigen test positive, saturation 94 %, echocardiography - significant left atrium dilatation, left ventricle ejction fraction 35 %, 24Feb2021 chest x-ray: infiltrates corresponding to bilateral viral pneumonia, 25Feb2021 chest x-ray: developed interstitial syndrome without effusion, progression obvious, 26Feb2021 transthoracal echocardiography: stress cardiomyopathy very suspected, severe systolic dysfunction, left ventricle ejection fraction 35-30 %, apical akinesia, midventricular hypokinesa anteroseptal. Without signs of low cardiac output, now 5-5.4 l/min cardiac output, without severe valve defects or right-sided dilatation, 26Feb2021 urine: legionella and pneumococcus negative, stool: Staphylococcus aureus, upper respiratory ways: Haemophillus influenzae, neck: Staphylococcus aureus, permanent urinary catheter: Escherichia coli 10*5/ml extended spectrum beta-lactamases, polymerase chain reaction SARS-CoV-2 positive, antigen negative, 28Feb2021 urea 19.2 mmol/l, creatinine 355 umol/l, bilirubin 43.3 mmol/l, C-reactive protein 274.9 mg/l, procalcitonin 107.93 umol/l, blood pH 7.177, pCO2 7.58 kPa, actual bicarbonates 21.1 mmol/l, standard bicarbonates 17.7 mmol/l, base excess actual: 8.1 mmol/l, pO2 7.8 kPa, glucose 11.8 mmol/l, leukocytes 17.65/nl, erythrocytes 3.51/pl, thrombocytes 112/nl, differential neutrofils 92.4 %, lymphocytes 2.9 %, Quick test INR 2.17, activated partial thromboplastin time 66.4 s. The patient died on 28Feb2021. An autopsy was not performed. Cause of death was reported as viral pneumonia (COVID-19 pneumonia), respiratory failure, septic shock, stress cardiomyopathy and hypotension/lowered blood pressure. Outcome of viral pneumonia (COVID-19 pneumonia), respiratory failure, septic shock, stress cardiomyopathy and hypotension/lowered blood pressure was fatal. Outcome of progressive weakness and atrial fibrillation was not resolved. Outcome of other events was unknown. No follow-up attempts are possible. Information on batch/lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: respiratory failure; septic shock; stress cardiomyopathy; viral pneumonia, respiratory failure, septic shock, stress cardiomyopathy; hypotension/lowered blood pressure


VAERS ID: 1573471 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9234 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute left ventricular failure, Acute myocardial infarction, Autopsy, Brain injury, Cardiac arrest, Pulmonary oedema
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mitral valve stenosis; Old myocardial infarction
Allergies:
Diagnostic Lab Data: Test Name: autopsy; Result Unstructured Data: Test Result:a fresh anterior wall infarction; Comments: In addition to the known findings, the autopsy showed macroscopically a fresh anterior wall infarction, several older myocardial infarction scars as well as the morphological, possibly a mitral valve stenosis without any further assessment of the hemodynamic relevance.
CDC Split Type: DEPFIZER INC202100987691

Write-up: Acute left ventricular failure; Arrest cardiac; Acute myocardial infarction; Pulmonary oedema; Hypoxic brain damage; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority number DE-PEI-202100134122. A 39-years-old female patient received bnt162b2 (COMIRNATY), Solution for injection, Lot number: FD9234 and Expiry date: Unknown), via an unspecified route of administration on 22Jun2021 as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization. Medical history included myocardial infarction, mitral valve stenosis from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 22Jun2021 the patient experienced acute left ventricular failure, arrest cardiac, acute myocardial infarction, pulmonary oedema, hypoxic brain damage. The patient underwent lab tests and procedures which included autopsy: a fresh anterior wall infarction on. In addition to the known findings, the autopsy showed macroscopically a fresh anterior wall infarction, several older myocardial infarction scars as well as the morphological, possibly a mitral valve stenosis without any further assessment of the hemodynamic relevance.The patient died on 24Jun2021.An autopsy was performed that revealed acute myocardial infarction. Reporter''s comments: In addition to the known findings, the autopsy showed macroscopically a fresh anterior wall infarction, several older myocardial infarction scars as well as the morphological, possibly a mitral valve stenosis without any further assessment of the hemodynamic relevance. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: In addition to the known findings, the autopsy showed macroscopically a fresh anterior wall infarction, several older myocardial infarction scars as well as the morphological, possibly a mitral valve stenosis without any further assessment of the hemodynamic relevance.; Autopsy-determined Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1573473 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987576

Write-up: Fibrillation ventricular; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, authority number DE-PEI-202100142230. A 75-year-old male patient received unspecified dose of BNT162B2 (COMIRNATY, solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration on 03Jun2021 as dose number unknown, 0.3 mL, single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. On an unspecified date on 2021, the patient experienced fibrillation ventricular. The patient died on an unspecified date. It was not reported if an autopsy was performed. The casual relationship of Comirnaty and Fibrillation ventricular assessed as Unclassifiable by the Regulatory Authority. No follow-up attempts possible. No further information expected. Lot/Batch number cannot be obtained.; Reported Cause(s) of Death: fibrillation ventricular


VAERS ID: 1573485 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
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: 2021-07-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101010418

Write-up: Exitus letalis, medical post-mortem examination; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority report number is DE-PEI-202100155990. An 83-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 23Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. There was no medical history or concomitant medications. 1 day after vaccination, on 24Jul2021 the patient experienced. The lethal outcome, medical post-mortem examination (unknown cause of death). The outcome of the event was fatal. It was not reported if an autopsy was performed. This report was assessed by the reporting physician as serious (death). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: The lethal outcome, medical post-mortem examination


VAERS ID: 1573486 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-01
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall, Hip fracture, Muscular weakness, Thrombosis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 91
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101010571

Write-up: Thrombosis; Hip fracture; Falling; Weakness in extremity; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority WEB DE-PEI-202100156067. An 82-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on Apr2021 as 0.3mL single for covid-19 immunisation. The patient''s medical history was not provided. Concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 on unspecified date as 0.3 mL single for covid-19 immunisation. On May2021 the patient experienced weakness in extremity, falling. On 25Jul2021 the patient experienced hip fracture. On 28Jul2021 the patient experienced thrombosis. Outcome of the event thrombosis was fatal, other events was unknown. The patient died on 31Jul2021. It was not reported if an autopsy was performed. The seriousness of the events hip fracture was resulted in hospitalization and was medically significant, thrombosis resulted in hospitalization and death, events falling and weakness in extremity assessed as medically significant. The casual relationship of Comirnaty and all events assessed as Unclassifiable by the PEI. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: thrombosis


VAERS ID: 1573516 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Loss of consciousness, Malaise, Ventricular fibrillation, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   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: Medical History/Concurrent Conditions: Allergy (Hay fever on hazelnut, birch and anaphylactic shock followed 5 years ago. Consumption of almonds); Anaphylactic reaction (Hay fever on hazelnut, birch and anaphylactic shock followed 5 years ago. Consumption of almonds); Asthma (Slightly allergic asthma during pollen count, otherwise no previous illnesses known); Food allergy; Hay fever
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987565

Write-up: Ventricular fibrillation, death; On the third day after vaccination, sudden malaise, unconsciousness, wheeze, Cardiac arrest. Rescue team tried to reanimate over 60 minutes, 7 times Defibrillator, ventricular fibrillation, death.; On the third day after vaccination, sudden malaise, unconsciousness, wheeze, Cardiac arrest. Rescue team tried to reanimate over 60 minutes, 7 times Defibrillator, ventricular fibrillation, death.; On the third day after vaccination, sudden malaise, unconsciousness, wheeze, Cardiac arrest. Rescue team tried to reanimate over 60 minutes, 7 times Defibrillator, ventricular fibrillation, death.; On the third day after vaccination, sudden malaise, unconsciousness, wheeze, Cardiac arrest. Rescue team tried to reanimate over 60 minutes, 7 times Defibrillator, ventricular fibrillation, death.; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority number DE-PEI-CADR2021124883. Sender (Case) Safety Report Unique Identifier DE-PEI-202100121137, received from Regulatory Authority. A 55-year-old male patient received BNT162B2 (COMIRNATY- mRNA TOZINAMERAN, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on 09Jun2021, DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient had no relevant medical history and concurrent conditions. The patient had allergy of hay fever on hazelnut, birch and anaphylactic shock followed 5 years ago to consumption of almonds. The patient risk factors, or previous illnesses included slightly allergic asthma during pollen count, otherwise no previous illnesses known. Concomitant medications were not reported. On 12Jun2021, on the third day after vaccination, the patient experienced sudden malaise, unconsciousness, rattle, cardiac arrest and ventricular fibrillation. It was reported that rescue team tried to reanimate over 60 minutes, 7 times defibrillator. The patient died on 12Jun2021. The death was due to sudden malaise, unconsciousness, rattle, cardiac arrest and ventricular fibrillation. It was unknown if an autopsy was performed. The outcome of the events was fatal. Comirnaty: Relatedness of drug to reaction(s)/event(s): Source of assessment: PEI/Result of Assessment: C, Inconsistent causal association to immunization. Health Authority comments: Are you or the person concerned known of any allergies, if yes, which: Hay fever on hazelnut, birch and anaphylactic shock followed 5 years ago on consumption of almonds. Information on risk factors or previous illnesses: Slightly allergic asthma during pollen count, otherwise no previous illnesses known / On the third day after vaccination, sudden malaise, unconsciousness, rattle, Cardiac arrest. Rescue team tried to reanimate over 60 minutes, 7 times Defibrillator, ventricular fibrillation, death. No follow-up attempts are possible. Information on batch number cannot be obtained.; Reported Cause(s) of Death: On the third day after vaccination, sudden malaise, unconsciousness, wheeze, Cardiac arrest. Rescue team tried to reanimate over 60 minutes, 7 times Defibrillator, ventricular fibrillation, death.; On the third day after vaccination, sudden malaise,


VAERS ID: 1573657 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-05-06
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: PCR; Test Result: Positive ; Comments: variant PCR based B.1.1.7; N501Y positive
CDC Split Type: ATPFIZER INC202101016245

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority. The Regulatory Authority report number is AT-BASGAGES-2021-39247. An 83 Years old Male patient received BNT162B2 (COMIRNATY) 1st dose on 04Mar2021 (batch/lot number: EJ6790), 2nd dose on 25Mar2021 (batch/lot number ET3620) for COVID-19 immunisation. No relevant medical history reported. No concomitant medication reported. On 06May2021 the patient experienced Vaccination failure, other, SARS-CoV-2 infection. Lab data was variant PCR based B.1.1.7; N501Y positive. The patient''s outcome was fatal. It was unknown whether autopsy has been done. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1573767 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-05-10
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Arthrosis; Atrial fibrillation; Breast cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT in an 84-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 immunisation. The patient''s past medical history included Atrial fibrillation, Arterial hypertension, Arthrosis and Breast cancer. On 10-Apr-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (seriousness criteria death and medically significant). The reported cause of death was Middle cerebral artery stroke. It is unknown if an autopsy was performed. The treatment history was not reported. The concomitant history was not reported. Company comment: Very limited information regarding this event has been provided at this time. Further information will not be received as it a Regulatory Authority report. Translation of Source Document is pending.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information will not be received as it a Regulatory Authority report. Translation of Source Document is pending.; Reported Cause(s) of Death: Middle cerebral artery stroke


VAERS ID: 1573791 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-23
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002339 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Amylase, Aspartate aminotransferase, Bacterial test, Band neutrophil count, Basophil count, Bilirubin conjugated, Blood alcohol increased, Blood alkaline phosphatase increased, Blood bilirubin, Blood urine, Brain natriuretic peptide, C-reactive protein increased, Death, Eosinophil count, Gamma-glutamyltransferase, Glomerular filtration rate, Glucose urine absent, Haemoglobin, International normalised ratio, Mean platelet volume, Monocyte count normal, Neutrophil count, Platelet count decreased, Procalcitonin normal, Protein urine, Prothrombin time, Prothrombin time ratio, Pulmonary embolism, Red blood cell count decreased, Tracheal aspirate culture, Troponin I, Urine ketone body absent, White blood cell count increased, White blood cells urine
SMQs:, Liver related investigations, signs and symptoms (broad), Haematopoietic erythropenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Biliary system related investigations, signs and symptoms (broad), Proteinuria (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 3
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MILGAMMA N [BENFOTIAMINE;CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE]; ESCITALOPRAM; HELICID [OMEPRAZOLE]
Current Illness: Monoparesis (Lower left limb); Smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Central European encephalitis; Concussion; COVID-19; Ilium fracture; Limb contusion (Shoulder)
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 4,67; 1,47; 2,31; 3,69; 3,03; Comments: Ratio; Test Date: 20210624; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 3,96; 2,49; 2,36; 2,85; Comments: Ratio; Test Date: 20210625; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 105,1 s; 66,1 s; 62,6 s; 75,5 s; Test Date: 20210625; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 3,82; Comments: Ratio; Test Date: 20210626; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 101.3 seconds; Test Date: 20210623; Test Name: Glutamic-pyruvate transaminase; Result Unstructured Data: 1.74 ukat/l; Test Date: 20210626; Test Name: Glutamic-pyruvate transaminase; Result Unstructured Data: 11,14 ukat/; Test Date: 20210623; Test Name: Blood alpha amylase; Result Unstructured Data: 4,2 ukat/l; Test Date: 20210623; Test Name: ASAT; Result Unstructured Data: 3,88 ukat/l; Test Date: 20210626; Test Name: ASAT; Result Unstructured Data: 3,88 ukat/l, 30,63 ukat/l; Test Date: 20210624; Test Name: Bacterial culture test; Test Result: Negative ; Result Unstructured Data: endotracheal cannula - klebsiella pneumoniae subspecies pneumoniae, uricult negative for bacteria, Tracheal aspirate: c.albicans 10^7 CFU/ml, Kl. pneumoniae 10^5 CFU/ml; Test Date: 20210623; Test Name: Bacterial urine; Result Unstructured Data: 159; Test Date: 20210623; Test Name: Band neutrophil count; Result Unstructured Data: 7.8 billion per liter; Test Date: 20210624; Test Name: Band neutrophil count; Result Unstructured Data: 3.1billion per liter; Test Date: 20210624; Test Name: Basophil count; Result Unstructured Data: 1.4 billion per litrer; Test Date: 20210623; Test Name: Blood basophils; Result Unstructured Data: 1.4 billion per liter.; Test Date: 20210623; Test Name: Bilirubin conjugated; Result Unstructured Data: 3.6 micromole per liter; Test Date: 20210626; Test Name: Bilirubin conjugated; Result Unstructured Data: 10.4 micromole per liter; Test Date: 20210623; Test Name: Blood alcohol; Result Unstructured Data: 2 ?; Test Date: 20210623; Test Name: Alk phos; Result Unstructured Data: 1,44 ukat/l; Test Date: 20210623; Test Name: Bilirubin; Result Unstructured Data: 7.1 micromole per liter; Test Date: 20210626; Test Name: Bilirubin; Result Unstructured Data: 22.5 micromole per liter; Test Date: 20210623; Test Name: Blood urine; Result Unstructured Data: 0; Test Date: 2021; Test Name: Body mass index; Result Unstructured Data: 25.25 kilogram per square meter.; Test Date: 20210623; Test Name: Brain natriuretic peptide; Result Unstructured Data: 499.2 nanogram per liter; Test Date: 20210624; Test Name: C-reactive protein; Result Unstructured Data: 14 milligram per liter; Test Date: 20210626; Test Name: C-reactive protein; Result Unstructured Data: 282.5 milligram per liter; Test Date: 20210623; Test Name: Eosinophil count; Result Unstructured Data: 1.4 billion per litre; Test Date: 20210624; Test Name: Eosinophil count; Result Unstructured Data: 0.1; Test Date: 20210623; Test Name: GGT; Result Unstructured Data: 3,05 ukat/l; Test Date: 20210623; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,92 ml/s per 1,73 m2; Test Date: 20210623; Test Name: Glomerular filtration rate; Result Unstructured Data: 1,06 ml/s per 1,73 m2; Test Date: 20210624; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,79 ml/s per 1,73 m2; Comments: corrected; Test Date: 20210624; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,91 ml/s per 1,73 m2; Test Date: 20210625; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,27 ml/s per 1,73 m2; Comments: corrected; Test Date: 20210625; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,31 ml/s per 1,73 m2; Test Date: 20210626; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,5 ml/s per 1,73 m2; Comments: corrected; Test Date: 20210626; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,58 ml/s per 1,73 m2; Test Date: 20210623; Test Name: Glucose urine; Result Unstructured Data: 0 millimole per liter; Test Date: 20210623; Test Name: Hemoglobin; Result Unstructured Data: 0; Test Date: 20210623; Test Name: INR; Result Unstructured Data: 2,15; Test Date: 20210625; Test Name: International normalised ratio; Result Unstructured Data: 2.18; Test Date: 20210626; Test Name: International normalised ratio; Result Unstructured Data: 2,59; Test Date: 20210623; Test Name: Mean platelet volume; Result Unstructured Data: 10.5; Test Date: 20210624; Test Name: Mean platelet volume; Result Unstructured Data: 10.3; Test Date: 20210625; Test Name: Mean platelet volume; Result Unstructured Data: 11.8; Test Date: 20210626; Test Name: Mean platelet volume; Result Unstructured Data: 12.4; Test Date: 20210623; Test Name: Monocyte count; Result Unstructured Data: 3.2 billion per liter; Test Date: 20210624; Test Name: Monocyte count; Result Unstructured Data: 3.2 billion per liter; Test Date: 20210623; Test Name: Neutrophils; Result Unstructured Data: 47.8 billion per liter; Test Date: 20210624; Test Name: Neutrophils; Result Unstructured Data: 88.3 billion per liter; Test Date: 20210623; Test Name: Urine pH; Result Unstructured Data: 6; Test Date: 20210623; Test Name: Platelet count; Result Unstructured Data: 89 billion per liter; Test Date: 20210624; Test Name: Platelet count; Result Unstructured Data: 160 billion per liter; Test Date: 20210626; Test Name: Platelet count; Result Unstructured Data: 47 billion per liter; Test Date: 20210625; Test Name: Thrombocyte count; Result Unstructured Data: 74 billion per liter; Test Date: 20210623; Test Name: Procalcitonin; Result Unstructured Data: 0.1 nanogram per millliiter; Test Date: 20210626; Test Name: Procalcitonin; Result Unstructured Data: $g100; Test Date: 20210623; Test Name: Protein urine; Result Unstructured Data: 0; Test Date: 20210623; Test Name: Quick''s test; Result Unstructured Data: 23.9; Test Date: 20210625; Test Name: Quick''s test; Result Unstructured Data: 24.2; Test Date: 20210626; Test Name: Quick''s test; Result Unstructured Data: 28.2; Test Date: 20210623; Test Name: Prothrombin ratio; Result Unstructured Data: 2,17; Test Date: 20210625; Test Name: Prothrombin ratio; Result Unstructured Data: 2,2; Test Date: 20210626; Test Name: Prothrombin ratio; Result Unstructured Data: 2,61; Test Date: 20210623; Test Name: Red blood cell count; Result Unstructured Data: 4.39; Test Date: 20210624; Test Name: Red blood cell count; Result Unstructured Data: 4.84; Test Date: 20210625; Test Name: Red blood cell count; Result Unstructured Data: 3.7; Test Date: 20210626; Test Name: Red blood cell count; Result Unstructured Data: 3.43; Test Date: 20210623; Test Name: Troponin I; Result Unstructured Data: 180.2; Test Date: 20210623; Test Name: Acetone urine; Result Unstructured Data: 0; Test Date: 20210623; Test Name: WBC count; Result Unstructured Data: 13.9; Test Date: 20210624; Test Name: WBC count; Result Unstructured Data: 13.9; Test Date: 20210625; Test Name: WBC count; Result Unstructured Data: 11.9; Test Date: 20210626; Test Name: WBC count; Result Unstructured Data: 9.5; Test Date: 20210623; Test Name: White blood cells urine; Result Unstructured Data: 0
CDC Split Type: CZMODERNATX, INC.MOD20212

Write-up: Massive pulmonary embolism; This case was received via Regulatory Authority (Reference number: 21008615) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Massive pulmonary embolism) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002339) for COVID-19 immunization. The patient''s past medical history included Limb contusion (Shoulder) in 2004, Concussion in 2014, COVID-19 from February 2021 to March 2021, Central European encephalitis and Ilium fracture in 2018. Concurrent medical conditions included Monoparesis (Lower left limb) and Smoker. Concomitant products included BENFOTIAMINE, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE (MILGAMMA N [BENFOTIAMINE;CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE]), ESCITALOPRAM and OMEPRAZOLE (HELICID [OMEPRAZOLE]) for an unknown indication. On 10-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 23-Jun-2021, after starting mRNA-1273 (Spikevax), the patient experienced PULMONARY EMBOLISM (Massive pulmonary embolism) (seriousness criteria death, hospitalization, disability, medically significant and life threatening). The patient died on 26-Jun-2021. The reported cause of death was Embolism lung. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body mass index: 25.25 (abnormal) 25.25 kilogram per square meter.. On 23-Jun-2021, Alanine aminotransferase: 1.74 (abnormal) 1.74 ukat/l. On 23-Jun-2021, Amylase: 4,2 (normal) 4,2 ukat/l. On 23-Jun-2021, Aspartate aminotransferase: 3,88 (Low) 3,88 ukat/l. On 23-Jun-2021, Bacterial test: 159 (abnormal) 159. On 23-Jun-2021, Band neutrophil count: 7.8 (High) 7.8 billion per liter. On 23-Jun-2021, Basophil count: 1.4 (abnormal) 1.4 billion per liter.. On 23-Jun-2021, Bilirubin conjugated: 3.6 (Low) 3.6 micromole per liter. On 23-Jun-2021, Blood alcohol: 2 (abnormal) 2 ?. On 23-Jun-2021, Blood alkaline phosphatase: 1,44 (High) 1,44 ukat/l. On 23-Jun-2021, Blood bilirubin: 7.1 (abnormal) 7.1 micromole per liter. On 23-Jun-2021, Blood urine: 0 (abnormal) 0. On 23-Jun-2021, Brain natriuretic peptide: 499.2 (High) 499.2 nanogram per liter. On 23-Jun-2021, Eosinophil count: 1.4 (abnormal) 1.4 billion per litre. On 23-Jun-2021, Gamma-glutamyltransferase: 3,05 (abnormal) 3,05 ukat/l. On 23-Jun-2021, Glomerular filtration rate: 0,92 (abnormal) 0,92 ml/s per 1,73 m2 and 1,06 ml/s per 1,73 m2 (normal) 1,06 ml/s per 1,73 m2. On 23-Jun-2021, Glucose urine: 0 (abnormal) 0 millimole per liter. On 23-Jun-2021, Haemoglobin: 0 (abnormal) 0. On 23-Jun-2021, International normalised ratio: 2,15 (abnormal) 2,15. On 23-Jun-2021, Mean platelet volume: 10.5 (normal) 10.5. On 23-Jun-2021, Monocyte count: 3.2 (normal) 3.2 billion per liter. On 23-Jun-2021, Neutrophil count: 47.8 (abnormal) 47.8 billion per liter. On 23-Jun-2021, Platelet count: 89 (Low) 89 billion per liter. On 23-Jun-2021, Procalcitonin: 0.1 (normal) 0.1 nanogram per millliiter. On 23-Jun-2021, Protein urine: 0 (abnormal) 0. On 23-Jun-2021, Prothrombin time: 23.9 (abnormal) 23.9. On 23-Jun-2021, Prothrombin time ratio: 2,17 (normal) 2,17. On 23-Jun-2021, Red blood cell count: 4.39 (Low) 4.39. On 23-Jun-2021, Troponin I: 180.2 (abnormal) 180.2. On 23-Jun-2021, Urine ketone body: 0 (abnormal) 0. On 23-Jun-2021, White blood cell count: 13.9 (High) 13.9. On 23-Jun-2021, White blood cells urine: 0 (abnormal) 0. On 23-Jun-2021, pH urine: 6 (normal) 6. On 24-Jun-2021, Activated partial thromboplastin time: 4,67; 1,47; 2,31; 3,69; 3,03 (High) 4,67; 1,47; 2,31; 3,69; 3,03 and 3,96; 2,49; 2,36; 2,85 (High) 3,96; 2,49; 2,36; 2,85. On 24-Jun-2021, Bacterial test: negative (Negative) endotracheal cannula - klebsiella pneumoniae subspecies pneumoniae, uricult negative for bacteria, Tracheal aspirate: c.albicans 10^7 CFU/ml, Kl. pneumoniae 10^5 CFU/ml. On 24-Jun-2021, Band neutrophil count: 3.1 (abnormal) 3.1billion per liter. On 24-Jun-2021, Basophil count: 1.4 (abnormal) 1.4 billion per litrer. On 24-Jun-2021, C-reactive protein: 14 (abnormal) 14 milligram per liter. On 24-Jun-2021, Eosinophil count: 0.1 (Low) 0.1. On 24-Jun-2021, Glomerular filtration rate: 0,79 ml/s per 1,73 m2 (abnormal) 0,79 ml/s per 1,73 m2 and 0,91 ml/s per 1,73 m2 (abnormal) 0,91 ml/s per 1,73 m2. On 24-Jun-2021, Mean platelet volume: 10.3 (normal) 10.3. On 24-Jun-2021, Monocyte count: 3.2 (normal) 3.2 billion per liter. On 24-Jun-2021, Neutrophil count: 88.3 (abnormal) 88.3 billion per liter. On 24-Jun-2021, Platelet count: 160 (normal) 160 billion per liter. On 24-Jun-2021, Red blood cell count: 4.84 (normal) 4.84. On 24-Jun-2021, White blood cell count: 13.9 (High) 13.9. On 25-Jun-2021, Activated partial thromboplastin time: 105,1 ; 66,1 ; 62,6 ; 75,5 (High) 105,1 s; 66,1 s; 62,6 s; 75,5 s and 3,82 (High) 3,82. On 25-Jun-2021, Glomerular filtration rate: 0,27 ml/s per 1,73 m2 (abnormal) 0,27 ml/s per 1,73 m2 and 0,31 ml/s per 1,73 m2 (abnormal) 0,31 ml/s per 1,73 m2. On 25-Jun-2021, International normalised ratio: 2.18 (abnormal) 2.18. On 25-Jun-2021, Mean platelet volume: 11.8 (normal) 11.8. On 25-Jun-2021, Platelet count: 74 (Low) 74 billion per liter. On 25-Jun-2021, Prothrombin time: 24.2 (abnormal) 24.2. On 25-Jun-2021, Prothrombin time ratio: 2,2 (normal) 2,2. On 25-Jun-2021, Red blood cell count: 3.7 (Low) 3.7. On 25-Jun-2021, White blood cell count: 11.9 (normal) 11.9. On 26-Jun-2021, Activated partial thromboplastin time: 101.3 (High) 101.3 seconds. On 26-Jun-2021, Alanine aminotransferase: 11,14 (abnormal) 11,14 ukat/. On 26-Jun-2021, Aspartate aminotransferase: 3,88, 30,63 (abnormal) 3,88 ukat/l, 30,63 ukat/l. On 26-Jun-2021, Bilirubin conjugated: 10.4 (abnormal) 10.4 micromole per liter. On 26-Jun-2021, Blood bilirubin: 22.5 (abnormal) 22.5 micromole per liter. On 26-Jun-2021, C-reactive protein: 282.5 (abnormal) 282.5 milligram per liter. On 26-Jun-2021, Glomerular filtration rate: 0,5 ml/s per 1,73 m2 (abnormal) 0,5 ml/s per 1,73 m2 and 0,58 ml/s per 1,73 m2 (abnormal) 0,58 ml/s per 1,73 m2. On 26-Jun-2021, International normalised ratio: 2,59 (abnormal) 2,59. On 26-Jun-2021, Mean platelet volume: 12.4 (abnormal) 12.4. On 26-Jun-2021, Platelet count: 47 (Low) 47 billion per liter. On 26-Jun-2021, Procalcitonin: $g100 (abnormal) $g100. On 26-Jun-2021, Prothrombin time: 28.2 28.2. On 26-Jun-2021, Prothrombin time ratio: 2,61 (normal) 2,61. On 26-Jun-2021, Red blood cell count: 3.43 (Low) 3.43. On 26-Jun-2021, White blood cell count: 9.5 (normal) 9.5. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Patient lab test includes activated partial thromboplastin time is not coagulated on 23-Jun-2021. 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.; 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: Embolism lung


VAERS ID: 1573826 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-10
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Immune thrombocytopenia, Pulmonary haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 35
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPINE
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210807044

Write-up: LUNG HEMORRHAGE; SEVERE BLEEDING COMPLICATIONS OF SYMPTOMATIC STEROID-REFRACTORY THROMBOCYTOPENIA (ITP); This spontaneous report received from a health care professional via a Regulatory Authority concerned a 59 year old male. The patient''s weight was 72 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 dosage forms, 1 total, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included amlodipine for drug used for unknown indication. On 10-JUN-2021, the patient experienced severe bleeding complications of symptomatic steroid-refractory thrombocytopenia (itp). On 29-JUN-2021, the patient experienced lung hemorrhage. On an unspecified date, patient was hospitalized. Number of days of hospitalization was not reported. It was unknown if patient was discharged. On 15-JUL-2021, the patient died from unknown cause of death. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of lung hemorrhage and severe bleeding complications of symptomatic steroid-refractory thrombocytopenia (itp) on 15-JUL-2021. This report was serious (Death, Hospitalization Caused / Prolonged, Life Threatening, and Disability Or Permanent Damage).; Sender''s Comments: V0: 20210807044-Covid-19 vaccine ad26.cov2.s-lung hemorrhage severe bleeding complications of symptomatic steroid-refractory thrombocytopenia (itp). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1573852 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Propranolol 40; novaminsulfon 500; Keppra 250 mg; acetylsalicylic acid 100
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial occlusive disease; Cranioencephalic trauma; Grand mal; Hemiparesis; Korsakoff''s syndrome; Nicotine abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEDCGMA21189997

Write-up: Death; Lung embolism; This case was received via Regulatory Authority (Reference number: 202100064309) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) and PULMONARY EMBOLISM (Lung embolism) in a 63-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for Prophylactic vaccination. The patient''s past medical history included Korsakoff''s syndrome, Cranioencephalic trauma in 1989, Arterial occlusive disease, Grand mal, Hemiparesis and Nicotine abuse. Concomitant products included propranolol hydrochloride (propranolol 40), metamizole sodium, levetiracetam and acetylsalicylic acid for an unknown indication. On 26-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and PULMONARY EMBOLISM (Lung embolism) (seriousness criteria death and medically significant). The patient died on 28-Apr-2021. The reported cause of death was Lung embolism. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route), the reporter did not provide any causality assessments. No treatment medication was provided. Very limited information regarding these events have been provided at this time. No further follow up information is expected.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1574671 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-06-09
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Autopsy, Cardiac arrest, Cardiogenic shock, Death, Myocarditis
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Myocarditis; Cardiac arrhythmia; Heart arrest; This case was received via Regulatory Authority (Reference number: 202100134159) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis), ARRHYTHMIA (Cardiac arrhythmia) and CARDIAC ARREST (Heart arrest) in a 65-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002620) for an unknown indication. No Medical History information was reported. On 27-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria death and medically significant), ARRHYTHMIA (Cardiac arrhythmia) (seriousness criteria death and medically significant) and CARDIAC ARREST (Heart arrest) (seriousness criteria death and medically significant). The patient died on 09-Jun-2021. The reported cause of death was Myocarditis. An autopsy was performed. The autopsy-determined cause of death was cardiogenic shock in acute left ventricular myocardial infarction. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up information received on 04-Aug-2021 and contains no new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Myocarditis; Autopsy-determined Cause(s) of Death: cardiogenic shock in acute left ventricular myocardial infarction


VAERS ID: 1574673 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Lung embolism; Thrombosis; This case was received via Regulatory Authority (Reference number: 202100135167) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of PULMONARY EMBOLISM (Lung embolism) and THROMBOSIS (Thrombosis) in a 68-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 10-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Lung embolism) (seriousness criteria death, medically significant and life threatening) and THROMBOSIS (Thrombosis) (seriousness criteria death, medically significant and life threatening). The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Company Comment: Very limited information regarding this events has been provided at this time. Further information will not be requested.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information will not be requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1574709 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-06-25
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100146583

Write-up: Myocarditis; Sudden cardiac death; This case was received via Regulatory Authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) and SUDDEN CARDIAC DEATH (Sudden cardiac death) in a 56-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002183) for COVID-19 vaccination. No Medical History information was reported. On 20-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria death, hospitalization and medically significant) and SUDDEN CARDIAC DEATH (Sudden cardiac death) (seriousness criteria death, hospitalization and medically significant). The patient died on 25-Jun-2021. An autopsy was performed. The autopsy-determined cause of death was lymphozyt?re myokarditis. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications reported. Autopsy was done on 07-JUL-2021. No treatment medications reported. Company Comment: Very limited information regarding this event has been provided at this time. Further information will not be requested.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information will not be requested.; Autopsy-determined Cause(s) of Death: Lymphozyt?re Myokarditis


VAERS ID: 1574714 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003609 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pulmonary embolism, Somnolence, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Syncope; Groggy; This case was received via Regulatory Authority (Reference number: 202100148174) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of PULMONARY EMBOLISM, SYNCOPE and SOMNOLENCE (Groggy) in a 37-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3003609) for an unknown indication. No Medical History information was reported. On 29-Jun-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (seriousness criteria death, hospitalization and medically significant), SYNCOPE (Syncope) (seriousness criterion medically significant) and SOMNOLENCE (Groggy) (seriousness criterion medically significant). The patient died on an unknown date. The reported cause of death was Lung embolism. It is unknown if an autopsy was performed. At the time of death, SYNCOPE (Syncope) and SOMNOLENCE (Groggy) had not resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medications were provided. Reporter''s Sender''s Comments: Very limited information has been provided at this time. Translation has been requested.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1574753 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dyspnoea, Off label use, Product use issue, Pulmonary embolism
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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Medication errors (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101010375

Write-up: fulminant pulmonary artery embolism; increasing dyspnea with cardiac arrest; increasing dyspnea with cardiac arrest; Patient received first dose of VAXZEVRIA(non pfizer vaccine) and Eventually received Comirnaty(pfizer vaccine); Patient received first dose of VAXZEVRIA(non pfizer vaccine) and Eventually received Comirnaty(pfizer vaccine); This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority [DE-PEI-202100156003]. A 54-year-old male patient (weight 130 kg, and height 185 cm) received bnt162b2 (COMIRNATY) via an unspecified route of administration on 21Jul2021 (Batch/Lot Number: FF0900) as DOSE 2, SINGLE for covid-19 immunisation; covid-19 vaccine (VAXZEVRIA), via an unspecified route of administration on 18May2021 (Batch/Lot number was not reported) at DOSE 1, SINGLE for covid-19 immunisation. Medical history included obesity and Arterial hypertension. The patient''s concomitant medications were not reported. This report is serious - death, hospitalization, life threatening. On 21Jul2021 the patient experienced Dyspnoea. On 26Jul2021 the patient experienced Lung embolism. The patient''s outcome was: fatal for Dyspnoea and Lung embolism and cardiac arrest. The patient died on 27Jul2021. It was not reported if an autopsy was performed. Senders comment: Pulmonary embolism with cardiac arrest, rescue lysis and Extracorporeal Life Support with Venoarterial Extracorporeal Membrane Oxygenation. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Lung embolism; Dyspnoea; cardiac arrest; cardiac arrest


VAERS ID: 1574754 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-06-09
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary heart disease (stable)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101009957

Write-up: Sudden cardiac death; This is a spontaneous report from a non-contactable physician downloaded from the Agency WEB regulatory authority DE-PEI-202100156054. A 63-years-old male patient received second dose of BNT162B2 (COMIRNATY) via unspecified route on 05May2021 (Lot Number: EX8679) 0.3 ml single for COVID-19 immunisation. Medical history included coronary heart disease (stable). The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY) 0.3 ml single for COVID-19 immunisation on 07Apr2021. The patient experienced sudden cardiac death (death, life threatening) on 09Jun2021. The patient died on 09Jun2021. It was unknown if an autopsy was performed. Relatedness of BNT162B2 to event by RA was assessed as unclassifiable. Sender Comment: known CHD, but was stable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1574755 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Angiocardiogram, Asthenia, Babinski reflex test, Brain herniation, Cerebral venous sinus thrombosis, Coagulation factor, Computerised tomogram head, Confusional state, Dizziness, Generalised tonic-clonic seizure, Glycosylated haemoglobin, Headache, Hemiparesis, Interchange of vaccine products, Muscular weakness, Neck pain, Off label use, Platelet count
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus with ketoacidosis; Erectile dysfunction; Hyperglycaemia
Allergies:
Diagnostic Lab Data: Test Name: partial thromboplastin time; Result Unstructured Data: Test Result:full anticoagulation was carried out; Test Name: coronary computed tomography angiography; Result Unstructured Data: Test Result:increase in congestive bleeding; Comments: with accompanying cerebral edema with persistent extensive sinus thrombosis despite therapeutic anticoagulation.; Test Name: Babinski reflex; Test Result: Positive ; Comments: on the right; Test Name: coagulation; Result Unstructured Data: Test Result:normal; Test Name: cranial computed tomography; Result Unstructured Data: Test Result:increase in congestive bleeding; Comments: with accompanying cerebral edema with persistent extensive sinus thrombosis despite therapeutic anticoagulation.; Test Name: HBA1c; Test Result: 11.4 %; Test Name: Platelets; Result Unstructured Data: Test Result:normal
CDC Split Type: DEPFIZER INC202101009973

Write-up: Hemiparesis; Tonic-clonic convulsion/generalized tonic-clonic seizure; Weakness; slight weakness in his left arm and leg; Neck pain; Light headedness; Thrombosis of venous sinuses; headache; confused; Brain stem herniation; 1st dose VAXZEVRIA/2nd dose COMIRNATY; 1st dose VAXZEVRIA/2nd dose COMIRNATY; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority. Report number; DE-PEI-202100156056. A 38-year-old male patient received 1st dose of BNT162B2 (COMIRNATY) at single dose on 19Jul2021 as second vaccination at 38-year-old via an unknown route for COVID-19 immunisation, and 1st dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (VAXZEVRIA) at single dose on an unknown date in May2021 as first vaccination via an unknown route for prophylactic vaccination. The patient''s medical history included Erectile dysfunction (ED), diabetes mellitus with ketoacidosis and hyperglycaemia. Concomitant drug was not provided. On 15Jul2021 patient experienced first time neck pain (also reported as patient experienced Cervical pain after Vaxzevria vaccination in May2021). On 22Jul2021 the patient experienced neck pain aggravated, light headedness. On 23Jul2021 the patient experienced weakness. On 26Jul2021 the patient experienced hemiparesis, tonic-clonic convulsion. The patient also experienced thrombosis of venous sinuses on an unknown date in Jul2021. The clinical course was reported as follows: Cranial computed tomography (CCT), Coronary computed tomography angiography (CCT-A) with diagnoses: extensive thrombosis of the superior sagittal sinus, the right transverse and sigmoid sinus, as well as several superficial bridging veins bihemispherically. congestive bleeding right occipital and left frontal cerebral edema, brainstem entrapment. Patient reported since 15Jul2021 about neck pain that was why he had been to the massage. From 22Jul2021 the neck pain increased, there was an unspecific dizziness. Since Friday, 23Jul2021, he also noticed a slight weakness in his left arm and leg, which was why he had problems with walking. He felt increasingly bad over the weekend. Due to persistent neck pain, he presented himself to the emergency room on Sunday. There he received an analgesic for the existing neck pain. On Monday, 26Jul2021 the patient presented himself with persistent weakness, neck pain and hemiparesis and suffered a generalized tonic-clonic seizure which ceased after administration of 10 mg midazolam. This was followed by an interview with the emergency doctor in the PRIVACY Clinic. On arrival the patient was awake, there was a hemiparesis on the left, a neglect to the left and a positive Babinski reflex on the right. When asked, the patient denied headaches. The patient was admitted while still awake and oriented, a Partial Thromboplastin Time-controlled full anticoagulation was carried out, and the already-started antiepileptic therapy was continued. The coagulation was normal on admission, the platelets were normal. On admission there was also diabetic ketoacidosis with Erectile dysfunction (ED) of diabetes mellitus with a HBA 1c of 11.4%, the therapy was carried out with fluids, insulin and close electrolyte controls, as well as electrolyte substitution. In the course of this, the headache continued to increase, and the patient became confused and had to be intubated. Several Cranial computed tomography (CCT) and Coronary computed tomography angiography (CCT-A) controls showed an increase in congestive bleeding with accompanying cerebral edema with persistent extensive sinus thrombosis despite therapeutic anticoagulation. Ultimately, under maximum therapy, there was Brain stem herniation. It remains unclear whether the previous vaccination was related to the sinus thrombosis; the patient certainly had other risk factors. Nevertheless, a notification according to Institute of Side effects has been made about a possible vaccination complication, but the batch number of the vaccination could not be determined. Outcome of thrombosis of venous sinuses was fatal. Patient died on 28Jul2021. Outcome of the other events was unknown. This report was serious with seriousness of death, hospitalization, life threatening. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Thrombosis of venous sinuses


VAERS ID: 1574756 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cor pulmonale, Echocardiogram, Fibrin D dimer, Inappropriate schedule of product administration, Interchange of vaccine products, Off label use, Pulmonary embolism
SMQs:, Cardiac failure (narrow), Embolic and thrombotic events, venous (narrow), Pulmonary hypertension (narrow), Medication errors (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Echocardiography; Result Unstructured Data: Test Result:Pulmonary heart disease; Test Name: D-dimer; Result Unstructured Data: Test Result:increased
CDC Split Type: DEPFIZER INC202101010060

Write-up: Lung embolism; pulmonary heart disease; COMIRNATY as second vaccination / VAXZEVRIA as 1st vaccination; COMIRNATY as second vaccination / VAXZEVRIA as 1st vaccination; second vaccination on 16Jul2021 / 1st vaccination on 04May2021; This is a spontaneous report from a non-contactable other health care professional downloaded from the Regulatory Authority. Report number; E-PEI-202100156059. A female patient of an unknown age received 1st dose of BNT162B2 (COMIRNATY, lot number FF0900) at single dose as second vaccination on 16Jul2021 for COVID-19 immunisation, and 1st dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (VAXZEVRIA) at single dose as 1st vaccination on 04May2021 for prophylactic vaccination. Medical history and concomitant drug were not provided. The patient experienced also lung embolism. Lab data included D-Dimer increased and Echocardiography revealed pulmonary heart disease. Outcome of lung embolism was fatal. Patient died on an unknown date (also reported unknown cause of death). It was unknown if autopsy was performed. Outcome of the other events was unknown. This report was serious with seriousness criteria of death, hospitalization, life threatening. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: lung embolism


VAERS ID: 1574757 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-16
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Chest X-ray, Dyspnoea, Inflammatory marker test, Pneumonia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: thorax x-ray; Result Unstructured Data: Test Result:infiltrate; Test Name: Infection values; Result Unstructured Data: Test Result:increased; Comments: laboratory
CDC Split Type: DEPFIZER INC202101009926

Write-up: Pneumonia; Dyspnoea; Acute kidney failure; This is a spontaneous report from a non-contactable physician downloaded from the Agency WEB DE-PEI-202100156064. An 87-year-old female patient received BNT162B2 (COMIRNATY, lot number EX8679) at 0.3 ml single dose via an unknown route on 05May2021 at 87-year-old for COVID-19 immunisation. Medical history and concomitant drug were not provided. On 16May2021 the patient experienced dyspnoea, acute kidney failure, and pneumonia. Lab data included infection values increased (laboratory), chest X-ray infiltrate. Patient died on 04Jun2021. The patient''s outcome was fatal (it was also reported that patient died of unknown cause of death). This report was serious with seriousness criteria of death, hospitalization, life threatening. No follow-up attempts are possible; No further information is expected.; Reported Cause(s) of Death: Pneumonia; dyspnoea; acute kidney failure


VAERS ID: 1574958 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 87
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: 202100134331) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of THROMBOSIS in a 45-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced THROMBOSIS (seriousness criteria death and medically significant). The patient died on 12-Jul-2021. The reported cause of death was Clot blood. An autopsy was not performed. Concomitant medication was not provided. Treatment information was not provided. Company comment: This case concerns a 45 year-old male patient who experienced the fatal unexpected event of thrombosis on the vaccination day. The patient died 2 months and 27 days after receiving the dose of the mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time. Translation has been requested.; Sender''s Comments: This case concerns a 45 year-old male patient who experienced the fatal unexpected event of thrombosis on the vaccination day. The patient died 2 months and 27 days after receiving the dose of the mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time. Translation has been requested.; Reported Cause(s) of Death: Clot blood


VAERS ID: 1574990 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2017-07-01
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0932 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Angiogram, Blood fibrinogen, Cardiac arrest, Cerebral artery occlusion, Cerebral thrombosis, Coma scale, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram thorax, Depressed level of consciousness, Diarrhoea, Echocardiogram, Electroencephalogram, Fibrin D dimer, Loss of consciousness, Malaria antigen test, Neurological examination, Platelet count, Polymerase chain reaction, Respiratory arrest, SARS-CoV-2 test, Smear test, Thrombocytopenia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 1487
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: Cerebral malaria (Returned from traveling 2 weeks ago. Positive for infections with Plasmodium Falciparum and Ovale)
Preexisting Conditions: Medical History/Concurrent Conditions: Plasmodium falciparum infection; Plasmodium ovale infection
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: CT angiography; Result Unstructured Data: Test Result:No signs of Pulmonary embolism; Test Date: 20210727; Test Name: Fibrinogen; Result Unstructured Data: Test Result:01.50 am: 12.1 not specified; Test Date: 20210727; Test Name: Fibrinogen; Result Unstructured Data: Test Result:05.00 am: 11.3 not specified; Test Date: 20210726; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:3 not specified; Test Date: 20210726; Test Name: Computerised tomogram abdomen; Result Unstructured Data: Test Result:Nothing abnormal; Test Date: 20210726; Test Name: CT brain scan; Result Unstructured Data: Test Result:No blood supply to the brain; Test Date: 20210726; Test Name: Computerised tomogram thorax; Result Unstructured Data: Test Result:Bilateral infiltrates of the lungs.; Test Date: 20210726; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Normal EF pump function; Test Date: 20210726; Test Name: Electroencephalogram; Result Unstructured Data: Test Result:No electrical activity in the cerebral cortex; Test Date: 20210726; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:02:39 pm: 2.2 not specified; Test Date: 20210727; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:01.50 am: 4.9 not specified; Test Date: 20210727; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:05.00 am: 4.2 not specified; Test Date: 20210726; Test Name: Malaria antigen test; Result Unstructured Data: Test Result:positive for Plasmodium Falciparum and Oval; Test Date: 20210727; Test Name: Neurological examination; Result Unstructured Data: Test Result:revoked brainstem reflexes - clinical braindead; Test Date: 20210727; Test Name: Neurological examination; Result Unstructured Data: Test Result:Two independent examinations; Test Date: 20210726; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:71 not specified; Test Date: 20210727; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:51 not specified; Test Date: 20210726; Test Name: PCR; Result Unstructured Data: Test Result:PCR positive for Plasmodium Falciparum and Ovale; Test Date: 20210726; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Two times with negative results; Test Date: 20210726; Test Name: Smear; Result Unstructured Data: Test Result:Malaria smear positive for Plasmodium Falciparum; Test Date: 20210726; Test Name: Smear; Result Unstructured Data: Test Result:and Ovale. Parasit infectionsdegree around 1%
CDC Split Type: DKPFIZER INC202101010166

Write-up: Lost blood supply to the brain; OBS Cerebral thrombosis; Respiratory arrest; Not contactable (GCS 3); Vaccine-induced Immune thrombosis and thrombocytopenia (VITT); Unconscious; Cardiac arrest; Abdominal pain; Vomiting for some days; Diarrhea over some days; This is a spontaneous report from a contactable physician and another physician downloaded from the Regulatory Authority, regulatory authority number DK-DKMA-WBS-0081270. A 55-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 20Jul2021 (Batch/Lot Number: FD0932) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included cerebral malaria (Returned from traveling 2 weeks ago. Positive for infection with Plasmodium Falciparum and Ovale) from 26Jul2021. The patient''s concomitant medications were not reported. The patient previously took Comirnaty, dose 1 intramuscular on 14Jun2021 (Batch/Lot Number: FC2336) as single dose for COVID-19 immunisation. On 26Jul2021, 6 days after the 2nd vaccination, the patient developed Thrombocytopenia, Cerebral artery occlusion, Cerebral thrombosis, Respiratory arrest, Cardiac arrest, Unconscious and Consciousness decreased. In Jul2021 the patient experienced Diarrhea, Vomiting and Abdominal pain. The ADRs were by the reporter reported resulting in hospitalisation on 26Jul2021, being life threatening and Fatal on 27Jul2021 (as reported). The patient was first treated with empirical antibiotics (not specified) and several antidots (not specified) without any effect. The patient was intubated at connected to a respirator. Later the patient was treated for malaria with Artesunate. The ADR Cardiac arrest was recovered on 26Jul2021. The ADRs Consciousness decreased, Vomiting, Abdominal pain, Unconscious and Diarrhea have an unknown outcome. The outcome of ADRs Cerebral artery occlusion, Cerebral thrombosis, Respiratory arrest and Thrombocytopenia were fatal on 27Jul2021. Reported causes of death: Thrombocytopenia, Cerebral artery occlusion, Cerebral thrombosis, Respiratory arrest and Cerebral malaria. Autopsy has been requested, and results are awaited. Causality: The original reporter stated that the findings from Computerised tomogram thorax can be seen with infection with COVID-19. The original reporter stated that treatment was stopped after two neurologists had identified the patient as braindead and further treatment was stopped. The other reporter stated that they primarily suspect the infection with malaria as being the reason for the patient''s condition, but that they cannot rule out that vaccination may have contributed to the development of VITT and the symptoms of a cerebral thrombosis. The thrombocytopenia can be due to the infection with malaria alone, but she will not rule out COMIRNATY. The physician is uncertain if the vaccine and malaria infection may have enhanced each other and caused stronger symptoms. The patient underwent lab tests and procedures which included CT brain scan, 26Jul2021: No blood supply to the brain; Computerised tomogram thorax, 26Jul2021: Bilateral infiltrates of the lungs; CT angiography, 26Jul2021, No signs of Pulmonary embolism; Computerised tomogram abdomen, 26Jul2021: Nothing abnormal; Echocardiogram, 26Jul2021: Normal EF pump function; Glasgow coma scale, 26Jul2021: 3 unit not specified; Electroencephalogram, 26Jul2021: No electrical activity in the cerebral cortex; COVID-19 PCR test, 26Jul2021: Two times with negative results; Thrombocyte count, 26Jul2021: 71 unit not specified; Thrombocyte count,27Jul2021: 51 unit not specified; Fibrin D dimer, 26Jul2021: 02:39 pm: 2.2 unit not specified; Fibrin D dimer,27Jul2021: 01.50 am: 4.9 unit not specified; Fibrin D dimer, 27Jul2021: 05.00 am: 4.2 unit not specified; Fibrinogen, 27Jul2021: 01.50 am: 12.1 unit not specified; Fibrinogen, 27Jul2021: 05.00 am: 11.3 unit not specified; Malaria antigen test, 26Jul2021: positive for Plasmodium Falciparum and Oval; Smear, 26Jul2021: Malaria smear positive for Plasmodium Falciparum and Ovale. Parasite infections degree around 1%; PCR, 26Jul2021: PCR positive for Plasmodium Falciparum and Ovale; Neurological examination, 27Jul2021, Two independent examinations - revoked brainstem reflexes - clinical braindead; Results for PF-4 awaits. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Cerebral artery occlusion; Cerebral thrombosis; Respiratory arrest; Thrombocytopenia; Cerebral malaria


VAERS ID: 1575016 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002339 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrioventricular block complete
SMQs:, Conduction defects (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIOVENTRICULAR BLOCK in a 54-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002339) for COVID-19 vaccination. No Medical History information was reported. On 24-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 30-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ATRIOVENTRICULAR BLOCK COMPLETE (seriousness criteria death and medically significant). The patient died on 30-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was withdrawn on 24-May-2021. Concomitant product was not provided by the reporter. Treatment information was not provided. Company Comment: This is a case of death in a 54-year-old male subject, who died 7 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 54-year-old male subject, who died 7 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575036 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-04-04
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy bronchus, Chronic obstructive pulmonary disease, Computerised tomogram, Disease recurrence, Haemoglobin, Haemoptysis, International normalised ratio, Organising pneumonia, Platelet count, Pulmonary embolism, Pulmonary haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (broad), Embolic and thrombotic events, venous (narrow), Eosinophilic pneumonia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 18
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: PREDNISOLON [PREDNISOLONE]; GHEMAXAN; ERDOPECT; XARELTO; PANTOPRAZOL [PANTOPRAZOLE]; IPRATROPIUM/SALBUTAMOL CIPLA; TARGINIQ
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anticoagulant therapy; Atrial fibrillation; COPD; Coronary heart disease; Hemoptysis
Allergies:
Diagnostic Lab Data: Test Name: Bronchoscopy samples; Result Unstructured Data: Test Result:no evidence of tuberculosis; Test Name: CT scan; Result Unstructured Data: Test Result:there was dense shading in the upper right block; Comments: there was dense shading in the upper right block, suitable as a bleeding area, but suspicion of lung cancer or tuberculosis also arose. In addition, a small pulmonary embolism was found.; Test Name: Hemoglobin; Result Unstructured Data: Test Result:87; Comments: The lowest value during the treatment period was 87; Test Date: 20210405; Test Name: Hemoglobin; Result Unstructured Data: Test Result:127; Comments: after acute haemorrhage on the day of admission ranged from 87 to 116.; Test Date: 20210422; Test Name: Hemoglobin; Result Unstructured Data: Test Result:93; Comments: on the morning of the day of death, when the haemorrhage had just started again, 93.; Test Date: 20210404; Test Name: INR; Result Unstructured Data: Test Result:2.2-1.9; Comments: on arrival (Xarelto medication on discontinuation); Test Date: 20210422; Test Name: INR; Result Unstructured Data: Test Result:1.4-1.1; Comments: on the morning of the day of death; Test Name: Thrombocyte; Result Unstructured Data: Test Result:200; Test Date: 20210409; Test Name: Thrombocyte; Result Unstructured Data: Test Result:122; Test Date: 20210422; Test Name: Thrombocyte; Result Unstructured Data: Test Result:475; Comments: on the morning of death
CDC Split Type: FIPFIZER INC202101010279

Write-up: acute severe hemoptysis; acute severe hemoptysis; COPD; Pulmonary embolism; Pulmonary haemorrhage; Organising pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FI-FIMEA-20213734. An 80-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 16Mar2021 at single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), coronary heart disease, atrial fibrillation, anticoagulant therapy, and haemoptysis from 2018 (then no specific cause was found, it was suspected to be related to COPD). Concomitant medications included prednisolone (PREDNISOLON) for COPD from 16Apr2021, enoxaparin sodium (GHEMAXAN) for pulmonary embolism from 09Apr2021, erdosteine (ERDOPECT), rivaroxaban (XARELTO) from an unspecified start date to 04Apr2021, pantoprazole (PANTOPRAZOL) from 09Apr2021, ipratropium bromide/salbutamol sulfate (IPRATROPIUM/SALBUTAMOL CIPLA), and naloxone hydrochloride/oxycodone hydrochloride (TARGINIQ) from 12Apr2021. The patient experienced pulmonary embolism, pulmonary haemorrhage, and organising pneumonia on 04Apr2021. On 04Apr2021, patient was hospitalized due to acute severe hemoptysis. On CT scan, there was a dense shadowing in the right upper lobe consistent with a bleeding area, but there was also suspicion of lung cancer or tuberculosis. A small pulmonary embolism was also found. On admission with haemorrhage, lifelessness and with resuscitation recovered. The hemoptysis recurred on 22Apr2021 very severe and the patient died at this time. Bronchoscopy samples taken from the bronchial aspiration specimens showed no evidence of tuberculosis. Results from obduction now obtained and surprisingly no suspected cancer was found in the lungs nor any other explanatory cause for the haemorrhage. The patient case was discussed together with the forensic team now that the obductomy result had been received. It was considered that it highly unlikely that there was a link to the coronary vaccine, as the patient had a history of hemoptysis and had both COPD and anticoagulant therapy, but it was decided to report a possible adverse reaction of the vaccine. The death certificate was written with the underlying cause of death being COPD and the immediate cause of death being pulmonary haemorrhage. Pulmonary embolism and secondary organizing pneumonia found on obduction as contributing factors. 28Jul2021 follow-up physician: Hemoglobin on admission 05Apr2021 was 127; after acute haemorrhage on the day of admission ranged from 87 to 116. The lowest value during the treatment period was 87 and on the morning of the day of death, when the haemorrhage had just started again, 93. Thrombocytes 200-122 (= lowest value on 09Apr2021) - 475 on the morning of death. INR 2.2-1.9 upon admission (rivaroxaban (XARELTO) medication stopped on admission) - then 1.4 - 1.1 on the morning of death. The patient died on 22Apr2021. Outcome of event hemoptysis was unknown. Autopsy has been done. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Sender''s Comments: based on trhe available information the causality between the fatal events Pulmonary embolism ,secondary organizing pneumonia , pulmonary haemorrhage,hemoptysis ,COPD, and the suspect vaccine BNT162B2 cannot be ruled out completely; Reported Cause(s) of Death: Pulmonary embolism; Organising pneumonia; COPD; Pulmonary haemorrhage


VAERS ID: 1575154 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2296 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Aspartate aminotransferase, Asthenia, Back pain, Bilirubin conjugated, Blood bicarbonate, Blood bilirubin unconjugated, Blood creatinine, Blood fibrinogen, Blood iron, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, C-reactive protein, Cardiovascular examination, Computerised tomogram, Coombs direct test, Death, Diarrhoea, Echocardiogram, HIV test, Haemolytic anaemia, Haptoglobin, Heart rate, Hepatitis B virus test, Hepatitis C virus test, Immunology test, Influenza like illness, Interchange of vaccine products, Legionella test, Lymphocyte count, Malaise, Mean cell volume, Myalgia, Neutrophil count, Off label use, PCO2, PO2, Platelet count, Prothrombin level, Prothrombin time ratio, Pulmonary embolism, Pyrexia, Red blood cell schistocytes, Reticulocyte count, Serum ferritin, Soluble fibrin monomer complex, Total complement activity test, Troponin, Viral test, Vomiting, White blood cell count, Wrong product administered, pH body fluid
SMQs:, Rhabdomyolysis/myopathy (broad), Haemolytic disorders (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 6
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: Cutaneous vasculitis; Idiopathic thrombocytopenic purpura (with favorable evolution under corticotherapy)
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: ALT; Result Unstructured Data: Test Result:524 IU/l; Test Date: 20210718; Test Name: anti-polynuclear cytoplasm; Result Unstructured Data: Test Result:negative; Test Date: 20210718; Test Name: antinuclear; Result Unstructured Data: Test Result:negative; Test Date: 20210718; Test Name: AST; Result Unstructured Data: Test Result:753 IU/l; Test Date: 20210718; Test Name: conjugated bilirubin; Result Unstructured Data: Test Result:22 umol/l; Test Date: 20210718; Test Name: bicarbonate; Result Unstructured Data: Test Result:25.3 mmol/L; Test Date: 20210718; Test Name: free bilirubin; Result Unstructured Data: Test Result:16 umol/l; Test Date: 20210718; Test Name: creatinine; Test Result: 52 umol; Test Date: 20210718; Test Name: fibrinogen; Result Unstructured Data: Test Result:less than 0.4 g/l; Test Date: 20210718; Test Name: anemia; Result Unstructured Data: Test Result:2.5 g/dl; Test Date: 20210718; Test Name: kalemia; Result Unstructured Data: Test Result:3.4 mmol/L; Test Date: 20210718; Test Name: blood pressure; Result Unstructured Data: Test Result:140 per 80 mmHg; Test Date: 20210718; Test Name: natraemia; Result Unstructured Data: Test Result:131 mmol/L; Test Date: 20210718; Test Name: uremia; Result Unstructured Data: Test Result:6.1 mmol/L; Test Date: 20210718; Test Name: body temperature; Result Unstructured Data: Test Result:apyretic; Test Date: 20210718; Test Name: cardiovascular examination; Result Unstructured Data: Test Result:regular heart sounds; Comments: regular heart sounds without perceived murmur, no chest pain, soft and painless calves, no edema of the lower limbs, no sign of peripheral hypoperfusion, clear and symmetrical pulmonary auscultation, polypnea without sign of struggle, soft abdomen, depressible, painless, mucocutaneous jaundice; Test Date: 20210718; Test Name: tap scan; Result Unstructured Data: Test Result:no pulmonary embolism; Comments: no pulmonary embolism, doubt on portal thrombosis, hepatomegaly, peritoneal effusion; Test Date: 20210718; Test Name: Coombs; Result Unstructured Data: Test Result:intense cold agglutinins; Comments: intense cold agglutinins not allowing typing of hemolytic anemia; Test Date: 20210718; Test Name: CRP; Result Unstructured Data: Test Result:17.8 mg/l; Test Date: 20210718; Test Name: trans-thoracic echocardiography; Result Unstructured Data: Test Result:suspicion of pulmonary embolism; Comments: suspicion of pulmonary embolism in front of right heart signs; Test Date: 20210718; Test Name: trans-thoracic echocardiography; Result Unstructured Data: Test Result:clear regression of dilatation and right ventricul; Test Date: 20210718; Test Name: haptoglobin; Result Unstructured Data: Test Result:collapsed; Test Date: 20210718; Test Name: heart rate; Result Unstructured Data: Test Result:116; Comments: bpm; Test Date: 20210718; Test Name: HBV serology; Test Result: Negative ; Test Date: 20210718; Test Name: HCV serology; Test Result: Negative ; Test Date: 20210718; Test Name: HIV test; Test Result: Negative ; Test Date: 20210718; Test Name: Immunofixation of serum proteins; Result Unstructured Data: Test Result:no monoclonal immunoglobulin or light chain; Test Date: 20210718; Test Name: legionella; Test Result: Negative ; Test Date: 20210718; Test Name: lymphocytes; Result Unstructured Data: Test Result:7.29; Comments: Giga per liter; Test Date: 20210718; Test Name: mean corpuscular volume; Result Unstructured Data: Test Result:78; Comments: fl; Test Date: 20210718; Test Name: polynuclear neutrophil; Result Unstructured Data: Test Result:7.4 x10 9/l; Comments: Giga per liter; Test Date: 20210718; Test Name: pco2; Result Unstructured Data: Test Result:27 mmHg; Test Date: 20210718; Test Name: ph; Result Unstructured Data: Test Result:7.58 pH units; Comments: respiratory alkalosis; Test Date: 20210718; Test Name: platelets; Result Unstructured Data: Test Result:138 x10 9/l; Comments: Giga per liter; Test Date: 20210718; Test Name: po2; Result Unstructured Data: Test Result:54 mmHg; Test Date: 20210718; Test Name: FII; Test Result: 26 %; Test Date: 20210718; Test Name: PT/APTT; Result Unstructured Data: Test Result:uninterpretable; Test Date: 20210718; Test Name: schizocyte count; Result Unstructured Data: Test Result:Two times negative; Test Date: 20210718; Test Name: reticulocytes; Result Unstructured Data: Test Result:122 x10 9/l; Comments: Giga per liter; Test Date: 20210718; Test Name: ferritin; Result Unstructured Data: Test Result:10000 ng/ml; Test Date: 20210718; Test Name: fibrin monomers; Result Unstructured Data: Test Result:105.24 ug/L; Test Date: 20210718; Test Name: CH50; Result Unstructured Data: Test Result:less than 15 IU/ml; Test Date: 20210718; Test Name: troponin; Result Unstructured Data: Test Result:593 ug/L; Test Date: 20210718; Test Name: lung swab; Result Unstructured Data: Test Result:PCR adenovirus, bocavirus; Comments: PCR adenovirus, bocavirus, bordetella pertussis, coronavirus, influenza, legionella, metapneumovirus, mycoplasma, parainfluenza virus, rhinovirus, enterovirus, RSV negative; Test Date: 20210718; Test Name: leukocytes; Result Unstructured Data: Test Result:18.5 x10 9/l; Comments: Giga per liter
CDC Split Type: FRPFIZER INC202101010659

Write-up: Feeling sick; Diarrhea; Emesis; Influenza like illness; fever; bilateral back pain; myalgias; asthenia; Death; Embolism pulmonary; Anaemia haemolytic; Interchange of vaccine products; Interchange of vaccine products; Wrong product administered; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-PO20213976. A 65-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 12Jul2021 (Lot Number: FE2296) as 0.3 ML SINGLE for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration from an unspecified date to an unspecified date, at DOSE 2, SINGLE for covid-19 immunisation (not administered). Medical history included Idiopathic thrombocytopenic purpura from 2011 with favorable evolution under corticotherapy, cutaneous vasculitis from 2015 to an unknown date. The patient''s concomitant medications were not reported. Patient previous received 1st IM injection of MODERNA vaccine (lot 3002543) on 27May2021 via Intramuscular for covid-19 immunisation. The patient experienced death on 18Jul2021, embolism pulmonary on 18Jul2021, anaemia haemolytic on 17Jul2021, all with fatal outcome. Influenza like illness on 16Jul2021 with outcome of recovered on 16Jul2021, fever on 16Jul2021 with outcome of unknown, bilateral back pain on 16Jul2021 with outcome of unknown , myalgias on 16Jul2021 with outcome of unknown , asthenia on 16Jul2021 with outcome of unknown , feeling sick on 17Jul2021 with outcome of recovered on 17Jul2021, diarrhea on 17Jul2021 with outcome of recovered on 17Jul2021, emesis on 17Jul2021 with outcome of recovered on 17Jul2021, interchange of vaccine products on 12Jul2021 with outcome of unknown. The patient died on 18Jul2021. Clinical course as follows: On 16Jul2021, influenza-like illness with fever, bilateral back pain, asthenia and myalgias. On 17Jul2021, persistent asthenia, recurrent malaise without loss of consciousness with prodromes, vomiting and diarrhea. Hospitalization on 18Jul2021 around 00:00. On admission, patient conscious and oriented, apyretic, BP 140/80mmHg, HR 116bpm, regular heart sounds without perceived murmur, no chest pain, soft and painless calves, no edema of the lower limbs, no sign of peripheral hypoperfusion, clear and symmetrical pulmonary auscultation, polypnea without sign of struggle, soft abdomen, depressible, painless, mucocutaneous jaundice. Biological workup on entry: anemia at 2.5g/dL, microcytic (MCV at 78fl), reticulocytes at 122G/L, platelets at 138G/L, CRP at 17.8mg/L, leukocytes at 18.5G/L with PNN at 7.4G/L and lymphocytes at 7.29G/L, natraemia at 131mmol/L, kalemia at 3.4mmol/L, creatinine 52uM, uremia 6.1mmol/L, AST 753IU/L, ALT 524IU/L, conjugated bilirubin 22umol/L, free bilirubin 16?mol/L, haploglobin collapsed, schizocyte count 2 times negative, ferritin 10000ng/mL. Blood gas on admission: respiratory alkalosis (pH 7.58) (pO2 54mmHg, pCO2 27mmHg, bicarbonates 25.3mmol/L) not compensated with moderate hypoxemia. Direct Coombs of 18Jul/2021: intense cold agglutinins not allowing typing of hemolytic anemia. Differential diagnoses: infectious hypothesis. HIV, HCV, HBV serology negative. Negative legionella/pneumococcal antigenuria. Protected distal lung specimen from 18Jul2021 : PCR adenovirus, bocavirus, bordetella pertussis, coronavirus, influenza, legionella, metapneumovirus, mycoplasma, parainfluenza virus, rhinovirus, enterovirus, RSV negative. Tumor hypothesis. Immunofixation of serum proteins on 18Jul2021: no monoclonal immunoglobulin or light chain. Autoimmune hypothesis. Autoimmune workup 18Jul2021: antinuclear negative, anti-native DNA negative, anti-polynuclear cytoplasm negative, CH50 <15IU/mL (N $g32). Evolution Initiation of oxygen therapy. On 18Jul2021 at 3:50 am, unconscious, bradycardic and hypotensive then cardiorespiratory arrest (ACR). cardiorespiratory arrest (ACR) recovered after a 10min low flow and 3mg of adrenaline. Thereafter, at least 5 episodes of cardiorespiratory arrest (ACR) rapidly recovered after administration of adrenaline and external cardiac massage. Relay with IV epinephrine electric syringe pump (PSE) at 3mg/h, administration of bicarbonates. trans-thoracic echocardiography (TTE) of 18Jul2021: suspicion of pulmonary embolism in front of right heart signs. Rescue thrombolysis by alteplase 10mg bolus then 90mg. Disappearance of bradycardia episodes, improvement of hemodynamics allowing a decrease of adrenalin to 2mg/h. Broad-spectrum antibiotic therapy with clarithromycin and cefotaxime. TAP scan of 18Jul2021: no pulmonary embolism, doubt on portal thrombosis, hepatomegaly, peritoneal effusion. Transfusion of reheated blood cells, initiation of hydrocortisone therapy 1mg/kg/d. Follow-up (Trans thoracic echocardiography) TTE: clear regression of dilatation and right ventricular dysfunction. Iterative cardiorespiratory arrest (ACR) with initial echocardiography with predominant right heart failure, regressed after salvage thrombolysis in favor of a pulmonary embolism despite normal angiogram. Biological workup on 18Jul2021 9:05 a.m.: TP/TCA uninterpretable, fibrinogen <0.4g/L, FII at 26%, VF at 2%, fibrin monomers at 105.24ug/L, troponin I at 593?g/L. TAP scan of 18Jul2021: no pulmonary embolism, doubt on portal thrombosis. Unfavorable evolution with hemodynamic instability of septic origin and multivisceral failure refractory to volemic resuscitation, transfusion and ino-vasopressor support related to probable mesenteric ischemia linked to the initial low flow. Death on 18Jul2021 at 18:20. Conclusion: Death at Day 6 (D6_ of the 2nd injection of the anti-COVID vaccine in a context of pulmonary embolism not objectified on imaging and hemolytic anemia. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1575155 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Multiple organ dysfunction syndrome
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), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   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: Congestive (dilated) cardiomyopathy; Hypertension arterial; Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Skull trauma
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210823446

Write-up: ARREST CARDIAC; MULTIORGAN FAILURE; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, FR-AFSSAPS-PP20211035] concerned a 62 year old male of unknown race and ethnicity. The patient''s weight was 75 kilograms, and height was 175 centimeters. The patient''s past medical history included skull trauma, and concurrent conditions included hypothyroidism, congestive (dilated) cardiomyopathy, and hypertension arterial. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C13-04, expiry: UNKNOWN) 1 dosage forms, 1 total, administered on 29-JUN-2021 for covid-19 vaccination. Drug start period 2 days. No concomitant medications were reported. On 30-JUN-2021, the patient had arrest cardiac and multiorgan failure which led to death on 04-JUL-2021. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of arrest cardiac and multiorgan failure on 04-JUL-2021. This report was serious (Death).; Sender''s Comments: V0- 20210823446- Covid-19 vaccine ad26.cov2.S ? Arrest cardiac, Multiorgan failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1575164 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1526 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Cardiac arrest, Cardiomegaly, Inappropriate schedule of product administration, Interchange of vaccine products
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (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), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101010345

Write-up: cardiac arrest; Interchange of vaccine products; Inappropriate schedule of vaccine administered; atheroma; cardiomegaly; This is a spontaneous report from a contactable other-HCP downloaded from the Regulatory Authority. The regulatory authority report number FR-AFSSAPS-RS20212536. A 48-year-old male patient received bnt162b2 (COMIRNATY) intramuscular on 05Jun2021 (Batch/Lot Number: FC1526) as DOSE 2, single for covid-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA), intramuscular from Mar2021 (Batch/Lot Number: Unknown) to Mar2021, at DOSE 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have history of covid. The patient had received a first dose of VAXZEVRIA in Mar2021. Case reported by the vaccination center manager, who had very little information in his possession: He reports the patient''s sudden death on 08Jun2021 a few days after receiving the 2nd dose of vaccine (COMIRNATY), administered on 05Jun2021, without further details. The patient became unwell while driving 3 days after receiving the 2nd dose. He died of a sudden cardiac arrest. An autopsy was performed. According to the family, the patient had no particular history or usual treatment. Additional information obtained by the CRPV from the forensic medicine department that performed the autopsy: At autopsy, the presence of atheroma was observed, as well as cardiomegaly (heart weight: 500 g). In total, sudden death of a 48-year-old man 3 days after Dose 2 (D2) Comirnaty; no known cardiac history or usual treatment but evidence of atheroma and cardiomegaly at autopsy. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: cardiac arrest; Autopsy-determined Cause(s) of Death: cardiomegaly (heart weight: 500 g); atheroma


VAERS ID: 1575179 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-07-01
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Death, Pulseless electrical activity, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Cardio-respiratory arrest; Electromechanical dissociation; Fibrillation ventricular; This case was received via Regulatory Authority (Reference number: TS20213218) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), PULSELESS ELECTRICAL ACTIVITY (Electromechanical dissociation) and VENTRICULAR FIBRILLATION (Fibrillation ventricular) in a 58-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 15-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria death and medically significant), PULSELESS ELECTRICAL ACTIVITY (Electromechanical dissociation) (seriousness criteria death and medically significant) and VENTRICULAR FIBRILLATION (Fibrillation ventricular) (seriousness criteria medically significant and life threatening). On 01-Jul-2021, VENTRICULAR FIBRILLATION (Fibrillation ventricular) had not resolved. The patient died on 01-Jul-2021. The reported cause of death was dissociation electromechanical. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information was reported by reporter. France Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-TS20213218. This case concerns a 58-year old female who experienced Cardio-respiratory arrest, Electromechanical dissociation and Fibrillation ventricular. The patient died 16 days after receiving the first dose of the vaccine. The reported cause of death was dissociation. It is unknown if an autopsy was performed. Very limited information regarding this event/s has been provided at this time.; Sender''s Comments: This case concerns a 58-year old female who experienced Cardio-respiratory arrest, Electromechanical dissociation and Fibrillation ventricular. The patient died 16 days after receiving the first dose of the vaccine. The reported cause of death was Electromechanical dissociation. It is unknown if an autopsy was performed. Very limited information regarding this event/s has been provided at this time.; Reported Cause(s) of Death: Dissociation Electromechanical.


VAERS ID: 1575183 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram thorax, Dyspnoea, Fatigue, Inappropriate schedule of product administration, Pulmonary embolism, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   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: FOSTAIR; CALCIUM AND COLECALCIFEROL; ASPIRIN [ACETYLSALICYLIC ACID]; ESOMEPRAZOLE; TAMSULOSIN; PREDNISOLONE; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (often breathless); Bronchiectasis (often breathless); Giant cell arteritis (Treated to good effect with high dose steroids, tapering dose by March 2021); Oesophageal stricture; Vasculitis
Allergies:
Diagnostic Lab Data: Test Date: 20210304; Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result:No evidence of PE
CDC Split Type: GBPFIZER INC202101014369

Write-up: Pulmonary embolism; Syncope; Fatigue; Dyspnoea; First dose on 15Jan2021, second dose on 31Mar2021; This is a spontaneous report from a contactable other healthcare professional and two physicians received from the Regulatory Authority report number is GB-MHRA-ADR 25758376. Safety Report Unique Identifier GB-MHRA-ADR 25758376. A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration on 31Mar2021 (at the age of 75-year-old) as single dose for covid-19 immunisation; zoledronic acid monohydrate (ACIDO ZOLEDRONICO TILLOMED), intravenous from 07Apr2021 to an unspecified date, at unknown dose for an unspecified indication. Medical history included giant cell arteritis (treated to good effect with high dose steroids, tapering dose by March 2021) from Dec2020, asthma (often breathless) from an unknown date, bronchiectasis (often breathless) from an unknown date, oesophageal stenosis from an unknown date, and vasculitis from an unknown date, all unknown if ongoing. Concomitant medications included beclometasone dipropionate, formoterol fumarate (FOSTAIR) taken for an unspecified indication from 11Feb2021 to an unspecified stop date; calcium carbonate, colecalciferol (CALCIUM AND COLECALCIFEROL) taken for an unspecified indication from Dec2020 to an unspecified stop date; aspirin (acetylsalicylic acid) taken for an unspecified indication from Dec2020 to an unspecified stop date; esomeprazole taken for an unspecified indication from 2008 to an unspecified stop date; tamsulosin taken for an unspecified indication from 2017 to an unspecified stop date; prednisolone taken for asthma, start and stop date were not reported; salbutamol taken for an unspecified indication from 2008 to an unspecified stop date. The patient previously received first dose of BNT162B2 on 15Jan2021 for COVID-19 Immunisation. The patient experienced pulmonary embolism and syncope on an unspecified date, fatigue and dyspnoea on 08Apr2021. Clinical course: 75 yr old male sudden death 17Apr2021 due to pulmonary embolus (PE). No previous history of venous thromboembolism (VTE). Previous Oesophageal stricture so oral bisphosphonate avoided -intravenous. 07Apr2021 at Hospital - planned zoledronic acid intravenous infusion (Tillomed) 5mg followed by severe fatigue/breathlessness the next day (could only walk a few steps) which persisted for about 6 days. He improved for 2 days then suddenly collapsed. Resuscitation unsuccessful. The reporters hypothesised that the combination of vasculitis (pre-coagulant state) + age + unusually severe fatigue from the Zoledronic acid infusion + perhaps the Pfizer vaccine all contributed to the PE. The patient underwent lab tests and procedures which included CT pulmonary angiogram: no evidence of PE on 04Mar2021. This case was reported as serious, serious criteria included death and hospitalization. The outcome of event pulmonary embolism was fatal, the rest of events outcome was unknown. The patient died on 17Apr2021. 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: Pulmonary embolus


VAERS ID: 1575273 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-04-27
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: Covid-19 test; Test Result: Positive; Comments: Variant sequenced B.1.1.7; N501Y positive.
CDC Split Type: ATPFIZER INC202101016169

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB: AT-BASGAGES-2021-39222. An 82-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection, strength: 2 ml), dose 2 via an unspecified route of administration on 10Feb2021 (lot Number: EJ6134; Expiration Date: 30Apr2021) as single dose; and dose 1 via an unspecified route of administration on 20Jan2021 (lot Number: EL1491; Expiration Date: 30Apr2021) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. As reported, on 27Apr2021 the patient experienced Vaccination failure, other, SARS-CoV-2 infection. The patient underwent lab tests and procedures which included COVID-19 test: positive on 27Apr2021 with Variant sequenced B.1.1.7; N501Y positive. The patient died on an unspecified date. It was not reported if an autopsy was performed. On 10Aug2021, Investigation results was provided as conclusion: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EL1491. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed." Conclusion: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6134. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1575281 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure congestive, Dyspnoea
SMQs:, Cardiac failure (narrow), 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: ELIGARD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Prostate cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101022711

Write-up: Cardiac failure congestive; Dyspnoea; This is a Non-Interventional Study report from a contactable Consumer. This is a report received from the Regulatory Authority via an on-line database search. Regulatory authority report No 000940311. This information was initially reported to Regulatory Authority between 24Feb2021 and 06Apr2021 from an unknown Authorization Holder AER# unspecified A 95-year-old male subject received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; leuprorelin acetate (ELIGARD), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 22.5 mg, every 3 months; subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 22.5 mg, every 3 months for prostate cancer. Medical history included prostate cancer from an unknown date. The subject''s concomitant medications were not reported. The subject experienced cardiac failure congestive, dyspnoea on an unspecified date. The action taken in response to the event(s) for leuprorelin acetate was unknown. The outcome of the event was fatal. The subject died on an unspecified date. It was not reported if an autopsy was performed The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment Pfizer is the Marketing authorization holder of COVID-19 VACCINE in the country of incidence. This may be a duplicate report if another marketing authorization holder of COVID-19 VACCINE has submitted the same report to regulatory authorities. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events Cardiac failure congestive and Dyspnoea cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac failure congestive; Dyspnoea


VAERS ID: 1575289 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 36
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: Carcinoma lung
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Body temperature; Result Unstructured Data: Test Result:increased
CDC Split Type: CZPFIZER INC202101016235

Write-up: Cardiac arrest; Fever; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority number CZ-CZSUKL-21009017. A 67-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 25Mar2021 (Batch/Lot Number: Unknown) at the age of 67-years-old as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Carcinoma lung. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest (death, hospitalization, medically significant, life threatening) on 30Apr2021, fever (medically significant) on 25Mar2021. The clinical course as following: patient experienced the following adverse reactions after the administration of the first dose of the COMIRNATY vaccine (25Mar2021): Fever every day after vaccination. On 30Apr2021 patient died of cardiac arrest. An autopsy was not done. The patient underwent lab tests and procedures which included body temperature: increased on an unknown date in Mar2021. The outcome of the event fever was unknown, and the outcome of the event cardiac arrest was fatal. No follow-up attempts are possible. Information on batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1575290 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   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: Amyotrophic lateral sclerosis; Arterial hypertension; Hypercholesteraemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987802

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, company number DE-DCGMA-21189374. A 66-year-old female patient received BNT162B2 (COMIRNATY; lot number: ER9480) via an unspecified route of administration on 08Apr2021 as dose number unknown, single for COVID-19 immunisation. Medical history included arterial hypertension, amyotrophic lateral sclerosis and hypercholesteraemia. The patient''s concomitant medications were not reported. The patient experienced unknown cause of death on 10Apr2021. The patient died on 10Apr2021. It was not reported if an autopsy was performed. Follow-up attempt are not possible. No expected further information.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575307 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987667

Write-up: Pulmonary embolus; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number is DE-PEI-202100144680. A 91-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 31Mar2021 (Batch/Lot Number: Unknown) (at the age of 91-years-old) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was previously administered with first dose of BNT162B2 (COMIRNATY) on 10Mar2021 (at the age of 91-years-old) as 0.3 mL, single for COVID-19 immunisation. On 03Apr2021, the patient experienced pulmonary embolus. Outcome of event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. The casual relationship of Comirnaty and event was assessed as Unclassifiable by the Regulatory Authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolus


VAERS ID: 1575313 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   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: Coronary disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987761

Write-up: Acute myocardial infarction; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100145102. A 53-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Jul2021 (Batch/Lot number was not reported) as dose number unknown, 0.3 ml, single for covid-19 immunisation. Medical history included coronary disease from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced acute myocardial on 03Jul2021. The patient died on 03Jul2021 due to acute myocardial infarction. An autopsy was not performed. No follow-up attempts are possible, information about batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1575314 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-06-03
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Systemic inflammatory response syndrome
SMQs:, Tumour lysis syndrome (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987556

Write-up: Systemic inflammatory response syndrome; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100146515. An 86-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Mar2021 (Batch/Lot Number: EP9598) (at age 85-years-old) as dose 2, single for covid-19 immunisation. The first dose was received on 05Feb2021. The patient''s medical history and concomitant medications were not reported. The patient experienced systemic inflammatory response syndrome on 03Jun2021. The patient died on 03Jun2021. 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: Systemic inflammatory response syndrome


VAERS ID: 1575321 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E028A / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987550

Write-up: Infarct myocardial; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, company number DE-PEI-202100150586. A 44-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 16Jul2021 (Batch/Lot Number: 1E028A) as UNKNOWN DOSE NUMBER, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient had his first dose of Comirnaty 0.3mL for COVID-19 immunisation on 06Jun2021. The patient experienced also Infarct myocardial. The outcome of the events was fatal. This report is serious - death, life threatening. No autopsy done. No post mortem examination. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1575323 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016103

Write-up: Suspected thrombosis; Suspected embolism; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100157111. A 54-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number: FF0900, strength: 0.3 ml) (mRNA tozinameran), at the age of 54 years old, on 02Aug2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown, strength: 0.3 ml), at the age of 54 years old, on 21Jun2021 at single dose for COVID-19 immunisation. On 03Aug2021 (1 day after vaccination), the patient experienced suspected thrombosis / embolism and died unexpectedly. Sudden death without further explanation in the night after the second vaccination. This report was serious - death. The patient died on 03Aug2021. It was not reported if an autopsy was performed. Relatedness of drug to events was assessed as D. Unclassifiable. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Suspected thrombosis; Suspected embolism


VAERS ID: 1575357 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-05-20
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, General physical health deterioration, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 48
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 INC202100987751

Write-up: extreme weakness; Renal failure; General physical condition decreased; Belly ache; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021132091. An 87-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 16May2021 (Batch/Lot Number: Unknown) as 0.3 ML SINGLE for prophylactic vaccination. The patient''s medical history and concomitant medications were not reported. On 20May2021, the patient experienced renal failure, general physical condition decreased, belly ache, and extreme weakness. The event renal failure was reported as serious (death). The patient died on 07Jul2021. An autopsy was not performed. The patient has not recovered from belly ache, general physical condition decreased; unknown for extreme weakness; while outcome of renal failure was fatal. Sender comment: Do you or the person concerned have any allergies? If so, which ones? No, cause not found, kidney failure only after tilting and extreme weakness in hospital. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Renal failure


VAERS ID: 1575358 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-18
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Dyspnoea, Malaise, Myocardial infarction, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987990

Write-up: infarct myocardial; diarrhea; dyspnoea; malaise; tachycardia; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021145461. An 85-year-old female patient received bnt162b2 (COMIRNATY, solution for injection), via unspecified route of administration on 06Apr2021 (batch/lot number and expiry date unknown) as dose 2, 0.3 ml single for covid-19 immunization. The patient''s medical history was not reported. There were no concomitant medications. On 18Apr2021, the patient experienced infarct myocardial, diarrhea, dyspnoea, malaise, tachycardia. The outcome of the events diarrhea, dyspnoea, malaise, tachycardia was not recovered. The patient died on 16May2021 due to infarct myocardial. It was unknown if an autopsy was performed. Sender''s comment: do you or the person concerned have any allergies? if so, which ones? no information on risk factors or previous diseases none/increasing signs of deterioration since the second vaccination over 4 weeks. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1575359 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5833 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Pulmonary embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nickel sensitivity
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100996135

Write-up: Death from pulmonary embolism; Thrombosis; dose 1 : 01-MAY-2021, dose 2: 12-JUN-2021; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021150740. Safety report unique identifier DE-PEI-202100151083. A 51-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 12Jun2021 (Lot Number: FA5833; at the age of 51-years) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included nickel allergy. The patient''s concomitant medications were not reported. Historical vaccine included Comirnaty (1st dose, batch unknown) on 01May2021 for COVID-19 immunisation. On 23Jun2021, the patient experienced pulmonary embolism and thrombosis. The patient died on 23Jun2021 and autopsy in forensic medicine showed death from pulmonary embolism. The outcome of thrombosis (medically significant) was not recovered. Drug-reaction/ Event Matrix: Relatedness of drug to reaction /event for all events: Source of assessment PEI. Result of Assessment: D. Unclassifiable Sender''s comment: Are you or the person concerned known of any allergies: Nickel allergy. Information on risk factors or previous illnesses: none / death found. Cause unclear at first. After autopsy in forensic medicine: death from pulmonary embolism. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death from pulmonary embolism


VAERS ID: 1575360 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Nausea, 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: DEPFIZER INC202100996119

Write-up: Vomiting; Nausea; Cardiac arrest 7 days after Comirnaty vaccination; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number is DE-PEI-CADR2021151214, Safety Report Unique Identifier is DE-PEI-202100150983. A 30-year-old patient of an unspecified gender received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 19Jun2021 (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Jun2021, the patient experienced cardiac arrest 7 days after Comirnaty vaccination. On unspecified date, patient experienced vomiting and nausea. Patient initially had nausea and vomiting, a little later cardiac arrest. Outcome of cardiac arrest was fatal, vomiting was not recovered while nausea was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s) Cardiac arrest: Source of assessment: Regulatory Authority; Result of Assessment: D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest 7 days after Comirnaty vaccination


VAERS ID: 1575361 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-07-08
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Dizziness, Dyspnoea, Fatigue, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016098

Write-up: suspected pulmonary embolism; feeling of weakness; Unknown cause of death; Dyspnoea/shortness of breath; Dizziness; Fatigue; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, Safety Report Unique Identifier DE-PEI-202100152003. An 80-year-old female patient received second dose of BNT162B2 (COMIRNATY, Lot Number: EY2172), via an unspecified route of administration on 06May2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2(COMIRNATY) on 15Apr2021 for COVID-19 immunisation. On 08Jul2021 the patient experienced dyspnoea, fatigue and dizziness. On 27Jul2021 the patient experienced unknown cause of death. First severe fatigue with a feeling of weakness, later shortness of breath, circulatory problems and then death with suspected pulmonary embolism. The outcome of event dyspnoea/shortness of breath, dizziness and fatigue was not recovered and of event suspected pulmonary embolism, feeling of weakness was unknown. The patient died on 27Jul2021. It was not reported if an autopsy was performed. This report is serious as death. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No. / First severe fatigue with a feeling of weakness, later shortness of breath, circulatory problems & then death with suspected pulmonary embolism. Assessment: Comirnaty/ Death/ PEI: D. Unclassifiable Comirnaty/ Dyspnoea/ PEI: D. Unclassifiable Comirnaty/ Dizziness/ PEI: D. Unclassifiable Comirnaty/ Fatigue/ PEI: D. Unclassifiable No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575362 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-21
Onset:2021-04-15
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (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: DEPFIZER INC202101016076

Write-up: Renal failure; Shingles; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021153365, Safety Report Unique Identifier DE-PEI-202100154859. A 98-year-old female patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on 21Feb2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced renal failure on 21May2021, shingles on 15Apr2021. The outcome of event renal failure was fatal and shingles was not recovered. The patient died on an unspecified date. It was not reported if an autopsy was performed. Sender Comment: Information on risk factors or previous illnesses. Patient was physically and mentally fit before the vaccination. Event assessment: renal failure, shingles as Unclassifiable. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Renal failure


VAERS ID: 1575364 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-13
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Malaise, Pain, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016093

Write-up: back pain; Renal failure; severe malaise with increasing pain after vaccination; severe malaise with increasing pain after vaccination; This is a spontaneous report downloaded from the Regulatory Authority. Report number DE-PEI-CADR2021155427, Safety Report Unique Identifier DE-PEI-202100156816, from a non-contactable consumer. A 74-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3ml), dose 2 via an unspecified route of administration on 07Jun2021 (Batch/Lot Number: Unknown) as dose 2, 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced renal failure on 13Jun2021 (Seriousness Criteria: death, hospitalization). It was also reported as severe malaise with increasing pain after vaccination. After about 4 weeks (Jul2021) hospital admission because of massive back pain. Screams in pain. 14 days hospital stay then died of kidney failure. The patient died on 20Jul2021 because of Renal failure. Outcome of other events was unknown. An autopsy was not performed. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No / Severe malaise with increasing pain after vaccination. After about 4 weeks hospital admission because of massive back pain. Screams in pain. 14 days hospital stay then died of kidney failure. Event assessment: Comirnaty/ event/PEI /Result of Assessment: D. Unclassifiable No follow-up Information on batch/lot number cannot be obtained attempts are possible. No further information expected. ; Reported Cause(s) of Death: Renal failure


VAERS ID: 1575379 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood sodium, Brain natriuretic peptide increased, C-reactive protein, Death, Electrocardiogram, Glomerular filtration rate, Inflammation, Lung disorder, Multiple organ dysfunction syndrome, Prohormone brain natriuretic peptide, Troponin, Troponin increased
SMQs:, Cardiac failure (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pulmonary hypertension (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden (for 3 months); Dementia; Glaucoma; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: hypernatremia; Result Unstructured Data: Test Result:167; Test Date: 20210724; Test Name: CRP; Result Unstructured Data: Test Result:548; Test Date: 20210724; Test Name: ecg; Result Unstructured Data: Test Result:notion of q wave negative; Comments: in d2/d3/avf/V2/V3; Test Date: 20210724; Test Name: GFR; Result Unstructured Data: Test Result:23; Test Date: 20210724; Test Name: proBNP; Result Unstructured Data: Test Result:8242; Test Date: 20210724; Test Name: troponin ic; Result Unstructured Data: Test Result:22
CDC Split Type: FRPFIZER INC202101010497

Write-up: multivisceral failure; proBNP 8242; troponin IC 22; pneumopathy; biological inflammatory syndrome; Death NOS; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority report number FR-AFSSAPS-LY20218521. A 91-years-old male patient received bnt162b2 (COMIRNATY), dose 2 on 20Jul2021 as single dose for covid-19 immunisation. Medical history included hypertension arterial, glaucoma, dementia, bedridden for 3 months. No history of COVID19. The patient''s concomitant medications were not reported. On 21Jul2021, patient experienced fever. On 23Jul2021: beginning of treatment by Augmentin for probable inhalation pneumopathy by the Treating doctor (no X-ray made). On 24Jul2021: in front of a persistent dyspnea, the patient was sent to the emergency room. He presented a biological inflammatory syndrome with a CRP 548, a renal insufficiency: GFR 23, hypernatremia 167, troponin IC 22, proBNP 8242. Modified ECG with notion of q wave neg in d2/d3/avf/V2/V3. Dyspnea in a context of multivisceral failure probably related to a pneumopathy. Given the age and the precariousness of the patient''s general condition, the collegial decision was made: no further cardiac exploration but exclusive palliative management, hospitalization in the palliative care unit. Death of the patient on 25Jul2021. In total, death occurred at Day 5 of Dose 2 of Comirnaty. Outcome for the other events was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1575382 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-26
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Ischaemic heart disease; Kidney failure chronic; Obesity.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101016186

Write-up: therapeutic inefficiency; Covid-19 infection, English variant; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-RN20212351. A 60-year-old male patient received BNT162B2 (COMIRNATY), first dose via intramuscular on 05Mar2021 as single dose, second dose via an unspecified route of administration on 01Apr2021 as single dose, for covid-19 immunisation. Medical history included ischaemic heart disease, obesity, kidney failure chronic and diabetes. The patient had no history of Covid-19. The patient''s concomitant medications were not reported. On 26Apr2021, patient presented with a Covid-19 infection, English variant, and therapeutic inefficiency. Non-resuscitative patient and died on 28Apr2021. The outcome of the events was fatal. The patient died on 28Apr2021. An autopsy was not 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: Covid-19 infection, English variant; therapeutic inefficiency


VAERS ID: 1575395 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-10
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101016174

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from two contactable consumers. This is a report received from the Regulatory Authority. The Regulatory authority report number is (GB-MHRA-WEBCOVID-202107050949162380-DNLOP) and the Safety Report Unique Identifier is (GB-MHRA-ADR 25594557). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jun2021 (Batch/Lot number was not reported) as Dose 2, Single, on an unknown date as dose 1, single for COVID-19 immunization. It was unsure if patient has had symptoms associated with COVID-19 and if patient is enrolled in clinical trial. The patient medical history & concomitant medications were not reported. The patient experienced sars-cov-2 infection on 01Jul2021 (as reported). The patient underwent lab tests and procedures which included COVID-19 virus test with Positive result on 10Jun2021. The patient died on 01Jul2021. It was not reported if an autopsy was performed. Outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; SARS-CoV-2 infection


VAERS ID: 1575490 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-25
Onset:2021-07-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Circulatory collapse, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Disorder circulatory system; Dyspnoea on effort (recurrent breathing/circulatory problems on exertion).
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary disease (Possible pre-existing coronary heart disease); Diaphragmatic hernia (Examined by GP primarily unremarkable-referral to specialist suspicion of diaphragmatic hernia); Fainting (sometimes passed out).
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100987845

Write-up: Circulatory failure; Myocardial infarction / STEMI; initial unconsciousness; This is a spontaneous report from a contactable consumer (patient''s chilld) downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-38503. A 51-year-old male patient received the second dose of bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration on 25Jul2021 14:00 (at the age of 51 years old) (Lot Number: FD0168) as dose 2, single for COVID-19 immunization. Medical history included coronary artery disease (possible pre-existing coronary heart disease), diaphragmatic hernia (examination by the general practitioner primarily unremarkable - referral to specialist, suspicion of possible diaphragmatic hernia), ongoing Dyspnoea on effort (recurrent breathing/circulatory problems on exertion), fainting (sometimes passed out), ongoing disorder circulatory system. The patient had no concomitant medications. The patient took the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. He was vaccinated at 14:00 on 25Jul2021 and in the evening the incident happened. Patient experienced initial unconsciousness and Myocardial infarction / STEMI (ST-segment elevation myocardial infarction). The next day on 26Jul2021, patient had circulatory failure and at 05:50, he died in the intensive care unit. Therapeutic measures were taken as a result of the events. Rescue transport to hospital, initial outpatient treatment in the emergency department until the onset of circulatory arrest - followed by ECMO (extracorporeal membrane oxygenation), PCI (percutaneous coronary intervention), treatment in the cardiac intensive care unit. Death the following morning. Patient had a history of recurrent respiratory and circulatory problems. Examination by the general practitioner was unremarkable - referral to a specialist, suspicion of a possible diaphragmatic hernia. Appointment could not be kept due to emergency / death. Possible pre-existing coronary heart disease - diagnosis not made by doctor. Suspicion that vaccination may have aggravated this possible CHD or led to the final infarction. The events ''initial unconsciousness'' and ''Myocardial infarction / STEMI'' resulted in an emergency room visit. The patient was hospitalized due to ''Myocardial infarction / STEMI'' and ''Circulatory failure''. The patient''s outcome was not recovered/not resolved for Unconsciousness, for the rest of the events was fatal. The patient died on 26Jul2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Circulatory failure; Myocardial infarction / STEMI


VAERS ID: 1575492 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-04-13
   Days after vaccination:74
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101016132

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority. The regulatory authority report number is AT-BASGAGES-2021-39201. A 65 years old female patient received the first dose of Comirnaty at single dose on 07Jan2021, the second dose of Comirnaty at single dose on 29Jan2021, both for COVID-19 immunisation. Relevant history and concomitant dugs were not reported. On 13Apr2021 the patient experienced Vaccination failure / SARS-CoV-2 infection. The outcome of event was unknown. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1575493 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-03-04
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210304; Test Name: N501Y-positive; Test Result: Positive
CDC Split Type: ATPFIZER INC202101016136

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number AT-BASGAGES-2021-39207. A 78-year-old male patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 02Feb2021 (Batch/Lot Number: EJ6797; Expiration Date: 30Apr2021) as single dose, dose 1 via an unspecified route of administration on 12Jan2021 (Batch/Lot Number: EJ6796; Expiration Date: 30Apr2021) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sars-cov-2 infection on 04Mar2021. The patient underwent lab test and which N501Y-positive on 04Mar2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of sars-cov-2 infection was fatal. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lot EJ6796 and EJ6797. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed on the reference samples. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; SARS-CoV-2 infection


VAERS ID: 1575494 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-03-22
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Variant Sequenced; Result Unstructured Data: Test Result:Variant Sequenced B.1.1.7 N501Y positive
CDC Split Type: ATPFIZER INC202101016177

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number AT-BASGAGES-2021-39223. A 92-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: Unknown) as SINGLE DOSE, dose 1 via an unspecified route of administration on 21Jan2021 (Batch/Lot Number: EL1491; Expiration Date: 30Apr2021) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 22Mar2021 the patient experienced Vaccination failure and SARS-CoV-2 infection. The case was reported as serious due to death, medically significant. The patient underwent lab tests and procedures which included Variant Sequenced B.1.1.7 N501Y positive on an unknown date. The outcome of the events was fatal. The patient died on an unspecified date. It was unknown if an autopsy was performed. Investigation results received on 10Aug2021: Product-Description: Compound bnt 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1. Lot number: EL1491 and expiration date: 30Apr2021. Conclusion: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EL1491. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No Lot-Specific Trend Identified. Site Sample Status: Not Received. No follow-up attempts possible. Information about lot/batch number of 2nd dose cannot be obtained. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


Result pages: prev   51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172   next

New Search

Link To This Search Result:

https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=150&PERPAGE=100&VAX=COVID19&VAXTYPES=COVID-19&DIED=Yes

Government Disclaimer on use of this data


Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166