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From the 11/19/2021 release of VAERS data:

Found 894,019 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 473 out of 8,941

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VAERS ID: 1872572 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-26
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Echocardiogram, Inflammatory marker test, Pericarditis, Troponin
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcohol use (Alcohol on weekends 3-4 units); Tobacco user (Smoking: Cigarettes 0.5p/day)
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperhidrosis (Hyperhydrosis of the feet)
Allergies:
Diagnostic Lab Data: Test Name: CK; Result Unstructured Data: Normal. No elevated CK; Test Name: Echocardiograpy; Result Unstructured Data: Normal.; Test Name: Inflamatory parameter; Result Unstructured Data: Normal. Inflamatory parameter normal; Test Name: Troponin; Result Unstructured Data: Normal. No elevated troponin
CDC Split Type: CHMODERNATX, INC.MOD20213

Write-up: Suspected pericarditis; This regulatory authority case was reported by a physician and describes the occurrence of PERICARDITIS (Suspected pericarditis) in a 20-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Hyperhidrosis (Hyperhydrosis of the feet). Concurrent medical conditions included Tobacco user (Smoking: Cigarettes 0.5p/day) and Alcohol use (Alcohol on weekends 3-4 units). On 03-Sep-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 100 microgram. On an unknown date, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 100 microgram. On 26-Sep-2021, the patient experienced PERICARDITIS (Suspected pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Suspected pericarditis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatine phosphokinase: normal (normal) Normal. No elevated CK. On an unknown date, Echocardiogram: normal (normal) Normal.. On an unknown date, Inflammatory marker test: normal (normal) Normal. Inflamatory parameter normal. On an unknown date, Troponin: normal (normal) Normal. No elevated troponin. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered PERICARDITIS (Suspected pericarditis) to be possibly related. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment - This is a regulatory authority case concerning a 20-year-old, male patient with medical history of hyperhidrosis and tobacco user, who experienced the expected serious (medically significant and AESI) event of Pericarditis. The event occurred approximately 24 days after the dose of mRNA 1273. Patient received two doses but only one start date was provided. The rechallenge is not applicable. The medical history of tobacco user could be a potential confounder for myocardial disease and hence pericarditis. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report. This spontaneous report was received from a Physician and concerns a patient (Male), age: 20 Year (born: 2001-04-15). This report is non-serious. The patient''s medical history and concurrent conditions included: no relevant medical history reported. The patient''s weight was not reported, and height was not reported. The patient received COVID-19 Vaccine Moderna (COVID-19 vaccine), a dosage of 200 microgram within a time interval of 28 days. Concomitant medications were: no concomitant medication reported. On 26.09.2021 the patient experienced unknown (). The patient''s outcome was: unknown for unknown. ADDITIONAL DOCUMENTS: Source of this Case Safety Report in E2B(R3) Format: Additional documents; Source of this Case Safety Report in E2B(R2) Format Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Translated document received on 10-Nov-2021 and contains medical history, concurrent conditions, results of tests, procedures for investigation of the patient, case narrative, and senders comments updated.; Reporter''s Comments: The case is serious and labelled. Due to temporal relationship and the known safety profile of the vaccine, the causality is assessed as possible.; Sender''s Comments: This is a regulatory authority case concerning a 20-year-old, male patient with medical history of hyperhidrosis and tobacco user, who experienced the expected serious (medically significant and AESI) event of Pericarditis. The event occurred approximately 24 days after the dose of mRNA 1273. Patient received two doses but only one start date was provided. The rechallenge is not applicable. The medical history of tobacco user could be a potential confounder for myocardial disease and hence pericarditis. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 1872749 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-09-26
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 2 - / OT

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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC202101490615

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-051757. This contactable physician reported at risk scenario for the same patient for the second dose of Comirnaty. This is the first of two reports. A 46-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 15Aug2021 (Batch/Lot Number: FF3318) as dose 2, single, and intramuscular on 04Jul2021 (Batch/Lot Number: FE6208) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced vaccination failure (as reported) and SARS-CoV-2 infection. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 26Sep2021. Outcome of the events was unknown. This report is serious. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101519188 same patient, same suspect, at risk scenario


VAERS ID: 1873087 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-06
Onset:2021-09-26
   Days after vaccination:204
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Test Date: 20210926; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y positive: No
CDC Split Type: ATPFIZER INC202101490133

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052541. A 64-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: EP2166), via intramuscular route of administration on 06Mar2021 as dose 2, single and received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: EJ6136) via intramuscular route of administration on 13Feb2021 as dose 1, single; both doses for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced SARS-CoV-2 infection, other, Vaccination failure. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021 with Variant PCR-based: B.1.617.2 Variant Sequenced: n501y positive: No. No follow-up attempts possible. No further information expected.


VAERS ID: 1873539 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-09-26
   Days after vaccination:104
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variante PCR-basiert: B.1.617.2 Variante Sequenziert: n501y-positive: No
CDC Split Type: ATPFIZER INC202101508245

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052926. A 39-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FD1921) via intramuscular on 14Jun2021 as DOSE 2, SINGLE for covid-19 immunization and received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EY7015) via intramuscular on 10May2021 as DOSE 1, SINGLE for covid-19 immunization. The patient''s medical history and concomitant medications was not reported. On 26Sep2021 the patient experienced sars-cov-2 infection, vaccination failure. On 26Sep2021 the patient underwent lab tests and procedures which included sars-cov-2 test: positive, Variant PCR-based: B.1.617.2, Sequenced variant n501y-positive: No. The outcome of the event was reported as unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1873585 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-09-26
   Days after vaccination:71
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Variant Sequenced: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101508253

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-2021-052929. A 36-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for Injection), dose 2 intramuscular on 17Jul2021 (Batch/Lot Number: FE6208) as dose 2, single and dose 1 intramuscular on 22Jun2021 (Batch/Lot Number: FD4555) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Sep2021 the patient experienced sars-cov-2 infection, vaccination failure. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 26Sep2021 Variant PCR-based: Variant Sequenced: n501y-positive: Unknown. The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1873613 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-09-26
   Days after vaccination:84
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101508259

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-2021-052931. A 35-year-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: FD4555, Expiry Date: Not Reported), via intramuscular route of administration on 04Jul2021 as dose 2, single; and first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: FC2473, Expiry Date: Not Reported), via intramuscular route of administration on 30May2021 as dose 1, single both doses for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced SARS-CoV-2 infection, and Vaccination failure. On 26Sep2021, the patient underwent lab tests and procedures which included sars-cov-2 test (Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No): positive. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1873639 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-09-26
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive; Comments: Variante PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No
CDC Split Type: ATPFIZER INC202101508264

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority-WEB. Regulatory authority number is AT-BASGAGES-2021-052932. A 30-years-old female patient received Second dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, lot number: FE6208, Expiry date: not reported), via intramuscular route of administration on 8Jul2021 as dose 2, single and first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, lot number: FC2473, Expiry date: not reported), via intramuscular route of administration on 03Jun2021 as dose 1, single; both for COVID-19 immunization. Medical history and concurrent conditions were not reported. Concomitant medications were not reported. On 26Sep2021, patient experienced SARS-CoV-2 infection, vaccination failure. Events were considered serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 PCR test: (Variant PCR-based B.1.617.2, Sequenced variant, n501y-positive: No) on 26Sep2021. Outcome of events was unknown. No follow up attempts possible, no further information expected.


VAERS ID: 1873687 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-09-26
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: PCR based variant: B.1.617.2 Variant sequenced: Blank N501Y positive: No
CDC Split Type: ATPFIZER INC202101508277

Write-up: Vaccination failure; SARS-CoV-2 infection, PCR based variant: B.1.617.2; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052935. A 51-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FC2473) via intramuscular on 29May2021 as dose 2, single and bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EY3014) via intramuscular on 01May2021 as dose 1, single both for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Sep2021 the patient experienced vaccination failure and sars-cov-2 infection. The patient underwent lab tests and procedures which included sars-cov-2 PCR test: positive on 26Sep2021 (PCR based variant: B.1.617.2 Variant sequenced: Blank N501Y positive: No). Outcome of the events was unknown. Follow-up attempts are not possible. No expected further information.


VAERS ID: 1873713 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-09-26
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508450

Write-up: COVID-19 PCR test positive; COVID-19 PCR test positive; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052936. A 55-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 17Jun2021 (Batch/Lot Number: FD4555) and dose 1 intramuscular on 08May2021 (Batch/Lot Number: EY7015) both as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced covid-19 pcr test positive (vaccination failure) (medically significant) on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021 Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No. No follow-up attempts are possible, No further information is expected.


VAERS ID: 1873744 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-09-26
   Days after vaccination:81
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101508268

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052937. A 29-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FD6840), via intramuscular route of administration on 07Jul2021 as dose 2, single; first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FD0168), via intramuscular route of administration, administered in arm left on 16Jun2021 as dose 1, single, both doses for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were reported as none. On 26Sep2021, the patient experienced vaccination failure and sars-cov-2 infection. The patient underwent lab tests and procedures which included COVID-19 PCR test was positive (variant PCR-based: B.1.617.2, sequenced variant: n501y-positive: No) on 26Sep2021. The report was assessed as serious by health authority. The outcome of event was unknown. No follow up attempts possible, no further information expected.


VAERS ID: 1873885 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-09-26
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant Polymerase chain reaction: B.1.617.2 Variant Sequenced n501y-positive: No
CDC Split Type: ATPFIZER INC202101508282

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-2021-052943. A 24-year-old female patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FD0168), via intramuscular route on 11Jun2021 as dose 1, single for covid-19 immunization and second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FE6208), via intramuscular route on 16Jul2021 as dose 2, single for covid-19 immunization. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On 26Sep2021, the patient experienced SARS-CoV-2 infection other and vaccination failure. The events were assessed as serious (medically significant) by health authority. The patient underwent lab tests and procedures on 26Sep2021 which included covid-19 PCR test: positive; variant polymerase chain reaction: B.1.617.2; variant sequenced; n501y-positive: no. The outcome of the events was unknown. No follow-up attempts are possible. No further information was expected.


VAERS ID: 1873913 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-09-26
   Days after vaccination:90
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Test Date: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Sequenced variant: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101508289

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number AT-BASGAGES-2021-052944. A 45-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection) via intramuscular route on 28Jun2021 (Lot number: FD4555) as Dose 2, Single and intramuscular route on 24May2021 (Lot number: FC0681) as Dose 1, Single, both doses for Covid-19 immunization. There was no relevant medical history and concomitant medications were reported. On 26Sep2021, the patient experienced Vaccination failure, SARS-CoV-2 infection. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive (Variant PCR-based: Sequenced variant: n501y-positive: Unknown) on 26Sep2021. The outcome of event SARS-CoV-2 infection was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1873934 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-09-26
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive; Comments: (Variant Polymerase chain reaction: B.1.617.2, Variant Sequenced: Not reported and n501y-negative)
CDC Split Type: ATPFIZER INC202101508293

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052945. A 35-year-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FE6208), via intramuscular route of administration on 29Jul2021 as dose 2, single and received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FD0168) via intramuscular route of administration on 24Jun2021 as dose 1, single both for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced SARS-CoV-2 infection, vaccination failure. Events were considered serious (medically significant). On 26Sep2021, the patient underwent lab tests and procedures which included SARS-CoV-2 test: positive, (Variant Polymerase chain reaction: B.1.617.2, Variant Sequenced: Not reported and n501y-positive: No). The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1873964 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-09-26
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101508297

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-2021-052946. A 42-year-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: FC2473) via intramuscular on 07Jun2021 as dose 1, single for covid-19 immunisation and second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: FD6840), via intramuscular on 12Jul2021 as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced sars-cov-2 infection and vaccination failure. The report was assessed as serious by health authority. The patient underwent lab tests and procedures which included sars-cov-2 test resulted positive on 26Sep2021, variant sequenced: n501y-positive: no. The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1873977 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-09-26
   Days after vaccination:143
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3014 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: variant polymerase chain reaction (PCR) based test, result was positive for B.1.617.2 (N501Y was negative); Test Date: 20210926; Test Name: n501y-positive; Result Unstructured Data: Test Result:n501y-positive: No; Test Date: 20210926; Test Name: Variant PCR-based; Result Unstructured Data: Test Result:Variant PCR-based: B.1.617.2; Test Date: 20210926; Test Name: Variant Sequenced; Result Unstructured Data: Test Result:Variant Sequenced: Not reported
CDC Split Type: ATPFIZER INC202101508308

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052949. A 67-year-old male patient received BNT162b2 (Comirnaty, Solution for injection, Batch/Lot Number: EY3014, Expiration Date was unknown) via intramuscular route of administration on 06May2021 as dose 2, single and received BNT162b2 (Comirnaty, Solution for injection, Batch/Lot Number: EW2239, Expiration Date was unknown) via intramuscular route of administration on 15Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 26Sep2021, patient experienced SARS-CoV-2 infection and drug ineffective. The patient underwent lab tests and procedures which included SARS-CoV -2 variant polymerase chain reaction (PCR) based test, result was positive for B.1.617.2 (N501Y was negative) on 26Sep2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1873978 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-09-26
   Days after vaccination:129
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC0681 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: n501y-positive; Result Unstructured Data: Test Result:No; Comments: (n501y-positive); Test Date: 20210926; Test Name: Variant Polymerase chain reaction; Result Unstructured Data: Test Result:B.1.617.2; Comments: (Variant Polymerase chain reaction); Test Date: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC202101508301

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA) -WEB, regulatory authority number AT-BASGAGES-2021-052950. A 74-years-old male patient received second dose of BNT162B2 (COMIRNATY solution for injection Batch/Lot Number: FC0681), via intramuscular on 20May2021 as dose 2, single and patient also received first dose of BNT162B2 (COMIRNATY solution for injection Batch/Lot Number: EW4815), via intramuscular on 15Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concurrent conditions included was no relevant medical history reported. The patient concomitant medications were not reported. On 26Sep2021 the patient experienced vaccination failure and sars-cov-2 infection. The patient underwent lab tests and procedures which included sars-cov-2 test was no on 26Sep2021 (n501y-positive), sars-cov-2 test: b.1.617.2 on 26Sep2021 (Variant Polymerase chain reaction), sars-cov-2 test positive was positive on 26Sep2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1873979 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-09-26
   Days after vaccination:111
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508305

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-052953. A 34-years-old female patient received first dose of (COMIRNATY, Formulation: solution for injection, Batch/Lot Number: EY3014), via intramuscular route of administration on 03May2021 as dose 1, single and received second dose of bnt162b2 (COMIRNATY, Formulation: solution for injection, Batch/Lot Number: FD1921) via intramuscular route of administration on 07Jun2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure, sars-cov-2 infection on 26Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: Positive (Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No) on 26Sep2021. The outcome of event sars-cov-2 infection was unknown. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1873980 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-09-26
   Days after vaccination:79
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / OT

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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Name: n501y-positiv; Result Unstructured Data: Test Result:No; Test Name: Variant PCR-based; Result Unstructured Data: Test Result:B.1.617.2
CDC Split Type: ATPFIZER INC202101508461

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-2021-052954. This is a report from regulatory authority. A 16-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 09Jul2021 (Lot Number: FE6208) as dose 2, single, and dose 1 intramuscular on 27May2021 (Lot Number: FC2473) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced drug ineffective and sars-cov-2 infection on 26Sep2021. The events were serious as medically significant with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 26Sep2021, n501y-positiv: no on unspecified date, Variant PCR-based: b.1.617.2 on unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1873981 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-09-26
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002916 / 1 - / OT

Administered by: Unknown       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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: positive
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: SARS-CoV-2 infection; Vaccination failure; This case was received via Regulatory Authority(Reference number: AT-BASGAGES-2021-052956) on 08-Nov-2021 and was forwarded to Moderna on 08-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 (SARS-CoV-2 infection) and VACCINATION FAILURE (Vaccination failure) in a 38-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3003606 and 3002916) for COVID-19 vaccination. No Medical History information was reported. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant). At the time of the report, COVID-19 (SARS-CoV-2 infection) and VACCINATION FAILURE (Vaccination failure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, SARS-CoV-2 test: positive (Positive) positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications was reported. No treatment drug details was reported.; Sender''s Comments: This case concerns a 38-year-old male patient with no details on relevant medical history, who experienced the unexpected serious event/AESI of COVID-19 and Vaccination failure after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred approximately 74 days after the second dose of mRNA- 1273 vaccine. No information regarding clinical course was provided. The rechallenge was not applicable due to the nature of the event. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report. Vaccination failure was captured by the regulatory authority, however, it is noted that the schedule of vaccination was inappropriate (window between doses of 42 days). The seriousness criteria of the events was assessed as per regulatory authority report. There is insufficient evidence to support this seriousness assessment from a clinical or regulatory standpoint.


VAERS ID: 1873982 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-09-26
   Days after vaccination:95
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617 not differentiated Sequenced variant: n501y-positive: No
CDC Split Type: ATPFIZER INC202101508311

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052959. A 39-years-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FD4555), dose 2 intramuscular on 23Jun2021 as dose 2, single and dose 1 intramuscular on 19May2021 (Lot Number: FA4598) as dose 1, single 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 26Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test resulted positive on 26Sep2021 (Variant PCR-based: B.1.617 not differentiated Sequenced variant: n501y-positive: No). No follow-up attempts are possible, no further information is expected.


VAERS ID: 1873983 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-09-26
   Days after vaccination:83
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Polymerase chain reaction (PCR) -based variant: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508320

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052962. A 46-years-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, lot number: FC2473) via an intramuscular route of administration on 31May2021 and second dose of BNT162B2 (COMIRNATY, solution for injection, lot number: FD4555) via an intramuscular route of administration on 5Jul2021 as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced sars-cov-2 infection, vaccination failure. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021, Polymerase chain reaction (PCR) -based variant: B.1.617.2, Sequenced variant: n501y-positive: No. Clinical outcome of the events was reported as unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1873984 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-11
Onset:2021-09-26
   Days after vaccination:168
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Investigation, 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? No
Permanent Disability? 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: n501y-positive: No; Result Unstructured Data: Test Result:n501y-positive: No; Test Date: 2021; Test Name: Variant PCR-based: B.1.617.2; Result Unstructured Data: Test Result:Variant PCR-based: B.1.617.2; Test Date: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC202101508325

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-2021-052963. A 78-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 intramuscularly on 11Apr2021 (Batch/Lot Number: EW2246) as DOSE 2, SINGLE and dose 1 intramuscularly on 21Mar2021 (Batch/Lot Number: ET1831) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced sars-cov-2 infection and vaccination failure. The patient underwent lab tests and procedures which included n501y-positive: no on an unknown date in 2021, variant PCR-based: b.1.617.2 on an unknown date in 2021, sars-cov-2 test: positive on 26Sep2021, sequenced variant: not reported. The outcome of the events was unknown at the time of report. No follow-up attempts are needed. No further information expected.


VAERS ID: 1873985 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-09-26
   Days after vaccination:73
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003606 / 1 - / OT

Administered by: Unknown       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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: Vaccination failure; SARS-CoV-2 infection; This case was received via regulatory authority (Reference number: AT-BASGAGES-2021-052964) on 08-Nov-2021 and was forwarded to Moderna on 08-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3004218 and 3003606) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant) and COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant). At the time of the report, VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant Medication was not provided by reporter. Treatment Medication was not provided by reporter. Company comment: This case of vaccination failure concerns a 44-year-old male patient, with no reported relevant medical history, who experienced the unexpected serious event of COVID-19 (AESI). The event occurred 1 month and 7 days after the administration of the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender''s Comments: This case of vaccination failure concerns a 44-year-old male patient, with no reported relevant medical history, who experienced the unexpected serious event of COVID-19 (AESI). The event occurred 1 month and 7 days after the administration of the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1873986 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-09-26
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508338

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052965. A 39-years-old male patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: FA4598) via intramuscular on 23May2021 as dose 1, single and second dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: FD6840) via intramuscular on 27Jun2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 26Sep2021, the patient experienced SARS-CoV-2 infection and vaccination failure. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021 (Variant PCR-based: B.1.617.2, Sequenced variant, n501y-positive: No). The outcome of the events was unknown. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1873988 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-09-26
   Days after vaccination:142
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001943 / 1 - / OT

Administered by: Unknown       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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: SARS-CoV-2 infection; Vaccination failure; This case was received via Regulatory Authority (Reference number: AT-BASGAGES-2021-052967) on 08-Nov-2021 and was forwarded to Moderna on 08-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 (SARS-CoV-2 infection) and VACCINATION FAILURE (Vaccination failure) in a 38-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3003602 and 3001943) for COVID-19 vaccination. No Medical History information was reported. On 07-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant). At the time of the report, COVID-19 (SARS-CoV-2 infection) and VACCINATION FAILURE (Vaccination failure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment medications were not reported. Company comment: This case concerns a 38-year-old, female patient with no medical history reported, who experienced the unexpected serious adverse event of special interest of COVID-19. Vaccination failure was considered an additional event. The events occurred approximately 3 months after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 38-year-old, female patient with no medical history reported, who experienced the unexpected serious adverse event of special interest of COVID-19. Vaccination failure was considered an additional event. The events occurred approximately 3 months after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1873991 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-09-26
   Days after vaccination:195
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Test Date: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive; Comments: Variant PCR-based: B.1.617.2, Sequenced variant, N501y-positive: No.
CDC Split Type: ATPFIZER INC202101508346

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician from the Regulatory Authority. The Regulatory Authority. The regulatory authority number AT-BASGAGES-2021-052972. A 37-year-old female patient received BNT162B2 (COMIRNATY, solution for injection) via intramuscular route on 15Mar2021 (Lot Number: ET1831) as Dose 2, Single and via intramuscular route on 22Feb2021 (Lot Number: EP2163) as Dose 1, Single, both doses for Covid-19 immunization. No relevant medical history and concomitant medications were reported. On 26Sep2021, the patient experienced SARS-CoV-2 infection and Vaccination failure. The patient underwent lab tests and procedures which included SARS-CoV-2 test was positive (variant PCR-based as B.1.617.2, Sequenced variant was Blank, and N501y-positive was No) on 26Sep2021. At the time of this report, the outcome of event SARS-CoV-2 infection was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1873992 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-09-26
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508352

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number AT-BASGAGES-2021-052974. A 78-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: FC2473 and expiry date was not reported), via intramuscularly, on 29May2021 as DOSE 2, SINGLE and first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: EX0893 and expiry date was not reported), via intramuscularly, on 24Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced sars-cov-2 infection and had vaccination failure. On 26Sep2021, the patient underwent lab tests and procedures which included COVID-19 PCR test which was positive Variant PCR-based: B.1.617. Sequenced variant: n501y-positive: No. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.?


VAERS ID: 1873993 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-09-26
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508359

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052975. A 54-year-old female patient received BNT162B2 (COMIRNATY, Solution for Injection), on 21May2021 (Lot Number: FC0681; Expiration Date: Not reported) as dose 1, single and on 03Jul2021 (Lot Number: FD6840; Expiration Date: Not reported) as dose 2, single both intramuscularly and for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure (as reported) and SARS-COV-2 infection on 26Sep2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 26Sep2021 (reported as Variant PCR-based: B.1.617.2, Sequenced variant: n501y-positive: No.). The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.?


VAERS ID: 1873995 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-09-26
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive; Comments: Variant PCR-based: B.1.617.2, Variant Sequenced: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508381

Write-up: This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number AT-BASGAGES-2021-052979. A 47-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 25Jun2021 (Lot Number: FD0168) as dose 2, single, and dose 1 intramuscular on 21May2021 (Lot Number: FC0681) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On 26Sep2021, the patient experienced vaccination failure and sars-cov-2 infection, other. The patient underwent lab tests and procedures which included COVID-19 PCR test was positive with variant PCR-based B.1.617.2, variant sequenced was not provided, and n501y-positive was no on 26Sep2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1873997 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-09-26
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Test Date: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result: Positive; Comments: Variant PCR-based: B.1.617.2, Variant Sequenced: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508387

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number AT-BASGAGES-2021-052982. A 59-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 09Apr2021 (Batch/Lot Number: EW2239) as single dose and dose 1 intramuscular on 14Mar2021 (Batch/Lot Number: ET1831) as single dose for covid-19 immunisation. The patient''s medical history and concurrent conditions included no relevant medical history reported. No concomitant medication reported. The patient experienced sars-cov-2 infection on 26Sep2021 with outcome of unknown. Variant PCR-based B.1.617.2, Variant Sequenced, n501y-positive: No. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1873998 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-09-26
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive
CDC Split Type: ATPFIZER INC202101508391

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052983. A 52-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 09Apr2021 (Lot Number: EW2239) as Dose 2, single; and intramuscular on 14Mar2021 (Lot Number: ET1831) as Dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced vaccination failure and sars-cov-2 infection. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1873999 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-09-26
   Days after vaccination:123
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002339 / 1 - / OT

Administered by: Unknown       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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: SARS-CoV-2 infection; Vaccination failure; This case was received via regulatory authority (Reference number: AT-BASGAGES-2021-052984) on 08-Nov-2021 and was forwarded to Moderna on 08-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 (SARS-CoV-2 infection) and VACCINATION FAILURE (Vaccination failure) in a 24-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3003606 and 3002339) for COVID-19 vaccination. No Medical History information was reported. On 26-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant). At the time of the report, COVID-19 (SARS-CoV-2 infection) and VACCINATION FAILURE (Vaccination failure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported . Treatment information was not provided. Company comment: This case concerns a 24 year old male with no reported medical history , who experienced Serious, unexpected, AESI events of Covid 19 and Vaccination failure which occurred 2 months 19 days after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 vaccine) . The re-challenge for this case is not applicable since the outcome of the event is unknown and there would be no other dose to be administered. The benefit-risk relationship of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) is not affected by this report. The seriousness of Medically significant for this case was captured per RA report. This is a RA case however from the medical reviewer''s standpoint additional event of Inaapropriate Schedule of Product Administration should be coded since the interval between the 1st and 2nd dose for this case is 42 days the recommended days should be 25-35 days only. Also vaccination failure should not be coded since it did not fulfill the 3 criteria for Vacciination failure that time interval was not fulfilled time interval between two doses exceeded the 35 days, , only the two doses given both Moderna Covid 19 vaccine and that the infection occurred more than 2 weeks after the 2nd dose of the vaccine criteria was fulfilled.; Sender''s Comments: This case concerns a 24 year old male with no reported medical history , who experienced Serious, unexpected, AESI events of Covid 19 and Vaccination failure which occurred 2 months 19 days after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 vaccine) . The re-challenge for this case is not applicable since the outcome of the event is unknown and there would be no other dose to be administered. The benefit-risk relationship of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) is not affected by this report. The seriousness of Medically significant for this case was captured per RA report. This is a RA case however from the medical reviewer''s standpoint additional event of Inaapropriate Schedule of Product Administration should be coded since the interval between the 1st and 2nd dose for this case is 42 days the recommended days should be 25-35 days only. Also vaccination failure should not be coded since it did not fulfill the 3 criteria for Vacciination failure that time interval was not fulfilled time interval between two doses exceeded the 35 days, , only the two doses given both Moderna Covid 19 vaccine and that the infection occurred more than 2 weeks after the 2nd dose of the vaccine criteria was fulfilled.


VAERS ID: 1874003 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-09-26
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508403

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052993. A 45-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 09Apr2021 (Batch/Lot Number: EW2239) as single dose and dose 1 intramuscular on 12Mar2021 (Batch/Lot Number: ET1831) as single dose for covid-19 immunisation. The patient''s medical history and concurrent conditions included: no relevant medical history reported. no concomitant medication reported. The patient experienced sars-cov-2 infection on 26Sep2021 with outcome of unknown. SARS-CoV-2 test: variant PCR-based: B.1.617.2, Variant Sequenced: n501y-positive: No. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1874004 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-09-26
   Days after vaccination:112
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 - / OT

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? No
Permanent Disability? 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: Test Date: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive; Comments: Variant PCR-based, Sequenced variant, n501y-positive: Unknown.
CDC Split Type: ATPFIZER INC202101508404

Write-up: drug ineffective; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number AT-BASGAGES-2021-052994. A 60-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 06Jun2021 (Batch/Lot Number: FD1921) as single dose and dose 1 intramuscular on 25Apr2021 (Batch/Lot Number: EX0893) as single dose for covid-19 immunisation. The patient''s medical history and concurrent conditions included no relevant medical history reported. No concomitant medication reported. The patient experienced sars-cov-2 infection on 26Sep2021 with outcome of unknown. SARS-CoV-2 test variant PCR-based: B.1.617.2, Variant Sequenced, n501y-positive: unknown. No follow-up attempts are possible, no further information is expected. Linked Report(s): AT-PFIZER INC-202101520791 same patient, same medication, different doses, different events. AT-PFIZER INC-202101520791 same patient, same medication, different doses, different events.


VAERS ID: 1874005 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-09-26
   Days after vaccination:67
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / OT

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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2. Variante Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101508415

Write-up: drug ineffective; SARS-CoV-2 infection; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is AT-BASGAGES-2021-053000. This is the first of two reports. A 29-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 21Jul2021 (Batch/Lot Number: FE6208) as dose 2, single, dose 1 via an unspecified route of administration on 09Jun2021 (Batch/Lot Number: FD 1921) as dose 1, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient''s weight was not reported, and height was not reported. The patient experienced drug ineffective, SARS-CoV-2 infection on 26Sep2021. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 26Sep2021 (Variant PCR-based: B.1.617.2. Variante Sequenced: n501y-positive: No). The outcome of events was unknown. The case was reported as serious per medically significant. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101519941 same patinet, drug, different event


VAERS ID: 1874008 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-09-26
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive; Test Date: 20210926; Test Name: n501y-positive; Result Unstructured Data: Test Result: No; Test Date: 20210926; Test Name: PCR-based Variant; Result Unstructured Data: Test Result: B.1.617.2; Comments: PCR-based Variant.
CDC Split Type: ATPFIZER INC202101508432

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician from the Regulatory Authority AT-BASGAGES-2021-053009. This is a report from regulatory authority. A 44-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 05Aug2021 (Lot Number: FF3318) as dose 2, single, and dose 1 intramuscular on 08Jul2021 (Lot Number: FD6840) as dose 1, single 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 26Sep2021.The events were serious as medically significant with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 PCR test positive on 26Sep2021, PCR-based Variant: b.1.617.2 on 26Sep2021, n501y-positive: No on 26Sep2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1874009 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-09-26
   Days after vaccination:234
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: n501y-positive: unknown
CDC Split Type: ATPFIZER INC202101508437

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB regulatory authority number AT-BASGAGES-2021-053012. A 26-years-old male patient received two doses of BNT162B2 (COMIRNATY), the first dose on 08Jan2021 (Lot. EJ6796) and the second dose on 04Feb2021 (Lot. EJ6134), both intramuscularly, at single dose, for COVID-19 immunisation. Relevant medical history, concurrent conditions and concomitant medications were unknown. The patient''s weight was not reported, and height was not reported. The patient experienced SARS-CoV-2 infection, vaccination failure on 26Sep2021. The events were serious as medically significant with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 26Sep2021, n501y-positive: unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1874010 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-09-26
   Days after vaccination:226
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Based variant: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508467

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053013. A 41-year-old female patient received two doses of BNT162b2 (COMIRNATY), dose 2 on 12Feb2021 (Lot Number: EK9788) and dose 1 intramuscular on 21Jan2021 (Lot Number: EL1491), both intramuscular as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced SARS-CoV-2 infection/vaccination failure on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which COVID-19 PCR test: positive (Based variant: B.1.617.2 Sequenced variant: n501y-positive: No) on 26Sep2021. No follow-up attempts are possible. No further information expected.


VAERS ID: 1874011 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-09-26
   Days after vaccination:186
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive; Comments: n501y-positive: unknown.
CDC Split Type: ATPFIZER INC202101508472

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician from the Regulatory Authority. The Regulatory Authority number AT-BASGAGES-2021-053014. A 59-year-old male patient received the 1st dose of bnt162b2 (COMIRNATY), intramuscular on 03Mar2021 (Batch/Lot Number: EP2166) as DOSE 1, SINGLE and 2nd dose intramuscular on 24Mar2021 (Batch/Lot Number: ET3620) as DOSE 2, SINGLE both for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced sars-cov-2 infection (medically significant) on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 26Sep2021 (n501y-positive: unknown). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1874014 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-09-26
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive; Comments: Variant PCR-based: B.1.617.2, Variant Sequenced, n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508488

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number AT-BASGAGES-2021-053022. A 72-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 20Apr2021 (Lot Number: EW4815) as DOSE 2, SINGLE, dose 1 intramuscular on 30Mar2021 (Lot Number: ET7205) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced vaccination failure (medically significant), SARS-CoV-2 infection (medically significant) with outcome of unknown. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 26Sep2021 (Variant PCR-based: B.1.617.2, Variant Sequenced, n501y-positive: No). No follow-up attempts are possible. No further information expected.


VAERS ID: 1874016 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-09-26
   Days after vaccination:169
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: variant: B.1.617.2, Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101508513

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053025. A 74-year-old female patient received bnt162b2 (COMIRNATY) intramuscularly on 10Apr2021 (Batch/Lot Number: EW2246) as dose 2, single and intramuscularly on 20Mar2021 (Batch/Lot Number: ET1831) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure and SARS-CoV-2 infection on 26Sep2021. The patient underwent lab tests and procedures which included COVID-19 PCR test (26Sep2021): Positive (variant: B.1.617.2, Variant Sequenced: n501y-positive: No). Outcome of events was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1874018 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-09-26
   Days after vaccination:187
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508454

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053033. A 91-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 23Mar2021 (Lot Number: ET1831) as DOSE 2, SINGLE, dose 1 intramuscular on 02Mar2021 (Lot Number: EP2163) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced vaccination failure (medically significant), SARS-CoV-2 infection (medically significant) with outcome of unknown. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 26Sep2021, (Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No). No follow-up attempts are possible, No further information is expected.


VAERS ID: 1874019 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-09-26
   Days after vaccination:136
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101508594

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053040. A 67-year-old male patient received two doses of BNT162b2 (COMIRNATY), dose 2 on 13May2021 (Lot Number: FA4598) and dose 1 on 22Apr2021 (Lot Number: EX0893) both intramuscular as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced SARS-CoV-2 infection/vaccination failure on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive (Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No) on 26Sep2021. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1874020 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-09-26
   Days after vaccination:215
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Investigation, 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? No
Permanent Disability? 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: 20210926; Test Name: n501y-positive: No.; Result Unstructured Data: Test Result:n501y-positive: No.; Comments: Sequenced variant: n501y-positive: No; Test Date: 20210926; Test Name: Variant PCR-based: B.1.617.2; Result Unstructured Data: Test Result:Variant PCR-based: B.1.617.2; Test Date: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC202101508600

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-2021-053041. This is a report from regulatory authority. A 42-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 23Feb2021 (Lot Number: EP2163) as Dose 2, single, and dose 1 intramuscular on 02Feb2021 (Lot Number: EJ6797) as Dose 1, single 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 26Sep2021. The events were serious as medically significant with outcome of unknown. The patient underwent lab tests and procedures which included on 26Sep2021: Sequenced variant: n501y-positive: No; Variant PCR-based: B.1.617.2; COVID-19 PCR test positive. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1874021 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-09-26
   Days after vaccination:184
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508614

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053042. A 82-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 26Mar2021 (Batch/Lot Number: ET3620) and dose 1 intramuscular on 05Mar2021 (Batch/Lot Number: EP2166) both as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced sars-cov-2 infection (vaccination failure) (medically significant) on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021 Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No. No follow-up attempts are needed. No further information expected.


VAERS ID: 1874022 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-09-26
   Days after vaccination:191
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2, Sequenced variant:n501y-positive: No
CDC Split Type: ATPFIZER INC202101508607

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053043. A 90-year-old male patient received bnt162b2 (COMIRNATY), intramuscularly on 19Mar2021 (Batch/Lot Number: ET3620) as dose 2, single and intramuscularly on 26Feb2021 (Batch/Lot Number: EK9788) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced SARS-CoV-2 infection and vaccination failure on 26Sep2021. The patient underwent lab tests and procedures which included COVID-19 PCR test (26Sep2021): Positive (Variant PCR-based: B.1.617.2, Sequenced variant:n501y-positive: No). Outcome of events was unknown. No follow-up attempts are needed. No further information expected.


VAERS ID: 1874023 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-09-26
   Days after vaccination:172
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2, n501y-positive: no.
CDC Split Type: ATPFIZER INC202101508619

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [Regulatory Authority number AT-BASGAGES-2021-053044]. An 82-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), intramuscular on 17Mar2021 (Batch/Lot Number: ET1831) as DOSE 1, SINGLE and 2nd dose intramuscular on 07Apr2021 (Batch/Lot Number: EW2239) as DOSE 2, SINGLE both for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced sars-cov-2 infection (medically significant) on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021 (Variant PCR-based: B.1.617.2, n501y-positive: no). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1874025 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-09-26
   Days after vaccination:186
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2, n501y-positive: no.
CDC Split Type: ATPFIZER INC202101508637

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [Regulatory Authority number AT-BASGAGES-2021-053049]. A 90-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), intramuscular on 03Mar2021 (Batch/Lot Number: ET1831) as DOSE 1, SINGLE and the 2nd dose intramuscular on 24Mar2021 (Batch/Lot Number: ET3620) as DOSE 2, SINGLE both for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced sars-cov-2 infection (medically significant) on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021 (variant PCR-based: B.1.617.2, n501y-positive: no). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1874028 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-09-26
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive; Comments: Variant polymerase chain reaction: B.1.617.2, n501y-positive: no.
CDC Split Type: ATPFIZER INC202101508671

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician from the Regulatory Authority. The Regulatory Authority number AT-BASGAGES-2021-053058. A 48-year-old male patient received the 1st dose of bnt162b2 (COMIRNATY), intramuscular on 20May2021 (Batch/Lot Number: FC0681) as DOSE 1, SINGLE and 2nd dose intramuscular on 30Jun2021 (Batch/Lot Number: FD4555) as DOSE 2, SINGLE both for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced sars-cov-2 infection (medically significant) on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 26Sep2021 (variant polymerase chain reaction: B.1.617.2, n501y-positive: no). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1874029 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-09-26
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617 not differentiated, n501y-positive: no.
CDC Split Type: ATPFIZER INC202101508650

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [Regulatory Authority number AT-BASGAGES-2021-053059]. A 58-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), intramuscular on 28Apr2021 (Batch/Lot Number: EY3014) as DOSE 1, SINGLE and 2nd dose intramuscular on 02Jun2021 (Batch/Lot Number: FC2473) as DOSE 2, SINGLE both for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced sars-cov-2 infection (medically significant) on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021 (variant PCR-based: B.1.617 not differentiated, n501y-positive: no). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1874032 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-09-26
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC202101508174

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the -WEB, regulatory authority number AT-BASGAGES-2021-053070. A 14-years-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection with Lot Number: FD6840), via intramuscular route on 16Jul2021 as dose 2, single and first dose of bnt162b2 (COMIRNATY, Solution for injection with Lot Number: FD4555) via intramuscular route on 25Jun2021 as dose 1, single 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 26Sep2021. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 26Sep2021. The events outcome was reported as unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1874033 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-09-26
   Days after vaccination:108
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC0168 / 2 - / OT

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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508177

Write-up: Drug ineffective; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority AT-BASGAGES-2021-053071. This is the first of two reports for the same patient. A 27-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: FC0168) as single dose via intramuscular on 10Jun2021 and first dose via intramuscular on 29Apr2021 (Batch/Lot Number: EY3014) as single dose , for covid-19 immunisation .The patient medical history and concomitant medications were not reported. On 26Sep2021 the patient experienced SARS-CoV-2 infection, other, Vaccination failure.The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021 Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No The outcome of events was unknown. . No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101519631 same patient, different adverse events;AT-PFIZER INC-202101519631 same patient, different adverse events


VAERS ID: 1874034 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-09-26
   Days after vaccination:191
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508182

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053073. A 68-year-old male patient received BNT162B2 (COMIRNATY solution for injection Batch/Lot Number: ET1831), via intramuscular on 19Mar2021 as dose 2, single and patient also received, BNT162B2 (COMIRNATY solution for injection Batch/Lot Number: EF1831) via intramuscular on 28Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concurrent conditions included was no relevant medical history reported. The patient concomitant medications were not reported. On 26Sep2021 the patient experienced vaccination failure, sars-cov-2 infection. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 26Sep2021 Variant PCR-based: B.1.617.2 Sequenced variant:n501y-positive: No. The outcome of the events was unknown. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1874035 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-09-26
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002916 / 1 - / OT

Administered by: Unknown       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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: Vaccination failure; SARS-CoV-2 infection; This case was received via Regulatory Authority (Reference number: AT-BASGAGES-2021-053074) on 08-Nov-2021 and was forwarded to Moderna on 08-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 214001 and 3002916) for COVID-19 vaccination. No Medical History information was reported. On 17-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant) and COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant). At the time of the report, VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product information was not provided. No treatment information was provided. Company comment: This is a regulatory case concerning a 26 years old, female patient with no clinical history who experienced the unexpected events of VACCINATION FAILURE and COVID-19 (AESI). The events occurred 65 days after the second dose of Moderna Covid 19 vaccine. The rechallenge is not applicable" as the events occurred after the second dose and no details were provided about the first dose The benefit-risk relationship of Moderna Covid 19 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 26 years old, female patient with no clinical history who experienced the unexpected events of VACCINATION FAILURE and COVID-19 (AESI). The events occurred 65 days after the second dose of Moderna Covid 19 vaccine. The rechallenge is not applicable" as the events occurred after the second dose and no details were provided about the first dose The benefit-risk relationship of Moderna Covid 19 vaccine is not affected by this report.


VAERS ID: 1874036 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-09-26
   Days after vaccination:176
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Sequenced variant: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101508210

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053075. A 90-year-old female patient received second dose of BNT162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: ET7205) on 03Apr2021 as dose 2, single and first dose of BNT162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: ET1831) on 13Mar2021 as dose 1, single both via intramuscular route of administration for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient height and weight were not reported. On 26Sep2021, patient experienced vaccination failure and SARS-COV-2 infection. The patient underwent lab tests and procedures which included SARS-COV-2 test: Positive (variant PCR-based: sequenced variant: n501y-positive: Unknown) on 26Sep2021. The outcome of event was unknown. No follow-up attempts are needed; No further information is expected.


VAERS ID: 1874037 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-09-26
   Days after vaccination:66
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Variant Sequenced: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101508205

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB AT-BASGAGES-2021-053078. A 42-year-old female patient received bnt162b2 (COMIRNATY, Solution for Injection, Lot Number: FE6208), intramuscular on 22Jul2021 as dose 2, single and received first dose of bnt162b2 (COMIRNATY, Solution for Injection, Lot Number: FD0168), intramuscular on 18Jun2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced SARS-CoV-2 infection (COVID-19) and vaccination failure. The patient underwent lab test which included COVID-19 PCR test was positive on 26Sep2021; Variant PCR-based, Variant Sequenced: n501y-positive: Unknown. The outcome of the event SARS-CoV-2 infection was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1874038 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-09-26
   Days after vaccination:104
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 - / OT

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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Sequenced variant: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101508190

Write-up: Drug ineffective; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053079. A 75-year-old female patient received second dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: FD0168, Expiration date: was not reported), via an intramuscular route of administration, administered anatomical location was not reported, on 14Jun2021 (at the age of 75 year), as DOSE 2, SINGLE for COVID-19 immunization and the patient receive first dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: EY3014, Expiration date: was not reported), via an intramuscular route of administration, administered anatomical location was not reported, on 03May2021 (at the age of 75-year-old), as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 26Sep2021, the patient experienced SARS-CoV-2 infection. The patient underwent lab tests and procedures which included sars-cov-2 test was positive Variant PCR-based: Sequenced variant: n501y-positive: Unknown on 26Sep2021. The outcome of the SARS-CoV-2 infection was unknown at the time of this report. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101520306 same patient, different adverse events


VAERS ID: 1874040 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-09-26
   Days after vaccination:239
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Sequenced variant: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101508682

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053084. A 40-year-old female patient received two doses of BNT162b2 (COMIRNATY), dose 2 on 30Jan2021 (Lot Number: EJ6136) and dose 1 on 09Jan2021 (Lot Number: EJ6796) both intramuscular as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced SARS-CoV-2 infection/vaccination failure on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (Sequenced variant: n501y-positive: unknown) on 26Sep2021. No follow-up attempts are possible. No further information is expected.?


VAERS ID: 1874046 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-09-26
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2, Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101508206

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053093. A 59-year-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: FD1921) on 04Jun2021 as dose 1, single and received second dose on 25Jun2021 (Lot Number: FD6840) as dose 2, single both via intramuscular route of administration for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced SARS-CoV-2 infection, and vaccination failure. The patient underwent lab tests and procedures which included SARS-COV-2 test: Positive (Variant PCR-based: B.1.617.2, Variant Sequenced: n501y-positive: No) on 26Sep2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1874049 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-09-26
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617 not differentiated, n501y-positive: no.
CDC Split Type: ATPFIZER INC202101508554

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [Regulatory Authority number AT-BASGAGES-2021-053124]. A 74-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), intramuscular on 03Aug2021 (Batch/Lot Number: FE6208) as DOSE 1, SINGLE and 2nd dose intramuscular on 25Aug2021 (Batch/Lot Number: FE7051) as DOSE 2, SINGLE both for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced sars-cov-2 infection (medically significant) on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021 (Variant PCR-based: B.1.617 not differentiated, n501y-positive: no). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1874051 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-09-26
   Days after vaccination:89
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2, Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101508574

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053127. A 44-year-old female patient received bnt162b2 (COMIRNATY) intramuscularly on 29Jun2021 (Batch/Lot Number: FD0168) as dose 2, single and intramuscularly on 26May2021 (Batch/Lot Number: FC0681) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced SARS-CoV-2 infection and vaccination failure on 26Sep2021. The patient underwent lab tests and procedures which included COVID-19 PCR test (26Sep2021): Positive (Variant PCR-based: B.1.617.2, Variant Sequenced: n501y-positive: No). Outcome of events was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1874198 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-09-26
   Days after vaccination:89
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2, Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101508549

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053122. A 58-year-old female patient received bnt162b2 (COMIRNATY) intramuscularly on 29Jun2021 (Batch/Lot Number: FD4555) as dose 2, single and intramuscularly on 22May2021 (Batch/Lot Number: FA4598) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure and SARS-CoV-2 infection on 26Sep2021. The patient underwent lab tests and procedures which included COVID-19 PCR test (26Sep2021): Positive (Variant PCR-based: B.1.617.2, Variant Sequenced: n501y-positive: No). Outcome of events was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1875398 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101499180

Write-up: peripheral neuropathy - numb hands/arms/spine and feet; This is a spontaneous report from a contactable consumer reporting on self (patient). A 26-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Right on 24Sep2021 10:30 (Batch/Lot Number: Unknown) at the age of 26-years-old as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient has no Covid prior vaccination. The patient is not pregnant at the time of vaccination. On 26Sep2021 08:00, the patient experienced peripheral neuropathy - numb hands/arms/spine and feet. The event required doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the event. The outcome of the event was not recovered. The lot number for BNT162b2, was not provided and will be requested during follow up.


VAERS ID: 1875500 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, Blood pressure measurement, Body temperature, C-reactive protein, CSF white blood cell count, Dyspnoea, Heart rate, Hyperventilation, Hypoaesthesia, Oxygen saturation, Respiratory rate, Troponin I
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: Creatinine; Test Result: 0.66 mg/dl; Test Date: 20210926; Test Name: Blood potassium; Result Unstructured Data: Test Result:3.8 mmol/L; Test Date: 20210926; Test Name: Blood pressure; Result Unstructured Data: Test Result:124/93 mmHg; Test Date: 20210926; Test Name: Body temperature; Result Unstructured Data: Test Result:37 Centigrade; Test Date: 20210926; Test Name: C-reactive protein; Result Unstructured Data: Test Result:8.75 mg/l; Test Date: 20210926; Test Name: CSF white blood cell count; Result Unstructured Data: Test Result:6.22 x10 3/mm3; Test Date: 20210926; Test Name: Heart rate; Result Unstructured Data: Test Result:101; Comments: Units:{beats}/min; Test Date: 20210926; Test Name: Arterial oxygen saturation; Test Result: 100 %; Test Date: 20210926; Test Name: Respiratory rate; Result Unstructured Data: Test Result:20; Comments: Units:{breaths}/min; Test Date: 20210926; Test Name: Cardiac troponin I; Result Unstructured Data: Test Result:0.0023 ng/ml
CDC Split Type: TWPFIZER INC202101572276

Write-up: EXCESSIVE VENTILATION; DID NOT BREATHE; HANDS AND FEET WERE NUMB; This is a spontaneous report from a non-contactable healthcare professional via Center for Disease Control (Regulatory authority report number: TW-TFDA-TVS-1100009613), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004479), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100009613. A 17-year-old female patient started to receive the 1st dose of Tozinameran (COMIRNATY) (batch number was not reported) on 24-Sep-2021 via intramuscular at 0.3 ml with unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication and past product were not reported. The patient experienced excessive ventilation, did not breathe, hands and feet were numb on 26-Sep-2021. On 24-Sep-2021, the patient received the 1st dose of BNT vaccine. On 26-Sep-2021, the patient went to hospital and complained that he did not breathe and his hands and feet were numb. The patient received examination of life signs: blood pressure (BP) was 124/93 mmHg; The heart rate (HR) was 101 times/min; respiratory rate (RR) was 20 times/min; body temperature (BT) was 37 C; arterial oxygen saturation (SPO2) was 100%. The patient received laboratory tests: white blood cell (WBC) was 6.22 x 1000/UL; C-reactive protein (CRP) was 8.75 mg/L; blood potassium (K) was 3.8 mmol/L; The creatinine was 0.66 mg/dl; Troponin-I was less than 0.0023 Ng/ml. The patient was administered medical treatment of 0.9% sodium chloride at 500 ml via intravenous drip (IVD) statim (St) according to the doctor''s diagnosis. The patient was stable and refused to do electrocardiogram (ECG) inspections. The doctor notified the COVID-19 vaccine of adverse reactions. Excessive ventilation, did not breathe, hands and feet were numb met the seriousness criterion of Other Medically Important Condition. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. Initial report was received on 03-Nov-2021. Follow-up closed, no further information is possible. Causality assessment Numbness of extremities, Breathing difficult, Hyperventilation Per Reporter=Possible Per Company=Possible


VAERS ID: 1875526 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dermatitis, Pruritus, Rash, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atopic dermatitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101572270

Write-up: SKIN INFLAMMATION; progressive facial swelling and itchy; progressive facial swelling and itchy; SKIN RASH (NON-INJECTION SITE); This is a spontaneous report from a non-contactable healthcare professional via regulatory authority (Regulatory authority report number: TW-TFDA-TVS-1100009694), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004513), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100009694. A 21-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: unknown) on 26-Sep-2021 (at the age of 21 years old) via intramuscular at single dose (reported as unspecified dosing frequency) for COVID-19 immunization. Medical history included atopic dermatitis. Concomitant medications and past product were not reported. The patient experienced skin rash (non-injection site) on 26-Sep-2021 and skin inflammation on 21-Oct-2021. On 26-Sep-2021, the patient received the vaccination COVID-19 (BNT) vaccine and experienced rash from the hand to the whole body. In the early morning of 09-Oct-2021, the patient went to the hospital emergency due to a rash. On 28-Sep-2021, progressive facial swelling and itchy were diagnosed in the hospital. After diagnosis and treatment, the patient was given an intramuscular injection of diphenhydramine and methylprednsolone, but the symptoms were not improved. On 10-Oct-2021, the patient left the hospital. On 11-Oct-2021, temption dermatology, brought back oral mequitazine, hydroxyzine with external flucort-f ointment, rinderon va cream were used. On 21-Oct-2021, the patient experienced skin inflammation. It was reported on 08-Oct-2021 and 18-Oct-2021, the patient went to hospital for medical treatment and expected to go to the hospital for reexamination next time on 25-Oct-2021. The VICP application method has been described. Skin rash (non-injection site) and skin inflammation met the seriousness criterion of Other Medically Important Condition. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. Initial report was received on 03-Nov-2021. Follow-up closed, no further information is possible. Causality assessment for events Skin rash, Skin inflammation was possible per Reporter and Per Company. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1876261 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-09-26
   Days after vaccination:230
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2, Sequenced variant:n501y-positive: No
CDC Split Type: ATPFIZER INC202101522932

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-2021-052744. A 53-year-old female patient received bnt162b2 intramuscularly on 08Feb2021 (Batch/Lot Number: EK9788) as dose 2, single and intramuscularly on 18Jan2021 (Batch/Lot Number: EL1491) as dose 1, single for COVID-19 immunisation. The patient''s medical history was not reported. There were no concomitant medications. The patient experienced vaccination failure and SARS-CoV-2 infection on 26Sep2021. The patient underwent lab tests and procedures which included COVID-19 PCR test (26Sep2021): Positive (Variant PCR-based: B.1.617.2, Sequenced variant:n501y-positive: No). Outcome of events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1876266 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-09-26
   Days after vaccination:129
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 2 - / OT

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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y positive: No
CDC Split Type: ATPFIZER INC202101523658

Write-up: Drug ineffective; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB AT-BASGAGES-2021-052761. The physician reported 2 cases for different events occurred with the same drug for the same patient. This is the 1st of 2 reports. A 47-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 08Apr2021 (Batch/Lot Number: EW2239) as single dose, dose 2 intramuscular on 20May2021 (at the age of 47-year-old) (Batch/Lot Number: FA4598) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced drug ineffective (medically significant) on 26Sep2021 with outcome of unknown, sars-cov-2 infection (medically significant) on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021 (Variant PCR-based: B.1.617.2. Variant Sequenced: n501y positive: No). No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101553360 same patient/vaccine, different events/doses


VAERS ID: 1876271 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-09-26
   Days after vaccination:102
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 - / OT

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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based or variant sequenced was unknown if n501y-positive
CDC Split Type: ATPFIZER INC202101522962

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the -WEB. The regulatory authority report number is AT-BASGAGES-2021-052769. A 63-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, on 05May2021 (Lot Number: EY3014), as dose 1, single, and then on 16Jun2021 (Lot Number: FD0168), as dose 2, single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced SARS-CoV-2 infection, other and vaccination failure with positive COVID-19 PCR test, variant PCR-based or variant sequenced was unknown if n501y-positive. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101544573 Same patient and product; different events and dose


VAERS ID: 1876280 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-09-26
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Sequenced variant: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101523010

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB AT-BASGAGES-2021-052791. This is a report from regulatory authority. This is first of two reports concerning the same patient. A 46-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 27Jun2021 (Lot Number: FD6840) as dose 2, single, dose 1 intramuscular on 16May2021 (Lot Number: FA4598) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications. The patient experienced vaccination failure (as reported) and sars-cov-2 infection on 26Sep2021. The events were serious as medically significant with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 26Sep2021 (Variant PCR-based: Sequenced variant: n501y-positive: Unknown). No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101555112 The same patient, different events, second dose


VAERS ID: 1876281 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-09-26
   Days after vaccination:134
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101523334

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052798. A 63-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 15May2021 (Batch/Lot Number: FA4598) as dose 2, single and intramuscular on 04Apr2021 (Batch/Lot Number: EW2239) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sars-cov-2 infection (covid-19) (medically significant) and vaccination failure (vaccination failure) (medically significant) on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021 (Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No). No follow-up attempts possible. No further information expected.


VAERS ID: 1876299 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-09-26
   Days after vaccination:94
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR - Baseline: B.1.617.2 Order of variants: n501y-positive: No; Test Date: 20210926; Test Name: Variant PCR - Baseline: B.1.617.2; Result Unstructured Data: Test Result:N501Y negative; Comments: Variant PCR - Baseline: B.1.617.2 Order of variants: n501y-positive: No
CDC Split Type: ATPFIZER INC202101522599

Write-up: drug ineffective; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is AT-BASGAGES-2021-052841. This is the first of two reports. A 63-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via intramuscular on 24Jun2021 (Lot Number: FD4555) as dose 2, single; and via intramuscular on 13May2021 (Lot Number: FA4598) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On 26Sep2021, the patient experienced drug ineffective and SARS-CoV-2 infection. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 26Sep2021 and SARS-CoV-2 test: N501Y negative on 26Sep2021 (Variant PCR - Baseline: B.1.617.2). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101547338 same patient,same suspect, at risk scenario


VAERS ID: 1876300 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-09-26
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2. Variant Sequenced: n501y negative.
CDC Split Type: ATPFIZER INC202101522604

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052842. A 29-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection), dose 2 intramuscularly, on 10Aug2021 (Batch/Lot Number: FE8244) as dose 2, single; dose 1 intramuscularly, on 01Jul2021 (Batch/Lot Number: FD4555) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure and SARS-CoV-2 infection on 26Sep2021. The patient underwent lab tests and procedures which included COVID-19 polymerase chain reaction (PCR) test: Positive on 26Sep2021 (Variant PCR-based: B.1.617.2. Variant Sequenced: n501y negative). The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1876302 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-09-26
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: PCR-based variant: Sequenced variant: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101523131

Write-up: Vaccination failure/SARS-CoV-2 infection; Vaccination failure/SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052846. A 30-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscularly on 31May2021 (lot number: FC2473) as dose 2, single and intramuscularly on 26Apr2021 (lot number: EW4815) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure/SARS-CoV-2 infection on 26Sep2021. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive (PCR-based variant: Sequenced variant: n501y-positive: Unknown) on 26Sep2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1876305 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-09-26
   Days after vaccination:71
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Sequenced variant: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101522634

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from a Regulatory Authority, regulatory authority number is AT-BASGAGES-2021-052856. A 24-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection), on 06Jun2021 (Batch/Lot number: FD1921, Expiration date was not reported) via an unspecified route of administration as dose 1, single and on 17Jul2021 (Batch/Lot number: FD6840, Expiration date was not reported) intramuscularly as dose 2, single; both for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced SARS-CoV-2 infection and vaccination failure. The patient underwent lab tests and procedures which included COVID-19 Polymerase chain reaction (PCR) test for variant PCR-based and sequenced variant: Positive and N501Y-Positive: Unknown, on 26Sep2021. The case was considered to be serious (medically significant) by the reporter. The outcome of the reported events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1876306 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-09-26
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 2 - / OT

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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101522641

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician. This is the first of two reports. The first, serious report is downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052857. A 76-year-old male patient received BNT162B2 (COMIRNATY, Solution for Injection), on 17Apr2021 (Lot Number: EW4815; Expiration Date: Not reported) as dose 1, single and on 29May2021 (Lot Number: FC2473; Expiration Date: Not reported) as dose 2, single both intramuscularly and for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure (as reported) and SARS-COV-2 infection on 26Sep2021. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 26Sep2021 (reported as Variant PCR-based: B.1.617.2, Variant Sequenced: n501y-positive: No). The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.?; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101546487 Same reporter, patient, and drug; different event


VAERS ID: 1876308 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-09-26
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2, n501y-positive: no.
CDC Split Type: ATPFIZER INC202101523169

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [Regulatory Authority number AT-BASGAGES-2021-052860]. A 39-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), intramuscular on 16May2021 (Batch/Lot Number: FA4598) as DOSE 1, SINGLE and 2nd dose intramuscular on 27Jun2021 (Batch/Lot Number: FD6840) as DOSE 2, SINGLE both for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced sars-cov-2 infection (medically significant) on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021 (variant PCR-based: B.1.617.2, n501y-positive: no). No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101553847 Same patient/drug, different event


VAERS ID: 1876310 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-09-26
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: PCR-based variant: Sequenced variant: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101522654

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number AT-BASGAGES-2021-052863. A 72-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), administered on 27Jul2021 (Batch/Lot number: FD6840, expiration date not reported) as dose 2, single and administered on 24Jun2021 (Batch/Lot number: FD4555, expiration date not reported) as dose 1, single both intramuscularly administered and for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced SARS-CoV-2 infection and Vaccination failure. Events were reported as serious, medically significant by the regulatory authority. The patient underwent lab tests and procedures which included COVID-19 PCR test: Positive (PCR-based variant:, Sequenced variant:, n501y-positive: Unknown) on 26Sep2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1876325 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-09-26
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 2 - / OT

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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101522733

Write-up: drug ineffective; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052888. This is the first of two reports. A 60-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 29May2021 (Lot Number: FC2473) as DOSE 2, SINGLE, dose 1 intramuscular on 17Apr2021 (Lot Number: EW4815) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced drug ineffective (medically significant), SARS-CoV-2 infection (medically significant) with outcome of unknown. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 26Sep2021 (Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No). No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101544196 Same patient, different events, different dose


VAERS ID: 1876333 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-21
Onset:2021-09-26
   Days after vaccination:189
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2. Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101522812

Write-up: Vaccination failure/SARS-CoV-2 infection; Vaccination failure/SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052906. An 86-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), intramuscularly on 21Mar2021 (lot number: ET3620) as dose 2, single and intramuscularly on 28Feb2021 (lot number: EP2163) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure/SARS-CoV-2 infection on 26Sep2021. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive (variant PCR-based: B.1.617.2. Sequenced variant: n501y-positive: No) on 26Sep2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1876334 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-21
Onset:2021-09-26
   Days after vaccination:189
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2, sequenced variant: not n501y-positive
CDC Split Type: ATPFIZER INC202101522819

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from a Regulatory Authority. The regulatory authority report number is AT-BASGAGES-2021-052907. An 83-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, on 28Feb2021 (Lot Number: EJ6790), as dose 1, single, and then on 21Mar2021 (Lot Number: ET3620), as dose 2, single, for COVID-19 immunization. The patient''s medical history was not reported. There were no concomitant medications. On 26Sep2021, the patient experienced SARS-CoV-2 infection, other and vaccination failure with positive COVID-19 PCR test, variant PCR-based: B.1.617.2, sequenced variant: not n501y-positive. The events were considered serious as important medical events. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1876341 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-09-26
   Days after vaccination:112
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Name: n501y-positiv; Result Unstructured Data: Test Result:Unknown
CDC Split Type: ATPFIZER INC202101508458

Write-up: Vaccination failure; SARS-CoV-2 infection; his is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number AT-BASGAGES-2021-052947. A 33-year-old male patient received bnt162b2, dose 2 intramuscular on 06Jun2021 (Batch/Lot Number: FD1921) as dose 2, single; and dose 1 intramuscular on 02May2021 (Batch/Lot Number: EY3014) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced vaccination failure and Sars-cov-2 infection. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021, sars-cov-2 test: n501y-positive: Unknown on an unspecified date. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1876342 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-09-26
   Days after vaccination:125
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive; Test Date: 20210926; Test Name: n501y-positive: Unknown; Result Unstructured Data: Test Result:n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101508317

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number AT-BASGAGES-2021-052961. A 79-year-old male patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FA4598) via intramuscular on 24May2021 as dose 2, single and first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EW4815) intramuscular on 19Apr2021 as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced SARS-CoV-2 infection and vaccination failure. Events were considered serious medically significant. The patient underwent lab tests and procedures which included sars-cov-2 PCR test resulting positive and sars-cov-2 test: n501y-positive resulting unknown (Variant PCR-based, Variant Sequenced, n501y-positive: Unknown) on 26Sep2021. Outcome of the events was unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1876345 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-09-26
   Days after vaccination:95
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 - / OT

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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive; Comments: variant sequenced: n501y-positive: unknown
CDC Split Type: ATPFIZER INC202101508401

Write-up: SARS-CoV-2 infection, other, Vaccination failure/ patient tested positive for COVID-19 PCR test; SARS-CoV-2 infection, other, Vaccination failure/ patient tested positive for COVID-19 PCR test; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB; the Regulatory Authority report number is AT-BASGAGES-2021-052989. A 53-year-old female patient received the second dose of bnt162b2 (COMIRNATY), intramuscular on 23Jun2021 (batch/lot number: FD0168) as DOSE 2, SINGLE and received the first dose of bnt162b2 (COMIRNATY) intramuscular on 12May2021 (batch/lot number: EY7015) as DOSE 1, SINGLE for COVID-19 immunization. The patient''s medical history, concurrent conditions, and concomitant medications were not reported. The patient received the first dose of Comirnaty on 12May2021 and the second dose on 23Jun2021 (43rd day). On 26Sep2021, the patient experienced SARS-CoV-2 infection, other, Vaccination failure. It was reported that the patient tested positive for COVID-19 PCR test on 26Sep2021; details included variant sequenced: n501y-positive: unknown. The outcome of the event "SARS-CoV-2 infection, other, Vaccination failure/ tested positive for COVID-19 PCR test" was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1876346 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-09-26
   Days after vaccination:221
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: PCR-based Variant; Result Unstructured Data: Test Result:B.1.617.2; Comments: PCR-based Variant: B.1.617.2. Variant Sequenced: . n501y-positive: No; Test Date: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive
CDC Split Type: ATPFIZER INC202101508412

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052995. An 80-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 28Jan2021 (Batch/Lot Number: EJ6134) as single dose, dose 2 intramuscular on 17Feb2021 (Batch/Lot Number: EJ6790) as single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure (medically significant) on 26Sep2021 with outcome of unknown, sars-cov-2 infection (medically significant) on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive on 26Sep2021, Sars-cov-2 test: b.1.617.2 (PCR-based Variant: B.1.617.2. Variant Sequenced: . n501y-positive: No) on 26Sep2021. No follow-up attempts are possible. No further information expected.


VAERS ID: 1876347 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-09-26
   Days after vaccination:89
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: PCR-based Variant; Result Unstructured Data: Test Result:B.1.617.2; Comments: PCR-based Variant: B.1.617.2. Variant Sequenced: n501y-positive: No; Test Date: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive
CDC Split Type: ATPFIZER INC202101508419

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053002. A 45-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 20May2021 (Batch/Lot Number: FC0681) as single dose, dose 2 intramuscular on 29Jun2021 (at the age 45-year-old) (Batch/Lot Number: FD6840) as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported The patient experienced vaccination failure (medically significant) on 26Sep2021 with outcome of unknown, sars-cov-2 infection (medically significant) on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive on 26Sep2021, Sars-cov-2 test: b.1.617.2 on 26Sep2021 (PCR-based Variant: B.1.617.2. Variant Sequenced: n501y-positive: No). No follow-up attempts are possible. No further information expected.


VAERS ID: 1876348 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-09-26
   Days after vaccination:226
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: SARS-CoV-2 test: b.1.617.2, PCR-based Variant, Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101508422

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053003. A 55-year-old female patient received bnt162b2 (COMIRNATY) intramuscular on 20Jan2021 (Batch/Lot Number: EL1491) as dose 1, single and intramuscular on 12Feb2021 (Batch/Lot Number: EJ6790) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced vaccination failure and sars-cov-2 infection. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive (SARS-CoV-2 test: b.1.617.2, PCR-based Variant, Variant Sequenced: n501y-positive: No) on 26Sep2021. Outcome of the events was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1876352 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-09-26
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7015 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20210926; Test Name: n501y-positive; Result Unstructured Data: Test Result:No; Test Date: 20210926; Test Name: Variant PCR-based; Result Unstructured Data: Test Result:B.1.617.2; Comments: Variant PCR-based: B.1.617.2. Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101508504

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053023. A 67-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 17Apr2021 (Batch/Lot Number: EW4815) as single dose, dose 2 intramuscular on 08May2021 (at the age of 67-year-old) (Batch/Lot Number: EY7015) as single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported The patient experienced vaccination failure (vaccination failure) (medically significant) on 26Sep2021 with outcome of unknown, Sars-cov-2 infection (covid-19) (medically significant) on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021, Sars-cov-2 test: b.1.617.2 (Variant PCR-based: B.1.617.2. Variant Sequenced: n501y-positive: No on 26Sep2021, Sars-cov-2 test: no on 26Sep2021. No follow-up attempts are possible. No further information expected.


VAERS ID: 1876353 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-09-26
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 2 - / OT

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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508523

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-2021-053027. A 28-year-old female patient received bnt162b2, intramuscular on 03Aug2021 (Batch/Lot Number: FF3318) as dose 2, single and intramuscular on 22Jul2021 (Batch/Lot Number: FD4555) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, it was reported that the patient experienced vaccination failure and SARS-CoV-2 infection. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive (Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No) on 26Sep2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1876354 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-09-26
   Days after vaccination:229
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: not reported n501y-positive: No
CDC Split Type: ATPFIZER INC202101508536

Write-up: Vaccination failure/Variant PCR-based: B.1.617.2; SARS-CoV-2 infection/Variant PCR-based: B.1.617.2; This is a spontaneous report from a contactable physician downloaded from a Regulatory Authority, regulatory authority number AT-BASGAGES-2021-053029. An 89-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular on 19Jan2021 (Batch/Lot Number: EJ6797) as dose 1, single, and intramuscular on 09Feb2021 (Batch/Lot Number: EJ6797) as dose 2, single, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced SARS-CoV-2 infection, other, vaccination failure. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive (Variant PCR-based: B.1.617.2; Variant Sequenced: not reported; n501y-positive: No) on 26Sep2021. The outcome of the events was unknown. The report was reported as serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1876357 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-09-26
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Test Date: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508459

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 report number is AT-BASGAGES-2021-053036. A 46-year-old female patient received BNT162B2, via intramuscular route on 30Jun2021 (Lot Number: FD4555; Expiration date: Not reported) as dose 2, single and on 09Jun2021 (Lot Number: FD1921; Expiration date: Not reported) as dose 1, single for COVID-19 immunization. No relevant medical history and no concomitant medications were reported. On 26Sep2021, the patient experienced severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and vaccination failure. On 26Sep2021, the patient''s variant polymerase chain reaction (PCR) based COVID-19 test was reported as B.1.617.2 with sequenced variation reported with no positive n501Y. The outcome of these events was unknown at the time of report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1876358 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-09-26
   Days after vaccination:162
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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 PCR-based; Result Unstructured Data: Test Result:B.1.617.2; Test Date: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive; Comments: COVID-19 PCR test
CDC Split Type: ATPFIZER INC202101508462

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-2021-053037. A 32-year-old male patient received bnt162b2, dose 1 intramuscular on 27Mar2021 (Batch/Lot Number: ET1831) as single dose, dose 2 intramuscular on 17Apr2021 (at the age of 32-year-old) (Batch/Lot Number: EW4815) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure (medically significant) on 26Sep2021 with outcome of unknown, sars-cov-2 infection (medically significant) on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive on 26Sep2021, Sars-cov-2 test: no on unspecified date, sars-cov-2 test: b.1.617.2 (Variant PCR-based: B.1.617.2. Sequenced variant: n501y-positive: No) on unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1876360 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-09-26
   Days after vaccination:179
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive; Comments: n501y-positive: No Variant PCR-based: B.1.617.2
CDC Split Type: ATPFIZER INC202101508625

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from a Regulatory Authority, regulatory authority number AT-BASGAGES-2021-053046. A 79-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 31Mar2021 (lot number: ET7205; expiry date: unknown) as dose 2, single, intramuscular on 10Mar2021 (lot number: EP2166; expiry date: unknown) as dose 1, single for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced SARS-CoV-2 infection, other, Vaccination failure. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (n501y-positive: No; Variant PCR-based: B.1.617.2) on 26Sep2021. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1876362 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-09-26
   Days after vaccination:130
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant Polymerase chain reaction: B.1.617.2 Variant sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101508677

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053060. A 45-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 14Apr2021 (Batch/Lot Number: EW2246) as DOSE 1, SINGLE and then intramuscular on 19May2021 (Batch/Lot Number: FA4598) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure and SARS-CoV-2 infection on 26Sep2021. The reporter assessed the event as serious medically significant. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive (Variant Polymerase chain reaction: B.1.617.2 Variant sequenced: n501y-positive: No) on 26Sep2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1876367 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-09-26
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 2 - / OT

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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508687

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-2021-053080. A 68-year-old male patient received bnt162b2, intramuscular on 02Jun2021 (Batch/Lot Number: FC2473) as dose 2, single and intramuscular on 21Apr2021 (Batch/Lot Number: EW4815) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 26Sep2021, it was reported that the patient experienced vaccination failure and SARS-CoV-2 infection. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive (Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No) on 26Sep2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1876369 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-09-26
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 2 - / OT

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? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617 not differentiated; Sequenced variant: unknown; n501y-positive: No
CDC Split Type: ATPFIZER INC202101522897

Write-up: Drug ineffective; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. The regulatory authority report number is AT-BASGAGES-2021-053106. This is the first of two reports. A 61-year-old female patient received BNT162B2 (solution for injection), on 21Apr2021 (lot number: EW4815) as dose 1, single; then on 02Jun2021 (lot number: FC2473) as dose 2, single - both administered intramuscularly for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced SARS-CoV-2 infection (drug ineffective). The patient had a positive COVID-19 PCR test (Variant PCR-based: B.1.617 not differentiated; Sequenced variant: unknown; n501y-positive: No) on 26Sep2021. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected. ; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101553759 same reporter, patient, and drug; different dose and event


VAERS ID: 1876370 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-09-26
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 not differentiated. Sequenced variant: n501y-positive: No
CDC Split Type: ATPFIZER INC202101522660

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 is AT-BASGAGES-2021-053108. A 34-year-old male patient received BNT162B2 (Solution for injection), on 10Jun2021 (Batch/Lot number: FC2473, Expiration date was not reported) as dose 1, single and on 16Jul2021 (Batch/Lot number: FF0680, Expiration date was not reported) as dose 2, single; both intramuscularly for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced SARS-CoV-2 infection and vaccination failure. The patient underwent lab tests and procedures which included COVID-19 Polymerase chain reaction (PCR) test for variant B.1.617.2 not differentiated, sequenced variant: Positive and N501Y-Positive: No, on 26Sep2021. The case was considered to be serious (medically significant) by the reporter. The outcome of the reported events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1876372 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-09-26
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Sequenced variant: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101523180

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from a Regulatory Authority AT-BASGAGES-2021-053111. This is a report from regulatory authority. An 82-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 20Apr2021 (Lot Number: EW4815) as dose 2, single, dose 1 intramuscular on 29Mar2021 (Lot Number: ET3620) as dose 1, single 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 26Sep2021. The events were serious as medically significant with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 26Sep2021 (Variant PCR-based: Sequenced variant: n501y-positive: Unknown). No follow up attempts needed, no further information is expected.


VAERS ID: 1876373 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-09-26
   Days after vaccination:180
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2. Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101522671

Write-up: Vaccination failure/SARS-CoV-2 infection; Vaccination failure/SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053113. A 79-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), intramuscularly on 04May2021 (lot number: EY3014) as dose 2, single and intramuscularly on 30Mar2021 (lot number: ET3620) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure/SARS-CoV-2 infection on 26Sep2021. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive (variant PCR-based: B.1.617.2. Sequenced variant: n501y-positive: No) on 26Sep2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1876374 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-09-26
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101523387

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053114. A 44-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 25Jun2021 (Batch/Lot Number: FD4555) as dose 2, single and intramuscular on 22May2021 (Batch/Lot Number: EY7015) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure (vaccination failure) (medically significant) and sars-cov-2 infection (covid-19) (medically significant) on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021 (Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No). No follow-up attempts possible. No further information expected.


VAERS ID: 1876378 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-09-26
   Days after vaccination:222
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210926; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC202101508579

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-053129. An 85-year-old male patient received BNT162B2 (COMIRNATY), intramuscular on 16Feb2021 (Lot Number: EJ6790) as Dose 2, single, and intramuscular on 26Jan2021 (Lot Number: EJ6134) as Dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced vaccination failure and SARS-CoV-2 infection on 26Sep2021. The patient underwent COVID-19 PCR test: positive on 26Sep2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


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