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This is VAERS ID 1763272

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History of Changes from the VAERS Wayback Machine

First Appeared on 10/15/2021

VAERS ID: 1763272
VAERS Form:2
Age:
Sex:Male
Location:Foreign
Vaccinated:2021-06-25
Onset:2021-09-07
Submitted:0000-00-00
Entered:2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2206 / 2 - / OT

Administered by: Other      Purchased by: ??
Symptoms: Ageusia, Cough, Pyrexia, Vaccination failure, COVID-19, SARS-CoV-2 test

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC 'Split Type': ITPFIZER INC202101239685

Write-up: On 07Sep2021 due to the appearance of fever performs molecular swab with finding of positivity for Sars Cov 2; On 07Sep2021 due to the appearance of fever, cough, ageusia performs molecular swab with finding of positivity for Sars Cov 2; Vaccination failure; On 07Sep2021 due to the appearance of cough performs molecular swab with finding of positivity for Sars Cov 2; On 07Sep2021 due to the appearance of ageusia performs molecular swab with finding of positivity for Sars Cov 2; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-788005. A 30-year-old male patient received first dose of BNT162B2 (Comirnaty; Solution for injection; Lot number: FY7065, expiration date: 31Aug2021), via an intramuscular route of administration on 19May2021 as DOSE 1, 0.3 ML SINGLE and received second dose of BNT162B2 (Comirnaty; Solution for injection; Lot number: FE2206), via an intramuscular route of administration on 25Jun2021 as DOSE 2, 0.3 ML SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 07sep2021, the patient experienced fever, cough, ageusia performs molecular swab with finding of positivity for Sars Cov 2. The lab tests included SARS-CoV-2 test: Positive on 07Sep2021.Therapeutic measures were taken as a result of events and treatment included Home therapy (Non-steroidal anti-inflammatory drugs. The outcome of events was not resolved. Health authority comments: I DOSE 19May2021 II DOSE 25Jun2021 Investigation conclusion (lot EY7065): The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EY7065. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Reporter''s Comments: I DOSE 19May2021 II DOSE 25Jun2021

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