Sex: M
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID virus, after being fully vaccinated.; Tested positive for COVID virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN5318, Expiry Date: unknown), via an unspecified route of administration on 28Jan2021 as dose 1, single and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9266, Expiry Date: unknown), via an unspecified route of administration on 23Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history was none. The patient concomitant medications were not reported. On 08Aug2021, the patient experienced Tested positive for COVID virus, after being fully vaccinated. The patient underwent lab tests and procedures which included body mass index: 31.9 on an unspecified date and SARS-COV-2 test (NAAT Covid test): positive on 08Aug2021. The outcome of the event was unknown.  Amendment: This follow-up report is being submitted to amend previously reported information. Narrative for Follow-up (20Aug2021) should only be: Follow up (20Aug2021): This is a follow-up spontaneous report from Product Quality Complaint group. This report includes investigation results: Conclusion of previously completed investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  This report includes investigation results. Conclusion of previously completed investigation: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. TA sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5585551 (see File attachment in this investigation record) The complaint for a positive COVID test after vaccination of ''PFIZER-BIONTECH COVID-19 VACCINE'' was investigated. The investigation included reviewing the involved batch records, deviation investigation, 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 EJ1686. 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. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The testing process determined that a regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101076365 similar report from same reporter