Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Several colleagues got the Covid vaccine and tested positive; Several colleagues got the Covid vaccine and tested positive; This is a spontaneous report from a contactable nurse. A male patient (colleagues' husband) of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6200), via an unspecified route of administration on 18Feb2021 as single dose for COVID-19 immunisation. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 26Jan2021 (Lot Number: EL8982; Expiration Date: 30May2021) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient's several colleagues got the COVID vaccine and tested positive. The patient underwent lab tests and procedures which included sars-cov-2 antibody test, which was positive on an unknown date in Jul2021, also tested positive on 10Jul2021 or 11Jul2021. The outcome of the events was unknown.  Follow up (14Jul2021): This is a follow-up spontaneous report received from Pfizer product quality group providing investigation results. This report included that: Conclusion about PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE Complaint - Lot Number: EL8982 - Lack of Effect  Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL8982 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL8982, fill lot EL8977, and the formulated drug product lot EL8975. 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  Follow-up (15Jul2021): This is a follow-up spontaneous report received from Pfizer product quality group providing investigation results. This report included that: Conclusion about PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE Complaint - Lot Number: EN6200 - Lack of Effect  Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6200was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6200, fill lot EN5332, and the formulated drug product lot EN5321. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up (15Jul2021): This is a follow-up spontaneous report received from Pfizer product quality group providing investigation results. This report included that: Conclusion about PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE Complaint - Lot Number: EL8982 - Lack of Effect  Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL8982 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL8982, fill lot EL8977, and the formulated drug product lot EL8975. 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.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association and profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event vaccination failure and SARS-CoV-2 test positive cannot be completely excluded.