Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test, Vaccination failure
Clinical narrative: exposed to someone 22Feb and then + Ag 25Feb, feeling no sx will get PCR now; exposed to someone 22Feb and then + Ag 25Feb, feeling no sx will get PCR now; exposed to someone 22Feb and then + Ag 25Feb, feeling no sx will get PCR now; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 27 year-old male patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: FF2589, Expiration Date: 31Mar2022) at the age of 27 years as dose 3 (booster), single, administration date 16Feb2021 (Lot number: EL3247, Expiration Date: 31May2021) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247, Expiration Date: 31May2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), EXPOSURE TO SARS-COV-2 (non-serious) all with onset 25Feb2022, outcome "unknown" and all described as "exposed to someone 22Feb and then + Ag 25Feb, feeling no sx will get PCR now". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Feb2022) negative, notes: Unknown; (24Feb2022) negative, notes: Unknown; (25Feb2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, exposure to sars-cov-2.  Clinical course: The patient exposed to someone 22Feb and then + Ag 25Feb, feeling no sx will get PCR now. Unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient had been tested for COVID-19 since the vaccination. Conclusion of lot EL3247: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL3247 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 EL3247, fill lot EL3230, and the formulated drug product lot EL3223. 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. Conclusion of lot FF2589: The complaint for 'Lack of Effect' of the PFIZERBIONTECH COVID-19 VACCINE lot FF2589 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 FF2589, fill lot FF2558, and the bulk formulated drug product lot FE5318. A complaint sample was not returned. 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.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.