Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Had a second test performed on 14Aug2021 and received positive result; began experiencing symptoms on 11Aug2021; This is a spontaneous report from a contactable consumer and from pfizer product quality group providing investigation results. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via intramuscular route, administered in left arm on 27Apr2021 (at the age of 45 -years) (Lot Number: EW0170; Expiration Date: 31Aug2021) as dose 1, single and dose 2 intramuscular, administered in left arm (at the age of 45 years) on 25May2021 (Lot Number: EW0191; Expiration Date: 30Sep2021) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that he had received positive COVID19 result. He had unknowingly exposed on 10Aug2021. The patient began experiencing symptoms on 11Aug2021. Tested showed negative for COVID-19 on 12Aug2021. Had a second test performed on 14Aug2021 and received positive result on 14Aug2021. Covid is tested post vaccination. The patient underwent lab tests which included Coronavirus PCR/Nasal Swab showed negative on 12Aug2021 and coronavirus Antigen/Nasal Swab showed positive on 14Aug2021. The patient had not received any treatment for the events. The outcome of the events was unknown.  Lot number: EW0170; Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0170 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 EW0170, fill lot EP8701, and the formulated drug product lot EP8603. 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.  Lot number: EW0191; Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0191 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 and product type. The final scope included the reported finished goods lot EW0191, fill lot EP8738, and bulk formulation lot EP8619. 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.  Evaluation Comment: Pfizer reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number is valid, and an investigation will be performed.  Follow-up attempts are completed. No further information is expected.