Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid 19; Tested positive for Covid 19; Cough; Sore throat; Fever, 100.3 degrees; Felt some pain in his chest; This is a spontaneous report from a contactable consumer or other non hcp. A 7-decade-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL9264), via an unspecified route of administration on 04Feb2021 as dose 1, single, and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EM9809) dose 2 via an unspecified route of administration on 25Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 02Aug2021 the patient was in a room with two other vaccinated individuals, in a meeting, without masks. The patient went and got a test on Thursday, 05Aug2021, and it was negative. On Friday, 06Aug2021, the patient started experiencing a sore throat, fever with a temperature of 100.3 degrees, cough, and felt some pain in his chest. The patient went back for another test on 07Aug2021 and it was positive. He was quarantined. He had a doctor friend who was a cardiologist who gave him a nebulizer and told him to keep check on his O2 levels. The patient underwent lab tests and procedures which included body temperature with 100.3. On 06Aug2021 100.3 degrees, sars-cov-2 test with negative on 05Aug2021 and sars-cov-2 test with positive on 07Aug2021. The outcome of the events cough, oropharyngeal pain, pyrexia and chest pain was recovered on an unspecified date in 2021 and covid-19 was unknown.  Conclusion: 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 5702833 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 im-pact 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.  The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL9264 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 EL9264, fill lot EL9255, and the formulated drug product lot EL9246. 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 attempts are completed. No further information is expected.