Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 56-year-old male patient received BNT162b2 (BNT162B2), on 07Mar2021 at 08:00 as dose 1, single (Lot number: En6200), in right arm, on 28Mar2021 at 08:00 as dose 2, single (Lot number: Er2613), in right arm and on 11Nov2021 at 08:00 as dose 3 (booster), single (Lot number: FH8030) at the age of 56 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: controlled with medication. The patient has no known allergies. Concomitant medication(s) included: NATURE MADE VITAMIN C, MULTI VITAMIN FOR MEN 50+ (BAYER). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (10Jun2022) Negative; (13Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19 which included PAXLOVID. Product quality group investigation results are as follows: Product- Description (CR): COMPOUND BNT162 COVID- 19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. Lot-# (CR): EN6200. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6200 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 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. Product- Description (CR): COMPOUND BNT162 COVID- 19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. Lot-# (CR): ER2613. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot ER2613 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 ER2613, fill lot EP8678, and the formulated drug product lot EP8565. 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. Product- Description (CR): COMPOUND BNT162 COVID- 19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. Lot-# (CR): FH8030. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FH8030 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 FH8030, fill lot FH4343, and the formulated drug product lot FA9187. 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 attempts are completed. No further information is expected.