Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: diagnosed with COVID after have 3 doses of the Pfizer COVID vaccine; diagnosed with COVID after have 3 doses of the Pfizer COVID vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 at 10:15 as dose 1, single (Lot number: EL9262), in left arm, on 25Feb2021 at 10:15 as dose 2, single (Lot number: EN6200), in left arm and on 15Oct2021 at 10:15 as dose 3 (booster), single (Lot number: FH8020) at the age of 74 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Open heart surgery", start date: 2014, stop date: 2014, notes: 8 years before reporting. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with COVID after have 3 doses of the Pfizer COVID vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Patient diagnosed with COVID after have 3 doses of the Pfizer COVID vaccine. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included Paxlovid. Clinical course: Patient was diagnosed with COVID after having 3 doses of the Pfizer COVID vaccine (got his COVID booster and shots). Patient had no additional vaccines administered on same date of the Pfizer suspect. He had minimal interference with his vaccines. After he was diagnosed with COVID he was knocked out for 3-4 days. He is taking Paxlovid from his internist who recommended it for COVID. The adverse event did not require a visit to emergency room or physician office. The product quality group provided investigation results regarding COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 (Lot numbe: EL9262): Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9262 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 EL9262, fill lot EL9253, and the formulated drug product lot EL9244. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. 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 product quality group provided investigation results regarding COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 (Lot number: EN6200): Conclusion of Previously Completed Investigation: 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. The product quality group provided investigation results regarding COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 (Lot number: FH8020): Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot FH8020 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FH8020, fill lot FG3521, and the bulk formulated drug product lot FH0137. 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.