Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8734), on 17Apr2021 as dose 2, single (Lot number: PBEW0164) and on 25Oct2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (17May2022) Negative, notes: Covid Symptoms reoccurred on 24May, positive home test on 25May. There were negative home tests on 17May, 19May and 21May with minor symptoms present at the first test and no symptoms as the next 2 times; (19May2022) Negative, notes: Covid Symptoms reoccurred on 24May, positive home test on 25May. There were negative home tests on 17May, 19May and 21May with minor symptoms present at the first test and no symptoms as the next 2 times; (21May2022) Negative, notes: Covid Symptoms reoccurred on 24May, positive home test on 25May. There were negative home tests on 17May, 19May and 21May with minor symptoms present at the first test and no symptoms as the next 2 times; (25May2022) Positive, notes: Covid Symptoms reoccurred on 24May, positive home test on 25May. There were negative home tests on 17May, 19May and 21May with minor symptoms present at the first test and no symptoms as the next 2 times. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2weeks is reported as no anti-viral details: Product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 13May2022, Treatment stop date: 18May2022, indication: Treatment of COVID-19. Covid Symptoms reoccurred on 24May, positive home test on 25May. There were negative home tests on 17May, 19May and 21May with minor symptoms present at the first test and no symptoms as the next 2 times.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8734 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 ER8734, fill lot EP8686, and the formulated drug product lot EP8573. 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.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot FG3527 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 FG3527, fill lot FG3512, and the formulated drug product lot FJ8500. 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.