Age: 58.0
Sex: F
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 contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6207), on 09Apr2021 as dose 2, single (Lot number: EW0153) and on 11Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; ESOMEPRAZOLE; LOSARTAN; METFORMIN; TRESIBA; INSULIN ASPART; ATORVASTATIN; PROZAC. Past drug history included: Morphine, reaction(s): "Drug Allergies: morphine"; Codeine, reaction(s): "Drug Allergies: codeine"; Cephalosporin, reaction(s): "Drug Allergies: cephalosporin"; Ace inhibitor, reaction(s): "Drug Allergies: ace inhibitor". The following information was reported: VACCINATION FAILURE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took Other medication in 2 weeks. Patient administered Paxlovid from 19May2022 to 22May2022 for COVID 19 treatment. Thyroid med were also taken in 2 weeks. Adverse event was reported as patient had a stroke requiring TPA and hospitalization on day 4 of paxlovid use for COVID on 22May2022 and resulted in Hospitalization for 4 days, Life threatening illness (immediate risk of death from the event), patient received TPA as treatment and was recovering. Patient had Known allergies and other medical history was reported. Conclusion: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot FE3590, EW0153 and EN6207 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FE3590, fill lot FA9134, and the bulk formulated drug product lot FE5064, finished goods lot EW0153, fill lot EP8692 and the bulk formulated drug product EW8071 and finished goods lot EN6207, fill lot EN5340, and the formulated drug product lot EN5328. 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 were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out