Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Lot number: EW0153), in Apr2021 as dose 2, single (Lot number: EW0175), in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) and in Jun2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: APRISO, start date: Jul2022; FOLIC ACID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jan2023, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jan2023) Positive, notes: tested positive for Covid on 10Jan2023; (15Jan2023) Negative, notes: tested negative on 15Jan2023 and 16Jan2023; (16Jan2023) Negative, notes: tested negative on 15Jan2023 and 16Jan2023; (19Jan2023) Positive, notes: tested positive on 19Jan2023 again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received COVID 19 Treatment with Paxlovid, Treatment start date was 11Jan2023, Treatment stop date was 15Jan2023. No Known allergies. The patient received other medication in 2weeks.  Conclusion of Previously Completed Investigation for FM0173: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FM0173 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 FM0173, fill lot FM0172, and the formulated drug product lot FM0147. 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.  Conclusion of Previously Completed Investigation for EW0175: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EW0175 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 EW0175, fill lot EP8726, and the bulk formulated drug product lot EP8607. 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.  Conclusion of Previously Completed Investigation for EW0153: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EW0153 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 EW0153, fill lot EP8692 and the formulated drug product lot EW8071. 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.