Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 4 (booster), single (Lot number: Gj5342) at the age of 42 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Lot number: FJ1620), in left arm for covid-19 immunisation; astra zeneca compound 677 (ASTRA ZENECA COMPOUND 677), on 13Nov2020 as dose 1, single (Lot number: A03322), in left arm and on 11Dec2020 as dose 2, single (Lot number: A03424), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: after three consecutive days of testing negative; Negative, notes: after three consecutive days of testing negative; Negative, notes: after three consecutive days of testing negative. Therapeutic measures, Paxlovid from 30Nov2022 to 05Dec2022, were taken as a result of drug ineffective, covid-19. The patient has no known allergies. Investigation results for Lot: FJ1620. Conclusion:  The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot FJ1620 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 FJ1620, fill lot FJ1606, and the bulk formulated drug product FJ8507. A complaint sample was not returned. No related quality issues were identified during the investigation. There was 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. For Lot: GJ5342: Conclusion: The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The Investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GJ5342. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. (Site Name withheld) concluded that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The (privacy) process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.