Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 5: Pfizer/BioNTech, Dose 4: Moderna; This is a spontaneous report received from a contactable reporter (Nurse) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 57 years, in left arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Zoloft, reaction: "Known allergies: Zoloft". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown", described as "Dose 5: Pfizer/BioNTech, Dose 4: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; Negative, notes: test day 5 and 7; Negative, notes: test day 5 and 7; positive, notes: positive day 10. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: Rebound positive COVID test and symptoms. Negative test day 5 and 7, positive day 10 with worse ache, body fatigue, headache, abdominal discomfort. The patient was treated with Paxlovid from 09Mar2023 to 14Mar2023. Product Quality Group provided investigation results on 21Mar2023 for BNT162b2. Conclusion of Previously Completed Investigation: The complaint for "PFIZER-BIONTECH 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 GH9694. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PRIVACY concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA 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.  Follow-up (21Mar2023): This is a follow-up report from product quality group providing investigation results.; Sender's Comments: Based on the limited information reported, a causal relationship between the event "COVID-19" and the suspect product cannot be completely excluded.