Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: her husband had 4 doses Covid 19 vaccine/Husband has too many interactions with his drugs and was past his 5 days to start Paxlovid; her husband had 4 doses Covid 19 vaccine/Husband has too many interactions with his drugs and was past his 5 days to start Paxlovid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9266) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "Drug interaction" (unspecified if ongoing), notes: Husband has too many interactions with his drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "her husband had 4 doses Covid 19 vaccine/Husband has too many interactions with his drugs and was past his 5 days to start Paxlovid".  Clinical course: the patient's wife reported "it's funny because when she had her 1st Pfizer Covid shot she had the same metallic taste in her mouth and so did her husband. Husband has too many interactions with his drugs and was past his 5 days to start Paxlovid for treatment of covid-19." The reporter stated that her husband had 4 doses of the Covid 19 vaccine. Received vaccine at (withheld) hospital "for chronically ill."   Conclusion of Previously Completed Investigation: The complaint for lack of effect of COVID-19 VACCINE lot EL9266 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 EL9266, fill lot EL9257, and the formulated drug product lot EL9248. A complaint sample was not returned, and photographs were not received. 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.  Therapeutic measures were taken as a result of drug ineffective, COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Follow-up (17Mar2023): This is a spontaneous follow-up report received from the product quality group. Updated information includes: product quality group investigation results.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300115993 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-202300115780 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;