Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure, Weight
Clinical narrative: COVID-19 Vaccine: COVID-19 positive; COVID-19 Vaccine: COVID-19 positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Apr2022 at mid-day as dose 4 (booster), single (Lot number: FK9895) for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Mar2021 at mid-day as dose 1, single (Lot number: EN6199), on 27Mar2021 at mid-day as dose 2, single (Lot number: ER8732) and on 20Oct2021 at mid-day as dose 3 (booster), single (Lot number: EW0168) for covid-19 immunisation. The patient's relevant medical history included: "Hepatitis C" (unspecified if ongoing), notes: His liver is not 100%. Was 5-6 years ago and he was treated, did the whole protocol for hepatitis C; "Prostate cancer" (unspecified if ongoing), notes: Clarified cancer as prostate cancer. Was 5-6 years ago, did the whole protocol for cancer; "Has neurology issues with his feet. Been taking Vicodin on and off once in a while to deal with the pain." (unspecified if ongoing). Concomitant medication(s) included: VICODIN taken for pain in extremity. There was no prior Vaccinations within 4 weeks. The Family Medical History was none. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Dec2022, outcome "recovering" and all described as "COVID-19 Vaccine: COVID-19 positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Dec2022) Positive; Weight: (unspecified date) About 170lbs, probably lost a lot of weight. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: He probably lost a lot of weight, has had no appetite in the last week. No appetite occurred prior to starting Paxlovid, it's more of a COVID-19 thing. Caller's COVID-19 symptoms kicked in on 09Dec2022 and was positive on 11Dec2022. He came down with COVID-19 last week and had all the vaccines and all the booster shots. Was doing everything, washing his hands, and came down with COVID-19. Was awful, but was feeling better. Took Paxlovid for the first time. He was a little spacey. COVID-19 really discombobulated him. Confirmed this began prior to taking Paxlovid. His chest didn't feel anything like it used to. He was breathing easy, it's much better.   Product Quality Group provided investigational results on 13Dec2022 for BNT162b2: As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Conclusion of Previously Completed Investigation:  For Lot# EN6199 and EW0168: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6199 and EW0168 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 EN6199, fill lot EN5331/EW0168, fill lot EP8699, and the formulated drug product lot EN5320/EP8601. 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.  For Lot# ER8732: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8732 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 and product type. The final scope included the reported finished goods lot ER8732, fill lot EP8684, and bulk formulation lot EP8571. 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 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# FK9895: 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 FK9895. 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. (Site name Withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM 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.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201368943 same patient, different drug/event;