Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 12:00 as dose 1, single (Lot number: HH7595) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (DOSE 7 (BOOSTER), SINGLE, Anatomical Location: Arm Left, Lot number: GL2042, At: 12:00), administration date: 21Apr2023, for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 6 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid on 25Sep2023.  Product Quality Group provided investigational results on 06Oct2023. Conclusion: The complaint for "Product Complaint Exchange: [BNT162b2: Covid 19 Treatment]." Of "Pfizer BioNTech Covid-19 Vaccine Injectable" was investigated. The investigation included reviewing the involved batch records, deviation investigation and 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 "GL2042". 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. PGS (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. Product Quality Group provided investigational results on 17Oct2023. The complaint for Lack of Effect of Pfizer BioNTech COVID-19 vaccine lot HH7595 was investigated. The investigation included a review of manufacturing and packaging records, deviations, and the complaint history for in scope lots. The final scope was determined to be the finished goods lot HH7595, fill lot HG8609, and bulk formulation lot HG8025. 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.  Follow-up (06Oct2023): This is a follow-up report from product quality group providing investigation results for lot number GL2042.  Follow-up (17Oct2023): This is a follow-up report from product quality group providing investigation results for lot number HH7595.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300319215 Same reporter/patient, different drug, different event.;