Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 23Mar2021 as dose 2, single (Lot number: ER8732), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 09Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Bladder cancer" (unspecified if ongoing). No known allergy. Concomitant medication(s) included: VITAMIN D3; DULOXETINE; TROKENDI. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient received Paxlovid from 28Jun2022 to 02Jul2022 for treatment.   Product Quality Group provided investigational results on 12Jul2022: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot FF2587 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 FF2587, fill lot FF2556, and the formulated drug product lot FE5315. A complaint sample was not returned. 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. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): 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. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6199 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, and the formulated drug product lot EN5320. 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. When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.