Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-platelet factor 4 antibody test, Antibody test, COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: BENICAR oral taken for hypertension (ongoing). Vaccination history included: BNT162b2 (Dose 1, Single; , Anatomical Site of injection: shoulder, Route of administration: checked Intramuscular, Batch/Lot number: ER8733), administration date: 04Apr2021, for Covid-19 immunization; BNT162b2 (Dose 2, Single; , Anatomical Site of injection: shoulder, Route of administration: checked Intramuscular, Batch/Lot number: EW0165), administration date: 25Apr2021, for Covid-19 immunization; BNT162b2 (Dose 3 (Booster), Single; , Anatomical Site of injection: shoulder, Batch/Lot number: FJ1620), administration date: 14Dec2021, for Covid-19 immunization; BNT162b2 (Dose 4 (Booster), Single;, Anatomical Site of injection: shoulder, Route of administration: Intramuscular, Batch/Lot number: GL0448(or 6?) or G10448?), administration date: 19Oct2022, for Covid-19 immunization.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Antibody test: (unspecified date) Unknown results, notes: Test: Antibody test to platelet factor IV; Platelet factor 4: (unspecified date) Unknown results, notes: Test: Antibody test to platelet factor IV; SARS-CoV-2 antibody test: (14Dec2023) negative, notes: Reached a negative test one day after the last day (Day 5); SARS-CoV-2 test: (21Dec2023) positive, notes: rapid antigen tests (mulitple types/ multiple times) still ongoing with positive virus today 21Dec2023. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The anti-viral Paxlovid Pfizer from 08Dec2023 to 13Dec2023 used for the treatment of COVID-19. Vaccine administration time: 12:00 AM. The patient had no known allergies.  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. Refer to the below table for details: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8733 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8733, fill lot EP8685, and the bulk formulated drug product EP8572. 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: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0165 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 EW0165, fill lot EP8697, and the formulated drug product lot EP8594. 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 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: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot FJ1620 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FJ1620, fill lot FJ1606, and the bulk formulated drug product FJ8507. 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.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.  Follow-up (21Dec2023): This is a spontaneous follow up report received from the same Consumer. This consumer (patient) reported in response to the Non-HCP letter sent which included that: Updated information included: Reporter and patient full name updated; Reporter slider #01 mailing address updated; Patient height and weight updated; Historical vaccine updated; Lab data, concomitant medication, Vaccine facility information, Outcome of Event updated.  Batch/lot number is not provided, and it cannot be obtained.  Follow-up (27Dec2023): This is a follow-up report from product quality group. Investigation results updated for historical vaccines.   The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received. Follow-up (15Feb2024): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained.