Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Indication=Treatment of covid 19; Indication=Treatment of covid 19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 09Jan2021 as dose 2, single (Lot number: EJ1686), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE; MAGNESIUM; CALM [DIAZEPAM]. The following information was reported: COVID-19 (medically significant) with onset 06May2022, outcome "not recovered", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Indication=Treatment of covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Positive; (26May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.Clinical course:This is a notification generated from the system.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 business process. Lot (CR): FF8841 Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FF8841 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 FF8841, fill lot FF8835, and the formulated drug product lot FA9156. 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. Lot (CR): EJ1686 Conclusion of Previously Completed Investigation: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. TA sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced resulted in the following conclusion: Reference (see File attachment in this investigation record) The complaint for a positive COVID test after vaccination of "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 EJ1686. 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)  concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The Agency process determined that a regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Lot (CR): EK5730 Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EK5730 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 EK5730, fill lot EK3313, and the formulated drug product lot EK3312. 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.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Vaccination failure and Covid 19  and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.