Age: 57.0
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) (Nurse) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EL1284), in left arm, on 11Jan2021 as dose 2, single (Lot number: EJ1686), in left arm and on 24Jan2022 as dose 3 (booster), single (Lot number: FE3592) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergy: seafood" (unspecified if ongoing); "known allergy: dust" (unspecified if ongoing); "known allergy:mites" (unspecified if ongoing); "known allergy: wheat" (unspecified if ongoing); "DM Type 2" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "chronic renal insufficiency" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN HCL; GLIMEPIRIDE; FARXIGA; FENOFIBRATE; OLMESARTAN MEDOXOMIL; TRULICITY; SOLIFENACIN [SOLIFENACIN SUCCINATE]; MONTELUKAST SODIUM; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LEVOTHYROXINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot FE3592 (Dose 3) 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 FE3592, fill lot FF2553, and the bulk formulated drug product lot FA9141. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality. No root cause 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 with the product for the COVID-19 Vaccine was investigated. The investigation included review of manufacturing records, analytical results at the time of lot release, retained reference samples, deviations, and complaint lot history trends. The final scope was limited to include the reported finished goods lot EL1284 (Dose 1), fill lot EL1282, the bulk formulated drug product lot EL1280. No returned complaint sample was received. All deviation Investigations performed during the manufacturing process of the lot were reviewed. The conclusion of all investigations confirmed there was no quality issue which would affect the quality of the lot. No root cause were identified as the complaint was not confirmed.  Conclusion: 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 (Dose 2). A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed. No root cause were identified as the complaint was not confirmed.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.