Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; 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 71-year-old male patient received BNT162b2 (BNT162B2), on 24Apr2022 at 16:00 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; ZYDUS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Positive; (16May2022) negative; (17May2022) negative; (24May2022) Positive, notes: positive Ag test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional Information:No known allergies. Paxlovid x 5 days due to age and hypertension from 13May2022 to 17May2022 as treatment of COVID-19. Mild nasal sxs. Clinically well and Ag negative on 16May2022 and 17May2022. Recurrence of rhinorrhea 24May2022 with new positive ag test. Sxs lasted 3-4 days. Recovering  Investigation results for lot FM9992. 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: Product- Description (CR): COMPOUND BNT 162 COVID- 19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML VIAL X 1 ADULT 10 X 2.25ML MULTIDOSE Lot-# (CR): FM9992. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): 'For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 7142695 (see File attachment in this investigation record) The complaint for PFIZERBIONTECH 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 FM9992. 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. Agency 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.'; Sender's Comments: Based on available information, a possible contributory role of the subject product BNT162b2,  cannot be excluded for suspected LOE.  There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.