Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 19Nov2021 as dose 3 (booster), single (Lot number: fh8028) at the age of 37 years for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: PROAIR [SALBUTAMOL SULFATE], also reported as other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid started from 21May2022 to 25May2022. Clinical course was reported as, on 29May2022, patient experienced covid resurgence after taking Paxlovid. Reported that, patient not received any treatment for covid resurgence and not recovered from covid resurgence.  Information from Product quality group, provided from division RA includes Investigation results for lot FH8028: This is a notification generated from the database 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 'One and Done' business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details: AE Ref No. (CC): 202200787697, PR ID (CR): 7236960, Product-description (CR): COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULA R 2ML MULTIPLE DOSE VIAL X 1, Lot-# (CR): FH8028; Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FH8028 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FH8028, fill lot FH4341 and the bulk formulated drug product lot FH4347. 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. PR ID of Previously Completed Inv: 6561366, PR Link (Previously Investigated CR): 6560906. 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.