Age: 34.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: EL1284), in left arm and on 03Feb2021 as dose 2, single (Lot number: EK4776) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "psoriatic arthritis" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing); "possible lupus" (unspecified if ongoing); "GERD" (unspecified if ongoing); "degenerative joint disease" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: red peppers" (unspecified if ongoing). Concomitant medication(s) included: TREMFYA, start date: 17May2022; IMURAN [AZATHIOPRINE SODIUM], stop date: 19May2022; PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE], stop date: 20May2022; PANTOPRAZOLE; DULOXETINE; EFFEXOR; TRAMADOL; TIZANIDINE; LORAZEPAM; ZOFRAN [ONDANSETRON]; FIORICET; IBUPROFEN; MIDOL [IBUPROFEN]. Past drug history included: Reglan, reaction(s): "Known allergies: reglan"; Aspirine, reaction(s): "Known allergies: Aspirin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (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: Unknown Result, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Anti-viral details, product: COVID 19 Treatment, Treatment start date: 21May2022, Treatment stop date: 24May2022, Indication: Treatment of COVID-19, taken the paxlovid, Product quality group investigation results. This report included that: This was a notification generated from the gQTS 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): 202200758572, PR ID (CR): 7208747. Product description (CR): Compound Bnt162 Covid 19 Vaccine Suspension For Intramuscular 2ml Multiple Dose Vial X 1. Lot (CR): EL1284. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): 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, 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 or CAPA were identified as the complaint was not confirmed. 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.