Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 71 years intramuscular, 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: "hypothyroid" (unspecified if ongoing); "obese" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; SIMVASTATIN. Past drug history included: Tetracycline, reaction(s): "known allergies: tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (12Jun2022) Unknown results, notes: rebound covid symptoms after completed 5 day dual medications. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had other medication in 2weeks. COVID 19 Treatment. Treatment start date: 04Jun2022 and stop date: 08Jun2022. Lot number: 0069-1085-30. On 10Jun2022, rebound covid symptoms after completeed 5 day dual medications.   Investigational results: 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: PR ID (CR): 7278594. Product-Description (CR): Compound bnt 162 covid-19 vaccine suspension for intramuscular 2ml vial x 1 adult 10 x 2.25ml multidose. Lot (CR): FJ6369  Conclusion of Previously Completed Investigation. The complaint for 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 FP FJ6369 (SF: FJ6287). 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. It was concluded that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The 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. PR ID of Previously Completed Inv: 6780093. PR Link (Previously Investigated CR): 6768751.