Age: 46.0
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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "sleepapnea" (unspecified if ongoing); "aortic aneurysm" (unspecified if ongoing). Concomitant medication(s) included: IRBESARTAN, start date: 02Jan2022; STATIN [ATORVASTATIN CALCIUM]; ATORVASTATIN, start date: 02Jan2022, stop date: 08May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: symptoms returned and tested positive again; Negative, notes: Took the full five days of Plaxlovid. Symptoms resolved, and test negative on day 6; Positive, notes: Took the full five days of Plaxlovid. Symptoms resolved, and test negative on day 6 and 9 after initial positive test; Positive, notes: On day 10 after initial positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment start date: 09May022, treatment stop date: 14May2022.  Clinical information: Patient age at time of onset of reaction 47 years. Patient received Irbesartan for Blood Pressure . Rebound of COVID after completing Plaxlovid. Took the full five days of Plaxlovid. Symptoms resolved, and test negative on day 6 and 9 after initial positive test. On day 10 after initial positive test, symptoms returned and tested positive again-even brighter and quicker positive results. Conclusion: Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1,Lot :30135BA. The complaint for a Lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot 30135BA was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as pre-formulated bulk, and is manufactured, labeled and packaged by Pfizer. The final scope was determined to be lot 30135BA. No quality issues were identified during the investigation. There is no impact on product quality. An NTM was not issued for the complaint. No regulatory notification or AQRTs were held as a result of this complaint. The complaint condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to manufacture or vendor processes. No corrective or preventative actions are required as the complaint condition was not determined to be manufacture or vendor related and there are quality systems in place to detect defects prior any lot being released to the market. No further investigation required.