Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 30-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 09Feb2021 at 09:30 as dose 2, single (Lot number: FN5318), in left arm and on 11Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Scarlett fever" (unspecified if ongoing), notes: Diagnosed with Scarlett fever when younger; "henoch-schonlein purpura" (unspecified if ongoing); "known allergies: dairy" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin"; Lactose, reaction(s): "known allergies: lactose", notes: lactose. The following information was reported: VACCINATION FAILURE (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: Positive, notes: I caught COVID again after taking Paxlovid for the first time testing positive; Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Vaccine received: Yes, other medication in 2 weeks: Yes, anti-viral details, product=COVID 19 Treatment, brand=Paxlovid, treatment start date=27May2022, treatment stop date=01Jun2022, indication=Treatment of COVID-19. Other medication details: other medication in 2weeks, product=Adderall 15mg a day, brand-Generic, One multivitamin, brand= Rainbow Light. Adverse event: I caught COVID again after taking Paxlovid for the first time testing positive. Symptoms of first round of COVID was fever, coughing, and sore throat, slight runny nose. Rebound COVID is more sinus pressure and excessive mucous production, and Slight cough. Known allergies: Amoxicillin, dairy/lactose. Other medical history: Diagnosed with Scarlett fever when younger, and henoch-schonlein purpura.   Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer-biontech covid-19 vaccine lot FF2593 and EL1283 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot.   The final scope included the reported finished goods lot FF2593, fill lot FF5584, and formulated drug product lot FA9147. The final scope included the reported finished goods lot EL1283, fill lot EL1281 and formulated drug product lot EL1279. A complaint sample was not returned. No related quality issues were identified during the investigation. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Previously Completed Inv: 6644902 (Previously Investigated): 6644462    Previously Completed Inv: 5643620 (Previously Investigated): 5630121  AE Ref No. (CC): 202200842962 ID: 7288327  Product-Description: Compound bnt 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1, Lot-#: EL1283