Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; 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 55-year-old patient received BNT162b2 (BNT162B2), on 03Feb2021 at 10:30 as dose number unknown, single (Lot number: CN5318), on 24Feb2021 at 10:30 as dose number unknown, single (Lot number: EN5318), in left arm and on 19Aug2021 at 16:30 as dose number unknown, single (Lot number: PA7485) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 22Jan2022 at 12:15 as dose number unknown, single (Lot number: 025Z21B) for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing Spondylitis" (unspecified if ongoing); "Sulfa Drugs" (unspecified if ongoing); "Hypercalcuria" (unspecified if ongoing); "Left Bundle Branch Block" (unspecified if ongoing); "Kidney Stones" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "Non-Alcoholic Fatty Liver" (unspecified if ongoing); "Metabolic Syndrome" (unspecified if ongoing); "Elevated Blood Glucose" (unspecified if ongoing). Concomitant medication(s) included: ENBREL, start date: 01Jan2022, stop date: 12May2022; VASCEPA; AMARIN [PHENIRAMINE MALEATE], start date: 01Jan2022; LOSARTAN, start date: 01Jan2022; METFORMIN; JARDIANCE, start date: 01Jan2022; DESCOVY, start date: 01Jan2022; POTASSIUM CITRATE, start date: 01Jan2022; HYDROCHLOROTHIAZIDE, start date: 01Jan2022; METOPROLOL, start date: 01Jan2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23May2022 at 10:00, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: testing negative for COVID-19 infection; (23May2022) Positive, notes: testing positive for COVID-19 for last five days (May 23rd onwards). Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Relapse three days after completing full Paxlovid treatment cycle and subsequently testing negative for COVID-19 infection. Relapse symptoms of sore throat, runny nose, cough, lowered oxygen levels (SpO2) and testing positive for COVID-19 for last five days (May23 onwards). AE treatment reported as telehealth visit to pcp, over the counter medicine.  Conclusion of Previously Completed Investigation for lot EN5316: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. A complaint sample was not returned. No related quality issues were identified during the investigation. There was 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