Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: test positive for covid after being vaccinated; test positive for covid after being vaccinated; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team and product quality group, Program ID: (172086). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER2613), on 15Apr2021 as dose 2, single (Lot number: EW0150) and on 28Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "bladder issues" (unspecified if ongoing); "had a knee replacement" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient's family history included: "heart disease" (unspecified if ongoing). Concomitant medication(s) included: VITAMINS C; OMEGA 100; VITAMIN D COMPLEX; ADDERALL; WELLBUTRIN; SEROQUEL; TRAZODONE.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "unknown" and all described as "test positive for covid after being vaccinated". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Expiry Date of Paxlovid: Feb2023 Paxlovid: Dosage previously discontinued/treatment completed. Agent states caller is calling in regards to Paxlovid, she mentioned she just finished taking paxlovid but her doctor did not tell her when to restart the other medications. Caller wanted to know if the vaccine will lose its potency after some time. Caller confirms above information and adds that she is curious, she had all the pfizer vaccines. States she did the additional protection when she had a knee replacement. States she had no issues but she got covid now after a year from being vaccinated, states it just seems unusual. Caller was a nurse for 33 and a half years. She is retired now. Caller states she tested positive for Covid: 26May2022. She stopped her medications the day she picked up the prescription. States it is embarrassing to say which medications she is on, they are all psychiatric medications. wellbutrin XL: 300mg 1 tablet morning, Seroquel ER: 300mg 1 at bedtime, Trazodone: 150mg at bedtime; all dispensed in pharmacy vial, NDC, lot and expiry unknown. Caller confirms she stopped all 3 of these medications before starting paxlovid, she tried to call her doctor to see when she can restart them but was not able to get ahold of her doctor. Caller wants to start them again because she can feel her depression is starting to get out of control. She doesn't want to take it out on her husband. Paxlovid: Started it on the night of 26May2022 that evening. Concomitant Products: she takes supplements, vitamins, omega's and vitamin D. Adds that she is also on 4 other blood pressure medications. She also takes Adderall. Caller proceeds to states that the other medications make her so sleepy so her doctor gave her the adderall and then that makes her bounce around like a ping pong ball. Attempted clarification and caller states that she doesn't keep up with everything like she use to, everything changes. Test: it was a nasal swab she is not sure what kind, they called her later that afternoon with the results. No emergency room and no physician office. No prior vaccinations (within 4 weeks). No AE(s) following prior vaccinations. No patient's medical history. Family Medical History: heart disease. Relevant Tests: Covid Nasal Swab. Caller reports that she received the Pfizer Covid-19 vaccine and has a medical history of knee replacement. Caller reports that she was diagnosed with Covid-19 and was prescribed Paxlovid. Caller reports that she was told that she got Covid-19 due to the variants Covid-19. The complaint for lack of effect of the PFIZER-BIONTECH Covid-19 vaccine lot FF2593, EW0150, ER2613 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 was determined to be the reported finished goods lot EW0150, fill lot EP8690, and the formulated drug product lot EP8587. The final scope included the reported finished goods lot ER2613, fill lot EP8678, and the formulated drug product lot EP8565. A complaint sample was not returned. 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. The controls in place were determined to be sufficient in order to prevent complaints of this nature.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.