Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Glomerular filtration rate, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid infection and has had 2 doses already. Caller also mentioned that she has had 5 Pfizer Covid19 vaccines; Covid infection and has had 2 doses already. Caller also mentioned that she has had 5 Pfizer Covid19 vaccines; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 77 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EN5318), on 22Feb2021 as dose 2, single (Lot number: EL9266), on 26Sep2021 as dose 3 (booster), single (Lot number: 30130BA) and on 30Mar2022 as dose 4 (booster), single (Lot number: FK9896) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (ongoing), notes: Well Controlled; "kidney damage" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Sep2022 at 09:45, outcome "unknown" and all described as "Covid infection and has had 2 doses already. Caller also mentioned that she has had 5 Pfizer Covid19 vaccines". The events "covid infection and has had 2 doses already. caller also mentioned that she has had 5 pfizer covid19 vaccines" required physician office visit. The patient underwent the following laboratory tests and procedures: Glomerular filtration rate: (unspecified date) 52; SARS-CoV-2 test: (19Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient has had 5 Pfizer Covid19 vaccines starting in 2021 and her most recent vaccine was the Pfizer Covid19 Bivalent vaccine on Monday 12Sep2022. Tested positive for Covid19 on Monday after 5 doses of Covid19 Vaccine, was prescribed and is taking Paxlovid. Stated that her 5th dose, the Bivalent, was just a week ago on 19Sep2022, so they didn't have the 2-3 week time to fully build immunity. Confirmed she tested positive for Covid19 on 19Sep2022. Reported she had her labs drawn on Monday at 09:45, and she was one of first ones to call on Tuesday morning and scheduling sent a message to her doctor's nurse that the patient had tested positive and she picked up the medication.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based information, a possible contributory role of the subject products exckuded for the reported events.  There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.