Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Investigation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; 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.  An 82-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 12:00 as dose1, single (Lot number: HH7595) at the age of 82 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "obese scale 31" (unspecified if ongoing); "history of hypersensitivity pneumonitis" (unspecified if ongoing); "history of high blood pressure (controlled)" (unspecified if ongoing); "history of PACs and SVTs (no recurrence since 22Oct ablation)" (unspecified if ongoing); "history of PACs and SVTs (no recurrence since 22Oct ablation)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "allergy"; Valacyclovir, reaction(s): "allergy"; Atorvastatin, reaction(s): "allergy". Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Vaccine lot number: EN6198, Vaccine location: Left arm), administration date: 26Feb2021, when the patient was 79-year-old, for Covid-19 immunization; bnt162b2 (DOSE 2, SINGLE, Vaccine lot number: FP6955, Vaccine location: Left arm), administration date: 17Mar2021, when the patient was 79-year-old, for Covid-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Vaccine lot number: Booster 80130BA, Vaccine location: Left arm), administration date: 07Oct2021, when the patient was 80-year-old, for Covid-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Vaccine lot number: FK9893, Vaccine location: Left arm), administration date: 19Apr2022, when the patient was 80-year-old, for Covid-19 immunization; bnt162b2, bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Vaccine lot number: GJ2524, Vaccine location: Left arm), administration date: 12Sep2022, when the patient was 81-year-old, for Covid-19 immunization, reaction(s): "history of PACs and SVTs (no recurrence since 22Oct ablation)"; bnt162b2, bnt162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE, Vaccine administration time: 11:00, Vaccine lot number: GJ6796 Bivalent, Vaccine location: Left arm), administration date: 06May2023, when the patient was 81-year-old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Oct2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: obese: (unspecified date) 31, notes: obese scale 31; SARS-CoV-2 test: (unspecified date) negative, notes: Tested negative on home test 24 hours after ending Paxlovid,; (unspecified date) Positive, notes: This test was positive; (unspecified date) Negative, notes: 2 negative tests; (09Oct2023) Positive, notes: Tested positive on Day 1.  Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300336611 same patient, different vaccine dose/AE.;