Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza virus test positive, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP.  An 81-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CAD", start date: 18Sep2023 (ongoing), notes: Had blockage+ Stent; "Hypertension", start date: 1998 (ongoing); "Acid Reflux", start date: 2003 (ongoing); "Asthma", start date: 1990 (ongoing); "Hypolipidemia" (unspecified if ongoing); "Stent" (unspecified if ongoing); "High BP" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE oral taken for hypolipidaemia, hypertension, start date: 2020 (ongoing); LOSARTAN oral taken for hypolipidaemia, hypertension, start date: 2004 (ongoing); PLAVIX oral taken for stent placement, start date: Sep2023 (ongoing); PANTOPRAZOLE oral taken for gastrooesophageal reflux disease, start date: 2004; ADVAIR oral taken for asthma, start date: 1994 (ongoing); PROTONIX [OMEPRAZOLE] oral taken for gastrooesophageal reflux disease; LIVALO oral taken for blood cholesterol increased, start date: Mar2022 (ongoing); FLUCELVAX QUADRIVALENT intramuscular, on 02Oct2023 as dose number unknown, single. Vaccination history included: BNT162b2 (DOSE 1; Lot number: ENG202, administered intramuscular in Upper left arm, around 2 PM), administration date: 26Feb2021, when the patient was 78-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2; Lot number: probably ER8730, administered intramuscular in Upper left arm, at 2 PM), administration date: 26Mar2021, when the patient was 78-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER); Lot number: 301458A, administered intramuscular in Upper left arm), administration date: 27Sep2021, when the patient was 79-year-old, for Covid-19 immunization; BNT162b2 (DOSE 4 (BOOSTER); Lot number: FM9893 (unreadable), administered intramuscular in Upper left arm), administration date: 11Apr2022, when the patient was 79-year-old, for Covid-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER); Lot number: G119693 (unreadable), administered in Upper left arm), administration date: 03Oct2022, when the patient was 80-year-old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jan2024, outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: Influenza virus test positive: (15Jan2024) Positive, notes: Had flu shot High dose; SARS-CoV-2 test: (22Jan2024) Positive, notes: Had all shots.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300354077 Same patient, drug and dose, different events.;