Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pyrexia, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 73-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 as dose 1, single (Lot number: HG4629) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Microscopic collagenous colitis" (unspecified if ongoing), notes: Microscopic collagenous colitis; "DCIS breast cancer", start date: 04Feb2020 (unspecified if ongoing), notes: DCIS breast cancer diagnosis 04Feb2020.; "Known allergies: NSAIDs" (unspecified if ongoing), notes: Known allergies: NSAIDs. Concomitant medication(s) included: LETROZOLE, start date: 04Feb2020; AMLODIPINE BESYLATE, start date: 18May2023; CITRACAL [CALCIUM CITRATE], start date: 04Feb2020; VITAMIN D3, start date: 04Mar2019. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (vaccine brand unknown=False,, vaccine lot number=GJ3268,, vaccine lot unknown=False, vaccine dose number=6,, vaccine dose number unknown=False,, vaccine location=Left arm), administration date: 24Apr2023, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (vaccine brand unknown=False,, vaccine lot number=bivalent 2324,, vaccine lot unknown=False, vaccine dose number=5,, vaccine dose number unknown=False,, vaccine location=Left arm), administration date: 20Sep2022, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2 (vaccine brand unknown=False,, vaccine lot number=FM9992,, vaccine lot unknown=False, vaccine dose number=4,, vaccine dose number unknown=False,, vaccine location=Left arm), administration date: 29Apr2022, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2 (vaccine brand unknown=False,, vaccine lot number=30308A,, vaccine lot unknown=False, vaccine dose number=3,, vaccine dose number unknown=False,, vaccine location=Left arm), administration date: 25Sep2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (vaccine brand unknown=False,, vaccine lot number=EP7534,, vaccine lot unknown=False, vaccine dose number=2,, vaccine dose number unknown=False,, vaccine location=Left arm), administration date: 05Mar2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (vaccine brand unknown=False,, vaccine lot number=EM9809,, vaccine lot unknown=False, vaccine dose number=1,, vaccine dose number unknown=False,, vaccine location=Left arm), administration date: 11Feb2021, when the patient was 71-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Pyrexia: (2023) 101.8, notes: fever of 101.8; SARS-CoV-2 test: (17Dec2023) Positive, notes: Tested positive for COVID on 17Dec2023; (26Dec2023) Negative, notes: Tested negative on 26Dec2023; (29Dec2023) Positive, notes: Tested positive 29Dec2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5  will be requested and submitted if and when received.