Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer) from medical information team and product quality group. The reporter is the patient.  An 85-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 85 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Metastatic breast cancer" (unspecified if ongoing); "estrogen supressor" (unspecified if ongoing). Concomitant medication(s) included: RSV VACCINE taken for immunisation as dose 1, single, on 31May2019 as dose 2, single; IBRANCE taken for breast cancer metastatic, start date: Jul2023 (ongoing); LETROZOLE (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE; Batch/Lot number: EL3249), administration date: 21Jan2021, for COVID-19 immunisation; bnt162b2 (DOSE 2, SINGLE; Batch/Lot number: EL3249), administration date: 11Feb2021, for COVID-19 immunisation; bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Batch/Lot number: FF2587), administration date: 04Oct2021, for COVID-19 immunisation; bnt162b2 (DOSE 4 (BOOSTER), SINGLE; Batch/Lot number: FJ4989), administration date: 15Apr2022, for COVID-19 immunisation; bnt162b2, bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE; Batch/Lot number: GJ6739), administration date: 12Oct2022, for COVID-19 immunisation; Second shingles shot (Did have reaction to second shingles shot.). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Oct2023, outcome "recovered" (Oct2023) and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) About 5 foot 5, maybe 5 foot, 5 and a half, shrunk, notes: Height: About 5 foot 5, maybe 5 foot, 5 and a half, shrunk a little; SARS-CoV-2 test: (09Oct2023) Negative, notes: Was negative last night; (10Oct2023) Positive, notes: she tested positive for COVID; Weight: (unspecified date) Weight: About 130, notes: Weight: About 130.  Based on investigation of PFIZER-BIONTECH COVID-19 VACCINE result conclusion: The complaint for lack of effect of the Pfizer BioNTech COVID-19 vaccine lot EL3249, FF2587, FJ4989 and GJ6739 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 EL3249, fill lot EL3232, and the formulated drug product lot EL3225. The final scope included the reported finished goods lot FF2587, fill lot FF2556, and the formulated drug product lot FE5315. The final scope was determined to be the reported finished goods lot FJ4989, fill lot FJ4986, and the bulk formulated drug product lot FJ4983. The final scope was determined to be the finished goods lot GJ6739, bulk and fill lots, GJ6726, and GJ6733. A complaint sample was not returned, and photographs were not received. 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 information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.  Follow-up (11Oct2023): This is a follow-up report from product quality group. Updated information included: Investigation results for lots EL3249, FF2587, FJ4989 and GJ6739 were captured.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300323499 Same patient/vaccine, different dose/events;