Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, COVID-19, Computerised tomogram, Magnetic resonance imaging, Physical breast examination
Clinical narrative: COVID-19 positive; COVID-19 positive; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 67 years, in arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL3302), in arm, on 05Mar2021 as dose 2, single (Lot number: EL3302), in left arm, on 20Aug2021 as dose 3 (booster), single (Lot number: FD8448), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9894), in arm for COVID-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: diagnosed 8 years ago, it's minor; "Muscle spasms" (unspecified if ongoing), notes: have been so severe over a 27-year period that finally, a year ago, some pain management doctor started injecting her with neurotoxin Botox to help keep it under control; "Severe osteoporosis" (unspecified if ongoing), notes: which is shocking but not shocking because women get it all the time; "Breast implant" (unspecified if ongoing); "Viral brain infection", start date: 06Jul2022 (unspecified if ongoing). Concomitant medications included: ALENDRONATE SODIUM taken for prophylaxis; BENAZEPRIL taken for hypertension; BONIVA taken for osteoporosis; SOMA [CARISOPRODOL] taken for muscle spasms; SUMATRIPTAN taken for migraine; TRAMADOL taken for muscle spasms. Past drug history included: Forteo for Severe osteoporosis, reaction: "Didn't do anything", notes: an 18-month program, an injectable drug injected into abdomen, this was about 8 years ago. Vaccination history included: Flu vaccine (up to date). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19May2023, outcome "unknown" and all described as "COVID-19 positive". The patient underwent the following laboratory tests and procedures: Biopsy: (2022) they were all benign, notes: but did discover she had silicone in her lymph nodes from a breast implant; Computerised tomogram: (unspecified date) didn't show any type of masses. tumors or anything; Magnetic resonance imaging: (unspecified date) no blockage, no masses; Physical breast examination: (2022) she did have 3 small masses; SARS-CoV-2 test: (19May2023) Negative; (20May2023) Positive; X-ray: (unspecified date) C1 and C2 were slightly out of alignment. Therapeutic measures were taken as a result of vaccination failure, COVID-19. Clinical course: COVID-19 symptoms started on 19May2023. First test was negative. She took two more tests and at midnight on 20May2023, she was COVID-19 positive. The doctor immediately called in Paxlovid. It was started probably on 20May2023 or 21May2023, but the patient was pretty sure it was on Sunday, 21May2023. Her COVID-19 was pretty mild, but she was vaccinated and boosted. In her opinion, COVID-19 has not gone away. She stated that they stay up to date on the shingles and flu vaccine. Got the 5th COVID-19 vaccine just to be proactive and because her husband is 77 and she is 68. Because she didn't have COVID-19, she hadn't built up any immunity because she hadn't had it. She's never had a cold in her life.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300211893 same patient and drug; different dose and event;