Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Lot number: EL3284), on 29Jan2021 as dose 2, single (Lot number: EL3248) and on 08Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "Smoldering multiple myeloma" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "post menopausal" (unspecified if ongoing); "fatigue and immunosuppression from treatment for myeloma" (unspecified if ongoing), notes: fatigue and immunosuppression from treatment for myeloma.; "fatigue and immunosuppression from treatment for myeloma" (unspecified if ongoing), notes: fatigue and immunosuppression from treatment for myeloma.; "shingles prophylaxis" (unspecified if ongoing). Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR], 400mg Q12 hrs for shingles prophylaxis (herpes zoster), start date: 22Sep2021; ASPIRIN [ACETYLSALICYLIC ACID], 324 mg QD (everyday), brand: Bayer enteric coated 81 mg tabs, lot number: NAA9Ek3, start date: 22Sep2021; ACETYL L CARNITINE [ACETYLCARNITINE], 500 mg Q12 hrs, brand: Protocol for life balance, lot number: 3252002, start date: 01Dec2021; ALPHA LIPOIC ACID, 600 mg QD (everyday), brand: Doctors Best, lot number: 222195A, start date: 01Dec2021; ZINC, 50 mg QD (everyday), lot number: 22CPF0047, start date: 01Sep2022; OMEGA 3 ACID ETHYL ESTERS, 1 gm, start date: 22Sep2021; VITAMIN E, 400 IU, lot number: 511021, start date: 22Sep2021; TOP CARE, Docusate sodium 100 mg Q12 hrs, lot number: WJ37854, start date: 01Oct2021; CHELATED MAGNESIUM [MAGNESIUM CHELATE], (True chelate magnesium) 150 mg QD (everyday), brand: Professional health products, lot number: Lot 110010, start date: 22Sep2021; CITRACAL + D3 (Calcium citrate plus d3), 650 mg/ 1000IU, lot number: 22A007, start date: 22Sep2021; VITAMIN C, 1000mg. QD (everyday), start date: 01Sep2022; B-COMPLEX WITH VITAMIN C, lot number: 2447307, start date: 22Sep2021 received in two weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: indication: COVID 19 Treatment; (10Sep2022) Positive, notes: initial symptoms of covid and did rapid test and quickly showed positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergies. Patients gender: Male (as reported). The patient received COVID 19 Treatment with Paxlovid from 01Sep2022 to 06Sep2022.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.