Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Physician, Program ID.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol high/elevated cholesterol" (ongoing); "type 2 diabetes/ Diabetes" (ongoing); "cardiac prevention" (ongoing); "for going to the bathroom too much at night, age related" (ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for influenza immunisation, in Oct2023 as dose number unknown, single; RSV VACCINE taken for immunisation, in Oct2023 as dose number unknown, single; ATORVASTATIN oral taken for blood cholesterol increased (ongoing); TAMSULOSIN taken for pollakiuria (ongoing); FISH OIL oral taken for blood cholesterol increased (ongoing); CINNAMON oral taken for type 2 diabetes mellitus (ongoing); JARDIANCE oral taken for type 2 diabetes mellitus (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] oral taken for cardiac disorder (ongoing); VITAMIN D3 oral (ongoing); METFORMIN ER oral taken for type 2 diabetes mellitus (ongoing); CHROMIUM PICOLINATE taken for type 2 diabetes mellitus (ongoing). The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset Jan2024, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Jan2024, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jan2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 29Jan2024 to 03Feb2024. Clinical course: Patient got sick enroute to vacation, was in (withheld) for 4 days at a (withheld). He got a runny nose, mild cold symptoms. Never had symptomatic covid before so he thought fatigue and travel. Last Monday went to (withheld) to visit and did Covid test and that was positive. He went to urgent care and got medication, like the 2nd day right away. 1st dose on Monday was feeling better on Tuesday with half day dose and Wednesday was completely asymptotic symptoms with no side effects except metallic taste. He was told not to take 2 other meds already on which are Atorvastatin 40mg and Tamsulosin 0.4mg. He stopped those while taking Paxlovid. He was vaccinated with primary series and got booster and his most recent Pfizer booster was just that Oct2023. He got flu and Covid and RSV vaccine shortly after that in Oct2023.   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: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event Vaccination Failure and COVID 19 cannot be ruled out