Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "Metabolic syndrome" (unspecified if ongoing); "Allergy: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Nov2023, outcome "recovered" (15Nov2023) and all described as "COVID 19 Treatment". The event "covid 19 treatment" required physician office visit. The patient underwent the following laboratory tests and procedures: Body temperature: (11Nov2023) 101.8, notes: woke Saturday the 12, extremally bad headache, fever 101.8; (21Nov2023) 101.9, notes: fever of 101.9; COVID-19: (10Nov2023) Negative, notes: Tested negative Friday evening; (11Nov2023) Positive, notes: woke Saturday the 12, extremally bad headache, fever 101.8 aches everywhere. Tested positive; (15Nov2023) Negative, notes: Tested negative on Wednesday evening the 15th; (16Nov2023) Negative, notes: went back to work Thursday / Friday, testing negative each day; (17Nov2023) Negative, notes: went back to work Thursday / Friday, testing negative each day; (19Nov2023) Negative, notes: tested negative on Sunday the 19th. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 12Nov2023 to 16Nov2023. Clinical course: Really bad headache Friday evening the 11th, received a notification the nursing home where patient was and her daughter was visiting for the week prior had an outbreak of COVID. Tested negative Friday evening, woke Saturday the 12, extremally bad headache, fever 101.8, aches everywhere. Tested positive, Did a telehealth visit and was prescribed Paxlovid, some symptoms got better, but side effects were really bad. Tested negative on Wednesday evening the 15th and went back to work Thursday / Friday, testing negative each day prior to interacting with staff. Feeling run down and headache returning tested negative on Sunday the 19th, went to church as the day went on increasing symptoms. Monday the 20th, mid-morning prior to working tested positive again all original symptoms back, worst headache ever had, couldn't sleep, bad cough, Phleem, headache ever had, couldn't sleep, bad cough, Phleem, and fever of 101.9 and still testing positive now on Tuesday the 21st. . 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: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300392823 same patient, different drug/event;