Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 at 13:45 as dose 1, single (Lot number: EP6955, Expiration Date: 30Jun2021), in left arm, on 12Apr2021 as dose 2, single (Lot number: EP6955, Expiration Date: 30Jun2021), in left arm and on 16Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bronchitis" (unspecified if ongoing), notes: Bronchitis has a history of bronchitis, seems like he gets it every year seasonally, and he thought that was what he had originally; "hiatal hernia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease, hiatus hernia (ongoing); VITAMINS NOS; ZYRTEC ALLERGY taken for seasonal allergy (ongoing). The following information was reported: VACCINATION FAILURE (medically significant) with onset 08May2022, outcome "unknown", COVID-19 (medically significant) with onset 08May2022, outcome "unknown" and all described as "tested positive for Covid". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: Body temperature: (08May2022) 102.9, notes: 102.9 fever yesterday; Influenza virus test: (09May2022) Unknown results, notes: Result: Not Provided; Unit: Not Provided; Respiratory syncytial virus test: (09May2022) Unknown results, notes: Result: Not Provided; Unit: Not Provided; SARS-CoV-2 test: (09May2022) Unknown results, notes: Result: Not Provided; Unit: Not Provided; (08May2022) Positive, notes: Result: positive; Unit: Not Provided.  Clinical information: drug: Additional Information for Other medicines Omeprazole (40mg capsule daily): started taking over 15 years ago. states he was finally diagnosed with hiatal hernia and he was under the impression it was for GERD. Zyrtec (regular 1 tablet daily at night): started probably about 2 months ago. Caller stated she was calling in to report on her husband who had been fully vaccinated in 2021 and boosted in Dec2021. Stated that he got the test yesterday because he was so sick Saturday and he went to an urgent care yesterday and they just did a Covid test, not a flu test.  Caller stated his symptoms were so bad Saturday and Sunday she was suspicious he ha the flu also. Stated he went to his regular doctor today and they did a whole test and he would get results later. Caller stated he really presented so extreme she was thinking they would do them all and not just Covid, she wouldn't expect a 102.9 fever yesterday. Caller stated he started a medication yesterday as he had a tendency for bronchitis and pneumonia. Stated he was given a script and got Paxlovid and started it yesterday. He did not have prior Vaccinations (within 4 weeks). Caller stated he had no known allergies or anything like that. Stated to add that he was recovering and did not have a fever today.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events Vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.