Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
came back positive for Covid; came back positive for Covid; This is a spontaneous report received from a Consumer or other non HCP. A 70-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Rheumatoid arthritis; "Overactive bladder" (unspecified if ongoing), notes: Overactive bladder; "Slightly elevated blood pressure" (unspecified if ongoing); "covid 19" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] as dose number unknown, single; LOSARTAN taken for blood pressure increased, start date: 2025. The patient also took other concomitant therapy. Vaccination history included: Bnt162b2 (DOSE 1), for covid-19 immunization; Bnt162b2 (DOSE 2), for covid-19 immunization; Bnt162b2 (DOSE 3), for covid-19 immunization; Bnt162b2 (DOSE 4), for covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Sep2025, outcome "unknown" and all described as "came back positive for Covid". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown results; COVID-19: (16Sep2025) Positive. Clinical course: Patient reported been vaccinated with Pfizer covid vaccine and has gotten all 5 vaccine. First time with Covid was 2022 or was 2 and half years after Covid pandemic broke out. Had Covid 3 times, got all 5 vaccines. Had it 2 times before this time, this is third time. When clarifying date he was made aware of Covid this time, caller states, earlier in week, was at friend's house, who's wife got sick, he was staying there couple days. Friend called Sunday, to tell him wife tested positive for Covid. It was Tuesday, 16Sep2025, he had sore throat, and same day, took self test that came back positive for Covid. Paxlovid was just prescribed yesterday. Last covid 19 vaccine one was not that long ago. was late last year, 2024, or early this year, 2025. The last time, had both flu shot and Covid booster at same time. Never had any negative reaction to any shot.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500186707 Same patient/AE, different vaccination (dose) and timeframe;
Medical History/Concurrent Conditions: Blood pressure increased; COVID-19; Overactive bladder; Rheumatoid arthritis
FLU [INFLUENZA VACCINE]; LOSARTAN
Test Name: Blood Work; Result Unstructured Data: Test Result:Unknown results; Test Date: 20250916; Test Name: COVID 19; Result Unstructured Data: Test Result:Positive