Received Mar 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Anaphylactic; he passed out.; the next day woke up from the neck down with a big red rash; a full body rash.; Blood pressure was low, 90/45.; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 73-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 21Nov2024 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 73 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure abnormal" (unspecified if ongoing); "Pulse abnormal" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal, pulse abnormal, start date: 2023 (ongoing); ATORVASTATIN taken for blood cholesterol increased (ongoing). Vaccination history included: Bnt162b2 (Dose number unknown, single; previous vaccines he had little reactions; just got minor chills and fever), for Covid-19 immunization, reaction(s): "minor chills", "fever"; Bnt162b2 (Dose number unknown, single; he missed one booster and got covid Jul2024 and was pretty sick), for Covid-19 immunization, reaction(s): "Covid". The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 22Nov2024, outcome "recovered" (Nov2024), described as "Anaphylactic"; HYPOTENSION (medically significant) with onset 22Nov2024, outcome "recovered" (Nov2024), described as "Blood pressure was low, 90/45."; LOSS OF CONSCIOUSNESS (medically significant) with onset 22Nov2024, outcome "recovered" (22Nov2024), described as "he passed out."; RASH ERYTHEMATOUS (medically significant) with onset 22Nov2024, outcome "recovered" (Nov2024), described as "the next day woke up from the neck down with a big red rash; a full body rash.". Clinical course: Patient started Metoprolol and Atorvastatin about 2 or 3 years ago and still taking. Patient first stated when he got the shot it was no big deal. He has gotten all the covid vaccines. He always had covid vaccine from Pfizer. With previous vaccines, he had little reactions. Haven't had anything go bad, just got minor chills and fever. Rash occurred the day after injection (22Nov2024): woke up from the neck down with a big red rash; a full body rash. Called the doctor where patient got the shot at and was told to come in. When the patient got there, he passed out. They called the paramedics. Patient got right up, wasn't passed out for long. Blood pressure was low, 90/45. It was recommended to go to the hospital. Was told it sounds like a reaction to the vaccine. Patient went to the emergency room, and they gave him an anaphylactic IV, within a matter of 20 minutes or so the rash started to clear up. Vitals went back to normal. Kept patient there for 4 hours just to make sure the IV was not going to have any adverse effects and was sent home. Within 12-14 hours, the rash was completely gone. Patient was sent home with epi pen just in case, because could possibly come back and it never did. It's now been almost 6 months. Besides reporting event, patient stated he is going to the allergist to see what he is allergic to in vaccine and would like a list of ingredients for the vaccine. The information on the batch/lot number for Bnt162b2 Omicron (KP.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500052878 same patient, different dose number/event;US-PFIZER INC-202500052876 same patient, different dose number/event;
Medical History/Concurrent Conditions: Blood pressure abnormal; High cholesterol; Pulse abnormal
METOPROLOL; ATORVASTATIN
Test Date: 20241122; Test Name: Blood pressure; Result Unstructured Data: Test Result:90/45; Comments: low