Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
it was so saturated with sweat/never in my life have I sweat like that; It's just a reaction like the chills or something; the chills is always a fever and I could have had a high fever to warm; CR-P was highly elevated; 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 (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 05Sep2025 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (primary immunisation series complete), for covid-19 immunisation. The following information was reported: HYPERHIDROSIS (non-serious), outcome "unknown", described as "it was so saturated with sweat/never in my life have I sweat like that"; CHILLS (non-serious), outcome "unknown", described as "It's just a reaction like the chills or something"; PYREXIA (non-serious), outcome "unknown", described as "the chills is always a fever and I could have had a high fever to warm"; C-REACTIVE PROTEIN INCREASED (non-serious), outcome "unknown", described as "CR-P was highly elevated". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hyperhidrosis, chills, pyrexia, c-reactive protein increased. Additional information: Caller states he had called this morning to report a reaction he had to the new Covid vaccine if they should take Pfizer next time it comes time for a shot. Caller verified the product as the Comirnaty 2025/2026 presentation, got it last Friday. Caller states, he is concerned because he has taken Pfizer from day 1, he wouldn't take Moderna; and he never had a reaction. He woke up Saturday, that night after he took it, he had to change the bed in the middle of the night, it was so saturated with sweat, never in his life have he sweat like that. He don't know if that is considered adverse or severe, he don't have to take another shot for quite a while or next year. Caller states, he don't think it's considered severe, he read quite a bit last night. It's just a reaction like the chills or something, but the chills is always a fever and he could have had a high fever to warm. So, he should be protected, they say the bigger reaction you have the more protection you are from Covid, he don't know how true that is either. It means your immunity in your system really worked itself up and your body was fighting off the injection. He haven't had Covid and he don't intend to get it. He stick with Pfizer, he won't go with Moderna, he don't like them. In an analysis of all unsolicited adverse events reported following any dose, includes night sweats. Complainant does not have the product with them at the time of call. Consumer stated, "Could you just, general thing, I had a Covid vaccine (Clarified as Pfizer Covid-19 vaccine) about a week ago on a Friday. I think it was Friday the 5th and that night, in the middle of the night (incomplete sentence). You know, I have had Pfizer, I specifically asked for Pfizer ever since you came out with it. Never had a reaction and I woke up with, my wife woke me up at 2 in the morning. A reaction, my wife woke me up because the bed was saturated. I had broken out into such a sweat that I am telling you, I never had a reaction to the vaccine and I think I lost half my body fluids. You know that we had to get up in the middle of the night and change the sheets and the mattress, cover everything because I sweat so much. Next day I called the doctor, she said that is definitely a reaction to the vaccine. I am just reporting it, I don't know. They don't give me anything other than the date and you know I have nothing on it, no." Consumer further stated, "It's a new, it is a new one. I had just gotten it in three days before, so I know it's the new one, the only thing I know is that the CR-P was highly elevated. You know, the doctor said that that is due to the vaccines." Consumer stated, "Yes, I just take it for blood pressure and Cholesterol. Do not ask me what I take, I have no clue." When probed if consumer receive any other vaccines on the same date as the Pfizer Covid-19 vaccine, consumer stated, "No." When probed if there were any other vaccinations within four weeks prior taking the Vaccine, consumer stated, "No." Route of administration (For Covid-19 vaccine): Consumer stated, "Well, vaccine is a needle, just the needle in the arm." The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Blood pressure abnormal; Cholesterol
Test Date: 20250906; Test Name: Blood work; Result Unstructured Data: Test Result:CR-P was highly elevated