Received Nov 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
experiencing shaking after bath; sweating; vomiting; heart beats very quickly; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID: . A 79-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 04Nov2025 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: 2020 (unspecified if ongoing), notes: in 2020, he got COVID and went to hospital.; "Chronic Lymphocytic Leukemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bnt162b2, start date: 2020, for COVID-19 immunization, reaction(s): "shaking", notes: in 2020, he got COVID and went to hospital. He spent 11 days in the ICU. Then he took the COVID vaccine and experienced shaking & sweating on a 12 hour period; Bnt162b2, start date: 2020, for COVID-19 immunization, reaction(s): "sweating", notes: in 2020, he got COVID and went to hospital. He spent 11 days in the ICU. Then he took the COVID vaccine and experienced shaking & sweating on a 12 hour period; Bnt162b2, start date: 2023, for COVID-19 immunization, reaction(s): "shaking", notes: after 3 years he was administered with COVID vaccine and had the same reaction; Bnt162b2, start date: 2023, for COVID-19 immunization, reaction(s): "sweating", notes: after 3 years he was administered with COVID vaccine and had the same reaction. The following information was reported: TREMOR (hospitalization, life threatening) with onset Nov2025, outcome "recovered", described as "experiencing shaking after bath"; HEART RATE INCREASED (non-serious) with onset Nov2025, outcome "unknown", described as "heart beats very quickly"; HYPERHIDROSIS (non-serious) with onset Nov2025, outcome "recovered", described as "sweating"; VOMITING (non-serious) with onset Nov2025, outcome "unknown". The patient underwent the following laboratory tests and procedures: Heart rate: very quickly. Additional information: Caller elaborated that he was last administered with Comirnaty on 04Nov2025 and in 2020, he got COVID and went to hospital. He spent 11 days in the ICU. Then he took the COVID vaccine and experienced shaking & sweating on a 12 hour period, after 3 years he was administered with COVID vaccine and had the same reaction. When paraphrased the above concern, consumer stated, "I started, in 2020, I got COVID and spend 11 days in ICU. 21 comes along and I took the shot (Pfizer COVID-19 Vaccine) and that evening until the next morning, I had sweats and shaking and very uncomfortable. Next year comes around, I do the same thing, this year, I come around I do the same thing, except this time, I throw up and my heart was just pounding. My concern is like I said I spend 11 days in ICU, I am thinking, should I continue to take this shot? Because I am 79 years old." 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: Chronic lymphocytic leukemia; COVID-19 (in 2020, he got COVID and went to hospital.)
Test Name: heart beat; Result Unstructured Data: Test Result:very quickly