Received Dec 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
Muscle twitch; it just happens sporadically; It could be anywhere, It could be my bicep; It in my left bicep; This is a spontaneous report received from a Consumer or other non HCP. A 64-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Nov2025 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "type II diabetic" (ongoing); "Blood pressure abnormal" (ongoing); "Pace maker in his heart" (ongoing). Concomitant medication(s) included: METFORMIN taken for type 2 diabetes mellitus. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for COVID-19 Immunization; Comirnaty (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: MUSCLE TWITCHING (non-serious) with onset Nov2025, outcome "unknown", described as "Muscle twitch; it just happens sporadically; It could be anywhere, It could be my bicep; It in my left bicep". Additional information: Patient stated, he got the Pfizer COVID vaccine during the pandemic. He had gotten all the Pfizer COVID shots, he got one a couple weeks ago and he was not sure with what's going on with him if it's associated with the vaccine or not but he just know that he had been getting muscle twitches in like his bicep just like anywhere there was a muscle at he had notice that there is a, he can feel like a twitch and it just happens sporadically. It could be anywhere, It could be his bicep. It could be in his you know mainly. It in his left bicep. When paraphrased the concern: patient stated, "Yes, and also different areas in his body, you know it could be his quads. It could be his abdominal muscles, he mean it just seems like it was the muscle that were clutching. Patient stated, Yes, he was not sure if that was the problem or not, he didn't have it beforehand you know but he don't know if it was a new development or if it had something to do with the vaccine, he just you know like he said he really don't know what. Patient was informed about role of Pfizer drug safety and Pfizer medical information. Patient was provided with the telephone number and department works from 09:00 AM to 05:00 PM from monday to friday as per time. Product details: patient stated, they did not give him anything at the pharmacy for it. Whenever he took the shot it just he filled out a form they know. They had those several questions asked. he felt they had a fever or anything you know and all but he don't have it now for this one. When clarified as Pfizer Covid 19 vaccine, patient stated, Yes. Concomitant medications: Patient stated, Well, patient was type II diabetic. He mean, he take metformin for that, you know he had a Pace maker in his heart, but you know like it's, yes do take some medication for blood pressure. Vaccine was administered at a facility. Start date of event: Patient stated, that's probably a week ago from the day of reporting. If still experiencing, patient stated, Well, he meant like the thing is he never had any of this point, he don't know what's causing it, you know if it was the vaccine or if it is a. He meant, he had no idea, he just know that he didn't have this going on before he got the vaccine. Treatment: Patient stated, he called his doctor and they had me called you know, the pharmacy and talk to the pharmacist and he said he didn't know of anything that was in. He had not heard of anything going on with that. So, then doctors office gave me this phone number to call and not sure what is going on with it. Patient meant why somebody would they know, it was like he was trying to make an appointment to figure out what was going on and he just had suspicions that. Patient stated, So, somebody be getting back with him or? They did forward information to them. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Artificial cardiac pacemaker user; Blood pressure abnormal; Type II diabetes mellitus
METFORMIN