Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 5 | CJ3270 | — |
sore arm; down with energy; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19May2023 as dose 5, single (Lot number: CJ3270) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing), notes: pre-existing for 30 years. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1 SINGLE; EM9810), administration date: 03Feb2021, for COVID-19 immunization; BNT162b2 (DOSE 2 SINGLE; EN6198), administration date: 26Feb2021, for COVID-19 immunization; BNT162b2 (DOSE 4 SINGLE; FN2908), administration date: 10May2022, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; ASTHENIA (non-serious), outcome "unknown", described as "down with energy". Additional Information: It was reported that caller on the line calling about the Comirnaty previous formulation/Covid-19 vaccines and reported that she had MS for 30 years. She had 6 booster doses from Pfizer. She reported not having any problems and was doing well. She also reported that she had a flu shot type response with the Pfizer covid vaccines. She got her 7th booster dose from Moderna and the Moderna vaccine activated her MS and had to go on steroids due to complications. Her neurologist advised against getting another covid vaccine and that was 2 years ago. She is ambulant, but did not want to activate her MS and was wanting advice on whether or not to get the new vaccine. Her final booster was Moderna and it activated her MS. She did not have anything other than a response like she would have with a flu shot from the Pfizer covid vaccines and she was good with that. She was on a immunosuppressant at the time she had the Moderna vaccine. Caller said that she is not immunosuppressed, but is modulated.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500177753 same patient/SD/AE, different dose;
Medical History/Concurrent Conditions: Multiple sclerosis (pre-existing for 30 years)