Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | EN6198 | — |
sore arm; down with energy a little bit; 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), on 26Feb2021 as dose 2, single (Lot number: EN6198), in arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing), notes: she had MS for 30 years. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EM9810, Site: Injection in the arm), administration date: 03Feb2021, for COVID-19 immunization, reaction(s): "sore arm", "down with energy a little bit". The following information was reported: ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "down with energy a little bit"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm". Additional information: Other Conditions: No; Investigations: No; Other Products: No; Caller on the line calling about the Comirnaty previous formulation/Covid-19 vaccines and reported that she had MS for 30 years and then she got the original covid vaccine in 2020. 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. 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. 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 clarified that she had a sore arm and down with energy a little bit for a day or so after receiving the Pfizer Covid-19 Vaccines. It was not a big deal and she does not see it as a negative at all. She has never had Covid anyway. Weight: Said it was too much. She was completely mobile. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500177753 same patient/SD/AE, different dose;
Medical History/Concurrent Conditions: Multiple sclerosis (she had MS for 30 years)