Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 4 | FN2908 | — |
sore arm; down with energy; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 70-year-old female patient received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 70 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing), notes: for 30 years. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Lot: EM9810, Site: Injection in the arm), administration date: 03Feb2021, when the patient was 69-year-old, for Covid-19 immunization, reaction(s): "sore arm", "down with energy a little bit"; BNT162b2 (Dose 2, single, Lot: EN6198, Site: Injection in the arm), administration date: 26Feb2021, when the patient was 69-year-old, for Covid-19 immunization, reaction(s): "sore arm", "down with energy a little bit"; BNT162b2 (Dose 3 (booster), single, Lot: FH8027 Expiry: 28Feb2022, Site: Injection in the Right arm), administration date: 22Oct2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "sore arm", "down with energy a little bit". 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: The report was not related to a study or programme. No other Conditions. No investigations. No other Products. 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. 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 was not immunosuppressed, but was modulated. 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. Caller said that she was calling about the new Comirnaty to see if it was suitable for someone older than 65 and immunocompromised that is modulated. She does not want it to come back and bite her like she did with the Moderna vaccine where she struggled to get out of bed for a couple of weeks. The Pfizer Covid-19 vaccines don't really have a negative, because she did not have the robust response like she did with the Moderna Covid-19 Vaccine. Her response was a level 1-2 as opposed to a level 9-10 like she had with Moderna. It is a big difference. It was way way less than the shingles vaccines. It is not even on her radar. She was calling because what she read was that the new Pfizer Covid-19 vaccine was termed to have a robust response. She has never had Covid anyway. She was completely mobile. Stated that the Moderna Covid-19 Vaccine kicked her butt. Patient took dose 5 on 19May2023 and dose 6 on 13Sep2023. Nothing that showed up and she was stable on her MRI's and did not show any active lesions or anything. Only needed steroids after the Moderna dose. She had no issue with Pfizer or the Pfizer Covid shots. It was just that she wanted to try and do a little bit of investigation and when she she saw the thing of a robust response, she questioned whether she wanted it or not.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500177753 same patient/SD/AE, different dose;
Medical History/Concurrent Conditions: MS (for 30 years)