Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
huge water blister at injection site/injection site there is a large water blister; arm and shoulder started getting sore; arm and shoulder started getting sore; This is a spontaneous report received from a Consumer or other non HCP. A 69-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 04Sep2025 at 12:07 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, lot number unknown), for Covid-19 immunization, reaction(s): "shoulder started getting sore as it has on previous occasions", "arm started getting sore as it has on previous occasions"; Bnt162b2 (Dose 2, single, lot number unknown), for Covid-19 immunization, reaction(s): "shoulder started getting sore as it has on previous occasions", "arm started getting sore as it has on previous occasions"; Bnt162b2 (Dose 3, single, lot number unknown), for Covid-19 immunization, reaction(s): "shoulder started getting sore as it has on previous occasions", "arm started getting sore as it has on previous occasions"; Bnt162b2 (Dose 4, single, lot number unknown), for Covid-19 immunization, reaction(s): "shoulder started getting sore as it has on previous occasions", "arm started getting sore as it has on previous occasions". The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 04Sep2025, outcome "unknown" and all described as "arm and shoulder started getting sore"; VACCINATION SITE VESICLES (non-serious) with onset 05Sep2025, outcome "recovering", described as "huge water blister at injection site/injection site there is a large water blister". The events "arm and shoulder started getting sore" and "huge water blister at injection site/injection site there is a large water blister" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of arthralgia, pain in extremity, vaccination site vesicles. Additional information: On 04Sep2025 at 12:07 caller was administered the vaccine. This was caller's 5th Pfizer vaccine shot. Pretty much knew the drill, what to expect and do. Everything was fine, good injection, didn't feel pinch or prick. He was administered and put a Band-Aid on, he didn't shower and 4 hours later his arm and shoulder started getting sore as it has on previous occasions. He started putting ice and arnica gel on it. Since he had prior experience with previous administration this was not the first time he tried ice and arnica gel. He did that from 4PM until bed, around 11:30 or 12. He slept alright. He woke up the following morning, felt arm and shoulder, felt weird. He rolled up the sleeve of pajamas, looked in mirror, had huge water blister at injection site, about 4.5 inches long (above and below the injection site) by close to 3 inches wide above and below and to the side of the injection site or 2 and 3/4 inches wide. It was a Friday, so he got on phone with triage nurse. Within probably a few hours after woke up, it burst on its own, was so full of water. The patient has active life with sports and different stuff, so has had water blisters before for various things. He knew how to treat it. Basically he just cleaned it with soap and water, put triple antibiotic on it, keeping covered with gauze pad. One nurse said agreed with caller's treatment, and another nurse said maybe get to urgent care. But it was a Friday afternoon, has excellent health care, didn't want to go to emergency room. Doctor and medical health system on Fridays are bad, was "not going to deal with that headache". The caller monitored and treated himself. If he had signs of infection, would go to urgent care. He was treating all weekend, fine since then, like a burn, raw, layers of skin peeled off on its own, looked like was healing. The patient then stated he already contacted his primary healthcare professional and went to urgent care. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.