Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
rash/back rash that looks like a COVID rash/a rash plus very small things on back, like little bumps itchy/red little things, plus it's been itchy; congestion; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash/back rash that looks like a COVID rash/a rash plus very small things on back, like little bumps itchy/red little things, plus it's been itchy) and NASAL CONGESTION (congestion) in a 65-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The patient's past medical history included Hand tendon injury (tendons were severed way bac) and Hand repair operation (3rd surgery but the patient was not on any medication for it) in July 2025. Concurrent medical conditions included Migraine (years before). Concomitant products included Paracetamol (Tylenol) and Sumatriptan succinate (Sumatriptan) for Migraine, Influenza vaccine (Influenza trivalent vaccine) for an unknown indication. On 22-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced RASH PRURITIC (rash/back rash that looks like a COVID rash/a rash plus very small things on back, like little bumps itchy/red little things, plus it's been itchy) and NASAL CONGESTION (congestion). In October 2025, NASAL CONGESTION (congestion) had resolved. At the time of the report, RASH PRURITIC (rash/back rash that looks like a COVID rash/a rash plus very small things on back, like little bumps itchy/red little things, plus it's been itchy) had not resolved. The patient did not have rash before from the vaccine. It was reported that the patient got the mNEXSPIKE and after that the patient dealt with a back rash that looked like a COVID rash. The patient did not report that when the rash was started, since she never had this before, but it might have been a number of days after she got the vaccine. It was reported that the rash plus very small things were on her back, like little bumps. The patient bought over the counter antihistamines treatment medication and the patient has been taking one of those for the last number of days now. At first, she was looking to see if the rash was caused by her bed or if it was fleas; she researched everything, and it was none of that. She checked for bedbugs too and there were no bedbugs. In future the patient will have a dermatologist visit for the symptom of rash. It was reported that for the patient the rash was red little things, plus it was itchy. It was reported that the patient had a little bit of congestion as well and for moments that were hard, but now the patient was fine. This case was linked to MOD-2025-791595 (Patient Link).; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
Migraine (years before)
Medical History/Concurrent Conditions: Hand repair operation (3rd surgery but the patient was not on any medication for it); Hand tendon injury (tendons were severed way bac)
Influenza trivalent vaccine; Tylenol; Sumatriptan