Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3032164 | IM |
rash all over body/it was on chest, on back, and on both arms, and not as much on the legs, but on the legs as well; itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over body/it was on chest, on back, and on both arms, and not as much on the legs, but on the legs as well) and RASH PRURITIC (itchy rash) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032164) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3032164) for COVID-19 prophylaxis. No Medical History information was reported. On 31-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In November 2023, the patient experienced RASH (rash all over body/it was on chest, on back, and on both arms, and not as much on the legs, but on the legs as well) and RASH PRURITIC (itchy rash). In November 2023, RASH (rash all over body/it was on chest, on back, and on both arms, and not as much on the legs, but on the legs as well) and RASH PRURITIC (itchy rash) had resolved. No concomitant medications were provided. Patient had no relevant medical history (vaccines within the past 4 weeks, medical conditions). The patient received a Moderna COVID vaccine 2 years ago in 2023. Typically, the patient had Moderna vaccine for COVID all along. But this last time, the patient had developed a rash all over body and it lasted for about 2 weeks. It was a lot. The patient had called the doctor. The patient had a telehealth visit about it and everything. It was advised just never to take the vaccine again. The patient had one doctor who told never take another mRNA vaccine, which seemed entirely wrong and then the patient had a doctor recently told either the Moderna or the Pfizer vaccine for COVID, but that means basically patient had no choice because nobody around here carries anything else. The patient had a concern that patient might have a bigger reaction the next time. The patient about to get a flu shot and had a flu shot last year and did not have anything more than just a little grumbling from that. The product was Fluzone HD 65+administered on 07-Oct-2024. The patient had developed rash instead; she had a telehealth visit with another provider. The patient asked about Moderna's most recent Spikevax and a new one that's for seniors (mNEXSPIKE). The rash for at least, not now, it was 2 years ago now. I did not have it now, but it started maybe the day after the injection. It was itchy. It was on chest, on back, and on both arms, and not as much on the legs, but on the legs as well and the patient was told by two healthcare providers that they thought it was an allergic reaction and that if patient was to get the vaccine again, the reaction might be a lot worse. No treatment medication was provided. This case was linked to MOD-2025-790821 (Patient Link).