Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
a pretty large area of erythema on her upper arm/her arm is red; had itching on other parts of her body/had body itching; allergic reaction to Spikevax 2025-2026; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (a pretty large area of erythema on her upper arm/her arm is red), PRURITUS (had itching on other parts of her body/had body itching) and HYPERSENSITIVITY (allergic reaction to Spikevax 2025-2026) in an elderly female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 08-May-2024; for COVID-19 prophylaxis: Spikevax NOS. Past adverse reactions to the above products included No adverse effect with PFIZER BIONTECH COVID-19 VACCINE and Spikevax NOS. On 26-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. In 2025, the patient experienced ERYTHEMA (a pretty large area of erythema on her upper arm/her arm is red), PRURITUS (had itching on other parts of her body/had body itching) and HYPERSENSITIVITY (allergic reaction to Spikevax 2025-2026). At the time of the report, ERYTHEMA (a pretty large area of erythema on her upper arm/her arm is red), PRURITUS (had itching on other parts of her body/had body itching) and HYPERSENSITIVITY (allergic reaction to Spikevax 2025-2026) had resolved with sequelae. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not reported. It was reported that patient had an allergic reaction to Spikevax 2025-2026. Reporter did not see it at its peak, but she had a pretty large area of erythema on her upper arm and itching on other parts of her body as well. People with large erythema were seen and that was often a local reaction, but she had body itching. It was stated that her symptoms were resolved pretty much, when asked to her she said her arm was red still, but the itching was gone. They both had Moderna except for 1 injection that was Pfizer. Pfizer vaccine was on May 8, 2024. Spikevax 2025-2026 would have been the third injection since. All the other vaccines were Moderna covid-19 vaccines, they have been receiving them in roughly 6-month intervals except for the Pfizer vaccine. It was unknown how many vaccines there were, but when they started out it was 2 initials, and then about every 6 months roughly. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789956 (E2B Linked Report). This case was linked to MOD-2022-660560 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789956:Invalid case with multiple people