Received Oct 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
it is purple and bruised; it is purple and bruised; it was also hot to touch and very itchy; it got bumpy and was itching; she woke up and the reaction was bigger and swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it got bumpy and was itching), FEELING HOT (it was also hot to touch and very itchy), SKIN DISCOLOURATION (it is purple and bruised), CONTUSION (it is purple and bruised) and SWELLING (she woke up and the reaction was bigger and swollen) in a 73-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: Penicillin; for COVID-19 prophylaxis: Spikevax NOS (This was the first time this had happened and and she had Moderna COVID vaccines every year since the beginning and had no problems.). Past adverse reactions to the above products included Drug allergy with Penicillin; and No adverse effect with Spikevax NOS. Concurrent medical conditions included Allergy to molds, Allergy to animals (pets), Smoke sensitivity and Penicillin allergy. On 17-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 17-Oct-2025, the patient experienced PRURITUS (it got bumpy and was itching) and SWELLING (she woke up and the reaction was bigger and swollen). On 18-Oct-2025, the patient experienced FEELING HOT (it was also hot to touch and very itchy). On 21-Oct-2025, the patient experienced SKIN DISCOLOURATION (it is purple and bruised) and CONTUSION (it is purple and bruised). The patient was treated with Hydrocortisone on 17-Oct-2025 at an unspecified dose and frequency and Acetylsalicylic acid (Aspirin) at an unspecified dose and frequency. On 21-Oct-2025, SWELLING (she woke up and the reaction was bigger and swollen) had resolved. At the time of the report, PRURITUS (it got bumpy and was itching) had not resolved and FEELING HOT (it was also hot to touch and very itchy), SKIN DISCOLOURATION (it is purple and bruised) and CONTUSION (it is purple and bruised) outcome was unknown. Concomitant product use was not provided by the reporter. Patient had received a dose of Moderna Spikevax (2025-2026) at a mall on Friday 17-Oct-2025 and it got bumpy and was itching while she was shopping in the mall. When she got home, the itchiness and bumps increased. She woke up and the reaction was bigger and swollen. On the second day the patient wondered if it would go away. It was also hot to touch and very itchy. On 20-Oct-2025, the patient went back to the mall to show the Pharmacist, and the Pharmacist provided her with information to contact Moderna to report it. The patient did not a fever. On 21-Oct-2025, it was purple and bruised, and the swelling went down, but it was still itchy around it. This was the first time this had happened, and she had Moderna COVID vaccines every year since the beginning and had no problems. No other details provided. The patient took Aspirin, but agent unsure when she took it. When she went home, she used hydrocortisone cream, but it continued to itch. It was unknown if the patient experienced any additional symptoms/events. Event causality not reported. Reporter did not allow further contact
Medical History/Concurrent Conditions: Allergy to animals (pets); Allergy to molds; Penicillin allergy; Smoke sensitivity