Received Dec 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
allergic reaction; spots all over her back and also on one thigh/itching drove her nuts/spots all over her back and also on one thigh; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction) and RASH PRURITIC (spots all over her back and also on one thigh/itching drove her nuts/spots all over her back and also on one thigh) in an 82-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. The patient's past medical history included Poison ivy rash (Poison ivy allergy). Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (The patient had very first time having a reaction to a COVID vaccine. The patient had Pfizer the first times) since 2021; for Drug use for unknown indication: Itraconazole. Past adverse reactions to the above products included Allergy to vaccine with PFIZER BIONTECH COVID-19 VACCINE; and Drug allergy with Itraconazole. Concurrent medical conditions included Allergy to plants, Drug allergy (The patient had an allergy to itraconazole EG ointment.), Plaster allergy (band aids) and Allergy to vaccine (The patient had allergy reaction post Pfizer COVID-19 vaccination.). On 02-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 03-Sep-2025, the patient experienced HYPERSENSITIVITY (allergic reaction) and RASH PRURITIC (spots all over her back and also on one thigh/itching drove her nuts/spots all over her back and also on one thigh). In September 2025, HYPERSENSITIVITY (allergic reaction) and RASH PRURITIC (spots all over her back and also on one thigh/itching drove her nuts/spots all over her back and also on one thigh) had resolved. No concomitant medications provided by the reporter. The patient had vaccination on Tuesday(02-SEP-2025) and the then Wednesday night (03-Sep-2025) the patient was in bed and thought she had a mosquito bite. On Thursday morning, the patient took shower and the patient looked in the mirror. The patient found the spots and then the itching made the patient extremely annoyed. The patient had spots all over her back and on one thigh. And then the patient kept getting more, but never in the front on one thigh. It was reported that the spots started in the back and on her thigh, and for a few days the spots were increased in number, and then it started to decrease. It was reported that the patient had an allergic reaction. It was confirmed that for the patient itchiness and spots symptoms were resolved and the symptom was lasted about 2 weeks. The patient would see her doctor in January, and the patient would visit with her dermatologist again for a scan and will discuss with dermatologist for recommendation for future covid vaccines. No treatment medications provided by the reporter.
Allergy to plants; Allergy to vaccine (The patient had allergy reaction post Pfizer COVID-19 vaccination.); Drug allergy (The patient had an allergy to itraconazole EG ointment.); Plaster allergy (band aids)
Medical History/Concurrent Conditions: Poison ivy rash (Poison ivy allergy)