Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 4 | — | IM / RA |
experienced an allergic reaction after 8 hours/bodily itching, flushed face; experienced an allergic reaction after 8 hours/bodily itching, flushed face; experienced an allergic reaction after 8 hours/ right cheek was not terrible but slightly puffy, swollen on the right side; Histamine reaction; had a rash on legs and arms. It was not like that fine rash. It was more like bigger and elongated rash. It just a weird looking rash; muscular aches; low-grade fever; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (experienced an allergic reaction after 8 hours/bodily itching, flushed face), FLUSHING (experienced an allergic reaction after 8 hours/bodily itching, flushed face), SWELLING FACE (experienced an allergic reaction after 8 hours/ right cheek was not terrible but slightly puffy, swollen on the right side), HISTAMINE INTOLERANCE (Histamine reaction) and RASH (had a rash on legs and arms. It was not like that fine rash. It was more like bigger and elongated rash. It just a weird looking rash) in a 74-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Sep-2025, the patient received fourth dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. In September 2025, the patient experienced PRURITUS (experienced an allergic reaction after 8 hours/bodily itching, flushed face), FLUSHING (experienced an allergic reaction after 8 hours/bodily itching, flushed face) and SWELLING FACE (experienced an allergic reaction after 8 hours/ right cheek was not terrible but slightly puffy, swollen on the right side). September 2025, the patient experienced HISTAMINE INTOLERANCE (Histamine reaction), MYALGIA (muscular aches) and PYREXIA (low-grade fever). September 2025, the patient experienced RASH (had a rash on legs and arms. It was not like that fine rash. It was more like bigger and elongated rash. It just a weird looking rash). The patient was treated with Cetirizine hydrochloride (Zyrtec) in September 2025 at an unspecified dose and frequency and Paracetamol (Tylenol) in September 2025 for Itching, at an unspecified dose and frequency. In September 2025, RASH (had a rash on legs and arms. It was not like that fine rash. It was more like bigger and elongated rash. It just a weird looking rash) had resolved. At the time of the report, PRURITUS (experienced an allergic reaction after 8 hours/bodily itching, flushed face), FLUSHING (experienced an allergic reaction after 8 hours/bodily itching, flushed face), SWELLING FACE (experienced an allergic reaction after 8 hours/ right cheek was not terrible but slightly puffy, swollen on the right side), HISTAMINE INTOLERANCE (Histamine reaction), MYALGIA (muscular aches) and PYREXIA (low-grade fever) outcome was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient experienced an allergic reaction after 8 hours of vaccination. Allergy was described as bodily itching, flushed face. The patient's right cheek was not terrible but slightly puffy, swollen on the right side. 16 hours after receiving the vaccine, upon waking up, the patient had a rash on legs and arms. It was not like that fine rash. It was more like a bigger and elongated rash, just a weird looking rash. The rash went away within a half hour or so, it did not last. The patient called her doctor and took a Zyrtec that next morning. She did not have any rash on hand on that night, so she just took a Tylenol when she had itching. This was her 4th dose of Moderna vaccine, and she never had a problem with it, and usually experienced the typical muscular aches and a low-grade fever for a little bit. The patient's primary care provider stated that she had a histamine reaction. It was unknown if the patient experienced any additional symptoms/events.