Received Apr 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 7+ | — | IM |
Delayed type hypersensitivity reaction to the Moderna Covid vaccination; Developed an outbreak of intensely itchy papules extending several centimeters out from the actual administration site; This spontaneous case was reported by a physician and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Delayed type hypersensitivity reaction to the Moderna Covid vaccination) and ADMINISTRATION SITE PAPULE (Developed an outbreak of intensely itchy papules extending several centimeters out from the actual administration site) in a female patient of an unknown age 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 COVID-19 prophylaxis: Spikevax NOS (Had 8 prior Moderna Covid vaccinations without any cutaneous reactions). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. In November 2025, the patient received ninth 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. In November 2025, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Delayed type hypersensitivity reaction to the Moderna Covid vaccination) and ADMINISTRATION SITE PAPULE (Developed an outbreak of intensely itchy papules extending several centimeters out from the actual administration site). In 2025, TYPE IV HYPERSENSITIVITY REACTION (Delayed type hypersensitivity reaction to the Moderna Covid vaccination) and ADMINISTRATION SITE PAPULE (Developed an outbreak of intensely itchy papules extending several centimeters out from the actual administration site) had resolved. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter considered TYPE IV HYPERSENSITIVITY REACTION (Delayed type hypersensitivity reaction to the Moderna Covid vaccination) and ADMINISTRATION SITE PAPULE (Developed an outbreak of intensely itchy papules extending several centimeters out from the actual administration site) to be related. For Pre-filled Syringe, the reporter did not provide any causality assessments. Concomitant medication use information was not provided by reporter. After the November 2025 injection, 3 to 4 days later, the patient developed an outbreak of intensely itchy papules extending several centimeters out from the actual administration site. These lasted 3 weeks and then resolved. The reporter was interested in knowing the non-mRNA components of the vaccine (the vehicle) to see if there was something, such as a preservative, that might have caused this allergic reaction, since the reporter wanted to avoid experiencing this again with future vaccinations. It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter.