Received May 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
hives appeared on feet, ankles, legs and back/wide spread hives/smaller patches of hives still appear intermittently on various parts of the body; MNEXSPIKE PFS was administered to a 7-year-old patient; High fever of 103f; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives appeared on feet, ankles, legs and back/wide spread hives/smaller patches of hives still appear intermittently on various parts of the body), PYREXIA (High fever of 103f) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (MNEXSPIKE PFS was administered to a 7-year-old patient) in a 6-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 02-Apr-2026, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 25 microgram. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 02-Apr-2026, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (MNEXSPIKE PFS was administered to a 7-year-old patient). On 12-Apr-2026, the patient experienced URTICARIA (hives appeared on feet, ankles, legs and back/wide spread hives/smaller patches of hives still appear intermittently on various parts of the body). In April 2026, the patient experienced PYREXIA (High fever of 103f). At the time of the report, URTICARIA (hives appeared on feet, ankles, legs and back/wide spread hives/smaller patches of hives still appear intermittently on various parts of the body) had not resolved, PYREXIA (High fever of 103f) had resolved and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (MNEXSPIKE PFS was administered to a 7-year-old patient) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2026, Body temperature: high fever of 103f. Concomitant medications were not reported. It was reported that patient experienced high fever of 103f occurred approximately 8 hours after vaccine, resolved with Motrin and the temperature remained normal after Motrin wore off. Hives resolved with a dose of Benadryl then hives returned after Benadryl wore off. It was reported that wide spread hives continued to return if not given antihistamine daily over 3 weeks later. Even with antihistamine smaller patches of hives still appeared intermittently on various parts of the body. Patient had visited dermatologist who diagnosed hives. It was unknown if the patient experienced any additional symptoms/events. The subject was treated with Motrin, 1 dose of 10ml liquid by mouth taken in response to fever, Benadryl 5ml taken by mouth once in response to first instance of hives and zyrtec 5mL twice daily, patient was still taking.; Reporter's Comments: The company assessed both events of PYREXIA and URTICARIA as related to suspected vaccine, as both events are compatible with safety profile of vaccine. PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE contributed to reported event. The benefit-risk relationship of product is not affected by this report.
Test Date: 202604; Test Name: High fever of 103f; Result Unstructured Data: high fever of 103f