Received Apr 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052296 | IM |
Rash that started at forehead and moved its way down, the rash now covers the face, neck, chest, back of her neck and hands/Redness on face, redness on hands and redness on chest; Hands look like blisters; Rash is very itchy; Face is swollen; Causes her not to focus at work; This spontaneous case was reported by an attorney and describes the occurrence of RASH ERYTHEMATOUS (Rash that started at forehead and moved its way down, the rash now covers the face, neck, chest, back of her neck and hands/Redness on face, redness on hands and redness on chest), BLISTER (Hands look like blisters), RASH PRURITIC (Rash is very itchy), SWELLING FACE (Face is swollen) and DISTURBANCE IN ATTENTION (Causes her not to focus at work) in a 67-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052296) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052296) for COVID-19 prophylaxis. Concurrent medical conditions included Food allergy (Cilantro) and Latex allergy. On 03-Apr-2026, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In April 2026, the patient experienced RASH ERYTHEMATOUS (Rash that started at forehead and moved its way down, the rash now covers the face, neck, chest, back of her neck and hands/Redness on face, redness on hands and redness on chest), BLISTER (Hands look like blisters), RASH PRURITIC (Rash is very itchy), SWELLING FACE (Face is swollen) and DISTURBANCE IN ATTENTION (Causes her not to focus at work). At the time of the report, RASH ERYTHEMATOUS (Rash that started at forehead and moved its way down, the rash now covers the face, neck, chest, back of her neck and hands/Redness on face, redness on hands and redness on chest), BLISTER (Hands look like blisters), RASH PRURITIC (Rash is very itchy), SWELLING FACE (Face is swollen) and DISTURBANCE IN ATTENTION (Causes her not to focus at work) had not resolved. No concomitant medications provided by the reporter. It was reported that post vaccination the patient started to develop a rash. The patient had a visit with a dermatologist, but their recommendations did not help the patient. The patient currently had redness on face, hands and chest and the patient hands looked like blisters. It was reported that the rash was very itchy and the patient's face was swollen. The patient finally described it as a blaring rash and that caused the patient not to focus on work. No treatment medications provided by the reporter. Information received on 13-Apr-2026 and 14-APR-2026 has been processed together in the same case cycle. Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2026: Live Significant information was received in which suspect product batch number was added and new reference number was added.; Reporter's Comments: The patient's history of allergic predisposition is considered a potential risk factor contributing to the reported events. The benefit-risk relationship of product is not affected by this report.
Food allergy (Cilantro); Latex allergy