Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 8080473 | IM |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8409CA | — |
Covid; severe rash and hives/quickly developed into welts/The welts all over his body were recurring; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid) and URTICARIA (severe rash and hives/quickly developed into welts/The welts all over his body were recurring) in an adult male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080473) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Fluzone) for an unknown indication. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (he did not have any problems in 2023). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. Concurrent medical conditions included Hypertrophic cardiomyopathy. On 12-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter and dose of Influenza vaccine (Fluzone) (unknown route) 1 dosage form. In 2024, the patient experienced COVID-19 (Covid) and URTICARIA (severe rash and hives/quickly developed into welts/The welts all over his body were recurring). The patient was treated with Diphenhydramine hydrochloride (Benadryl) in 2024 at an unspecified dose and frequency; Levocetirizine dihydrochloride (Xyzal) in 2024 at an unspecified dose and frequency and Famotidine (Pepcid) in 2024 at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid) outcome was unknown and URTICARIA (severe rash and hives/quickly developed into welts/The welts all over his body were recurring) had resolved. He received the Spikevax and flu vaccine on the same day last year and had a 4 1/2-month-long reaction, severe rash and hives. He had taken it every year (the Spikevax vaccine) it had been available, and this was his first adverse reaction. He had a serious heart condition, hypertrophic cardiomyopathy, that puts him at risk (it was genetic). He was on some really powerful drugs that precluded him from taking Paxlovid, so his health professionals wanted him to take Spikevax. It was one of the worst reactions they had ever seen. His symptoms started with rashes at various locations on his body (eyes, lips) and quickly developed into welts. The welts all over his body were recurring. The welts were 2 inches in diameter all over his body, on his eyes and routinely on his lips. He phased off eventually after 4 or 5 months and kept trying alternate and, finally, the reaction subsided in his body, and he was free of the issues. He was symptom-free. The patient did not want to go through COVID again, he had been through it and could not take Paxlovid as he did not want to risk his chance of dying. It was unknown if the patient experienced any additional symptoms/events. The immediate treatment was Benadryl. It made him draggy, sleepy and feel yucky. He was living on Benadryl until he started on Xyzal. He actually started with a daily antihistamine, and it provided him with some relief, but he would still sporadically develop hives. Then he tried Pepcid in addition to that. The cocktail of Xyzal and Pepcid allowed him to stop Benadryl. The overnight antihistamine, Xyzal and Pepcid (an antacid which goes to one of the receptors on the histamine). Reporter causality was not provided. This case was linked to US-MODERNATX, INC.-MOD-2025-789512 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789512:Invalid case with multiple people
Hypertrophic cardiomyopathy