Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19-2 | COVID19 (COVID19 (MODERNA BIVALENT)) | MODERNA | UNK | — | IM |
hives/previously developing hives from a Moderna COVID booster; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/previously developing hives from a Moderna COVID booster) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The patient's past medical history included Sinus infection. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (over the past 4-5 years). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. Concurrent medical conditions included Diabetes. Concomitant products included Methylprednisolone (Medrol) for Sinus infection. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. In 2023, the patient experienced URTICARIA (hives/previously developing hives from a Moderna COVID booster). The patient was treated with Fexofenadine hydrochloride (Allegra) in 2023 for Hives, at a dose of 6 weeks. In 2023, URTICARIA (hives/previously developing hives from a Moderna COVID booster) had resolved. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) were reported as none. The patient had no medical history, concomitant disease or risk factors. The patient had several shots before without any adverse reactions. Patient was on oral steroids called Medrol Pack while he had his last Moderna COVID-19 vaccine in 2023. A couple of years ago, a patient had the Moderna booster, stating he had several Moderna COVID shots over the past 4-5 years, starting with the original ones that came out in 2020 or 2021. And one of the boosters he received in July of 2023, a couple of weeks after he got that booster, he developed hives. He received multiple vaccines previously without developing hives. When he had the shot, he was on steroids. So, when the patient came off, when he came for a sinus infection, so when he came off the steroids, 2 weeks after that, the hives started. So, it's essentially the same as 2 weeks after the vaccine. The hives stopped. He had no other side effects but just the itching and the hives. Patient switched to Pfizer COVID-19 boosters for the past 2 years and had no reaction aside from the sore arm. He had no systemic reaction from the Pfizer COVID-19 vaccine. It did last like 6 weeks, and it was annoying. Patient had probably about 5 or 6 Moderna COVID-19 vaccines and probably about maybe 3 Pfizer COVID-19 boosters. There were no lab data/results available. It was unknown if the patient experienced any additional symptoms/events. Reporter causality was not reported. Patient took Allegra for 6 weeks, an antihistamine before the hives stopped. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2025: Live follow-up received: Patient age updated, and reference id added. On 17-Sep-2025: Live follow-up received: Patient age updated, and current condition added. Suspect drug coding and start date updated and reference id added.
Diabetes
Medical History/Concurrent Conditions: Sinus infection
Medrol