Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: broke out into hives around 2 days after the vaccine was administered. The hives present themselves on both arms; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (broke out into hives around 2 days after the vaccine was administered. The hives present themselves on both arms) in a 74-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031912) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 2), Pfizer vaccine (Dose 6), Pfizer vaccine (Dose 4), Pfizer vaccine (Dose 5) and Pfizer vaccine (Dose 3). Past adverse reactions to the above products included No adverse effect with Pfizer vaccine, Pfizer vaccine, Pfizer vaccine, Pfizer vaccine, Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Reaction to monosodium glutamate (MSG (spice in Chinese food)) and Penicillin allergy ((hives reaction)  get a z-pack whenever he needs medication).    On 20-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 22-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced URTICARIA (broke out into hives around 2 days after the vaccine was administered. The hives present themselves on both arms). The patient was treated with HYDROCORTISONE for Hives, at a dose of 1%. In November 2023, URTICARIA (broke out into hives around 2 days after the vaccine was administered. The hives present themselves on both arms) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient stated the symptoms were same both times and broke out into hives around 2 days after the vaccine was administered. The hives were present on both the arms. The symptoms were lasted for 10 days to 2 weeks. Patient stated that he used 'the same kind of cream taken for poison ivy'- hydrocortisone 1%. Patient applied the cream on and then wrapped the arms in gauze bandages.   Patient had done this to prevent additional irritation and to help in the healing process. If he doesn't do this, the friction on the hives causes pain and discomfort. Patient cannot wear short sleeve shirts, and it was ugly and currently still had them on the arms and said they were almost gone. Patient was reporting these side effects to the pharmacist and was advised to report to Moderna as it was valuable to know. Patient was nervous about getting future Moderna vaccines at pharmacy because of the hive symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2024-774318 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Sep-2024: Live non-significant follow up received. Reference numbers were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774318:Same Patient Different product (Spikevax 2024-2025 PFS)