Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Heart rate, Heart rate increased
Clinical narrative: The heart rate was noted to be elevated while in the ER; concerns of anaphylaxis/Very itchy with hives all over; This spontaneous case was reported by a patient and describes the occurrence of ANAPHYLACTIC REACTION (concerns of anaphylaxis/Very itchy with hives all over) in a 25-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042558) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (:All have been Moderna). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine. Concurrent medical conditions included Cerebral palsy (rare form since birth not on any medications.) and Immunocompromised (Immunocompromised due to Cerebral Palsy).    On 03-Sep-2024, the patient received fifth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) .5 milliliter. On 04-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced ANAPHYLACTIC REACTION (concerns of anaphylaxis/Very itchy with hives all over) (seriousness criterion medically significant). On an unknown date, the patient experienced HEART RATE INCREASED (The heart rate was noted to be elevated while in the ER). The patient was treated with PREDNISONE at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency and EPINEPHRINE (EPIPEN [EPINEPHRINE]) at an unspecified dose and frequency. On 05-Sep-2024, ANAPHYLACTIC REACTION (concerns of anaphylaxis/Very itchy with hives all over) had resolved with sequelae. At the time of the report, HEART RATE INCREASED (The heart rate was noted to be elevated while in the ER) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: elevated heart rate noted in ER, did not resolve upon discharge, so referred to cardiologist..     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. On 04-SEP-2024 morning woke up patient had very itchy with hives all over. Every dose of Covid vaccine received had been Moderna, this had never happened before. Hives got progressively worse throughout the day. Hives were observed on the arms, neck, on the scalp near the forehead and really bad on the legs. Patient called a 24-hour hotline and was directed to go to the ER due to concerns of anaphylaxis. The heartrate was noted to be elevated while in the ER. The elevated heart rate did not resolve by the time of discharge. Patient was not admitted to the hospital. Patient was immunocompromised due to a rare form of Cerebral Palsy which was diagnosed at birth. Patient does not currently take any medications for the immunocompromising diagnosiomment-   Company comment- This is a spontaneous case concerning a 25-year-old female patient with Concurrent medical condition of Cerebral palsy since birth, who experienced the serious (due to medically significant) expected event of anaphylactic reaction which occurred the following day after a dose of SPIKEVAX 2024-2025 KP.2 PFS vaccine, received as the fifth dose of COVID-19 vaccination schedule. It was reported that she experienced Hives got progressively worse throughout the day on the arms, neck, on the scalp near the forehead and on the legs. The patient was directed to go to the ER due to concerns of anaphylaxis. I was also reported that the heartrate was noted to be elevated while in the ER. The elevated heartrate did not resolve by the time of discharge. The patient was treated with PREDNISOLONE, FAMOTIDINE  and was sent home with an Epipen (ephinephrine).  The outcome of the event was reported as resolved with sequelae. The benefit-risk relationship of SPIKEVAX 2024-2025 KP.2 PFS vaccine is not affected by this report.