Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria, Fatigue, Hypersensitivity, Influenza, Insomnia
Clinical narrative: Patient needed to took an antihistamine to be able to go to sleep; also felt little sore arm; hypersensitive immune reaction; tired; little achy; flu symptoms; chronic spontaneous urticaria; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu symptoms), CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria), INSOMNIA (Patient needed to took an antihistamine to be able to go to sleep), PAIN IN EXTREMITY (also felt little sore arm) and MYALGIA (little achy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 040B21A and 013A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic hepatitis C (she was treated with interferon for chronic hepatitis C.), Pain in arm and Tiredness. Concurrent medical conditions included Blood pressure high.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced INFLUENZA (flu symptoms) and MYALGIA (little achy). In November 2021, the patient experienced CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria). On 10-Nov-2022, the patient experienced FATIGUE (tired). On an unknown date, the patient experienced INSOMNIA (Patient needed to took an antihistamine to be able to go to sleep), PAIN IN EXTREMITY (also felt little sore arm) and HYPERSENSITIVITY (hypersensitive immune reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency. At the time of the report, INFLUENZA (flu symptoms), CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria), INSOMNIA (Patient needed to took an antihistamine to be able to go to sleep), PAIN IN EXTREMITY (also felt little sore arm), MYALGIA (little achy), FATIGUE (tired) and HYPERSENSITIVITY (hypersensitive immune reaction) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking blood pressure medication.  It was reported that the patient had experienced soreness in the arm, and felt a little tired next day after the first vaccination and there was nothing major. After the first booster, the next day patient felt little sore arm, real super mild flu symptoms, a little achy and tired, but approximately 10 days later patient experienced chronic spontaneous urticaria, generalized in all her body that lasted 4 months, it itched and if she scratched it came out like hives. Patient needed to took an antihistamine to be able to go to sleep. Initially took Benadryl but then remembered there can be an interaction with her blood pressure medication and switched to Claritin. It was further reported that patient asked an allergist if this could be an allergic reaction to the vaccine but doctor told her it might be a hypersensitive immune reaction because of the delay of 10 days. At the time of report these symptoms were resolved.