Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood pressure increased, Erythema, Fatigue, Headache
Clinical narrative: thinks she also had a loud roaring noise in her ear after the first dose; My blood pressure has been higher on occasions; Feeling a little sickly in my stomach; Redness and itching around abdominal area; Itching all over/itching/triggered the mast cells to go a little crazy for a while; Hurting in my arm and a little muscular pain; A little bit of a headache; Came home after shot and was so tired fell asleep for about 4 hours; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (My blood pressure has been higher on occasions), ABDOMINAL DISCOMFORT (Feeling a little sickly in my stomach), ERYTHEMA (Redness and itching around abdominal area), PRURITUS (Itching all over/itching/triggered the mast cells to go a little crazy for a while) and TINNITUS (thinks she also had a loud roaring noise in her ear after the first dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Mastocytosis. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRURITUS (Itching all over/itching/triggered the mast cells to go a little crazy for a while), MYALGIA (Hurting in my arm and a little muscular pain), HEADACHE (A little bit of a headache) and FATIGUE (Came home after shot and was so tired fell asleep for about 4 hours). On 13-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (My blood pressure has been higher on occasions), ABDOMINAL DISCOMFORT (Feeling a little sickly in my stomach) and ERYTHEMA (Redness and itching around abdominal area). On an unknown date, the patient experienced TINNITUS (thinks she also had a loud roaring noise in her ear after the first dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Mar-2021, PRURITUS (Itching all over/itching/triggered the mast cells to go a little crazy for a while), MYALGIA (Hurting in my arm and a little muscular pain) and HEADACHE (A little bit of a headache) had resolved. On 13-Mar-2021, ABDOMINAL DISCOMFORT (Feeling a little sickly in my stomach) and ERYTHEMA (Redness and itching around abdominal area) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (My blood pressure has been higher on occasions) and FATIGUE (Came home after shot and was so tired fell asleep for about 4 hours) had not resolved and TINNITUS (thinks she also had a loud roaring noise in her ear after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient produces too much histamine and too much acid.   This case was linked to MOD-2021-263879 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received and contains added event - loud roaring noise in the ear, current condition,  information about 2nd dose and events related to second dose and updated treatment medication.