Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Influenza like illness, Myalgia, Product dose omission issue
Clinical narrative: Her 2nd dose was due; My right arm broke out in hives; I was short of breath; I had a large bruise that started from my elbow & covered my shoulder; I felt tired; Achy; My arm was sore at the injection site; Like I had the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Like I had the flu), URTICARIA (My right arm broke out in hives), DYSPNOEA (I was short of breath), VACCINATION SITE BRUISING (I had a large bruise that started from my elbow & covered my shoulder) and FATIGUE (I felt tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymphedema (In left arm). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), AMLODIPINE and METOPROLOL TARTRATE for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Like I had the flu), VACCINATION SITE BRUISING (I had a large bruise that started from my elbow & covered my shoulder), FATIGUE (I felt tired), MYALGIA (Achy) and VACCINATION SITE PAIN (My arm was sore at the injection site). On 12-Feb-2021, the patient experienced URTICARIA (My right arm broke out in hives) and DYSPNOEA (I was short of breath). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Her 2nd dose was due). At the time of the report, INFLUENZA LIKE ILLNESS (Like I had the flu), URTICARIA (My right arm broke out in hives), DYSPNOEA (I was short of breath), VACCINATION SITE BRUISING (I had a large bruise that started from my elbow & covered my shoulder), FATIGUE (I felt tired), MYALGIA (Achy), VACCINATION SITE PAIN (My arm was sore at the injection site) and PRODUCT DOSE OMISSION ISSUE (Her 2nd dose was due) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications provided by the reporter.   On 05-Feb-2021, patient reported of having a large bruise that started from her elbow & covered her shoulder (injection site), her arm was sore at the injection site, patient felt tired, achy, like had the flu.  Patient admit that did see doctor within a few days for the bruise and doctor felt that it might be that the person giving the injection may have hit a vessel.  On 12-Feb-2021, patient's right arm broke out in hives and was short of breath.  Patient requested to give the shot in right arm, because of having lymphedema in left arm.  On 20-Jul-2021, patient's 2nd dose was due.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.