Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site bruising, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Red circle around injection site/Red sweelling started on day 6-7; Itching/woke up in the night, it was itching like crazy; Swollen/Red swelling started on day 6-7; Hot; Small bluish bruise; Arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE BRUISING (Small bluish bruise), PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE WARMTH (Hot), VACCINATION SITE ERYTHEMA (Red circle around injection site/Red sweelling started on day 6-7) and PRURITUS (Itching/woke up in the night, it was itching like crazy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 11-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Small bluish bruise). On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot), PRURITUS (Itching/woke up in the night, it was itching like crazy) and VACCINATION SITE SWELLING (Swollen/Red swelling started on day 6-7). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red circle around injection site/Red sweelling started on day 6-7). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) for Cellulitis, at a dose of 500 milligram four times per day; LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Redness, at a dose of 1 dosage form once a day. On 24-Jan-2021, VACCINATION SITE BRUISING (Small bluish bruise) and PAIN IN EXTREMITY (Arm was sore) had resolved. On 25-Jan-2021, VACCINATION SITE WARMTH (Hot), VACCINATION SITE ERYTHEMA (Red circle around injection site/Red sweelling started on day 6-7), PRURITUS (Itching/woke up in the night, it was itching like crazy) and VACCINATION SITE SWELLING (Swollen/Red swelling started on day 6-7) had resolved.        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.   No concomitant medications were provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Email updated On 02-Jul-2021: Event information updated for vaccination site swelling and pain in extremity from not recovered to recovered; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.