Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site pain
Clinical narrative: Hypersensitive reaction; rash on face and arm; Chills; tiredness; itchy; hives; vaccination site pain; vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitive reaction), PRURITUS (itchy), URTICARIA (hives), VACCINATION SITE PAIN (vaccination site pain) and VACCINATION SITE ERYTHEMA (vaccination site erythema) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles (A year ago) and Cataract operation (cataract surgery in November and December). Concomitant products included ASCORBIC ACID (VIT C), MULTIVITAMIN [VITAMINS NOS], CALCIUM and KERATIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain) and VACCINATION SITE ERYTHEMA (vaccination site erythema). On 06-Mar-2021, the patient experienced PRURITUS (itchy) and URTICARIA (hives). On an unknown date, the patient experienced HYPERSENSITIVITY (Hypersensitive reaction), RASH (rash on face and arm), CHILLS (Chills) and FATIGUE (tiredness). At the time of the report, HYPERSENSITIVITY (Hypersensitive reaction), PRURITUS (itchy), URTICARIA (hives), VACCINATION SITE ERYTHEMA (vaccination site erythema), CHILLS (Chills) and FATIGUE (tiredness) outcome was unknown, VACCINATION SITE PAIN (vaccination site pain) had resolved and RASH (rash on face and arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient received 1st dose in left arm(non-dominant) on 26 Feb 2021 with lot# 012A21A at the pharmacy. Patient stated she is healthy 73-year-old who just takes vitamins. Patient stated she didn't wait the 15 minutes. Her arm hurt for 18 hours and was in agony. Patient took nothing for pain and has a high threshold for pain, Arm pain went away after 18 hours but still red. Then on Saturday, 6 March her arm started itching and hives. She put alcohol on it and by Sunday it stopped itching. Patient said ok for safety to contact. Patient said her husband (heart patient) had a sore arm and on Saturday his arm was a bothering him but not as bad as hers. Patient feels HCP doesn't know much about the virus.  First dose patient had a rash on face and arm and tiredness for about 2 weeks. Still had rash on face and arm. Today patient still have something on her arm where the vaccine went in. It is like a birth mark or something. It is elevated. Does not bother her anymore. Patient face still has a rash.  She never had a reaction to anything. she was perfectly healthy, took a covid test and was negative. people were saying she must have had covid. patient don't think so. she did not go anyplace for 2 years! Mask on etc.   This case was linked to MOD-2021-102149 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up report received on 03-MAY-2021 and included no new information On 22-Jun-2021: Follow up received on 22-Jun-2021 and included significant information such as new events were added, new medical history was added, New concomitant drugs were added.