Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: every time when sweats or when rubs, skin broke out in hives everything but his neck and head, getting hives; itching; Rash in his armpit for a couple of months; Got COVID already after vaccination; Lack of drug effect/got COVID already after vaccination 3 weeks ago; coming out of a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (coming out of a cold), URTICARIA (every time when sweats or when rubs, skin broke out in hives everything but his neck and head, getting hives), PRURITUS (itching), DRUG INEFFECTIVE (Lack of drug effect/got COVID already after vaccination 3 weeks ago) and RASH (Rash in his armpit for a couple of months) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (allergic to honey and that it was not an allergy, started when got the vaccine) and Allergy NOS (Patient had allergies).    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced NASOPHARYNGITIS (coming out of a cold), DRUG INEFFECTIVE (Lack of drug effect/got COVID already after vaccination 3 weeks ago) and COVID-19 (Got COVID already after vaccination). On an unknown date, the patient experienced URTICARIA (every time when sweats or when rubs, skin broke out in hives everything but his neck and head, getting hives), PRURITUS (itching) and RASH (Rash in his armpit for a couple of months). The patient was treated with PREDNISONE for Rash and Hives, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (coming out of a cold), URTICARIA (every time when sweats or when rubs, skin broke out in hives everything but his neck and head, getting hives), PRURITUS (itching), RASH (Rash in his armpit for a couple of months) and COVID-19 (Got COVID already after vaccination) outcome was unknown and DRUG INEFFECTIVE (Lack of drug effect/got COVID already after vaccination 3 weeks ago) had resolved.            Concomitant drugs included decongestant every now and then for his allergies.  Patient had allergies so took prednisone when the hives got really bad HCP prescribed prednisone and got rid of the rash after a few hours but it came again when patient sweats.  This report concerns a 57-year-old male patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID 19. Additionally, Drug ineffective was considered as an event. The events occurred approximately 5 months after receiving the second dose of Spikevax. Rechallenge is not applicable since it is a COVID 19 case. The benefit-risk relation of Spikevax is not affected by this report.   This case was linked to MOD-2021-356174 (Patient Link).; Sender's Comments: This report concerns a 57-year-old male patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID 19. Additionally, Drug ineffective was considered as an event. The events occurred approximately 5 months after receiving the second dose of Spikevax. Rechallenge is not applicable since it is a COVID 19 case. The benefit-risk relation of Spikevax is not affected by this report.