Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Fear, Poor quality sleep, Rash, Rash macular
Clinical narrative: I think I may have a delayed reaction; I'm concerned, kind of worried; Scared; Three episodes in the last three weeks with a spontaneous onset; couldn't sleep well; Hives returned/ Getting tired of itching/ has under two dozen areas; Hives returns/ Called it as rash/ Itching like hell; started on stomach, and during that evening went to chest, back, legs, arms, shoulders, everywhere all over my body; Itchy hives/ started on stomach, and during that evening went to chest, back, legs, arms, shoulders, everywhere all over my body; Red bumps/ red spots ( don't know what to call them) are red bumps that itch went everywhere; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE (Three episodes in the last three weeks with a spontaneous onset), URTICARIA (Hives returned/ Getting tired of itching/ has under two dozen areas), VACCINATION COMPLICATION (I think I may have a delayed reaction), ANXIETY (I'm concerned, kind of worried) and FEAR (Scared) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery (Stays mostly in home post surgery). Concomitant products included CLOPIDOGREL BISULFATE, METOPROLOL TARTRATE, LISINOPRIL, EMPAGLIFLOZIN, ATORVASTATIN, FINASTERIDE, INSULIN ASPART, GEMFIBROZIL, INSULIN GLARGINE, POTASSIUM CHLORIDE, METFORMIN HCL, COLECALCIFEROL (VITAMIN D3) and VITAMIN B COMPLEX for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2021, the patient experienced URTICARIA (Hives returned/ Getting tired of itching/ has under two dozen areas). On an unknown date, the patient experienced SYMPTOM RECURRENCE (Three episodes in the last three weeks with a spontaneous onset), VACCINATION COMPLICATION (I think I may have a delayed reaction), ANXIETY (I'm concerned, kind of worried), FEAR (Scared), URTICARIA (Itchy hives/ started on stomach, and during that evening went to chest, back, legs, arms, shoulders, everywhere all over my body), RASH MACULAR (Red bumps/ red spots ( don't know what to call them) are red bumps that itch went everywhere), POOR QUALITY SLEEP (couldn't sleep well), RASH PRURITIC (Hives returns/ Called it as rash/ Itching like hell) and RASH (started on stomach, and during that evening went to chest, back, legs, arms, shoulders, everywhere all over my body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 25 mg; HYDROCORTISONE (CORTIZONE 10) for Adverse event, at an unspecified dose and frequency; FAMOTIDINE for Adverse event, at a dose of 20 mg twice a day; FAMOTIDINE on 13-Aug-2021 for Adverse event, at a dose of 20 mg, morning once; HYDROXYZINE PAMOATE for Adverse event, at a dose of 25 mg four times per day; HYDROXYZINE PAMOATE on 13-Aug-2021 for Adverse event, at a dose of 25 mg, once morning; METHYLPREDNISOLONE for Adverse event, at a dose of 4 mg and TRIAMCINOLONE ACETONIDE for Adverse event, at an unspecified dose and frequency. At the time of the report, SYMPTOM RECURRENCE (Three episodes in the last three weeks with a spontaneous onset), URTICARIA (Hives returned/ Getting tired of itching/ has under two dozen areas), VACCINATION COMPLICATION (I think I may have a delayed reaction), ANXIETY (I'm concerned, kind of worried) and FEAR (Scared) had not resolved and URTICARIA (Itchy hives/ started on stomach, and during that evening went to chest, back, legs, arms, shoulders, everywhere all over my body), RASH MACULAR (Red bumps/ red spots ( don't know what to call them) are red bumps that itch went everywhere), POOR QUALITY SLEEP (couldn't sleep well), RASH PRURITIC (Hives returns/ Called it as rash/ Itching like hell) and RASH (started on stomach, and during that evening went to chest, back, legs, arms, shoulders, everywhere all over my body) had resolved.            Concomitant medications also included vitamins and Centrum multivitamin   Most recent FOLLOW-UP information incorporated above includes: On 14-Aug-2021: Follow-up received contains no new information.