Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Arm broke out, moved down upper arm/ hives; Rash on chest, neck , arms and legs/ rash on neck, chest and arms; Arm broke out with both shots/Arm broke up /Moderna rash; Arm was red and hot/ red area on arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Arm broke out, moved down upper arm/ hives), VACCINATION SITE RASH (Arm broke out with both shots/Arm broke up /Moderna rash), RASH (Rash on chest, neck , arms and legs/ rash on neck, chest and arms) and VACCINATION SITE ERYTHEMA (Arm was red and hot/ red area on arm at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 022M20A) for COVID-19 vaccination.     Previously administered products included for Hives: Benedryl (sulfa drug allergy.). Concurrent medical conditions included Drug allergy (Hives, treated with Benedryl and they went away). Concomitant products included LOVASTATIN for Cholesterol.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm was red and hot/ red area on arm at injection site). On 27-Mar-2021, the patient experienced VACCINATION SITE RASH (Arm broke out with both shots/Arm broke up /Moderna rash). On 28-Mar-2021, the patient experienced URTICARIA (Arm broke out, moved down upper arm/ hives) and RASH (Rash on chest, neck , arms and legs/ rash on neck, chest and arms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) on 27-Mar-2021 for Hives and Vaccination site rash, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 15-Apr-2021 for Hives and Vaccination site rash, at a dose of UNK UNK, q6h; PREDNISONE from 28-Mar-2021 to 12-May-2021 for Hives and Vaccination site rash, at an unspecified dose and frequency; PREDNISONE on 30-Mar-2021 for Hives and Vaccination site rash, at a dose of higher dose; PREDNISONE on 09-Apr-2021 for Hives and Vaccination site rash, at a dose of lower dose taper; PREDNISONE on 15-Apr-2021 for Hives and Vaccination site rash, at a dose of increased dose, Every 6 hours; ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) ongoing since an unknown date at an unspecified dose and frequency; EPINEPHRINE (EPIPEN) on 09-Apr-2021 for Vaccination site rash, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, URTICARIA (Arm broke out, moved down upper arm/ hives) and VACCINATION SITE RASH (Arm broke out with both shots/Arm broke up /Moderna rash) had resolved and RASH (Rash on chest, neck , arms and legs/ rash on neck, chest and arms) and VACCINATION SITE ERYTHEMA (Arm was red and hot/ red area on arm at injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Blood pressure measurement: 175-98 (Inconclusive) 175-98. On 27-Mar-2021, Body temperature: 97.8 (normal) 97.8°F. On 27-Mar-2021, Heart rate: 86 (Inconclusive) 86.         Treatment includes Allegra, Zyrtek and Sinulair. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular)  was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-076444 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Updated patient weight, added historical drug in relevant medical history and lab data information. Updated the indication of Lovastatin. Added start and stop date of Prednisone.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076444:Cross link with Dose 2