Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Feeling hot, Flushing, Product dose omission issue
Clinical narrative: Redness; Sneezing/runny nose; Sneezing/runny nose; Burning Sensation; Feeling hot; Flushing; Itching; Not to take second dose of the Moderna vaccine; SEVERE RASH/HIVES ALL OVER MY BODY TORSO.; Severe rash all over the body, Rash was mainly on her torso; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), URTICARIA (SEVERE RASH/HIVES ALL OVER MY BODY TORSO.), ERYTHEMA (Redness), SNEEZING (Sneezing/runny nose) and RHINORRHOEA (Sneezing/runny nose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included TOLTERODINE TARTRATE, ROSUVASTATIN, ESTRADIOL (ESTRACE) and CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM & VITAMIN D3) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced URTICARIA (SEVERE RASH/HIVES ALL OVER MY BODY TORSO.) and RASH (Severe rash all over the body, Rash was mainly on her torso). On an unknown date, the patient experienced PRURITUS (Itching), ERYTHEMA (Redness), SNEEZING (Sneezing/runny nose), RHINORRHOEA (Sneezing/runny nose), BURNING SENSATION (Burning Sensation), FEELING HOT (Feeling hot), FLUSHING (Flushing) and PRODUCT DOSE OMISSION ISSUE (Not to take second dose of the Moderna vaccine). The patient was treated with FAMOTIDINE at a dose of UNK UNK, bid; CETIRIZINE HYDROCHLORIDE (CETRIZINE) at a dose of UNK UNK, bid and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) (topical) for Itch and Burning sensation NOS, at a dose of as needed. On 15-Feb-2021, URTICARIA (SEVERE RASH/HIVES ALL OVER MY BODY TORSO.) and RASH (Severe rash all over the body, Rash was mainly on her torso) had resolved. On 24-Feb-2021, PRURITUS (Itching), ERYTHEMA (Redness), SNEEZING (Sneezing/runny nose), RHINORRHOEA (Sneezing/runny nose), BURNING SENSATION (Burning Sensation), FEELING HOT (Feeling hot) and FLUSHING (Flushing) had resolved. On 24-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Not to take second dose of the Moderna vaccine) 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 considered PRURITUS (Itching), URTICARIA (SEVERE RASH/HIVES ALL OVER MY BODY TORSO.), ERYTHEMA (Redness), SNEEZING (Sneezing/runny nose), RHINORRHOEA (Sneezing/runny nose), BURNING SENSATION (Burning Sensation), FEELING HOT (Feeling hot), FLUSHING (Flushing), RASH (Severe rash all over the body, Rash was mainly on her torso) and PRODUCT DOSE OMISSION ISSUE (Not to take second dose of the Moderna vaccine) to be possibly related.    Concomitant medication taken were multivitamin,B12,Biotin daily. Treatment medications taken were antihistamine and steroid injections. Patient visited doctor on 02 Apr 2021. Doctor advised not to take second dose, hence patient decided not to take another dose.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Updated patient demographics[Race, Ethnicity, Weight, Height]. Added Concomitant medicines and treatment medicine[Calamine]. Added Newevents [Itching, Burning sensation, Pruritis, Erythema, sneezing, Runnynose, Feeling hot, Flushing].; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash is consistent with the product safety profile.