Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Missed dose; Heat in Ear; Elevated heart Rate; tingly" and "pinchy" sensation all over her body externally and internally; Hives began to appear on the stomach area hat began to spread; "pinchy" sensation all over her body externally and internally; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingly" and "pinchy" sensation all over her body externally and internally), URTICARIA (Hives began to appear on the stomach area hat began to spread), SKIN BURNING SENSATION ("pinchy" sensation all over her body externally and internally), PRODUCT DOSE OMISSION ISSUE (Missed dose) and FEELING HOT (Heat in Ear) in a 48-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.     Concurrent medical conditions included Penicillin allergy, Drug allergy (patient is allergic to codeine, sulfa, keflex) and Seasonal allergy. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) from 29-Jan-2021 to 31-Jan-2021 and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, METOPROLOL for Heart disease, unspecified, ALPRAZOLAM for Sleep disorder, ALPRAZOLAM (XANAX), LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D), MULTIVITAMIN & MINERAL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 31-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021 at 11:30 AM, the patient experienced PARAESTHESIA (tingly" and "pinchy" sensation all over her body externally and internally). 31-Jan-2021 at 11:30 AM, the patient experienced URTICARIA (Hives began to appear on the stomach area hat began to spread). 31-Jan-2021 at 11:30 AM, the patient experienced SKIN BURNING SENSATION ("pinchy" sensation all over her body externally and internally). On 01-Feb-2021, the patient experienced FEELING HOT (Heat in Ear) and HEART RATE INCREASED (Elevated heart Rate). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC HIVES RELIEF) ongoing since an unknown date for Hives, at a dose of 40 mg once a day; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date for Hives, at a dose of 180 mg once a day; ALPRAZOLAM (ATARAX [ALPRAZOLAM]) ongoing since an unknown date for Hives, at a dose of 50 mg; FAMOTIDINE (PEPCID AC) ongoing since an unknown date at a dose of 80 mg twice a day; PREDNISONE ongoing since an unknown date for Hives, at a dose of for 10 day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PARAESTHESIA (tingly" and "pinchy" sensation all over her body externally and internally), SKIN BURNING SENSATION ("pinchy" sensation all over her body externally and internally) and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved, URTICARIA (Hives began to appear on the stomach area hat began to spread) had not resolved and FEELING HOT (Heat in Ear) and HEART RATE INCREASED (Elevated heart Rate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Benadryl, Zyrtec, Steroid Shot, Steroid Pack   This case was linked to US-MODERNATX, INC.-MOD-2021-021403, US-MODERNATX, INC.-MOD-2021-021403 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Vaccine information, patient demographics, medical history, new concomitant medication, treatment medications, event missed dose added, outcome of hives(from unknown to not recovered), burning and tingling (from unknown to recovered).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-021403:Crosslinked (MOD21-021954) US-MODERNATX, INC.-MOD-2021-021403:Crosslinked (MOD21-021954)