Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Product dose omission issue, Rash, Urticaria, Vaccination site pain
Clinical narrative: Missed dose; hives were smaller but still red; a bad rash on my left arm; "3 hives ...red, raised, felt hard, dime size hives" on the left lower leg; mild soreness at the site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA ("3 hives ...red, raised, felt hard, dime size hives" on the left lower leg), PRODUCT DOSE OMISSION ISSUE (Missed dose), ERYTHEMA (hives were smaller but still red), RASH (a bad rash on my left arm) and VACCINATION SITE PAIN (mild soreness at the site) in a 77-year-old female patient who received mRNA-1273 for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Cardiac Lidocaine (Cardiac Lidocaine); for an unreported indication: Tetanus. Past adverse reactions to the above products included Cardiac arrest with Cardiac Lidocaine. Concurrent medical conditions included Atrial fibrillation (A-Fib, Worsening) since 2020, Ventricular ectopics (Ventricular Ectopy,shows improvement) since 1998, Macular degeneration (Gradual worsening) since 2010, Arthritis (Much worsening) since 2009, GERD (gerd, worsening) since 1997 and Diverticulitis. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for GERD, METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MAGNESIUM OXIDE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (mild soreness at the site). On 30-Mar-2021, the patient experienced URTICARIA ("3 hives ...red, raised, felt hard, dime size hives" on the left lower leg). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose), ERYTHEMA (hives were smaller but still red) and RASH (a bad rash on my left arm). At the time of the report, URTICARIA ("3 hives ..red, raised, felt hard, dime size hives" on the left lower leg), ERYTHEMA (hives were smaller but still red) and VACCINATION SITE PAIN (mild soreness at the site) had resolved with sequelae, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved and RASH (a bad rash on my left arm) was resolving. Not Provided      mRNA-1273 (Intramuscular) was withdrawn on an unknown date.       Patient reported in the allergic history that  she had hypersensitivity reactions Patient reported that  she had redness at the injection site after Tetanus vaccine It was reported in the adverse event information as Systemic allergy Patient reported that doctor advised her to take anti histamines and not to take second dose of Moderna vaccine   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Initial additional: Blank ADR form, MI query On 16-Jul-2021: Follow up information received and contains significant information. Patient address and demographics updated. In the medial history current conditions Macular degeneration, Arthritis and GERD were added. Historical drug and historical vaccine information added. Added new concomitant product Nexium and also updated dosage information of the other concomitant products. Added new events Rash, Erythema and Product dose omission issue