Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Myalgia, Urticaria
Clinical narrative: severe allergic reaction; Sunday morning she got hives / hives broke out on hands / went to face  / went to lips/ Reaction got worse; muscle aches// Reaction got worse; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (severe allergic reaction), URTICARIA (Sunday morning she got hives / hives broke out on hands / went to face  / went to lips/ Reaction got worse) and MYALGIA (muscle aches// Reaction got worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F2114) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), PREDNISONE and EPINEPHRINE (EPIPEN) for an unknown indication.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, the patient experienced ALLERGY TO VACCINE (severe allergic reaction) (seriousness criterion hospitalization), URTICARIA (Sunday morning she got hives / hives broke out on hands / went to face  / went to lips/ Reaction got worse) (seriousness criterion hospitalization) and MYALGIA (muscle aches// Reaction got worse) (seriousness criterion hospitalization). The patient was hospitalized on 26-Sep-2021 due to ALLERGY TO VACCINE, MYALGIA and URTICARIA. The patient was treated with EPINEPHRINE (EPIPEN) on 26-Sep-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ALLERGY TO VACCINE (severe allergic reaction), URTICARIA (Sunday morning she got hives / hives broke out on hands / went to face  / went to lips/ Reaction got worse) and MYALGIA (muscle aches// Reaction got worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient called and stated that she had the first vaccine this past Friday, she states that she had a severe allergic reaction.  She stated that she was in the hospital on Sunday since the reaction got worse and was given the EpiPen on Sunday. Reaction started Saturday.  She said this happened right after the first vaccine.  Saturday morning she got hives, then the hives broke out on her hands and went to her face and lips she had muscle aches.  Since the onset she still has these adverse events.  The hospital thought that this could have been an allergy to nuts but it was not.  She states the hospital thinks it is from the vaccination.  Company comment: This case concerns a female patient of unknown age with history of asthma, who experienced the unexpected serious events of Allergy to vaccine, Urticaria, and Myalgia. The events occurred one day after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Seriousness criteria of Hospitalization based on reference to being in the hospital, although not specifically stated that hospital admission occurred.; Sender's Comments: This case concerns a female patient of unknown age with history of asthma, who experienced the unexpected serious events of Allergy to vaccine, Urticaria, and Myalgia. The events occurred one day after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Seriousness criteria of Hospitalization based on reference to being in the hospital, although not specifically stated that hospital admission occurred.