Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Joint stiffness, Nausea, Oropharyngeal discomfort
Clinical narrative: She started having convulsions; Had a metal taste in her mouth; She was having an allergic reaction; Her jaw started locking; Her face was big; Her face was red; She was shaking like she had epilepsy; She didn't feel good; Sensation of throat closing; Felt dizzy; She had a light headache; nausea; Palpitations; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (She started having convulsions) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059EZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included RA and Hypertension. Concomitant products included SARILUMAB (KEVZARA), ASPIRIN [ACETYLSALICYLIC ACID] and AMLODIPINE for an unknown indication.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021, the patient experienced SEIZURE (She started having convulsions) (seriousness criterion medically significant), DYSGEUSIA (Had a metal taste in her mouth), HYPERSENSITIVITY (She was having an allergic reaction), JOINT STIFFNESS (Her jaw started locking), SWELLING FACE (Her face was big), ERYTHEMA (Her face was red), TREMOR (She was shaking like she had epilepsy), FEELING ABNORMAL (She didn't feel good), OROPHARYNGEAL DISCOMFORT (Sensation of throat closing), DIZZINESS (Felt dizzy), HEADACHE (She had a light headache), NAUSEA (nausea), PALPITATIONS (Palpitations) and VOMITING (Vomiting). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, SEIZURE (She started having convulsions), DYSGEUSIA (Had a metal taste in her mouth), HYPERSENSITIVITY (She was having an allergic reaction), JOINT STIFFNESS (Her jaw started locking), SWELLING FACE (Her face was big), ERYTHEMA (Her face was red), TREMOR (She was shaking like she had epilepsy), FEELING ABNORMAL (She didn't feel good), OROPHARYNGEAL DISCOMFORT (Sensation of throat closing), DIZZINESS (Felt dizzy), HEADACHE (She had a light headache), NAUSEA (nausea), PALPITATIONS (Palpitations) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jul-2021, Blood pressure measurement: 240/110 (High) 240/110 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was reported as given IV to reverse the side effects and Epinephrine (Epi pen) by paramedics.  The patient was taken via ambulance to the hospital and stayed in the Emergency room for half a day.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Significant FU received added patient details, treatment drugs, concomitant drug information and events was added. On 09-Sep-2021: Consent Form updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.