Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: pressure in her head; sinus pressure; couldn't walk very good with her legs; epileptic reaction; swollen rash on left arm; swollen rash on left arm; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of EPILEPSY (epileptic reaction) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21, 046A21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Amoxicillin-rash), Sulfonamide allergy (rash), Cancer and Diabetes (Not taking any Diabetic medication.). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced HEADACHE (really bad headache). On 30-Aug-2021, the patient experienced PERIPHERAL SWELLING (swollen rash on left arm) and RASH (swollen rash on left arm). On an unknown date, the patient experienced EPILEPSY (epileptic reaction) (seriousness criterion medically significant), HEAD DISCOMFORT (pressure in her head), PARANASAL SINUS DISCOMFORT (sinus pressure) and GAIT DISTURBANCE (couldn't walk very good with her legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 2 dosage form every four hours. At the time of the report, EPILEPSY (epileptic reaction), PERIPHERAL SWELLING (swollen rash on left arm), HEAD DISCOMFORT (pressure in her head), PARANASAL SINUS DISCOMFORT (sinus pressure), GAIT DISTURBANCE (couldn't walk very good with her legs), RASH (swollen rash on left arm) and HEADACHE (really bad headache) outcome was unknown.            Patient reported that she tried to go to urgent care for her rash and the doctor told her to take Benadryl (high doses) 2 tablets every 4 hours which she took for a week.   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. However, underlying medical history of diabetes and cancer are cofounder. The event was downgrade to non-serious, due the patient did not seek medical attention for the epileptic reaction, but she sought for medical attention for the rash.; 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. However, underlying medical history of diabetes and cancer are cofounder. The event was downgrade to non-serious, due the patient did not seek medical attention for the epileptic reaction, but she sought for medical attention for the rash.