Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Ear pain, Electroencephalogram, Hypoaesthesia
Clinical narrative: Breakthrough seizure (with no shaking, confusion, loss of consciousness); Numbness in left foot; Tingling in left foot; Sharp pain in left ear; Upper arm, back, neck and above shoulder starting aching and Whole torso aching; Back, neck and above shoulder starting aching and Whole torso aching; Neck and above shoulder starting aching and Whole torso aching; whole torso was aching; Shoulder starting aching; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Breakthrough seizure (with no shaking, confusion, loss of consciousness)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M02A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Epilepsy (had not had an episode in two years.).   On 24-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021 at 9:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced SEIZURE (Breakthrough seizure (with no shaking, confusion, loss of consciousness)) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness in left foot), PARAESTHESIA (Tingling in left foot), EAR PAIN (Sharp pain in left ear), PAIN IN EXTREMITY (Upper arm, back, neck and above shoulder starting aching and Whole torso aching), BACK PAIN (Back, neck and above shoulder starting aching and Whole torso aching), NECK PAIN (Neck and above shoulder starting aching and Whole torso aching), PAIN (whole torso was aching) and ARTHRALGIA (Shoulder starting aching). On 31-Mar-2021, SEIZURE (Breakthrough seizure (with no shaking, confusion, loss of consciousness)), HYPOAESTHESIA (Numbness in left foot), PARAESTHESIA (Tingling in left foot) and EAR PAIN (Sharp pain in left ear) had resolved. At the time of the report, PAIN IN EXTREMITY (Upper arm, back, neck and above shoulder starting aching and Whole torso aching), BACK PAIN (Back, neck and above shoulder starting aching and Whole torso aching), NECK PAIN (Neck and above shoulder starting aching and Whole torso aching), PAIN (whole torso was aching) and ARTHRALGIA (Shoulder starting aching) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electroencephalogram: seizure Seizure.         No concomitant medication was reported. Patient reported she recognized the event as a seizure due to her electroencephalography (EEG) and her vagus nerve stimulation (VNS) machine overshooting. Patient reported taking naproxen (Aleve) and lorazepam (Ativan) to treat the events.  Action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: This case concerns a 68-year-old female with a serious unexpected event of seizure, and nonserious unexpected hypoaesthesia, paraesthesia, ear pain, pain in extremity, back pain, neck pain, pain, and expected arthralgia. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MODERNATX, INC.-MOD-2021-080130 (E2B Linked Report).; Sender's Comments: This case concerns a 68-year-old female with a serious unexpected event of seizure, and nonserious unexpected hypoaesthesia, paraesthesia, ear pain, pain in extremity, back pain, neck pain, pain, and expected arthralgia. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-080130:1st Dose