Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: no use of her right hand; slept all day; Caller stated that his wife received the third dose at home, nurse from facility came to their home to administer the vaccine; They decided she needed third dose because she was about begin physical therapy for broken femur; had seizures Fri evening/was worse and unusual; Several seizures; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (had seizures Fri. evening/was worse and unusual), SEIZURE CLUSTER (Several seizures) and MONOPLEGIA (no use of her right hand) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A, 007B21A and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Femur fracture (She broke her femur in Aug 2021. She had surgery, rehab and rehabilitation for the broken femur) and Surgery in August 2021. Concurrent medical conditions included Complex partial seizures. Concomitant products included ZONISAMIDE (ZONISAMIDE 1 A FARMA), CLOBAZAM, BRIVARACETAM and ESCITALOPRAM for Seizure, FOLIC ACID for an unknown indication, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID; ERGOCALCIFEROL; NICOTINAMIDE; RETINOL; RIBOFLAVIN; THIAMINE HYDROCHLORIDE]).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced CONDITION AGGRAVATED (had seizures Fri evening/was worse and unusual) (seriousness criterion medically significant) and SEIZURE CLUSTER (Several seizures) (seriousness criterion medically significant). 01-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Caller stated that his wife received the third dose at home, nurse from facility came to their home to administer the vaccine) and OFF LABEL USE (They decided she needed third dose because she was about begin physical therapy for broken femur). On 02-Oct-2021, the patient experienced MONOPLEGIA (no use of her right hand) (seriousness criterion medically significant) and SOMNOLENCE (slept all day). The patient was treated with MIDAZOLAM for Adverse event, at an unspecified dose and frequency. On 01-Oct-2021, PRODUCT ADMINISTRATION ERROR (Caller stated that his wife received the third dose at home, nurse from facility came to their home to administer the vaccine) had resolved. On 02-Oct-2021, CONDITION AGGRAVATED (had seizures Fri evening/was worse and unusual) and SEIZURE CLUSTER (Several seizures) had resolved. On 03-Oct-2021, MONOPLEGIA (no use of her right hand) had resolved. At the time of the report, SOMNOLENCE (slept all day) and OFF LABEL USE (They decided she needed third dose because she was about begin physical therapy for broken femur) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included iron supplements. Reporter was reporting adverse event for his wife. He stated that his wife has a history of seizure disorder, Complex partial seizure. She received the 3rd dose of the Moderna COVID-19 vaccine on 01-Oct-2021 and had seizures Friday evening 01-Oct-2021 and Saturday 02-Oct-2021. He stated the seizure on Friday was worse and unusual. She had several seizures on the evening of Friday 01-Oct-2021. Caller stated his wife did not lose consciousness but had several seizures 5-10 min apart. The seizure on Saturday 02-Oct-2021 was fairly brief. She slept all day Saturday. He stated he had to give her medication, Midazolam nasal spray. He noted that the midazolam had expired on 18-May-2021. At its worst, she had no use of her right hand. They decided she needed the third dose because she is about to begin physical therapy for a broken femur. He stated she broke her femur in August 2021. She had surgery, rehab and rehabilitation for the broken femur. The event is considered medically significant as per this MSA medical assessment because of the worsening of a chronic condition. Company comment: This case concerns a 65-year-old, female with a history of Complex partial seizure under treatment with Brivaracetam, escitalopram, zonisamide, folic acid, iron supplements, vitamins and clobazam; who experienced the serious unexpected events of Seizure Cluster (AESI) and Monoplegia, approximately 24 hours after a 3rd booster off-label dose of Moderna COVID-19 vaccine. The event Seizure cluster required treatment with Midazolam nasal spray which was expired. The booster dose was considered off-label use, as per the patient was not immunosuppressed. Additionally, the event of misadministration was captured, as per the booster was administered at patient´s home. The primary scheduled administration of Moderna COVID-19 Vaccine was proper, with a timeframe of 28 days between first and second dose. The rechallenge is assessed as not applicable for the 3rd dose, since Seizure cluster event occurred after the 3rd dose and further doses are not expected. As per the information provided, the rechallenge for first and second dose are assessed as unknown (no information regarding adverse events for first and second doses are provided). The medical history of Complex partial seizure and the use of Escitalopram remain a confounder for Seizure cluster event. Further information has been requested. The benefit-risk relationship of drug X in not affected by this report.; Sender's Comments: This case concerns a 65-year-old, female with a history of Complex partial seizure under treatment with Brivaracetam, escitalopram, zonisamide, folic acid, iron supplements, vitamins and clobazam; who experienced the serious unexpected events of Seizure Cluster (AESI) and Monoplegia, approximately 24 hours after a 3rd booster off-label dose of Moderna COVID-19 vaccine. The event Seizure cluster required treatment with Midazolam nasal spray which was expired. The booster dose was considered off-label use, as per the patient was not immunosuppressed. Additionally, the event of misadministration was captured, as per the booster was administered at patient´s home. The primary scheduled administration of Moderna COVID-19 Vaccine was proper, with a timeframe of 28 days between first and second dose. The rechallenge is assessed as not applicable for the 3rd dose, since Seizure cluster event occurred after the 3rd dose and further doses are not expected. As per the information provided, the rechallenge for first and second dose are assessed as unknown (no information regarding adverse events for first and second doses are provided). The medical history of Complex partial seizure and the use of Escitalopram remain a confounder for Seizure cluster event. Further information has been requested. The benefit-risk relationship of drug x in not affected by this report.