Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Arthralgia, Cerebral haemorrhage, Dysphagia, Feeding disorder
Clinical narrative: Seizures; Outer skull brain bleed, 7 cm by 10 cm and she had two veins that were leaking off; She couldn't talk, couldn't eat.; She couldn't swallow; She couldn't talk; Pain in her legs / pain in the upper legs, pain scale of 1 through 10, it was a 19; Pain in her legs and her knee.; Headache that was number 19 on the scale we usually go 1 to 10/ Head pain; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizures) and CEREBRAL HAEMORRHAGE (Outer skull brain bleed, 7 cm by 10 cm and she had two veins that were leaking off) in a 71-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products GABAPENTIN for an unknown indication, VALPROATE SEMISODIUM (DEPAKOTE) for an unknown indication, PHENYTOIN (DILANTIN [PHENYTOIN]) for Seizures, ACETAZOLAMIDE for Seizures, VALPROATE SEMISODIUM (DIVALPROEX) for Seizures, PHENYTOINE for an unknown indication, PRIMIDONE for Seizures, WARFARIN for an unknown indication and APIXABAN (ELIQUIS) for an unknown indication.    Concurrent medical conditions included Epilepsy.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form, GABAPENTIN (unknown route) at an unspecified dose, VALPROATE SEMISODIUM (DEPAKOTE) (unknown route) at an unspecified dose, PHENYTOIN (DILANTIN [PHENYTOIN]) (unknown route) at an unspecified dose, ACETAZOLAMIDE (unknown route) at an unspecified dose, VALPROATE SEMISODIUM (DIVALPROEX) (unknown route) at an unspecified dose, PHENYTOINE (unknown route) at an unspecified dose, PRIMIDONE (unknown route) at an unspecified dose, WARFARIN (unknown route) at an unspecified dose and APIXABAN (ELIQUIS) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SEIZURE (Seizures) (seriousness criterion medically significant), CEREBRAL HAEMORRHAGE (Outer skull brain bleed, 7 cm by 10 cm and she had two veins that were leaking off) (seriousness criterion medically significant), FEEDING DISORDER (She couldn't talk, couldn't eat.), DYSPHAGIA (She couldn't swallow), APHASIA (She couldn't talk), PAIN IN EXTREMITY (Pain in her legs / pain in the upper legs, pain scale of 1 through 10, it was a 19), ARTHRALGIA (Pain in her legs and her knee.) and HEADACHE (Headache that was number 19 on the scale we usually go 1 to 10/ Head pain). At the time of the report, SEIZURE (Seizures), CEREBRAL HAEMORRHAGE (Outer skull brain bleed, 7 cm by 10 cm and she had two veins that were leaking off), FEEDING DISORDER (She couldn't talk, couldn't eat.), DYSPHAGIA (She couldn't swallow), APHASIA (She couldn't talk), PAIN IN EXTREMITY (Pain in her legs / pain in the upper legs, pain scale of 1 through 10, it was a 19), ARTHRALGIA (Pain in her legs and her knee.) and HEADACHE (Headache that was number 19 on the scale we usually go 1 to 10/ Head pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment (1-10): 19.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. Reporters wife was 3 months in rehab and has had reactions whilst there. She cant talk, eat or swallow now currently. While in rehab, she had very bad leg pain, was a 19 on the pain scale, which they measure from 1 to 10 usually. Patient had head pain which was bad as well. Was taking multiple medications while at the rehab place so all captured as co-suspect conservatively. Reporter believes gabapentin could have caused this as well. Her doctor did switch from Eliquis to warfarin as well. After taking the Moderna vaccine, she had a headache and seizure, this occurred before the gabapentin incident, where she suddenly could not talk, eat or swallow and so was taken to the hospital where she had a outer skull brain bleed, 7 cm by 10 cm and she had two veins that were leaking off and on and they fixed that.  Wanted to inform as their doctor said she was the 8th patient they had who was taking warfarin and then took Moderna and had a bleed. No treatment information mentioned.  Company Comment: This spontaneous case concerns a 71 year old  female  patient with relevant concurrent medical history of Epilepsy taking the following medications  captured as Co-suspect drugs  namely Gabapentin, Valproate Semisodium ( Depakote) , phenytoin ( Dilantin ) , Acetazolamide, Valproate Semisodium ( Divalporex) , Primidone , Warfarin and Apixaban. This patient experienced Serious ( medically significant ) , AESI of Seizure. Cerebral hemorrhage which occurred on an unknown date post vaccination with an unknown dose number of mRNA-1273 vaccine. This was accompanied by other non-serious , unexpected events of feeding disorder ( unable to eat ) , aphasia , pain in extremity and non-serious , expected event of headache and  arthralgia. It was reported that the patient was undergoing rehabilitation for 3 months when she  had reactions.   She cant talk, eat or swallow.  Also while in rehabilitation  she had very bad leg pain and head pain.   She was taking multiple medications as mentioned above . Reporter believes gabapentin could have caused this as well. After taking the Moderna vaccine, she had a headache and seizure, which  occurred before the gabapentin incident, where she suddenly could not talk, eat or swallow and so was taken to the hospital where she had a outer skull brain bleed, 7 cm by 10 cm and she had two veins that were leaking off and on and they fixed that. Other details surrounding the events like treatment medication , results of laboratories and other diagnostic procedures were not reported. Outcome of the events was unknown.  The concurrent medical history mentioned above , the age of this patient and the  reported co-suspect drugs are all considered as confounders for the events Cerebral hemorrhage , Seizures , headache .  The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2022-649147 (Patient Link).; Sender's Comments: This spontaneous case concerns a 71 year old  female  patient with relevant concurrent medical history of Epilepsy taking the following medications  captured as Co-suspect drugs  namely Gabapentin, Valproate Semisodium ( Depakote) , phenytoin ( Dilantin ) , Acetazolamide, Valproate Semisodium ( Divalporex) , Primidone , Warfarin and Apixaban. This patient experienced Serious ( medically significant ) , AESI of Seizure. Cerebral hemorrhage which occurred on an unknown date post vaccination with an unknown dose number of mRNA-1273 vaccine. This was accompanied by other non-serious , unexpected events of feeding disorder ( unable to eat ) , aphasia , pain in extremity and non-serious , expected event of headache and  arthralgia. It was reported that the patient was undergoing rehabilitation for 3 months when she  had reactions.   She cant talk, eat or swallow.  Also while in rehabilitation  she had very bad leg pain and head pain.   She was taking multiple medications as mentioned above . Reporter believes gabapentin could have caused this as well. After taking the Moderna vaccine, she had a headache and seizure, which  occurred before the gabapentin incident, where she suddenly could not talk, eat or swallow and so was taken to the hospital where she had a outer skull brain bleed, 7 cm by 10 cm and she had two veins that were leaking off and on and they fixed that. Other details surrounding the events like treatment medication , results of laboratories and other diagnostic procedures were not reported. Outcome of the events was unknown.  The concurrent medical history mentioned above , the age of this patient and the  reported co-suspect drugs are all considered as confounders for the events Cerebral hemorrhage , Seizures , headache .  The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.