Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Epilepsy, Influenza, Peripheral swelling, Seizure, X-ray
Clinical narrative: Epilepsy; seizure; Swelling of limbs; Flu; This spontaneous case was reported by a consumer and describes the occurrence of EPILEPSY (Epilepsy) and SEIZURE (seizure) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis.    Stimulator on back.  The patient's past medical history included Ex-smoker (Half a pack of the Cigarette a day) from 1970 to 1995. Previously administered products included for Drug use for unknown indication: FLAGYL, SULFONAMIDE (sulpha drug), GABAPENTIN and DARVOCET [DEXTROPROPOXYPHENE HYDROCHLORIDE;PARACETAMOL]. Past adverse reactions to the above products included No adverse event with DARVOCET [DEXTROPROPOXYPHENE HYDROCHLORIDE; andPARACETAMOL], FLAGYL, GABAPENTIN and SULFONAMIDE. Concurrent medical conditions included Head injury since 2001, Drug allergy (Flagyl allergy manifested by stop breathing), Drug allergy (Darvocet allergy manifested by stop breathing), Drug allergy (Gabapentin allergy manifested by trouble in breathing), Grass allergy (manifested by trouble in breathing), Smoke sensitivity (Cigarette smoke allergy manifested by trouble in breathing), Dust allergy (manifested by trouble in breathing), Allergy to molds (Mold allergy manifested by trouble in breathing), Perfume sensitivity (Perfume allergy manifested by trouble in breathing), Food allergy (Wheat flour allergy manifested by trouble in breathing), Sulfonamide allergy (Sulpha drug allergy), Fibromyalgia, Osteoporosis, Osteoarthritis, Chronic obstructive pulmonary disease, Complex regional pain syndrome Type I and Complex regional pain syndrome Type II. Concomitant products included PREGABALIN and CELECOXIB for Arthritis, DENOSUMAB (PROLIA) for Bone disorder NOS, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Chronic obstructive pulmonary disease, NAPROXEN SODIUM (ALEVE), OXYCODONE, LIDOCAINE and DICLOFENAC SODIUM for Pain, DIPHENHYDRAMINE HYDROCHLORIDE (SLEEP AID [DIPHENHYDRAMINE HYDROCHLORIDE]) for Sleep disorder, LIDOCAINE HYDROCHLORIDE, PRILOCAINE HYDROCHLORIDE (LIDOCAINE PRILOCAINE BIOGARAN) for an unknown indication.   In 2020, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 milligram once a day. In May 2020, the patient experienced SEIZURE (seizure) (seriousness criteria hospitalization and medically significant). In March 2021, the patient experienced INFLUENZA (Flu). In April 2021, the patient experienced PERIPHERAL SWELLING (Swelling of limbs). In June 2021, the patient experienced EPILEPSY (Epilepsy) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in June 2021 due to EPILEPSY and SEIZURE. The patient was treated with LEVETIRACETAM at an unspecified dose and frequency. In March 2021, INFLUENZA (Flu) had resolved. In May 2021, SEIZURE (seizure) had resolved. At the time of the report, EPILEPSY (Epilepsy) had not resolved and PERIPHERAL SWELLING (Swelling of limbs) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, X-ray: Seizure.         The patient had a stimulator on back years before she started with Rinvoq.  Patient discontinued RINVOQ for two to three days in Apr 2021 because she thought she was having problems with RINVOQ and discontinued RINVOQ on her own without the knowledge of her physician.  Patient was not hospitalized when patient was in a car Accident last May 2021. Patient was sent to the hospital in Jun 2021 because patient had a seizure. Patient had another two Seizures while was in the hospital and was released after three days. Patient was diagnosed with epilepsy, Brought on by head injury in 2001. Tests done and discovered mini seizures and then the bigger ones were Happening, Patient was on medication for that. Patient did not took second dose of covid 19 vaccine because of the Reaction Patient experienced after first dose. The causality of recurred seizure occurred in Jun 2021 was Reported as not related for both Rinvoq and covid 19 vaccine. The reporter alternative etiology for the event Of car accident was reported to seizure and for flu that was reported to covid 19 vaccine. The alternative Etiology for the event of swelling worsened was reported due to not taking Rinvoq.  It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient does not used alcohol. Action taken for moderna covid-19 vaccine for the event flu was reported as drug discontinued. The patient had sulfa drugs in the past.  The reporter's causality for the events of for Seizure, Automobile accident, Swelling of limbs and Flu was not related, for Epilepsy No reasonable possibility and for Intentional misuse in product use duration was not provided for the product Rinvoq.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case, reported by a consumer, concerning a 64-year-old female patient with relevant medical history of head injury, who was hospitalized due to the unexpected serious (medically significant) adverse events of special interest Epilepsy and Seizure. Seizure occurred approximately 10 month prior to mRNA-1273 vaccination, while the event Epilepsy occurred approximately 3 months after receiving the first dose of mRNA-1273 vaccine. It was reported that the patient discontinued RINVOQ for two to three days without the knowledge of her physician leading to worsened swelling of her hands feet and legs. Patient also had a car accident three months post mRNA-1273 vaccination, however patient was not hospitalized. One month after, patient had a seizure and was sent to the hospital. She had another two seizures while she was in the hospital and was released after three days. She was diagnosed with epilepsy brought on by a head injury 20 years ago. Brain imaging and tests were done which revealed seizure episodes, and patient was prescribed with unspecified medication. Patient did not take the second dose of COVID-19 vaccine because of the reaction she experienced after her first dose. No further details about the specific diagnostic procedures and specific treatments were provided. It was reported that the event Seizure had resolved, while Epilepsy was not resolved. The medical history of head injury remains as a confounder for the events Epilepsy and Seizure, and the car accident could be an aggravating factor for this events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 64-year-old female patient with relevant medical history of head injury, who was hospitalized due to the unexpected serious (medically significant) adverse events of special interest Epilepsy and Seizure. Seizure occurred approximately 10 month prior to mRNA-1273 vaccination, while the event Epilepsy occurred approximately 3 months after receiving the first dose of mRNA-1273 vaccine. It was reported that the patient discontinued RINVOQ for two to three days without the knowledge of her physician leading to worsened swelling of her hands feet and legs. Patient also had a car accident three months post mRNA-1273 vaccination, however patient was not hospitalized. One month after, patient had a seizure and was sent to the hospital. She had another two seizures while she was in the hospital and was released after three days. She was diagnosed with epilepsy brought on by a head injury 20 years ago. Brain imaging and tests were done which revealed seizure episodes, and patient was prescribed with unspecified medication. Patient did not take the second dose of COVID-19 vaccine because of the reaction she experienced after her first dose. No further details about the specific diagnostic procedures and specific treatments were provided. It was reported that the event Seizure had resolved, while Epilepsy was not resolved. The medical history of head injury remains as a confounder for the events Epilepsy and Seizure, and the car accident could be an aggravating factor for this events. The benefit-risk relationship of mRNA-1273 is not affected by this report.