Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Condition aggravated, Magnetic resonance imaging, Pain in extremity, Seizure
Clinical narrative: Symptom worsened; Sharp pain in his arm/ he can barely use his arm; Patient had one seizure in October, one in December, and on Saturday night and Sunday morning; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Patient had one seizure in October, one in December, and on Saturday night and Sunday morning) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch nos. 006M70A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizure (Patient hasn't had a seizure for 6 years) and Tumor excision (Patient who has had several tumors removed). Concurrent medical conditions included Carcinoma brain (Stage 3 brain cancer) since 2015 and Illness (Acute and Chronic illnesses at the time of vaccination).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced SEIZURE (Patient had one seizure in October, one in December, and on Saturday night and Sunday morning) (seriousness criterion medically significant). On an unknown date, the patient experienced CONDITION AGGRAVATED (Symptom worsened) and PAIN IN EXTREMITY (Sharp pain in his arm/ he can barely use his arm). The patient was treated with Physical therapy (several physical therapies) for Seizure and Physical therapy (several physical therapies) for Pain in extremity. At the time of the report, SEIZURE (Patient had one seizure in October, one in December, and on Saturday night and Sunday morning), CONDITION AGGRAVATED (Symptom worsened) and PAIN IN EXTREMITY (Sharp pain in his arm/ he can barely use his arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: results not reported Doctors can't figure out why even though they have done ct scans.. On an unknown date, Magnetic resonance imaging: results not reported Doctors can't figure out why even though they have done MRI.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant/regular medication reported was Seizure medication 200 mg.  Medical history included history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Patient stated that 15 days after getting the Moderna COVID-19 vaccine he started experiencing a sharp pain in his arm and it has been going on for 2 years. The patient had several physical therapies, MRI, scans. Patient stated he hasn't had a seizure for 6 years until after the 2nd shot of the vaccine. The symptoms are worsened.  Treatment medications included medication for seizures 200 mg.   Company comment: This spontaneous case concerns a male patient of an unknown age, with relevant history of stage 3 brain tumor and past history of seizures, who experienced the serious (medically significant) unexpected AESI of seizure after the second dose of mRNA-1273. No information regarding vaccination date was provided. The first seizure occurred in October and at the time of report was not resolved. Patient´s underlying disease and medical history remains confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of an unknown age, with relevant history of stage 3 brain tumor and past history of seizures, who experienced the serious (medically significant) unexpected AESI of seizure after the second dose of mRNA-1273. No information regarding vaccination date was provided. The first seizure occurred in October and at the time of report was not resolved. Patient´s underlying disease and medical history remains confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.