Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Hypotension, Seizure, Tremor
Clinical narrative: Seizure or seizure like activity; Hypotension; bilateral lower extremeties continuously shaking; they had 9 patients who had AE after getting the Spikevax vaccine. The had common AE - chest pains, hypo or hypertension and seizures or seizure like activity; This spontaneous case was reported by an other health care professional and describes the occurrence of SEIZURE (Seizure or seizure like activity) in a 54-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058877) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 since an unknown date. Previously administered products included for Product used for unknown indication: Pfizer on 19-Jan-2021, Pfizer on 09-Feb-2021, Pfizer on 09-Sep-2021, Pfizer (Lot #FP7139  Exp. 08/13/22) on 21-Jul-2022, PFIZER BIONTECH COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/5) (Lot #GJ2524  Exp. 10/14/22) on 20-Sep-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5), Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Drug allergy, Traumatic brain injury, Constipation, Cerebrovascular disorder, Flaccid hemiplegia (FLACCID HEMIPLEGIA AFFECTING LEFT NONDOMINANT SIDE), Facial weakness, Cerebrovascular disorder, Aphasia (APHASIA FOLLOWING UNSPECIFIED CEREBROVASCULAR DISEASE), Hyperlipidemia, Hypertension (ESSENTIAL (PRIMARY) HYPERTENSION), Schizoaffective disorder, Cardiac arrhythmia, Polyneuropathy, Psychotic disorder (OTHER PSYCHOTIC DISORDER NOT DUE TO A SUBSTANCE OR KNOWN PHYSIOLOGICAL CONDITION), Anxiety disorder, Major depressive disorder (SINGLE EPISODE), Convulsions, Cerebral infarction (CEREBRAL INFARCTION DUE TO EMBOLISM OF UNSPECIFIED CEREBRAL ARTERY), Insomnia and Dysarthria (DYSARTHRIA FOLLOWING UNSPECIFIED CEREBROVASCULAR DISEASE). Concomitant products included APIXABAN (ELIQUIS) and OXCARBAZEPINE for AFib, ALPRAZOLAM for Anxiety, POLYETHYLENE GLYCOL 3350 for Constipation, ESCITALOPRAM OXALATE for Depression, METOPROLOL TARTRATE for Hypertension, CALCIUM CARBONATE (TUMS 500 CALCIUM) for Hypocalcemia, TRAZODONE HCL for Insomnia, GABAPENTIN for Neuropathy, ACETAMINOPHEN for Pain, HALOPERIDOL for Schizo-affective type schizophrenia, DIVALPROEX SODIUM for Seizures, CHOLECALCIFEROL for Vitamin D deficiency.    On 07-Nov-2023 at 9:20 AM, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 07-Nov-2023 at 10:05 PM, the patient experienced HYPOTENSION (Hypotension), TREMOR (bilateral lower extremeties continuously shaking) and CHEST PAIN (they had 9 patients who had AE after getting the Spikevax vaccine. The had common AE - chest pains, hypo or hypertension and seizures or seizure like activity). On an unknown date, the patient experienced SEIZURE (Seizure or seizure like activity) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizure or seizure like activity) outcome was unknown and HYPOTENSION (Hypotension), TREMOR (bilateral lower extremeties continuously shaking) and CHEST PAIN (they had 9 patients who had AE after getting the Spikevax vaccine. The had common AE - chest pains, hypo or hypertension and seizures or seizure like activity) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Patient returned from facility via transportation on stretcher.  Lab test was performed for CBC, CMP, BNP, Troponin, EKG, Chest x-ray and results was not provided.  This case referred to 9 out of 9 patients who just had chest pains, hypo or hypertension and seizures or seizure like activity.  It was reported that they had 9 patients who had AE after getting the Spikevax vaccine. The had common AE - chest pains, hypo or hypertension and seizures or seizure like activity.  No treatments medications were reported.  Company Comment: This is a spontaneous case concerning a 54-year-old male patient with concurrent medical history of Drug allergy, Traumatic brain injury, Constipation, Cerebrovascular disorder, Flaccid hemiplegia, who experienced the serious (due to medically significant) unexpected, AESI of Seizures (Seizure or seizure like activity), among other non-serious events. The event Seizure occurred on an unknown date after a dose of mRNA-1273.815 vaccine, received as the sixth dose of COVID-19 vaccination schedule, and the rest of the events Hypotension, Tremor and Chest pain occurred on the same day after the vaccine administration. It was reported that the patient presented Chest pain, Hypotension, bilateral lower extremeties continuously shaking, he was examined at ER, lab test completed CBC, CMP, BNP, Troponin, EKG and Chest xray however results were not provided. Treatment information was not provided. The patient's mentioned medical history remains as confounders. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-749140 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2023: Live significant follow-up received. LOT number updated. On 10-Nov-2023: Live follow-up received with significant information: historical vaccine details updated. On 10-Nov-2023: Live follow-up received that contains significant information: Patient details, lab data, concomitant drug and events updated. On 13-Nov-2023: Live follow-up information received with no new information. On 13-Nov-2023: Live Significant follow up added. Reporter was added. Patient age group added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749140:Master case