Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Chest pain, Dyskinesia, Seizure
Clinical narrative: 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; 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; 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; Involuntayr movement/jerking of R extremities observed by staff.  Resident unresponsive to questioning by staff, only responding "Oh God."; This spontaneous case was reported by an other health care professional and describes the occurrence of SEIZURE (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) in a 72-year-old female 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.     Previously administered products included for COVID-19 prophylaxis: Pfizer (Lot #EL3249 Exp. 06/30/21) on 18-Jan-2021, Pfizer (Lot #EL8982 Exp. 05/31/21) on 08-Feb-2021, Pfizer (Lot #FH8020 Exp. 01/01/22) on 14-Oct-2021, Moderna (Lot #001M1A Exp. 05/11/22) on 07-Apr-2022 and Pfizer Bivalent (Lot #GJ2524 Exp. 10/14/22) on 16-Sep-2022. Past adverse reactions to the above products included No adverse event with Moderna, Pfizer, Pfizer, Pfizer and Pfizer Bivalent. Concurrent medical conditions included Drug allergy, Generalized anxiety disorder, Hypocalcemia, Seizures, Pain, DVT, Vitamin D deficiency, Iron low, Neuropathy, Constipation and Hypothyroidism. Concomitant products included LACTULOSE for Constipation, APIXABAN (ELIQUIS) for DVT, LORAZEPAM (ATIVAN) for Generalized anxiety disorder, ASPIRIN [ACETYLSALICYLIC ACID] for Heart disorder, CALCIUM CARBONATE (CALCIUM [CALCIUM CARBONATE]) for Hypocalcemia, LEVOTHYROXINE SODIUM for Hypothyroidism, FERROUS SULFATE for Iron low, GABAPENTIN for Neuropathy, DULOXETINE HYDROCHLORIDE (CYMBALTA) and HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) for Pain, CARBAMAZEPINE for Seizures, ERGOCALCIFEROL for Vitamin D deficiency, POTASSIUM CHLORIDE for an unknown indication.    On 07-Nov-2023 at 10:12 AM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 08-Nov-2023 at 9:11 AM,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced DYSKINESIA (Involuntayr movement/jerking of R extremities observed by staff.  Resident unresponsive to questioning by staff, only responding "Oh God."). On an unknown date, the patient experienced SEIZURE (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) (seriousness criterion medically significant), 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) and BLOOD PRESSURE FLUCTUATION (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). The patient was treated with DIAZEPAM (intramuscular use) ongoing since an unknown date at a dose of 5 milligram (one time). At the time of the report, SEIZURE (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), 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), BLOOD PRESSURE FLUCTUATION (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) and DYSKINESIA (Involuntayr movement/jerking of R extremities observed by staff.  Resident unresponsive to questioning by staff, only responding "Oh God.") had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   This case contains information about the 6th patient out of 6 patients as described by the reporter.  All the patients had common side effects after receiving the vaccine which included chest pains, hypotension or hypertension, and seizures or seizure like activity.  keppra and tegretol serum levels ordered for the patient, along with CBC, CMP, UA with C&S and CXR.  Signs/symptoms noted to be resolved.  Company Comment: This is a spontaneous case concerning a 72 year-old female patient, with medical history of seizures and concomitant use of duloxetine and levothyroxine sodium, who experienced the serious (due to medically significant) unexpected, AESI of Seizure, which occurred after the Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula, sixth dose reported in the case. Temporal association cannot be assessed due to lack of information on onset date of the event. The outcome was reported as recovered. The mentioned medical history and concomitant medication remain as confounders. Additionally, Interchange of vaccine products and Revaccination with different COVID-19 vaccine (prior vaccination with four doses of COVID-19 vaccine Tozinameran) was noted in the case. No further clinical information was available for medical review. The benefit-risk relationship of Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-749140 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2023: Live follow-up received on 13-Nov-2023, contains historical vaccine and dose details. On 10-Nov-2023: Live follow-up received on 14-Nov-2023, patient details, medical history, concomitant medications and events updated. On 13-Nov-2023: Live follow-up received that contains significant information: Reporter details and Reference ids updated. On 13-Nov-2023: Live follow up received on 15-Nov-2023, reporter was added, patient age group added and reference numbers added. On 15-Nov-2023: Live follow-up received on 15-Nov-2023, LOT number updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749140:Master case