Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Somnolence
Clinical narrative: lethargic; slept throughout day; Acute chest syndrome/Chest pain/Chest discomfort/Musculoskeletal chest pain; seizure; sore arm; Feeling tired; headache; This spontaneous case was reported by a patient and describes the occurrence of ACUTE CHEST SYNDROME (Acute chest syndrome/Chest pain/Chest discomfort/Musculoskeletal chest pain) and SEIZURE (seizure) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030342) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Overactive bladder. Concurrent medical conditions included Hypercholesteremia. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for High cholesterol.    On 19-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In September 2023, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant), PAIN IN EXTREMITY (sore arm), FATIGUE (Feeling tired) and HEADACHE (headache). On 19-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced ACUTE CHEST SYNDROME (Acute chest syndrome/Chest pain/Chest discomfort/Musculoskeletal chest pain) (seriousness criterion medically significant). On 20-Sep-2023, the patient experienced LETHARGY (lethargic) and SOMNOLENCE (slept throughout day). On 20-Sep-2023, ACUTE CHEST SYNDROME (Acute chest syndrome/Chest pain/Chest discomfort/Musculoskeletal chest pain) had resolved. At the time of the report, SEIZURE (seizure) had resolved, PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic), SOMNOLENCE (slept throughout day) and FATIGUE (Feeling tired) outcome was unknown and HEADACHE (headache) had not resolved.            The patient had Z-Tab.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medication not reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 76-year-old female patient, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) events of Acute chest syndrome and Seizure (AESI), which occurred within the first day after mRNA-1273.815 (SPIKEVAX 2023-2024), administered as fifth dose within COVID-19 vaccination schedule. As reported, the patient experienced chest pain on the left side some hours after vaccination (that night before she went to sleep). This went on off and she was awakened by it. At around 1:00am, this was accompanied by a strong seizure and her husband had to help her to the bathroom where she kept on seizing. This only stopped when she laid back in bed but then she tried to lift her head or get up from bed and the seizure again recurred. No consultations were done. When she woke up, she was lethargic and she slept throughout day. At the time of the report, the events had resolved. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-741557, US-MODERNATX, INC.-MOD-2023-742199, US-MODERNATX, INC.-MOD-2023-742560 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741557:Husband case US-MODERNATX, INC.-MOD-2023-742199:Monovalent case US-MODERNATX, INC.-MOD-2023-742560:Dose 4