Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Moaning, Syncope, Vomiting
Clinical narrative: She felt like she was going to pass out; high blood pressure; moaning; She didn't had any taste; vomiting; stomach was in terrible Pain; migraine; headache; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (She felt like she was going to pass out) in an 8-decade-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy (She states because of the cancer treatment in 2019, sometimes she tries to say something, and it doesn't always come out the way she intended.) in 2019. Concurrent medical conditions included Cancer since 2019, Epilepsy (She states the Epilepsy medication makes her whole body slow. That is why she is slow to respond. My whole system is like that, just in general without a vaccination, that's just from every day. She states this part didn't change after vaccination.) and Blood pressure high (She did mention that they were monitoring her blood pressure and had not prescribed any medication for it.). Concomitant products included PRIMIDONE (MYSOLINE) for Epilepsy, COLECALCIFEROL (VIT D3) for an unknown indication.    On 27-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced HEADACHE (headache). On 28-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced MIGRAINE (migraine), ABDOMINAL PAIN UPPER (stomach was in terrible Pain) and VOMITING (vomiting). On 29-Oct-2023, the patient experienced AGEUSIA (She didn't had any taste). On 31-Oct-2023, the patient experienced SYNCOPE (She felt like she was going to pass out) (seriousness criterion medically significant), HYPERTENSION (high blood pressure) and MOANING (moaning). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 29-Oct-2023 at an unspecified dose and frequency. At the time of the report, SYNCOPE (She felt like she was going to pass out), MIGRAINE (migraine), HYPERTENSION (high blood pressure), ABDOMINAL PAIN UPPER (stomach was in terrible Pain), AGEUSIA (She didn't had any taste) and MOANING (moaning) had not resolved and HEADACHE (headache) and VOMITING (vomiting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2023, Blood pressure measurement: She states it could had been high.         Company Comment This spontaneous case concerns a 8-decade-old female patient with medical history of Cancer treated with Chemotherapy since 2019, Epilepsy and Blood pressure high; Concomitant products included PRIMIDONE (MYSOLINE) for Epilepsy who experienced the unexpected medically significant seriousness criteria event of syncope; the unexpected events of ageusia (AESI), migraine, hypertension, abdominal pain upper, moaning and other expected events beginning the following day after 5th. dose of mRNA-1273.815 vaccine. The medical history of Blood pressure high is a contributor for hypertension  and migraine event; epilepsy for migraine event. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-748132, US-MODERNATX, INC.-MOD-2023-748135 (E2B Linked Report). This case was linked to MOD-2023-748132, MOD-2023-748135 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748132:Monovalent case US-MODERNATX, INC.-MOD-2023-748135:Bi-valent case