Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain in extremity
Clinical narrative: started losing appetite; She went to their kitchen but then she passed out; headache; She felt that her brain was not functioning; dizziness; fatigued/ tired; arm felt a little sore; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (She went to their kitchen but then she passed out) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1, Lot number EL3247) on 25-Feb-2021, Pfizer vaccine (Dose 2, Lot number EL3247) on 18-Mar-2021, Pfizer vaccine (Dose 3, Lot number FF8839) on 17-Nov-2021, Pfizer vaccine (Dose 4, Lot number FJ6369) on 06-May-2022, Pfizer vaccine (Dose 5 and Lot number GJ6796) on 19-Nov-2022. Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine, Pfizer vaccine, Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Controlled hypertension.    On 04-Jan-2024, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 04-Jan-2024, the patient experienced PAIN IN EXTREMITY (arm felt a little sore) and FATIGUE (fatigued/ tired). On 05-Jan-2024, the patient experienced BRAIN FOG (She felt that her brain was not functioning), DIZZINESS (dizziness) and HEADACHE (headache). On 06-Jan-2024, the patient experienced LOSS OF CONSCIOUSNESS (She went to their kitchen but then she passed out) (seriousness criterion medically significant) and DECREASED APPETITE (started losing appetite). In January 2024, LOSS OF CONSCIOUSNESS (She went to their kitchen but then she passed out), PAIN IN EXTREMITY (arm felt a little sore), DIZZINESS (dizziness) and HEADACHE (headache) had resolved. On 16-Jan-2024, FATIGUE (fatigued/ tired) had resolved. At the time of the report, DECREASED APPETITE (started losing appetite) and BRAIN FOG (She felt that her brain was not functioning) outcome was unknown.            The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The concomitant medication was not reported by reporter.   The patient had side effects after getting the Spikevax for the 1st time. She had the vaccine in the early afternoon of 04 Jan 2024. Her arm felt a little sore and, in the evening, she felt so tired and went to bed early. On 05 Jan 2024, she felt extremely fatigued that she cancelled all her appointments. She felt that her brain was not functioning. She had headache and dizziness. On 06 Jan 2024, she still felt very tired, and she started losing appetite. She went to their kitchen but then she passed out. It was a good thing her husband was around. She came back to consciousness after a short period of time. The dizziness eventually resolved but the fatigued lingered on for a while. She finally was able to drive on 12 Jan 2024. She said that the fatigued had resolved at the time of the call and that she was now recovered.  The treatment medication was not reported by reporter.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 63-year-old female patient, with underlying hypertension, who experienced the unexpected and serious (due to medically significant) event of Loss of consciousness, which occurred 2 days after SPIKEVAX 2023-2024 vaccine, administered as sixth dose within COVID-19 vaccination schedule. As reported, 2 days after vaccination patient passed out. She came back to consciousness after a short period of time. No information disclosed about diagnostic tests performed or treatments received. Underlying hypertension could be a confounding factor for the case. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.