Age: 69.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Cerebrovascular accident, Coma, Fatigue, Gait inability, Magnetic resonance imaging
Clinical narrative: My dad is currently in the hospital in a coma; we thought seizure at first. He went to the hospital; He had 4 mini strokes; he started not feeling well; lost ability to walk and went into rehab for a couple of weeks; Tingling in his legs and feet; His symptoms started the same day as the vaccine administration, with feeling tired and achy. He was totally healthy before the vaccines; His symptoms started the same day as the vaccine administration, with feeling tired and achy. He was totally healthy before the vaccines; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COMA (My dad is currently in the hospital in a coma), SEIZURE (we thought seizure at first. He went to the hospital) and CEREBROVASCULAR ACCIDENT (He had 4 mini strokes) in a 69-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RSV VACCINE for an unknown indication.    Concurrent medical conditions included Hypertension. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Hypertension.   On 24-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of RSV VACCINE (unknown route) 1 dosage form. On 24-Nov-2023, the patient experienced PAIN (His symptoms started the same day as the vaccine administration, with feeling tired and achy. He was totally healthy before the vaccines) and FATIGUE (His symptoms started the same day as the vaccine administration, with feeling tired and achy. He was totally healthy before the vaccines). On an unknown date, the patient experienced COMA (My dad is currently in the hospital in a coma) (seriousness criteria hospitalization, medically significant and life threatening), SEIZURE (we thought seizure at first. He went to the hospital) (seriousness criteria hospitalization, medically significant and life threatening) and GAIT INABILITY (lost ability to walk and went into rehab for a couple of weeks). an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (He had 4 mini strokes) (seriousness criterion medically significant), MALAISE (he started not feeling well) and PARAESTHESIA (Tingling in his legs and feet). The patient was treated with PREDNISONE at an unspecified dose and frequency and Rehabilitation therapy (rehab for a couple of weeks) for Gait inability. At the time of the report, COMA (My dad is currently in the hospital in a coma) had not resolved and SEIZURE (we thought seizure at first. He went to the hospital), CEREBROVASCULAR ACCIDENT (He had 4 mini strokes), MALAISE (he started not feeling well), GAIT INABILITY (lost ability to walk and went into rehab for a couple of weeks), PAIN (His symptoms started the same day as the vaccine administration, with feeling tired and achy. He was totally healthy before the vaccines), FATIGUE (His symptoms started the same day as the vaccine administration, with feeling tired and achy. He was totally healthy before the vaccines) and PARAESTHESIA (Tingling in his legs and feet) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: 4 mini strokes. On an unknown date, Scan brain: 4 mini strokes.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the patient was currently in the hospital in a coma and he got the COVID vaccine and the RSV vaccine the day after thanksgiving, both vaccines together and started not feeling well. The patient had tingling in his legs and feet. He went to his regular doctor who gave him prednisone. Three weeks after that the patient lost ability to walk and went into rehab for a couple of weeks. He was home a couple of days then we thought seizure at first. The patient went to the hospital and they did MRI and brain scans. He had 4 mini strokes. He had another seizure and has been in a coma for 3 days. It could be inflammatory reaction from the vaccines since he got 2 together but they cannot decipher which vaccine he could be reacting to. His symptoms started the same day as the vaccine administration, with feeling tired and achy. He was totally healthy before the vaccines.  Company Comment: This is a spontaneous case concerning a 69-year-old male patient, with medical history of hypertension treated with atorvastatin, who experienced the serious (due to medically significant) unexpected AESI of CEREBROVASCULAR ACCIDENT and the serious (hospitalization, medically significant and life threatening) unexpected events of COMA and SEIZURE (AESI), among other non-serious events. On the same day of vaccination with an unspecified dose of mRNA-1273.815 (SPIKEVAX 2023-2024), he felt tired and achy. He had tingling in his legs and feet. His doctor gave him prednisone. Three weeks after that he lost ability to walk and went into rehab for a couple of weeks. It seemed he had a seizure at first, but he went to the hospital and an MRI and brain scans revealed he had 4 mini strokes. He had another seizure and had been in a coma for 3 days. The exact onset date of the events was not reported; hence latency could not be properly assessed. The vaccination with the non-company product RSV VACCINE on the same day of mRNA.1273.815 vaccination, remain a confounder for all the events. Patient´s medical history of hypertension remains as a confounder for the event CEREBROVASCULAR ACCIDENT. Concomitant atorvastatin remains as a confounder for the achy experienced. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.