Sex: F
Vaccine: COVID19
Symptoms: Apnoea, Blood glucose, Hyperhidrosis, Unresponsive to stimuli
Clinical narrative: Apnoea; hyperhidrosis; Unresponsive to stimuli; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Aug-2024 and was forwarded to Moderna on 12-Aug-2024.      This spontaneous case was reported by a non-health professional and describes the occurrence of APNOEA (Apnoea), HYPERHIDROSIS (hyperhidrosis) and UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 203J23A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension, Degenerative joint disease, Anemia, Tricuspid insufficiency, Hyperlipidemia, Type 2 diabetes mellitus and Osteoarthritis. Concomitant products included HYDRALAZINE, METFORMIN, LOPERAMIDE, PARACETAMOL (TYLENOL), MENTHOL (ROBITUSSIN [MENTHOL]), LISINOPRIL, FERROUS SULFATE, ACETYLSALICYLIC ACID (ASPIRINE), MULTIVITAMINS [VITAMINS NOS], DONEPEZIL, LATANOPROST, LOVASTATIN, CARVEDILOL (COREG) and CIMETIDINE (TAGAMET [CIMETIDINE]) for an unknown indication.    On 27-Jun-2024, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 28-Jun-2024, the patient experienced APNOEA (Apnoea) (seriousness criteria hospitalization, medically significant and life threatening), HYPERHIDROSIS (hyperhidrosis) (seriousness criteria hospitalization, medically significant and life threatening) and UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, APNOEA (Apnoea), HYPERHIDROSIS (hyperhidrosis) and UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: Normal.         No treatment medication was reported.  The patient received Lanuts medicine at time of vaccination.  Patient was found unresponsive by nursing home staff, diaphoretic with normal blood glucose. Patient transported to facility where she was noted to have periods of apnea. Patient had lab tests, CT and EKG; results were not available.  Company Comment: This is a spontaneous case concerning a female patient of an unknown age with concurrent medical history of Hypertension, Degenerative joint disease, Anemia, Tricuspid insufficiency, Hyperlipidemia, Type 2 diabetes mellitus and Osteoarthritis, who experienced the serious (per hospitalization, medically significant and life threatening) unexpected events of Apnoea, Hyperhidrosis and Unresponsive to stimuli which occurred on the day after a dose of SPIKEVAX 2023-2024 PFS received as the first dose of COVID-19 Vaccination schedule. It was reported that he was found unresponsive by Nursing home staff, diaphoretic with normal blood glucose, transported to a facility where she was noted to have periods of apnea. The mentioned comorbidities could remain as confounding risk factors. No further clinical information or diagnostic tests results were disclosed for analysis. No concomitant medication or treatment information was reported. Case is further confounded by polypharmacy. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS is not affected by this report.