Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hypotension, Loss of consciousness
Clinical narrative: low blood pressure; Central sleep apnea; passed out while on the toilet; chills; nausea; tiredness; headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out while on the toilet) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sleep apnea (Recent change in status of chronic condition took place. On 8 Apr 2021 a sleep study found that the patient have Central apnea.) since 13-May-2009, Hypothyroidism since 01-Jul-1977 and Allergic reaction to analgesics (Hydrocodone). Concomitant products included ATORVASTATIN from 2000 to an unknown date for High cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) from 1977 to an unknown date for Hypothyroidism, VITAMIN D [VITAMIN D NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out while on the toilet) (seriousness criterion medically significant), CHILLS (chills), NAUSEA (nausea), FATIGUE (tiredness) and HEADACHE (headache). On 06-Apr-2021, the patient experienced SLEEP APNOEA SYNDROME (Central sleep apnea). On an unknown date, the patient experienced HYPOTENSION (low blood pressure). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 04-Feb-2021, LOSS OF CONSCIOUSNESS (passed out while on the toilet) had resolved. At the time of the report, SLEEP APNOEA SYNDROME (Central sleep apnea) had not resolved and HYPOTENSION (low blood pressure), CHILLS (chills), NAUSEA (nausea), FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown.            Patient needed a machine for central sleep apnea. Concomitant medication also included Multivitamin daily for an unknown indication.  For 10 years, the patient have been treated for obstructive sleep apnea with a dental appliance.  At that time and on 03 Jug 2016, The Patient was diagnosed with obstructive sleep apnea. In order to get a new appliance the patient needed a recent sleep study.  That sleep study on  08 Apr 2021 showed that the patient now have central sleep apnea. The patient have to use a CPAP machine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-024979 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Reporters information was updated, Patients demographics and race was updated , Patients relevant historical condition was added, Vaccine facility information added, concomitant medications added, New events chills, nausea, tiredness, and headache was added and outcome of the events updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.