Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Disorientation, Dyspnoea, Feeling cold
Clinical narrative: Loss of balance; Disorientation; Difficult breathing; Was extremely cold; Was trembling; no strength; passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Fruit allergy (The patient have allergy towards bananas.) and Pollen allergy. Concomitant products included FENOFIBRATE, SERTRALINE, ASCORBIC ACID, BETACAROTENE, COPPER, NICOTINAMIDE, SELENIUM, TOCOPHEROL, XANTOFYL, ZINC (LUTEIN +) and VITAMIN D3 for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), FEELING COLD (Was extremely cold), TREMOR (Was trembling) and ASTHENIA (no strength). On 27-Feb-2021, the patient experienced BALANCE DISORDER (Loss of balance), DISORIENTATION (Disorientation) and DYSPNOEA (Difficult breathing). On 26-Feb-2021, LOSS OF CONSCIOUSNESS (passed out) had resolved. On 27-Feb-2021, FEELING COLD (Was extremely cold), TREMOR (Was trembling) and ASTHENIA (no strength) had resolved. At the time of the report, BALANCE DISORDER (Loss of balance), DISORIENTATION (Disorientation) and DYSPNOEA (Difficult breathing) outcome was unknown.            Patient wok up 10 to 12 hours after receiving second shot and was extremely cold, trembling or shaking uncontrollably. All limbs and jaw could not stop trembling. Got out of bed to find another blanket and raise thermostat. Could not find thermostat (disoriented) struggled to find blanket. By the time patient found blanket he began to have great difficulty breathing. By the time patient stumbled into bed, he was gasping as if there was no air in the room. Stayed in bed gasping, trembling and freezing till he fell asleep or passed out. Patient had no strength to call for help, thought he was dying. Patient woke up about 8:00 AM with no illness, aches, pains or any physical issues. Patient had no further issues till date of report. 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.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: No specific follow-up information recorded. On 24-May-2021: Follow up received on 25 May 2021 and it contain significant information. Additional new event added and one event upgrade the case to serious. Patient demographics updated. History, concomitant and narrative information also get 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.