Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Pyrexia, Tremor
Clinical narrative: went to answer a text and never sent it because he passed out and woke 2-3 hours later and had a 94.9 degrees F core temperature; Brain fog; Shaking; headache, chills and 99.1 fever; chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (went to answer a text and never sent it because he passed out and woke 2-3 hours later and had a 94.9 degrees F core temperature) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic (preexisting diabetic). Concomitant products included INSULIN for an unknown indication.   On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (went to answer a text and never sent it because he passed out and woke 2-3 hours later and had a 94.9 degrees F core temperature) (seriousness criterion medically significant), FEELING ABNORMAL (Brain fog), TREMOR (Shaking), HEADACHE (headache, chills and 99.1 fever), CHILLS (chills) and PYREXIA (Fever). At the time of the report, LOSS OF CONSCIOUSNESS (went to answer a text and never sent it because he passed out and woke 2-3 hours later and had a 94.9 degrees F core temperature) and TREMOR (Shaking) outcome was unknown, FEELING ABNORMAL (Brain fog) had not resolved and HEADACHE (headache, chills and 99.1 fever), CHILLS (chills) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 49 (Low) 49. On an unknown date, Body temperature: 99.1 (High) 99.1 and 94.9 (Low) 94.9 degrees F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Concomitant medications include vitamin gummies. The Treatment information was not provided.  Company comment: This case concerns a 48-year-old, male patient with previous relevant medical history diabetes and use of concomitant medication insulin, who experienced the unexpected loss of consciousness. The event occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown, as the event happened after the first dose and have resolved, and no information about second dose was disclosed. The reporter assessed the events as possible. The medical history of diabetes and use of concomitant medication insulin remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 48-year-old, male patient with previous relevant medical history diabetes and use of concomitant medication insulin, who experienced the unexpected loss of consciousness. The event occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown, as the event happened after the first dose and have resolved, and no information about second dose was disclosed. The reporter assessed the events as possible. The medical history of diabetes and use of concomitant medication insulin remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.