Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Bone pain, Chills, Feeling hot, Heart rate
Clinical narrative: I passed out again; I fainted twice; lethargic; aches; overheating; hurt my tailbone; nauseated; chills; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (I passed out again) and SYNCOPE (I fainted twice) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059F72A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had no medical history, concomitant disease or risk factor.  The patient's past medical history included COVID-19 on 23-Dec-2021. Previously administered products included for Product used for unknown indication: Influenza on 17-Nov-2022. Past adverse reactions to the above products included No adverse event with Influenza.    On 20-Nov-2022 at 3:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 21-Nov-2022, the patient experienced LOSS OF CONSCIOUSNESS (I passed out again) (seriousness criterion medically significant), SYNCOPE (I fainted twice) (seriousness criterion medically significant), LETHARGY (lethargic), PAIN (aches), FEELING HOT (overheating), BONE PAIN (hurt my tailbone), NAUSEA (nauseated) and CHILLS (chills). The patient was treated with ONDANSETRON (ZOFRAN MELT) (intravenous) at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (TORADOL) (intravenous) at an unspecified dose and frequency. On 22-Nov-2022, LOSS OF CONSCIOUSNESS (I passed out again), SYNCOPE (I fainted twice), LETHARGY (lethargic), PAIN (aches), FEELING HOT (overheating), BONE PAIN (hurt my tailbone), NAUSEA (nauseated) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2022, Blood pressure measurement: blood pressure decreased, BP systolic under 90. On 21-Nov-2022, Heart rate: pulse rate under 40, decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Patient fainted twice in a row due to a significant drop in her blood pressure and heart rate. This was 16 hours after patient got the vaccination. Patient had the vaccination at 3:00 PM EST. By 6:30pm patient was feeling lethargic. She went to bed later and was overheating, then chills and aches. She woke up in the morning and felt very nauseated. she brushed her teeth, then went to the kitchen to get water and passed out. She landed on her bottom and hurt her tailbone. About 10 minutes later her husband came home to help her up and she passed out again. Called EMT who found BP systolic under 90 and pulse rate under 40. The patient did not experience any additional symptoms/events.   Patient received intravenous fluids, zofran and Toradol.  There were no lab data/results available.  Company Comment: This is a spontaneous case concerning  a 40-year-old, female patient with no reported medical history, who experienced the unexpected (medically significant) serious event of Loss of consciousness and expected (medically significant) serious event of Syncope and and non-serious unexpected events of Lethargy, Pain, Feeling hot, Bone Pain and expected non-serious events of Nausea, Chills. The events occurred approximately 1 day after the unspecified dose of mRNA-1273 Vaccine. Patient fainted twice in a row due to a significant drop in her blood pressure and heart rate. This was 16 hours after patient got the vaccination. Patient was feeling lethargic. She went to bed later and was overheating, then chills and aches started. She woke up the next day and felt very nauseated. Patient passed out and landed on her bottom and hurt her tailbone. About 10 minutes later her husband came home to help her up and she passed out again. Called EMT, BP systolic under 90 and pulse rate under 40. The patient did not experience any additional symptoms/events. Patient received intravenous fluids, zofran and Toradol. The events were reported as resolved. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a 40-year-old, female patient with no reported medical history, who experienced the unexpected (medically significant) serious event of Loss of consciousness and expected (medically significant) serious event of Syncope and and non-serious unexpected events of Lethargy, Pain, Feeling hot, Bone Pain and expected non-serious events of Nausea, Chills. The events occurred approximately 1 day after the unspecified dose of mRNA-1273 Vaccine. Patient fainted twice in a row due to a significant drop in her blood pressure and heart rate. This was 16 hours after patient got the vaccination. Patient was feeling lethargic. She went to bed later and was overheating, then chills and aches started. She woke up the next day and felt very nauseated. Patient passed out and landed on her bottom and hurt her tailbone. About 10 minutes later her husband came home to help her up and she passed out again. Called EMT, BP systolic under 90 and pulse rate under 40. The patient did not experience any additional symptoms/events. Patient received intravenous fluids, zofran and Toradol. The events were reported as resolved. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.