Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Palpitations, Prostatic disorder
Clinical narrative: he's had the sweats; his heart will race, then slow down/heart started racing & doing weird things/this happens every now & then & is becoming less frequent; had heartburn; had a tight chest & it hurts; thinks it might be messing with his prostate; hit his head; dizzy; had a sore arm; has a dull headache every once in awhile; passed out & hit his head at one point; Was not feeling good/He was down; felt like he had the flu; had shortness of breath yesterday/shortness of breath; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out & hit his head at one point) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2022, the patient experienced DYSPNOEA (had shortness of breath yesterday/shortness of breath). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out & hit his head at one point) (seriousness criterion medically significant), FEELING ABNORMAL (Was not feeling good/He was down), INFLUENZA LIKE ILLNESS (felt like he had the flu), HYPERHIDROSIS (he's had the sweats), PALPITATIONS (his heart will race, then slow down/heart started racing & doing weird things/this happens every now & then & is becoming less frequent), DYSPEPSIA (had heartburn), CHEST PAIN (had a tight chest & it hurts), PROSTATIC DISORDER (thinks it might be messing with his prostate), HEAD INJURY (hit his head), DIZZINESS (dizzy), PAIN IN EXTREMITY (had a sore arm) and HEADACHE (has a dull headache every once in awhile). At the time of the report, LOSS OF CONSCIOUSNESS (passed out & hit his head at one point), FEELING ABNORMAL (Was not feeling good/He was down), INFLUENZA LIKE ILLNESS (felt like he had the flu), DYSPNOEA (had shortness of breath yesterday/shortness of breath), HYPERHIDROSIS (he's had the sweats), PALPITATIONS (his heart will race, then slow down/heart started racing & doing weird things/this happens every now & then & is becoming less frequent), DYSPEPSIA (had heartburn), CHEST PAIN (had a tight chest & it hurts), PROSTATIC DISORDER (thinks it might be messing with his prostate), HEAD INJURY (hit his head), DIZZINESS (dizzy), PAIN IN EXTREMITY (had a sore arm) and HEADACHE (has a dull headache every once in awhile) outcome was unknown.            Concomitant medication details were not reported by the reporter.  Patient stated was sick for 2 days meaning was down, was not feeling good, felt like had the flu, & had a sore arm when patient got the doses. About a month or a month & a half after his second dose patient was getting ready to play tennis by swinging around the racket & jumping around and patient began feeling dizzy, had shortness of breath, heart started racing & doing weird things. Patient said this happens every now & then & was becoming less frequent. Patient said had shortness of breath yesterday but none of this has happened for a couple of months. Patient stated that none of this has ever happened before got the vaccine, patient was not obese, has no other problems, and patient was active. Patient had the sweats, patient passed out & hit head at one point, has a dull headache every once in awhile, patient heart will race, then slow down, patient had heartburn, had a tight chest & it hurts, & he thinks it might be messing with prostate. Patient stated that patient was not seen a doctor & does not have one. Treatment details was not reported by the reporter.  Company comment: This spontaneous case concerns a 56-year-old, male patient with no medical history reported, who experienced the unexpected serious (medically significant) event of loss of consciousness along with other non serious events. The event of loss of consciousness occurred on an unknown date after the second dose of mRNA-1273. As reported, after the second shot the patient was not feeling good, felt like had the flu and sore arm. About 1.5 months after his second dose patient began feeling dizzy, had shortness of breath, and patient's heart started racing. Patient also reported he had the sweats and passed out and hit head at one point. No further information regarding event of loss of consciousness was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-629662 (Patient Link).; Sender's Comments: This spontaneous case concerns a 56-year-old, male patient with no medical history reported, who experienced the unexpected serious (medically significant) event of loss of consciousness along with other non serious events. The event of loss of consciousness occurred on an unknown date after the second dose of mRNA-1273. As reported, after the second shot the patient was not feeling good, felt like had the flu and sore arm. About 1.5 months after his second dose patient began feeling dizzy, had shortness of breath,  and patient's heart started racing. Patient stated this was happening now and then but becoming less frequent. Patient also reported he had the sweats and passed out and hit head at one point. No further information regarding event of loss of consciousness was provided. Patient also described having dull headache every once in awhile, heartburn, tight chest which hurts, and was thinking it might be messing with prostate. The benefit-risk relationship of mRNA-1273 is not affected by this report.