Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fall, Head injury, Loss of consciousness, SARS-CoV-2 test
Clinical narrative: Passing out, dry cough so bad that he would faint; Stood up to cough, passed out, and fell and his head hit the concrete; Head hit the concrete floor, hitting head on floor; Bad, dry cough; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out, dry cough so bad that he would faint) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. G17-C21A and G26-B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Smoker (30+ years of smoking.) and Vapor cigarette smoker (vaping the past two years.). Concomitant products included BENZTROPINE [BENZATROPINE], FLUOXETINE, TAMSULOSIN, CLONAZEPAM, AMLODIPINE and LURASIDONE HYDROCHLORIDE (LATUDA) for an unknown indication.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passing out, dry cough so bad that he would faint) (seriousness criterion medically significant), FALL (Stood up to cough, passed out, and fell and his head hit the concrete), HEAD INJURY (Head hit the concrete floor, hitting head on floor) and COUGH (Bad, dry cough). On 12-May-2021, LOSS OF CONSCIOUSNESS (Passing out, dry cough so bad that he would faint) and COUGH (Bad, dry cough) had resolved. At the time of the report, FALL (Stood up to cough, passed out, and fell and his head hit the concrete) and HEAD INJURY (Head hit the concrete floor, hitting head on floor) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: negative (Negative) Went to get tested for COVID-19 due to dry, bad cough and came back negative.         The patient stated that approximately one week after the first dose, he was having a bad dry cough.  The dry cough was so bad that when he was sitting on recliner he would cough so bad, he would faint and pass out. One time the patient stood up to cough, passed out, and fell and his head hit the concrete floor. He went to emergency department three times because of this cough. On 12 MAY 2021, the patient stopped experiencing coughing and passing out. The patient also stated that he has no other side effects and that his healthcare provider thinks this experience was attributed to the first vaccine. Patient was prescribed an "inhaler" from his healthcare provider to help with "lungs and stuff."  The patient also has an appointment with a pulmonologist in June.  Action taken with mRNA-1273 in response to the events was not applicable.  Head injury was due to fall and thus cannot be directly associated with mRNA-1273 use.  The other events are temporarily associated with the product use and a causal relationship cannot be excluded   This case was linked to MOD-2021-138832 (Patient Link).; Sender's Comments: Head injury was due to fall and thus cannot be directly associated with mRNA-1273 use.  The other events are temporarily associated with the product use and a causal relationship cannot be excluded