Age: 33.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Headache, Hot flush, Influenza like illness, Nausea, Neck pain
Clinical narrative: Worse coughing; Neck hurts from artery pumping hard; Back pain; Arm pain; has been in bed all month; Flu like symptoms; Nausea; Headache; Joint ache; Cold chills; Jaw pain; Hot flushing; Severe bilateral foot pain; Shortness of breath; Felt like having heart attack with bad chest pain; sick to his stomach; Feeling worse since getting second covid shot; Fainted a couple times/collapsed/becomes faint if he exerts himself; Pulmonary hypertension was high at 124; Suspected immune response to the vaccine; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted a couple times/collapsed/becomes faint if he exerts himself) and PULMONARY HYPERTENSION (Pulmonary hypertension was high at 124) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product MACITENTAN tablet for Pulmonary hypertension.    Concomitant products included SILDENAFIL CITRATE and TREPROSTINIL SODIUM for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and MACITENTAN (Oral) 10 mg once a day. In March 2021, the patient experienced SYNCOPE (Fainted a couple times/collapsed/becomes faint if he exerts himself) (seriousness criterion medically significant), PULMONARY HYPERTENSION (Pulmonary hypertension was high at 124) (seriousness criterion medically significant), VACCINATION COMPLICATION (Suspected immune response to the vaccine) and CONDITION AGGRAVATED (Feeling worse since getting second covid shot). On an unknown date, the patient experienced PAIN IN JAW (Jaw pain), HOT FLUSH (Hot flushing), PAIN IN EXTREMITY (Severe bilateral foot pain), DYSPNOEA (Shortness of breath), CHEST PAIN (Felt like having heart attack with bad chest pain), ABDOMINAL DISCOMFORT (sick to his stomach), COUGH (Worse coughing), NECK PAIN (Neck hurts from artery pumping hard), BACK PAIN (Back pain), PAIN IN EXTREMITY (Arm pain), BEDRIDDEN (has been in bed all month), INFLUENZA LIKE ILLNESS (Flu like symptoms), NAUSEA (Nausea), HEADACHE (Headache), ARTHRALGIA (Joint ache) and CHILLS (Cold chills). At the time of the report, SYNCOPE (Fainted a couple times/collapsed/becomes faint if he exerts himself), PULMONARY HYPERTENSION (Pulmonary hypertension was high at 124), VACCINATION COMPLICATION (Suspected immune response to the vaccine), PAIN IN JAW (Jaw pain), HOT FLUSH (Hot flushing), PAIN IN EXTREMITY (Severe bilateral foot pain), DYSPNOEA (Shortness of breath), CHEST PAIN (Felt like having heart attack with bad chest pain), ABDOMINAL DISCOMFORT (sick to his stomach), CONDITION AGGRAVATED (Feeling worse since getting second covid shot), COUGH (Worse coughing), NECK PAIN (Neck hurts from artery pumping hard), BACK PAIN (Back pain), PAIN IN EXTREMITY (Arm pain), BEDRIDDEN (has been in bed all month), INFLUENZA LIKE ILLNESS (Flu like symptoms), NAUSEA (Nausea), HEADACHE (Headache), ARTHRALGIA (Joint ache) and CHILLS (Cold chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Brain natriuretic peptide: 570 (High) elevated up to 570.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included paracetamol.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.