Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Haemoptysis, Malaise, Pneumonia, Pulmonary thrombosis
Clinical narrative: Pneumonia in one of her lungs and possible blood clot; Pneumonia in one of her lungs/ Left lobe pneumonia; Coughing up blood; Feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Pneumonia in one of her lungs and possible blood clot), PNEUMONIA (Pneumonia in one of her lungs/ Left lobe pneumonia) and HAEMOPTYSIS (Coughing up blood) in a 65-year-old female 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 TREPROSTINIL SODIUM (TYVASO) inhalation gas for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TADALAFIL for an unknown indication.   On 10-Sep-2020, the patient started TREPROSTINIL SODIUM (TYVASO) (unknown route) at an unspecified dose four times per day. On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PULMONARY THROMBOSIS (Pneumonia in one of her lungs and possible blood clot) (seriousness criteria hospitalization and medically significant), PNEUMONIA (Pneumonia in one of her lungs/ Left lobe pneumonia) (seriousness criteria hospitalization and medically significant), HAEMOPTYSIS (Coughing up blood) (seriousness criterion hospitalization) and MALAISE (Feeling sick). The patient was hospitalized on 01-Nov-2021 due to HAEMOPTYSIS, PNEUMONIA and PULMONARY THROMBOSIS. At the time of the report, PULMONARY THROMBOSIS (Pneumonia in one of her lungs and possible blood clot), PNEUMONIA (Pneumonia in one of her lungs/ Left lobe pneumonia), HAEMOPTYSIS (Coughing up blood) and MALAISE (Feeling sick) outcome was unknown.            After 18 hours later at night of receiving Moderna COVID vaccine booster dose, patient started feeling sick, had chest pain, and started coughing up blood. The patient was rushed to the emergency department, where they (physician) found that patient had pneumonia in one of lungs and possible blood clot. The patient was diagnosed with left lobe pneumonia. The patient had been hospitalized on same date for hemoptysis and pneumonia.  On 02-Nov-2021, patient was scheduled for angiogram. The patient was still in the hospital (at the time of this report).  Treatment medications was not reported. Tyvaso  delivered by Inhalation Device, 18-54 microgram (3-9 breaths), four times a day.  Company comment: This case concerns a 65-year-old female patient with a relevant medical history of Pulmonary arterial hypertension undergoing treatment with tadalafil and Treprostinil, who experienced the unexpected serious (hospitalization and medically significant) event/AESI of Haemoptysis, Pneumonia and Pulmonary thrombosis after mRNA- 1273 Moderna vaccine. The onset of the event occurred approximately 18 hours after the booster dose of mRNA- 1273 vaccine. Clinical manifestations included chest pain, malaise and haemoptysis. Final diagnosis of left lobe pneumonia and provisional diagnosis of pulmonary thrombosis were done. The rechallenge is not applicable since the event occurred after the booster dose. Underlying pulmonary hypertension and concomitant treatment with tadalafil and treprostinil remain a confounder/confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report; Sender's Comments: This case concerns a 65-year-old female patient with a relevant medical history of Pulmonary arterial hypertension undergoing treatment with tadalafil and Treprostinil, who experienced the unexpected serious (hospitalization and medically significant) event/AESI of Haemoptysis, Pneumonia and Pulmonary thrombosis after mRNA- 1273 Moderna vaccine. The onset of the event occurred approximately 18 hours after the booster dose of mRNA- 1273 vaccine. Clinical manifestations included chest pain, malaise and haemoptysis. Final diagnosis of left lobe pneumonia and provisional diagnosis of pulmonary thrombosis were done. The rechallenge is not applicable since the event occurred after the booster dose. Underlying pulmonary hypertension and concomitant treatment with tadalafil and treprostinil remain a confounder/confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report