Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Haemoptysis, SARS-CoV-2 test
Clinical narrative: Spitting and coughing blood, haemoptysis; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOPTYSIS (Spitting and coughing blood, haemoptysis) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included AFib (Last episode in Jul-2020) from 2018 to 2020. Concurrent medical conditions included Asthma since 1956. Concomitant products included DILTIAZEM HYDROCHLORIDE (CARTIA XT) from 2018 to an unknown date for AFib and BP, FLUTICASONE FUROATE (ARNUITY ELLIPTA) from 2020 to an unknown date and MEPOLIZUMAB (NUCALA) from 2019 to an unknown date for Asthma, FLUVASTATIN SODIUM (LESCOL XL) from 2015 to an unknown date for Cholesterol, MAGNESIUM CITRATE from 2018 to an unknown date for Heart disease, unspecified, VIT D [VITAMIN D NOS] from 2018 to an unknown date for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021 at 8:00 AM, the patient experienced HAEMOPTYSIS (Spitting and coughing blood, haemoptysis) (seriousness criterion hospitalization). The patient was hospitalized from 24-Apr-2021 to 25-Apr-2021 due to HAEMOPTYSIS. On 05-May-2021, HAEMOPTYSIS (Spitting and coughing blood, haemoptysis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Computerised tomogram: abnormal (abnormal) A possible pneumonia in lungs. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         On 24-Apr-2021, the patient woke up and started spitting and coughing up blood. The patient went to emergency department and got hospitalized on same night.  On an unknown date, the patient had a CT scan which showed a possible pneumonia in lung.  On 25-Apr-2021, the patient was discharged on antibiotics. The patient had some residual bleeding (spitting out blood) which resolved in approximately eight to ten days.  The patient was never diagnosed or tested positive for COVID-19.  company comment: This case concerns a 66-year-old, male patient with medical history of asthma, who experienced the unexpected and serious event of hemoptysis. The event occurred approximately 65 days after the second dose of Moderna COVID vaccine was administered. The rechallenge was not applicable, as the event occurred after the second dose and we are not expecting more doses. The medical history of asthma remains as a confounder. The benefit-risk relationship of Moderna COVID vaccine is not affected by this report.   This case was linked to MOD-2021-017661 (Patient Link).; Sender's Comments: This case concerns a 66-year-old, male patient with medical history of asthma, who experienced the unexpected and serious event of hemoptysis. The event occurred approximately 65 days after the second dose of Moderna COVID vaccine was administered. The rechallenge was not applicable, as the event occurred after the second dose and we are not expecting more doses. The medical history of asthma remains as a confounder. The benefit-risk relationship of Moderna COVID vaccine is not affected by this report.