Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Inappropriate schedule of product administration, Pneumonia, Pulmonary haemorrhage
Clinical narrative: Blood in her lung, (she's not sure which); Pneumonia; Bronchitis; 1st dose on 11Jan2021; 2nd dose on 2Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY HAEMORRHAGE (Blood in her lung, (she's not sure which)), PNEUMONIA (Pneumonia) and BRONCHITIS (Bronchitis) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY HAEMORRHAGE (Blood in her lung, (she's not sure which)) (seriousness criteria hospitalization and medically significant), PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant), BRONCHITIS (Bronchitis) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 11Jan2021; 2nd dose on 2Feb2021). The patient was hospitalized for 2 days due to BRONCHITIS, PNEUMONIA and PULMONARY HAEMORRHAGE. The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for Adverse event, at a dose of 5 mg twice daily. At the time of the report, PULMONARY HAEMORRHAGE (Blood in her lung, (she's not sure which)), PNEUMONIA (Pneumonia) and BRONCHITIS (Bronchitis) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 11Jan2021; 2nd dose on 2Feb2021) had resolved.            No Treatment medications were reported.  Patient stated that she was in the hospital for 2 days two and a half to three weeks ago due to blood in her lung, (she's not sure which), pneumonia, and bronchitis.  Patient asked if patient can get the 3rd shot now since she got the flu shot a week ago.  Company comment: This is a spontaneous case concerning a 83-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Pulmonary haemorrhage, Pneumonia, Bronchitis. The events occurred approximately on an unknown day after the unknown dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 83-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Pulmonary haemorrhage, Pneumonia, Bronchitis. The events occurred approximately on an unknown day after the unknown dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.