Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, Bronchitis, Cataract, Feeling abnormal, Pulmonary oedema
Clinical narrative: Fluid in lung; Cataracts/he noticed a decline in her vision; Bronchitis; Sore arm due to covid vaccine/Vaccination site pain; Ran a temperature following covid booster/fever; Felt blah; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY OEDEMA (Fluid in lung) and CATARACT (Cataracts/he noticed a decline in her vision) in a 76-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 ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (Felt blah), VACCINATION SITE PAIN (Sore arm due to covid vaccine/Vaccination site pain) and PYREXIA (Ran a temperature following covid booster/fever). On an unknown date, the patient experienced PULMONARY OEDEMA (Fluid in lung) (seriousness criterion medically significant), CATARACT (Cataracts/he noticed a decline in her vision) (seriousness criterion medically significant) and BRONCHITIS (Bronchitis). The patient was treated with Surgery (Cataracts surgery was done in Oct-2021) for Cataract. In 2021, PYREXIA (Ran a temperature following covid booster/fever) had resolved. At the time of the report, PULMONARY OEDEMA (Fluid in lung), CATARACT (Cataracts/he noticed a decline in her vision), FEELING ABNORMAL (Felt blah), BRONCHITIS (Bronchitis) and VACCINATION SITE PAIN (Sore arm due to covid vaccine/Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. It was reported that the patient ran with a temperature for a day or two with fever following booster. Treatment information was not provided. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. Company comment: This is a Spontaneous case concerning a 76-year-old female patient, with no medical history reported, who experienced the unexpected and serious events of Pulmonary edema and Cataract (Seriousness criteria medically significant) which occurred on unspecified day after the third dose of mRNA-1273 vaccine. It was reported that patient experienced the non-serious events of vaccination site pain and Pyrexia and later developed cataract and pulmonary edema after the administration of Co-suspect non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis. The co- suspect product ADALIMUMAB could be contributing for the events pulmonary edema and bronchitis. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 76-year-old female patient, with no medical history reported, who experienced the unexpected and serious events of Pulmonary edema and Cataract (Seriousness criteria medically significant) which occurred on unspecified day after the third dose of mRNA-1273 vaccine. It was reported that patient experienced the non-serious events of vaccination site pain and Pyrexia and later developed cataract and pulmonary edema after the administration of Co-suspect non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis. The co- suspect product ADALIMUMAB could be contributing for the events pulmonary edema and bronchitis. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.