Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site mass
Clinical narrative: bronchiectasis; feeling nervous/very revved up/feeling "electric"; tinnitus in ear which became a bit louder; little bit of headache; Rash; big bumps localized in the upper left arm; This spontaneous case was reported by a patient and describes the occurrence of BRONCHIECTASIS (bronchiectasis) in a 73-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.     Previously administered products included for Product used for unknown indication: flu vaccine, pneumococcal vaccine and shingles vaccine. Past adverse reactions to the above products included No adverse event with flu vaccine, pneumococcal vaccine and shingles vaccine.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (feeling nervous/very revved up/feeling "electric"), TINNITUS (tinnitus in ear which became a bit louder), HEADACHE (little bit of headache), RASH (Rash) and VACCINATION SITE MASS (big bumps localized in the upper left arm). On an unknown date, the patient experienced BRONCHIECTASIS (bronchiectasis) (seriousness criterion medically significant). In 2021, RASH (Rash) had resolved. At the time of the report, BRONCHIECTASIS (bronchiectasis), FEELING ABNORMAL (feeling nervous/very revved up/feeling "electric"), TINNITUS (tinnitus in ear which became a bit louder), HEADACHE (little bit of headache) and VACCINATION SITE MASS (big bumps localized in the upper left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient did not experience similar event in the past. Adverse events did not cause death. Patient reported that rash stayed for 6-8 weeks. Patient had no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No treatment medications were reported. Patient had no known allergies. Patient did not test COVID-19 positive or diagnosis in the past.  Company comment: This spontaneous case concerns a 73-year-old female patient with no relevant medical history who experienced serious (medically significant) unexpected event of bronchiectasis. The exact time to onset was not provided and it was not clear whether the event occurred prior to the 1st dose of mRNA-1273 or after. No further details regarding the event were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-657540, MOD-2022-657532 (Patient Link).; Sender's Comments: This spontaneous case concerns a 73-year-old female patient with no relevant medical history who experienced serious (medically significant) unexpected event of bronchiectasis. The exact time to onset was not provided and it was not clear whether the event occurred prior to the 1st dose of mRNA-1273 or after. No further details regarding the event were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.