Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Headache, Influenza, Pain in extremity
Clinical narrative: Bronchitis; Flu; Headache; Arm was hurting/Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), INFLUENZA (Flu), HEADACHE (Headache) and PAIN IN EXTREMITY (Arm was hurting/Pain in arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis.    The patient's past medical history included Breast cancer (Patient had a breast cancer in 2018 and on an unknown date,  breast cancer resolved) in 2018 and Cane user (Patient had been walking with a walker since 2018.) in 2018. Concurrent medical conditions included Walking difficulty (walking issues) in 2018 and Panuveitis (Non-infectious intermediate posterior and panuveitis).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Oct-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) Citrate Free. On an unknown date, the patient experienced BRONCHITIS (Bronchitis) (seriousness criterion medically significant), INFLUENZA (Flu) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Arm was hurting/Pain in arm) (seriousness criterion medically significant). At the time of the report, BRONCHITIS (Bronchitis), INFLUENZA (Flu), HEADACHE (Headache) and PAIN IN EXTREMITY (Arm was hurting/Pain in arm) outcome was unknown.            No concomitant product use was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine trial. Patient reported events of breast cancer, and non-serious bronchitis, flu, headache, arm was hurting and walking issues with Humira (Adalimumab). The reporter's causality for the event(s) of breast cancer, bronchitis, flu, headache, arm was hurting and walking issues with Humira (Adalimumab) was not provided. Manufacturer opinion was that the events of breast cancer, bronchitis, flu, and walking issues are not assessable and there was no reasonable possibility that the events of headache and arm was hurting are related to Humira (Adalimumab).  No treatment medications were reported.  Company Comment: This spontaneous case concerns a 53-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Bronchitis, Influenza, Headache, and Pain in extremity unspecified days after the third dose of mRNA-1273 vaccine. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 53-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Bronchitis, Influenza, Headache, and Pain in extremity unspecified days after the third dose of mRNA-1273 vaccine. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.