Age: 70.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Knots at injection site; Joint issues; Allergic to flu shots; Itching at injection site; Interchange of vaccine products; Itchiness and swollen at the injection site; Itchiness and swollen at the injection site; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), VACCINATION SITE NODULE (Knots at injection site), ARTHROPATHY (Joint issues), VACCINATION SITE PRURITUS (Itchiness and swollen at the injection site) and VACCINATION SITE SWELLING (Itchiness and swollen at the injection site) in a 70-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 products included non-company products INFLUENZA VACCINE for an unknown indication and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe Rheumatoid arthritis). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, dose of INFLUENZA VACCINE (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In August 2021, the patient experienced COVID-19 (COVID-19). In 2022, the patient experienced VACCINATION SITE PRURITUS (Itchiness and swollen at the injection site) and VACCINATION SITE SWELLING (Itchiness and swollen at the injection site). On an unknown date, the patient experienced VACCINATION SITE NODULE (Knots at injection site), ARTHROPATHY (Joint issues), ALLERGY TO VACCINE (Allergic to flu shots), VACCINATION SITE PRURITUS (Itching at injection site) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). In 2022, VACCINATION SITE PRURITUS (Itchiness and swollen at the injection site) and VACCINATION SITE SWELLING (Itchiness and swollen at the injection site) had resolved. At the time of the report, COVID-19 (COVID-19), ALLERGY TO VACCINE (Allergic to flu shots) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown, VACCINATION SITE NODULE (Knots at injection site) and VACCINATION SITE PRURITUS (Itching at injection site) had resolved and ARTHROPATHY (Joint issues) had not resolved.            The patient had fourth Covid shot and had joint issues.  On an unknown date in 2022, the patient had second episode of itchiness at injection site. On an unknown date in 2022, the second episode of itchiness at injection site had resolved.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of allergic to flu shots, knots at injection site and itching at injection site was not provided and for the events of swollen at the injection site, itchiness and swollen at the injection site, Covid and joint issues with Humira was no reasonable possibility.  The reporter's causality for the events of knots at injection site, itching at injection site, itchiness and swollen at the injection site, Covid and joint issues with Influenza vaccine was not provided and for the event of allergic to flu shot was reasonable possibility.  No treatment medications were provided by the reporter.  Company Comment: This spontaneous case concerns a 70-year-old, female patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unknown interval after receiving mRNA-1273 taken as unknown booster dose number of COVID-19 vaccination. Interchange of vaccine products is noted in the case as patient received Comirnaty as primary series and booster dose of COVID-19 immunization series. The clinical presentation, clinical course, diagnostic evaluation including COVID-19 test and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 70-year-old, female patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unknown interval after receiving mRNA-1273 taken as unknown booster dose number of COVID-19 vaccination. Interchange of vaccine products is noted in the case as patient received Comirnaty as primary series and booster dose of COVID-19 immunization series. The clinical presentation, clinical course, diagnostic evaluation including COVID-19 test and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.