Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Exposure to SARS-CoV-2, Inappropriate schedule of product administration, SARS-CoV-2 test, Speech disorder
Clinical narrative: Exposure to COVID-19; Bronchitis; Speech disorder/talking was difficult; Second dose Jun-2021 and third dose Oct-2021; This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER (Speech disorder/talking was difficult), EXPOSURE TO SARS-COV-2 (Exposure to COVID-19), BRONCHITIS (Bronchitis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose Jun-2021 and third dose Oct-2021) in a 42-year-old male 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 Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. In October 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,Solution for injection in pre-filled pen. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. In October 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose Jun-2021 and third dose Oct-2021). In 2022, the patient experienced SPEECH DISORDER (Speech disorder/talking was difficult). In June 2022, the patient experienced BRONCHITIS (Bronchitis). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Exposure to COVID-19). In 2022, BRONCHITIS (Bronchitis) had resolved. At the time of the report, SPEECH DISORDER (Speech disorder/talking was difficult) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose Jun-2021 and third dose Oct-2021) outcome was unknown and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.         No concomitant medications were reported.  It was reported that on an unknown date in 2022, the patient experienced the event needle bent in two different directions with Co-suspect humira (adalimumab) and action taken with response to the event needle bent in two different directions was reported as Unknown for both the Suspect drug and Suspect vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB) for the event(s) of talking was difficult, exposed to covid and needle bent in two different directions was not provided. The reporter's causality for the event(s) of bronchitis with humira(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of talking was difficult, exposed to covid, bronchitis and needle bent in two different directions was not provided.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2022: Additional follow up received and event details were updated.