Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration
Clinical narrative: Sickness; First Dose adminstered 06-Apr-2021 and second Dose adminstered after 54 days on 30-May-2021; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sickness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose adminstered 06-Apr-2021 and second Dose adminstered after 54 days on 30-May-2021) in a 44-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) for Ankylosing spondylitis.    No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, received second 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) at an unspecified dose. On 30-May-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose adminstered 06-Apr-2021 and second Dose adminstered after 54 days on 30-May-2021). On an unknown date, the patient experienced ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose adminstered 06-Apr-2021 and second Dose adminstered after 54 days on 30-May-2021) outcome was unknown.            No concomitant medications was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the events of sickness and Drug ineffective was reasonable possibility. No treatment medications was provided by the reporter.  Company comment: This spontaneous case concerns 44 years old female patient, with no relevant medical history reported, who experienced the unexpected non-serious events of Illness and Inappropriate schedule of product administration that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since event onset was not disclosed. It was reported that patient received co-suspect ADALIMUMAB (HUMIRA) for Ankylosing spondylitis unknown date. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns 44 years old female patient, with no relevant medical history reported, who experienced the unexpected non-serious events of Illness and Inappropriate schedule of product administration that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since event onset was not disclosed. It was reported that patient received co-suspect ADALIMUMAB (HUMIRA) for Ankylosing spondylitis unknown date. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.