Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Inappropriate schedule of product administration, Pain
Clinical narrative: Drug ineffective; Inappropriate schedule of vaccination as the interval between 1st and 2nd dose is 17 days; Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), DRUG INEFFECTIVE (Drug ineffective) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccination as the interval between 1st and 2nd dose is 17 days) in a 64-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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-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) Citrate Free. On 01-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccination as the interval between 1st and 2nd dose is 17 days). In 2021, the patient experienced PAIN (Pain). On an unknown date, the patient experienced DRUG INEFFECTIVE (Drug ineffective). At the time of the report, PAIN (Pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccination as the interval between 1st and 2nd dose is 17 days) outcome was unknown and DRUG INEFFECTIVE (Drug ineffective) had not resolved.            Formulation of Humira was reported as Solution for injection in pre-filled pen.   No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment-This spontaneous case concerns a female patient aged 64 years with concurrent condition of Rheumatoid Arthritis on Humira reported, who experienced the non-serious unexpected event of Drug ineffective that occurred on an unknown date in the context of mRNA-1273 vaccination. In 2021, the patient experienced HUMIRA WAS NOT WORKING AS WELL AS EXPECTED. Additionally Inappropriate schedule of vaccination was noted as patient had received initial two doses of mRNA-1273 at an interval of17 days. No further information on clinical course, investigations and treatment received was available in the report.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case concerns a female patient aged 64 years with concurrent condition of Rheumatoid Arthritis on Humira reported, who experienced the non-serious unexpected event of Drug ineffective that occurred on an unknown date in the context of mRNA-1273 vaccination. In 2021, the patient experienced HUMIRA WAS NOT WORKING AS WELL AS EXPECTED. Additionally Inappropriate schedule of vaccination was noted as patient had received initial two doses of mRNA-1273 at an interval of17 days. No further information on clinical course, investigations and treatment received was available in the report.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.