Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pain, Therapeutic product effect incomplete, Vaccination site pain
Clinical narrative: Pain; Drug effect incomplete; Condition aggravated; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), CONDITION AGGRAVATED (Condition aggravated) and VACCINATION SITE PAIN (Vaccination site pain) in an adult 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 aggravated and Ankylosing spondylitis.    Concurrent medical conditions included Rheumatoid arthritis and Ankylosing spondylitis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced PAIN (Pain), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), CONDITION AGGRAVATED (Condition aggravated) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, PAIN (Pain), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown and CONDITION AGGRAVATED (Condition aggravated) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medication use information was not provided by reporter.  On unknown dates, the patient experienced flare ups, felt covid vaccine was not working to its full effect/sore arm and lot of pain with humira (adalimumab)  It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality of the humira vaccine for the events of flare ups, felt covid vaccine was not working to its full effect/sore arm, lot of pain unknown onset was not provided.  Treatment Medication use information was not provided by reporter.  Company comment-This spontaneous case concerns an adult female patient of unspecified age with relevant medical history of Rheumatoid Arthritis and Ankylosing spondylitis on Humira reported, who experienced the non-serious unexpected events of Therapeutic product effect incomplete and Condition aggravated that occurred on an unknown date in the context of mRNA-1273 vaccination. Patient reported FLARE UPS, FELT COVID VACCINE WAS NOT WORKING TO ITS FULL EFFECT. 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.   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. Sender's Comments: This spontaneous case concerns an adult female patient of unspecified age with relevant medical history of Rheumatoid Arthritis and Ankylosing spondylitis on Humira reported, who experienced the non-serious unexpected events of Therapeutic product effect incomplete and Condition aggravated that occurred on an unknown date in the context of mRNA-1273 vaccination. Patient reported FLARE UPS, FELT COVID VACCINE WAS NOT WORKING TO ITS FULL EFFECT. 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.