Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Therapeutic response shortened, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), VACCINATION SITE PAIN (Vaccination site pain), ARTHRALGIA (Pain in joint involving hand) and FATIGUE (Tiredness) in an elderly 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), VACCINATION SITE PAIN (Vaccination site pain), ARTHRALGIA (Pain in joint involving hand) and FATIGUE (Tiredness). At the time of the report, THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) outcome was unknown and VACCINATION SITE PAIN (Vaccination site pain), ARTHRALGIA (Pain in joint involving hand) and FATIGUE (Tiredness) had not resolved. Concomitant medications were not reported. On unknown dates, after Covid vaccine booster shot the patient felt tired and injection spot was sore and middle finger joint was sore and achy when it was almost time for Humira shot. Moderna covid-19 vaccine (covid-19 vaccine mrna (MRNA 1273)) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of after Covid vaccine booster shot felt tired and injection spot sore unknown onset, after Covid vaccine booster shot felt tired and injection spot sore unknown onset, middle Finger joint was sore and achy when it was almost time for HUMIRA shot unknown onset and middle finger joint was sore and achy when it was almost time for HUMIRA shot unknown onset was not 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. Treatment information was not provided. Company comment: This spontaneous case concerns an elderly female patient with concurrent condition of rheumatoid arthritis and reported non serious event of Therapeutic response shortened (reported as Wearing off effect) along with the non serious events of arthralgia and fatigue, unknown days after receiving the booster dose of mRNA-1273 vaccine. The patient received the first and second doses of the same vaccine on unknown dates. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 was available in the report. Adalimumab for rheumatoid arthritis was reported as co suspect. The benefit-risk relationship of mRNA-1273 is not affected by this report. Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns an elderly female patient with concurrent condition of rheumatoid arthritis and reported non serious event of Therapeutic response shortened (reported as Wearing off effect) along with the non serious events of arthralgia and fatigue, unknown days after receiving the booster dose of mRNA-1273 vaccine. The patient received the first and second doses of the same vaccine on unknown dates. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 was available in the report. Adalimumab for rheumatoid arthritis was reported as co suspect. The benefit-risk relationship of mRNA-1273 is not affected by this report.