Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Therapeutic product effect incomplete
Clinical narrative: Drug effect incomplete; Chills; Tiredness; Ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), CHILLS (Chills) and FATIGUE (Tiredness) in a 52-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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Oct-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, 1 in 1 wk, Solution for injection in pre-filled pen. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In October 2021, the patient experienced PAIN (Ache), CHILLS (Chills) and FATIGUE (Tiredness). On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete). In October 2021, PAIN (Ache), CHILLS (Chills) and FATIGUE (Tiredness) had resolved. At the time of the report, THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete) was resolving.            Concomitant drugs not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Primary reporter dose not had the lot number information because the packaging was discarded.   Action taken for humira was reported as dose increased for the event drug effect incomplete.  The reporter's causality for the events of body chills, tired, aches and humira dose increased to weekly to be more effective was not provided.  No treatment medication were 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 52 years with relevant medical history of Rheumatoid Arthritis on Humira reported, who experienced the non-serious unexpected events of Pain and Therapeutic product effect incomplete that occurred on an unknown date in the context of mRNA-1273 vaccination. patient had received initial two doses of mRNA-1273 at an interval of one month and 3rd dose 7 months later. It was reported that Humira dose was increased to weekly to be more effective.  No further information on clinical course, investigations and treatment received was available in the report. Relevant medical history could be confounder to the event Pain. 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 52 years with relevant medical history of Rheumatoid Arthritis on Humira reported, who experienced the non-serious unexpected events of Pain and Therapeutic product effect incomplete that occurred on an unknown date in the context of mRNA-1273 vaccination. patient had received initial two doses of mRNA-1273 at an interval of one month and 3rd dose 7 months later. It was reported that Humira dose was increased to weekly to be more effective.  No further information on clinical course, investigations and treatment received was available in the report. Relevant medical history could be confounder to the event Pain. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.