Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bone pain, Chills, Groin pain, Headache, Immunisation reaction
Clinical narrative: Bone pain; General body pain; Fever; Chills; Headache; Vaccination adverse reaction; Mobility decreased; General body pain; Groin pain; Swelling arm; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction), MOBILITY DECREASED (Mobility decreased), the first episode of PAIN (General body pain), GROIN PAIN (Groin pain) and PERIPHERAL SWELLING (Swelling arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Bone disorder, Liver disorder, Drug allergy (Tramadol cause undescribed reactions with other medications), Psoriatic arthritis, Penicillin allergy (manifested by itching and swelling) and Drug allergy (Antiacids). Concomitant products included CALCIUM and VITAMIN D NOS for Bone disorder, URSODIOL for Liver disorder.   In 2008, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction), MOBILITY DECREASED (Mobility decreased), the first episode of PAIN (General body pain), GROIN PAIN (Groin pain), PERIPHERAL SWELLING (Swelling arm), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced BONE PAIN (Bone pain) and the second episode of PAIN (General body pain). The patient was treated with PARACETAMOL (PANADOL) at an unspecified dose and frequency. On 05-Sep-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. On 06-Sep-2021, MOBILITY DECREASED (Mobility decreased), PERIPHERAL SWELLING (Swelling arm) and HEADACHE (Headache) had resolved. At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) and GROIN PAIN (Groin pain) had not resolved and BONE PAIN (Bone pain) and the last episode of PAIN (General body pain) outcome was unknown.            The reporter did not provide any causality assessment for the event of vaccination adverse reaction with Humira.  The reporter did not provide any causality assessment for the event of bone pain and general body pain (second episode) with Humira and assessed rest other events as not related to Humira.  The reporter did not provide any causality assessment for the event of bone pain and general body pain (second episode) with Moderna vaccine and assessed rest other events as possibly related to Moderna vaccine.  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.