Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Cough, Influenza like illness
Clinical narrative: Back pain; KNEES WERE HURTING ON/OFF AROUND TENDONS; Cough; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) in a 70-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) solution for injection for Panuveitis.    Concurrent medical conditions included Panuveitis.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-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) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 14-Sep-2021, the patient experienced COUGH (Cough) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced BACK PAIN (Back pain) (seriousness criterion medically significant) and ARTHRALGIA (KNEES WERE HURTING ON/OFF AROUND TENDONS). In 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, BACK PAIN (Back pain) had not resolved, COUGH (Cough) outcome was unknown and ARTHRALGIA (KNEES WERE HURTING ON/OFF AROUND TENDONS) was resolving.            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.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of BACK HURT and KNEES WERE HURTING ON/OFF AROUND TENDONS with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of COUGH, FLU LIKE SYMPTOMS and LOT OF ISSUES was not provided. RA's opinion is that there is no reasonable possibility that the events of BACK HURT and KNEES WERE HURTING ON/OFF AROUND TENDONS are related to HUMIRA(ADALIMUMAB). RA's opinion is that the events of COUGH, FLU LIKE SYMPTOMS and LOT OF ISSUES are not assessable.   Company comment:   This spontaneous case concerns a 70 year old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Back pain, unknown days after receiving the first dose of mRNA-1273 vaccine. It was reported that the patient got an epidural for her back which did not work quite well (status, after about 7 months of the first dose). She also had arthralgia (knees). Meanwhile, she developed flu like symptoms with cough which was not COVID 19 and had another epidural which again led to back pain. No information on exact date of the event, detailed clinical course, relevant investigations, treatment and outcome was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 70 year old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Back pain, unknown days after receiving the first dose of mRNA-1273 vaccine. It was reported that the patient got an epidural for her back which did not work quite well (status, after about 7 months of the first dose). She also had arthralgia (knees). Meanwhile, she developed flu like symptoms with cough which was not COVID 19 and had another epidural which again led to back pain. No information on exact date of the event, detailed clinical course, relevant investigations, treatment and outcome was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.