Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Arthritis, Immunodeficiency, Intervertebral disc disorder, Musculoskeletal discomfort
Clinical narrative: Immunodeficiency; Joint inflammation/Inflammation localized; Neck pain; Back discomfort; Discopathy; Joint pain; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Immunodeficiency) in a 60-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 Ankylosing spondylitis.    There was no reported medical history.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-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) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In December 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced IMMUNODEFICIENCY (Immunodeficiency) (seriousness criterion medically significant), ARTHRITIS (Joint inflammation/Inflammation localized), NECK PAIN (Neck pain), MUSCULOSKELETAL DISCOMFORT (Back discomfort), INTERVERTEBRAL DISC DISORDER (Discopathy) and ARTHRALGIA (Joint pain). At the time of the report, IMMUNODEFICIENCY (Immunodeficiency), MUSCULOSKELETAL DISCOMFORT (Back discomfort), INTERVERTEBRAL DISC DISORDER (Discopathy) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown and ARTHRITIS (Joint inflammation/Inflammation localized), NECK PAIN (Neck pain) and ARTHRALGIA (Joint pain) had not resolved. Not Provided          No concomitant medications were reported.  It was reported that, the patient had low immune system, covid shot three caused soreness in arm, two discs in neck area causing problems, inflammation in neck, inflammation in hips and shoulders, pain in neck, pain in hips and shoulder and two discs in lower back creating pressure in left side of body.  it was unknown if patient was enrolled in a covid-19 vaccine trial.  No treatment medications were reported.  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 60-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of Immunodeficiency and unexpected non-serious AESI Arthritis on an unknown date after receiving a dose of mRNA-1273 vaccine along with non-serious event of neck pain and arthralgia. Patient received 3 doses of mRNA-1273 vaccine, with primary series given at 28 days apart, and 3rd dose given after 7 months. Patient was treated with Andalimumab for ankylosing spondylitis could be considered as confounder. Clinical course and treatment details were not reported. The outcome of event was reported as. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of Immunodeficiency and unexpected non-serious AESI Arthritis on an unknown date after receiving a dose of mRNA-1273 vaccine along with non-serious event of neck pain and arthralgia. Patient received 3 doses of mRNA-1273 vaccine, with primary series given at 28 days apart, and 3rd dose given after 7 months. Patient was treated with Andalimumab for ankylosing spondylitis could be considered as confounder. Clinical course and treatment details were not reported. The outcome of event was reported as. The benefit-risk relationship of mRNA-1273 is not affected by this report.