Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Therapeutic response shortened
Clinical narrative: Neck pain; Back pain; Pain aggravated; Wearing off effect; Pain in hand; Chills; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), BACK PAIN (Back pain), PAIN (Pain aggravated), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and PAIN IN EXTREMITY (Pain in hand) in an adult 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) injection for Ankylosing spondylitis.    The patient's past medical history included Gastrointestinal disorder NOS and Gallbladder removal. Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third 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 NECK PAIN (Neck pain), BACK PAIN (Back pain), PAIN (Pain aggravated), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), PAIN IN EXTREMITY (Pain in hand), FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, NECK PAIN (Neck pain), BACK PAIN (Back pain), PAIN (Pain aggravated), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and PAIN IN EXTREMITY (Pain in hand) had not resolved and FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea) had resolved.            Concomitant products were not provided. Treatment medication were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown dates, the patient experienced fatigue, chills, nausea, pain in neck, pain in back, pain in hands and pain more than two to three days.  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 is a spontaneous case reported by a consumer. An adult female patient received 3 doses of mRNA-1273 vaccine and experienced non serious events of neck pain, back pain, pain aggravated, therapeutic response shortened, fatigue, chills, nausea and pain in hand. Vaccination dates and onset date of the events were not provided; hence, latency cannot be assessed. Relevant medical history included gastrointestinal disorder NOS which could be a contributory factor for nausea. Relevant concurrent medical conditions included Ankylosing spondylitis which could be a contributory factor for fatigue, neck pain, back pain, pain aggravated and pain in hand. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. An adult female patient received 3 doses of mRNA-1273 vaccine and experienced non serious events of neck pain, back pain, pain aggravated, therapeutic response shortened, fatigue, chills, nausea and pain in hand. Vaccination dates and onset date of the events were not provided; hence, latency cannot be assessed. Relevant medical history included gastrointestinal disorder NOS which could be a contributory factor for nausea. Relevant concurrent medical conditions included Ankylosing spondylitis which could be a contributory factor for fatigue, neck pain, back pain, pain aggravated and pain in hand. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.