Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pain in jaw, Tinnitus, Vision blurred
Clinical narrative: Ringing in the left ear after the 2nd dose; Terrible migraine headache after the 2nd dose; Pain behind his eyes after the 2nd dose; Lower really bad back pain after the 2nd dose; blurry vision; neck pain; could hardly even walk; can't pick something off the ground; Pain in jaw; burning feet; Burning pain in his hands after the 2nd dose; Knees are so bad; Soreness in the arm after the 2nd dose; Extra dose administered; Little worse headache after the 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Ringing in the left ear after the 2nd dose), MIGRAINE (Terrible migraine headache after the 2nd dose), EYE PAIN (Pain behind his eyes after the 2nd dose), BACK PAIN (Lower really bad back pain after the 2nd dose), VISION BLURRED (blurry vision), NECK PAIN (neck pain), GAIT DISTURBANCE (could hardly even walk), MOVEMENT DISORDER (can't pick something off the ground), PAIN IN JAW (Pain in jaw), PAIN IN EXTREMITY (burning feet), PAIN (Burning pain in his hands after the 2nd dose) and ARTHRALGIA (Knees are so bad) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included CETIRIZINE for Allergy, LEVOTHYROXINE and DOXAZOSIN MESILATE (DOXAZOCIN) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm after the 2nd dose), EXTRA DOSE ADMINISTERED (Extra dose administered) and HEADACHE (Little worse headache after the 2nd dose). On 31-Mar-2021, the patient experienced TINNITUS (Ringing in the left ear after the 2nd dose) (seriousness criterion disability), MIGRAINE (Terrible migraine headache after the 2nd dose) (seriousness criterion disability), EYE PAIN (Pain behind his eyes after the 2nd dose) (seriousness criterion disability), BACK PAIN (Lower really bad back pain after the 2nd dose) (seriousness criterion disability), VISION BLURRED (blurry vision) (seriousness criterion disability), NECK PAIN (neck pain) (seriousness criterion disability), GAIT DISTURBANCE (could hardly even walk) (seriousness criterion disability), MOVEMENT DISORDER (can't pick something off the ground) (seriousness criterion disability) and PAIN IN JAW (Pain in jaw) (seriousness criterion disability). 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (burning feet) (seriousness criterion disability), PAIN (Burning pain in his hands after the 2nd dose) (seriousness criterion disability) and ARTHRALGIA (Knees are so bad) (seriousness criterion disability). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 21-Mar-2021, PAIN IN EXTREMITY (Soreness in the arm after the 2nd dose) and HEADACHE (Little worse headache after the 2nd dose) had resolved. At the time of the report, TINNITUS (Ringing in the left ear after the 2nd dose), MIGRAINE (Terrible migraine headache after the 2nd dose), EYE PAIN (Pain behind his eyes after the 2nd dose), BACK PAIN (Lower really bad back pain after the 2nd dose), VISION BLURRED (blurry vision), NECK PAIN (neck pain), GAIT DISTURBANCE (could hardly even walk), MOVEMENT DISORDER (can't pick something off the ground), PAIN IN JAW (Pain in jaw), PAIN IN EXTREMITY (burning feet), ARTHRALGIA (Knees are so bad) and EXTRA DOSE ADMINISTERED (Extra dose administered) outcome was unknown and PAIN (Burning pain in his hands after the 2nd dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal there was nothing life-threatening on the CT scan.         Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-133281 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Follow up was received on 05-JUN-2021. Additional events (pain in the jaw, knee pain, burning feet, gait disturbance, blurry vision, movement disorder, neck pain) were added. Primary source reporter causality was updated to probable. Case was upgraded to serious (disabling).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.