Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dizziness, Dysstasia, Head discomfort
Clinical narrative: COVID-19; Heavy feeling in head occasionally; Some stiffness in neck; Difficulty to do physically demanding activities/full days activities; Difficulty to look over shoulder without turning body/difficulty bending down forward from the waist to pick up pen; At morning and night difficult to put socks/tights/to get up out of an armless chair without using hands; At morning and night to stand unsupported for ten minutes without discomfort/difficult climbing 12 to 15 steps; Light headedness; Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Difficulty to do physically demanding activities/full days activities), JOINT RANGE OF MOTION DECREASED (Difficulty to look over shoulder without turning body/difficulty bending down forward from the waist to pick up pen), MOBILITY DECREASED (At morning and night difficult to put socks/tights/to get up out of an armless chair without using hands), DYSSTASIA (At morning and night to stand unsupported for ten minutes without discomfort/difficult climbing 12 to 15 steps) and HEAD DISCOMFORT (Heavy feeling in head occasionally) in a 59-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.    The patient's past medical history included Fall on 05-Jun-2021 and Foot fracture on 05-Jun-2021. Concurrent medical conditions included Mobility decreased (Difficulty to do physically demanding activities/full days activities), Difficulty in standing (Difficult to stand unsupported for ten minutes without discomfort), Activities of daily living impaired and Joint range of motion decreased (Difficulty to look over shoulder without turning body).   On 18-Jun-2021, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. 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) at an unspecified dose. In 2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Difficulty to do physically demanding activities/full days activities), JOINT RANGE OF MOTION DECREASED (Difficulty to look over shoulder without turning body/difficulty bending down forward from the waist to pick up pen), MOBILITY DECREASED (At morning and night difficult to put socks/tights/to get up out of an armless chair without using hands), DYSSTASIA (At morning and night to stand unsupported for ten minutes without discomfort/difficult climbing 12 to 15 steps), HEAD DISCOMFORT (Heavy feeling in head occasionally), MUSCULOSKELETAL STIFFNESS (Some stiffness in neck), DIZZINESS (Light headedness), CHILLS (Chills) and PYREXIA (fever). In January 2022, the patient experienced COVID-19 (COVID-19). In 2021, CHILLS (Chills) and PYREXIA (fever) had resolved. In 2022, COVID-19 (COVID-19) had resolved. At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Difficulty to do physically demanding activities/full days activities), JOINT RANGE OF MOTION DECREASED (Difficulty to look over shoulder without turning body/difficulty bending down forward from the waist to pick up pen), MOBILITY DECREASED (At morning and night difficult to put socks/tights/to get up out of an armless chair without using hands) and DYSSTASIA (At morning and night to stand unsupported for ten minutes without discomfort/difficult climbing 12 to 15 steps) was resolving and HEAD DISCOMFORT (Heavy feeling in head occasionally), MUSCULOSKELETAL STIFFNESS (Some stiffness in neck) and DIZZINESS (Light headedness) outcome was unknown.            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.  Concomitant medication was not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the events of difficulty to do physically demanding activities/full days activities, difficulty to look over shoulder without turning body/difficulty bending down forward from the waist to pick up pen, at morning and night difficult to put socks/tights/to get up out of an armless chair without using hands/to stand unsupported for ten minutes without discomfort/difficult climbing 12 to 15 steps onset in 2021, at morning and night difficult to put socks/tights/to get up out of an armless chair without using hands/to stand unsupported for ten minutes without discomfort/difficult climbing 12 to 15 steps onset in 2021, some stiffness in neck, heavy feeling in head occasionally, light headedness, chills, fever and covid was not provided for co-suspect drug Humira.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Significant Follow Up Appended (Live FU)_ Event information and narrative description updated. On 10-Feb-2022: Significant Follow Up Appended (Live FU)_ Event information, Event  and narrative description updated.