Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Impaired driving ability, Injection site haemorrhage, Injection site pain, Migraine
Clinical narrative: Trouble moving or getting out of position; Pain in his arm; Feeling some symptoms including some chill; A little bit of blood after the injection; Pain during injection; When he has the headaches, he cannot even be driving; Headaches and has bad vision during his migraines; Bad vision during his migraines; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED DRIVING ABILITY (When he has the headaches, he cannot even be driving) in a 65-year-old male 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 DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concurrent medical conditions included Sleep disorder and Eczema.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 mg once a day. On 12-Mar-2021, the patient experienced INJECTION SITE HAEMORRHAGE (A little bit of blood after the injection) and INJECTION SITE PAIN (Pain during injection). On 18-Mar-2021, the patient experienced MOVEMENT DISORDER (Trouble moving or getting out of position), PAIN IN EXTREMITY (Pain in his arm) and CHILLS (Feeling some symptoms including some chill). In 2021, the patient experienced IMPAIRED DRIVING ABILITY (When he has the headaches, he cannot even be driving) (seriousness criterion disability), MIGRAINE (Headaches and has bad vision during his migraines) and VISUAL IMPAIRMENT (Bad vision during his migraines). On 21-Mar-2021, MOVEMENT DISORDER (Trouble moving or getting out of position), PAIN IN EXTREMITY (Pain in his arm) and CHILLS (Feeling some symptoms including some chill) had resolved. At the time of the report, IMPAIRED DRIVING ABILITY (When he has the headaches, he cannot even be driving), MIGRAINE (Headaches and has bad vision during his migraines) and VISUAL IMPAIRMENT (Bad vision during his migraines) had not resolved and INJECTION SITE HAEMORRHAGE (A little bit of blood after the injection) and INJECTION SITE PAIN (Pain during injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter causality was updated from not reported to unassessable.  No treatment information provided.  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.  however, the concomitant use if DUPILUMAB could be a confounder because visual impairment is an adverse event for this drug. No further information is available for this case because patient denied follow-up.; 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.  however, the concomitant use if DUPILUMAB could be a confounder because visual impairment is an adverse event for this drug. No further information is available for this case because patient denied follow-up.