Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Feeling abnormal, Flank pain, Hypersomnia
Clinical narrative: Vaccination related malaise; GOT SICK/REACTION AFTER FOURTH COVID VACCINE; BRAIN FOG; Chills; COULD NOT GET OUT OF BED/COULD NOT MAKE IT TO THE BATHROOM JUST 12 FEET; SLEPT A LOT; HIPS FELT LIKE THEY WERE ON FIRE; Fever; Urinary tract infection; PAIN IN SIDE; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination related malaise), ILLNESS (GOT SICK/REACTION AFTER FOURTH COVID VACCINE), FEELING ABNORMAL (BRAIN FOG), CHILLS (Chills) and MOBILITY DECREASED (COULD NOT GET OUT OF BED/COULD NOT MAKE IT TO THE BATHROOM JUST 12 FEET) 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) solution for injection for Panuveitis.    No Medical History information was reported.   On 01-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third 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, first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination related malaise), ILLNESS (GOT SICK/REACTION AFTER FOURTH COVID VACCINE), FEELING ABNORMAL (BRAIN FOG), CHILLS (Chills), MOBILITY DECREASED (COULD NOT GET OUT OF BED/COULD NOT MAKE IT TO THE BATHROOM JUST 12 FEET), HYPERSOMNIA (SLEPT A LOT), BURNING SENSATION (HIPS FELT LIKE THEY WERE ON FIRE), PYREXIA (Fever), URINARY TRACT INFECTION (Urinary tract infection) and FLANK PAIN (PAIN IN SIDE ). At the time of the report, IMMUNISATION REACTION (Vaccination related malaise), ILLNESS (GOT SICK/REACTION AFTER FOURTH COVID VACCINE) and URINARY TRACT INFECTION (Urinary tract infection) had resolved and FEELING ABNORMAL (BRAIN FOG), CHILLS (Chills), MOBILITY DECREASED (COULD NOT GET OUT OF BED/COULD NOT MAKE IT TO THE BATHROOM JUST 12 FEET), HYPERSOMNIA (SLEPT A LOT), BURNING SENSATION (HIPS FELT LIKE THEY WERE ON FIRE), PYREXIA (Fever) and FLANK PAIN (PAIN IN SIDE ) outcome was unknown.            Concomitant products were not provided. Treatment medications were not reported.  Company comment: This is a spontaneous case concerning an adult female, with no medical history reported, who experienced the unexpected non-serious adverse events of special interest Hypersomnia and non-serious events Urinary tract infection and Mobility decreased, which occurred unknown day after the fourth dose of mRNA-1273 vaccine administration. No information provided regarding previous doses of COVID-19 vaccine received. No treatment medication details was reported. Concomitant use of adalimumab and patient's gender may be confounders for the events. The outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning an adult female, with no medical history reported, who experienced the unexpected non-serious adverse events of special interest Hypersomnia and non-serious events Urinary tract infection and Mobility decreased, which occurred unknown day after the fourth dose of mRNA-1273 vaccine administration. No information provided regarding previous doses of COVID-19 vaccine received. No treatment medication details was reported. Concomitant use of adalimumab and patient's gender may be confounders for the events. The outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.