Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fall, Hypothyroidism, Impaired driving ability, Limb deformity
Clinical narrative: Low thyroid; Not been able to drive; Leg would turn inward; Falling; Dropped foot; Chills; Clubbed foot; Neuropathy,severe neuropathy of the right foot; This spontaneous case was reported by a patient and describes the occurrence of LIMB DEFORMITY (Clubbed foot), NEUROPATHY PERIPHERAL (Neuropathy,severe neuropathy of the right foot), HYPOTHYROIDISM (Low thyroid) and PERONEAL NERVE PALSY (Dropped foot) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 806M21A, 030(H or A)21B, 028A21A and 026A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent placement (takes a blood thinner because patient had stents in the left side of body due to blood clots.). Concurrent medical conditions included Lupus erythematosus systemic, Anxiety, Sleep problem and Clot blood. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Lupus erythematosus systemic and Anxiety, TRAZODONE for Sleep problem.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced LIMB DEFORMITY (Clubbed foot) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (Neuropathy,severe neuropathy of the right foot) (seriousness criterion medically significant), IMPAIRED DRIVING ABILITY (Not been able to drive), LIMB DISCOMFORT (Leg would turn inward), FALL (Falling), PERONEAL NERVE PALSY (Dropped foot) (seriousness criterion medically significant) and CHILLS (Chills). On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOTHYROIDISM (Low thyroid) (seriousness criterion medically significant). At the time of the report, LIMB DEFORMITY (Clubbed foot), NEUROPATHY PERIPHERAL (Neuropathy,severe neuropathy of the right foot), IMPAIRED DRIVING ABILITY (Not been able to drive), LIMB DISCOMFORT (Leg would turn inward), FALL (Falling), PERONEAL NERVE PALSY (Dropped foot) and CHILLS (Chills) outcome was unknown and HYPOTHYROIDISM (Low thyroid) had resolved.            Concomitant medication included blood thinner (unspecified). Patient got ill from Moderna booster vaccine. Patient had no feeling and not enough feeling to trust it with a car peddle ever since in right leg. Patient thought it was related to lupus that patient had since she was a small child. Patient was diagnosed with a new ailment low thyroid the same day when patient got the vaccine. Patient was put on new thyroid medication which made the patient very sleepy and eventually was taken off of it. The patient went back to the doctor on 29-Sep-2022, was diagnosed with drop foot right and severe neuropathy of the right foot but thyroid was fine. Patient was going to do all of these nerve conduction studies.  Patient not had any previous reactions to the vaccine except for the booster.  Company Comment: This spontaneous case concerns a 56 year old female patient with relevant medical history of Systemic Lupus erythematosus and thrombosis on blood thinners ( S/P stent placement)  , who experienced Serious ( Medically significant ) , unexpected events of peripheral neuropathy , hypoythyroidism  and other non-serious unexpected events of limb deformity , impaired driving ability , limb discomfort , fall and non-serious expected event of chills. The event hypothyroidism occurred on the same day of vaccination with the 2nd booster dose of mRNA-1273 vaccine while the rest of the events occurred on an unknown date in 2022 post vaccination with the 2nd booster dose of the mRNA-1273 vaccine. The primary series Covid 19 vaccine of this patient were also mRNA-1273 vaccine as well as her 1st booster dose. It was reported that the patient  got ill from the 2nd  Moderna booster vaccine which occurred 2 weeks after the vaccination .  She has not been able to drive, dropped foot, chills, falling, no feeling, leg would turn inward, clubbed foot, neuropathy, not enough feeling to trust it with a car peddle ever since in her right leg. She thinks it is related to her lupus that she has had since she was a small child. She also  has  been diagnosed with a new ailment low thyroid the same day they got the vaccine and was placed in a  new thyroid medication which made her very sleepy and was eventually discontinued. The patient made a follow up with her doctor around 2 months post vaccination and she was diagnosed with  foot drop  right and severe neuropathy of the right foot and her thyroid was fine.  She will be scheduled to undergo nerve conduction studies. Outcome of the event hypothyroidism was resolved and the other events it is unknown. The current medical history of Systemic lupus erythematosus and thrombosis may be considered as confounders for the events peripheral neuropathy . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 56 year old female patient with relevant medical history of Systemic Lupus erythematosus and thrombosis on blood thinners ( S/P stent placement)  , who experienced Serious ( Medically significant ) , unexpected events of peripheral neuropathy , hypoythyroidism  and other non-serious unexpected events of limb deformity , impaired driving ability , limb discomfort , fall and non-serious expected event of chills. The event hypothyroidism occurred on the same day of vaccination with the 2nd booster dose of mRNA-1273 vaccine while the rest of the events occurred on an unknown date in 2022 post vaccination with the 2nd booster dose of the mRNA-1273 vaccine. The primary series Covid 19 vaccine of this patient were also mRNA-1273 vaccine as well as her 1st booster dose. It was reported that the patient  got ill from the 2nd  Moderna booster vaccine which occurred 2 weeks after the vaccination .  She has not been able to drive, dropped foot, chills, falling, no feeling, leg would turn inward, clubbed foot, neuropathy, not enough feeling to trust it with a car peddle ever since in her right leg. She thinks it is related to her lupus that she has had since she was a small child. She also  has  been diagnosed with a new ailment low thyroid the same day they got the vaccine and was placed in a  new thyroid medication which made her very sleepy and was eventually discontinued. The patient made a follow up with her doctor around 2 months post vaccination and she was diagnosed with  foot drop  right and severe neuropathy of the right foot and her thyroid was fine.  She will be scheduled to undergo nerve conduction studies. Outcome of the event hypothyroidism was resolved and the other events it is unknown. The current medical history of Systemic lupus erythematosus and thrombosis may be considered as confounders for the events peripheral neuropathy . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.