Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching, Musculoskeletal disorder, Pain in extremity, Palpitations
Clinical narrative: Back pain; Palpitations; Photopsia; Fatigue; Paraesthesia; Monoplegia; Dysgeusia; Gait inability; Hypoaesthesia; Immediate post-injection reaction; Impaired driving ability; Limb discomfort; Loss of personal independence in daily activities; Muscle spasms; Muscle twitching; Musculoskeletal disorder; Pain in extremity; This case was received on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of MONOPLEGIA (Monoplegia) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lupus syndrome (mild Lupus in remission). Previously administered products included for Influenza immunization: influenza vaccine. Concomitant products included TOPIRAMATE (TOPAMAX) and ONDANSETRON (ZOFRAN [ONDANSETRON]) for an unknown indication, DROSPIRENONE, ETHINYLESTRADIOL (YASMIN) for product used for unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced MONOPLEGIA (Monoplegia) (seriousness criterion medically significant), DYSGEUSIA (Dysgeusia), GAIT INABILITY (Gait inability), HYPOAESTHESIA (Hypoaesthesia), IMMEDIATE POST-INJECTION REACTION (Immediate post-injection reaction), IMPAIRED DRIVING ABILITY (Impaired driving ability), LIMB DISCOMFORT (Limb discomfort), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Loss of personal independence in daily activities), MUSCLE SPASMS (Muscle spasms), MUSCLE TWITCHING (Muscle twitching), MUSCULOSKELETAL DISORDER (Musculoskeletal disorder), PAIN IN EXTREMITY (Pain in extremity), PARAESTHESIA (Paraesthesia) and FATIGUE (Fatigue). On 23-Feb-2021, the patient experienced BACK PAIN (Back pain), PALPITATIONS (Palpitations) and PHOTOPSIA (Photopsia). At the time of the report, MONOPLEGIA (Monoplegia), BACK PAIN (Back pain), DYSGEUSIA (Dysgeusia), GAIT INABILITY (Gait inability), HYPOAESTHESIA (Hypoaesthesia), IMMEDIATE POST-INJECTION REACTION (Immediate post-injection reaction), IMPAIRED DRIVING ABILITY (Impaired driving ability), LIMB DISCOMFORT (Limb discomfort), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Loss of personal independence in daily activities), MUSCLE SPASMS (Muscle spasms), MUSCLE TWITCHING (Muscle twitching), MUSCULOSKELETAL DISORDER (Musculoskeletal disorder), PAIN IN EXTREMITY (Pain in extremity), PALPITATIONS (Palpitations), PARAESTHESIA (Paraesthesia), PHOTOPSIA (Photopsia) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Event terms, onset dates and outcomes captured per SD Authority reporting.  Patient referred to being advised to avoid second dose of vaccine but it is not specified whether this was missed.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Event terms, onset dates and outcomes captured per SD Authority reporting.  Patient referred to being advised to avoid second dose of vaccine but it is not specified whether this was missed.