Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Back pain, Bell's palsy, Burning sensation, Gait disturbance
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre' syndrome), MONOPLEGIA (leg paralysis), PARALYSIS (Paralyzed), PAIN IN EXTREMITY (Pain in leg) and BELL'S PALSY (Bell's palsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007021A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported by the reporter. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jul-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration). On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barré syndrome) (seriousness criterion medically significant), MONOPLEGIA (leg paralysis) (seriousness criterion medically significant), PARALYSIS (Paralyzed) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in leg) (seriousness criterion hospitalization), BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant), GAIT DISTURBANCE (Can not walk), BACK PAIN (Pain in back), SENSORY DISTURBANCE (Nerve sensation), BURNING SENSATION (Burning sensation) and ASTHENIA (No energy/No strength). The patient was treated with IMMUNOGLOBULIN HUMAN NORMAL (IVIGLOB-EX) for Adverse event, at a dose of UNK, QMO. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barré syndrome), MONOPLEGIA (leg paralysis), PARALYSIS (Paralyzed), BELL'S PALSY (Bell's palsy), GAIT DISTURBANCE (Can not walk), BACK PAIN (Pain in back), SENSORY DISTURBANCE (Nerve sensation), BURNING SENSATION (Burning sensation), ASTHENIA (No energy/No strength) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration) outcome was unknown and PAIN IN EXTREMITY (Pain in leg) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Neurological examination: results not reported Results not reported. No concomitant medications were reported. After receiving vaccine, patient visited ER and her primary care doctor due to ongoing leg pain and later hospitalized. It was reported that initially HCP did not found anything and was sent home. Later patient experienced leg paralysis and visited ER again. HCP conducted higher level nerve test and end up putting patient on IVIG for every 30 days caller says. Company comment: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the serious (medically significant) unexpected AESI of Guillain-Barre syndrome, serious (medically significant), unexpected events of monoplegia, and paralysis, serious (hospitalization) unexpected event of pain in extremity (pain in legs) and serious (medically significant) expected AESI of Bell's Palsy. Patient received 2 doses of mRNA 1273 COVID-19 vaccine with 3 months interval between doses. On unknown date, patient had Guillain-Barre syndrome, Bell's palsy, pain in leg, pain in back, paralysis, can not walk, nerve sensation, burning sensation, and asthenia. After unspecified dose of mRNA 1273 Vaccine, patient visited Emergency room (ER) due to ongoing leg pain, was hospitalized however was discharged since no abnormality was noted. Patient visited the ER again due to leg paralysis. Physician conducted higher level nerve test but no results were provided. Patient was given IVIG for 30 days. Additional event of inappropriate schedule of vaccine administration was captured. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the serious (medically significant) unexpected AESI of Guillain-Barre syndrome, serious (medically significant), unexpected events of monoplegia, and paralysis, serious (hospitalization) unexpected event of pain in extremity (pain in legs) and serious (medically significant) expected AESI of Bell's Palsy. Patient received 2 doses of mRNA 1273 COVID-19 vaccine with 3 months interval between doses. On unknown date, patient had Guillain-Barre syndrome, Bell's palsy, pain in leg, pain in back, paralysis, can not walk, nerve sensation, burning sensation, and asthenia. After unspecified dose of mRNA 1273 Vaccine, patient visited Emergency room (ER) due to ongoing leg pain, was hospitalized however was discharged since no abnormality was noted. Patient visited the ER again due to leg paralysis. Physician conducted higher level nerve test but no results were provided. Patient was given IVIG for 30 days. Additional event of inappropriate schedule of vaccine administration was captured. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.