Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Condition aggravated, Dry mouth, Hypoaesthesia oral, Incomplete course of vaccination
Clinical narrative: Did not receive the 2nd dose of vaccine; Bell's palsy got worse; Bell's palsy got worse; Mouth got numb, and has to use straw at the corner of the mouth for drinking; Difficulty to speak/problem to forming words/problem while eating; Mouth gets dry soon; Have eye problem; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's palsy got worse) and CONDITION AGGRAVATED (Bell's palsy got worse) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bell's palsy since December 2020.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced BELL'S PALSY (Bell's palsy got worse) (seriousness criterion medically significant), CONDITION AGGRAVATED (Bell's palsy got worse) (seriousness criterion medically significant), HYPOAESTHESIA ORAL (Mouth got numb, and has to use straw at the corner of the mouth for drinking), ORAL DISCOMFORT (Difficulty to speak/problem to forming words/problem while eating), DRY MOUTH (Mouth gets dry soon) and OCULAR DISCOMFORT (Have eye problem). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Did not receive the 2nd dose of vaccine). The patient was treated with DOXYCYCLINE for Bell's palsy, at a dose of UNK dosage form; Physical therapy (Acupuncture and facial physiotherapy) for Bell's palsy; Physical therapy (Acupuncture and facial physiotherapy) for Condition aggravated; Physical therapy (Acupuncture and facial physiotherapy) for Hypoaesthesia oral; Physical therapy (Acupuncture and facial physiotherapy) for Oral discomfort; Physical therapy (Acupuncture and facial physiotherapy) for Dry mouth and Physical therapy (Acupuncture and facial physiotherapy) for Ocular discomfort. At the time of the report, BELL'S PALSY (Bell's palsy got worse), CONDITION AGGRAVATED (Bell's palsy got worse), HYPOAESTHESIA ORAL (Mouth got numb, and has to use straw at the corner of the mouth for drinking), ORAL DISCOMFORT (Difficulty to speak/problem to forming words/problem while eating), DRY MOUTH (Mouth gets dry soon) and OCULAR DISCOMFORT (Have eye problem) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (Did not receive the 2nd dose of vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Patient visited the Neurologist, and the Infectious Disease Physician.  Concomitant product use was not provided by the reporter.  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 for the event of Bell's palsy got worse. Company causality for Incomplete course of vaccination was assessed as not applicable.; 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 for the event of Bell's palsy got worse. Company causality for Incomplete course of vaccination was assessed as not applicable.