Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Dizziness, Inappropriate schedule of product administration, Paraesthesia, Presyncope
Clinical narrative: Inappropriate schedule of vaccine administered; Bell's palsy (the palsy reached her throat); Almost like passing out; Tingling returned; Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy (the palsy reached her throat)) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced BELL'S PALSY (Bell's palsy (the palsy reached her throat)) (seriousness criterion medically significant), PRESYNCOPE (Almost like passing out), PARAESTHESIA (Tingling returned) and DIZZINESS (Light headedness). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, BELL'S PALSY (Bell's palsy (the palsy reached her throat)), PRESYNCOPE (Almost like passing out), PARAESTHESIA (Tingling returned) and DIZZINESS (Light headedness) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.      Treatment medication included steroids for tingling.  She had a prescription but only takes it when necessary.  After the second vaccination the bell palsy and the tingling returned (the palsy reached her throat), also she felt light headedness and almost like passing out. This symptoms have been present for at least 5 days at the time of the call.  Company Comment : This case of Inappropriate schedule of product administration concerns a 38-year-old female patient, with no reported medical history, who experienced the expected serious AESI event of Bell's palsy, the unexpected events of Presyncope and Paraesthesia; and the expected event of Dizziness. The events occurred on an unknown date after the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was not resolved. The rechallenge is positive since the events Bell's palsy and Paraesthesia returned upon re-administration of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-419529 (Patient Link).; Sender's Comments: This case of Inappropriate schedule of product administration concerns a 38-year-old female patient, with no reported medical history, who experienced the expected serious AESI event of Bell's palsy, the unexpected events of Presyncope and Paraesthesia; and the expected event of Dizziness. The events occurred on an unknown date after the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was not resolved. The rechallenge is positive since the events Bell's palsy and Paraesthesia returned upon re-administration of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.