Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug interaction, Facial paralysis
Clinical narrative: facial palsy; patient received the Moderna Covid vaccineabout 10 days prior to her second injection; This spontaneous case was reported by a nurse and describes the occurrence of FACIAL PARALYSIS (facial palsy) in a 50-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.    Co-suspect product included non-company product BOTULINUM TOXIN TYPE A (BOTOX COSMETIC) injection for Cosmetic allergy.    The patient's past medical history included Operation NOS (Recently had breast implants removed. (mhb)). Concurrent medical conditions included Fibromyalgia and Autoimmune disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 21-Jul-2021, the patient BOTULINUM TOXIN TYPE A (BOTOX COSMETIC) (unknown route) dosage was changed to 24 unit and BOTULINUM TOXIN TYPE A (BOTOX COSMETIC) (unknown route) dosage was changed to 24 unit. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started BOTULINUM TOXIN TYPE A (BOTOX COSMETIC) (Topical) 10 unit. On an unknown date, the patient experienced FACIAL PARALYSIS (facial palsy) (seriousness criterion medically significant) and DRUG INTERACTION (patient received the Moderna Covid vaccineabout 10 days prior to her second injection). At the time of the report, FACIAL PARALYSIS (facial palsy) and DRUG INTERACTION (patient received the Moderna Covid vaccineabout 10 days prior to her second injection) outcome was unknown. Not Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant drug includes: Nutritional supplements.  Company comment This case concerns a 50year-old, female patient with a medical history fibromyalgia and autoimmune disorder, who experienced the unexpected event of facial paralysis. Botulinum toxin type A is a Co-suspect product in this case. The events facial paralysis and drug interaction occurred on an unknown date while  the first dose of Moderna Covid-19 vaccine was received on 26-July-2021. The co-suspect drug was received on 21-July-2021 with a total of 58 units for cosmetic purposes. The rechallenge is not applicable as the events occurred after the first dose with no information about the second was provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a 50year-old, female patient with a medical history fibromyalgia and autoimmune disorder, who experienced the unexpected event of facial paralysis. Botulinum toxin type A is a Co-suspect product in this case. The events facial paralysis and drug interaction occurred on an unknown date while  the first dose of Moderna Covid-19 vaccine was received on 26-July-2021. The co-suspect drug was received on 21-July-2021 with a total of 58 units for cosmetic purposes. The rechallenge is not applicable as the events occurred after the first dose with no information about the second was provided. The benefit-risk relationship of the vaccine is not affected by this report.