Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Muscle spasms
Clinical narrative: facial paralysis/still have permanent paralysis with spasms on the right side of my face; spasms/still have permanent paralysis with spasms on the right side of my face; This spontaneous case was reported by a patient and describes the occurrence of FACIAL PARALYSIS (facial paralysis/still have permanent paralysis with spasms on the right side of my face) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 026B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had Bells Palsy on left side of her face before the first dose. Patient reaction was violent nausea and vomiting, then was fine the next day 09Mar2021. The left side of her face had resolved. Patient never had Covid-19 positive test and nor diagnosed. No other vaccine was taken by the patient within one month or prior to Moderna COVID-19 Vaccine.  The patient's past medical history included Bell's palsy from 08-Mar-2021 to 2021. Concurrent medical conditions included Allergy to antibiotic, Alpha-1 antitrypsin deficiency (no recent change in status) since 2015 and Diabetes (Started 2 years ago no recent change in status).   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced FACIAL PARALYSIS (facial paralysis/still have permanent paralysis with spasms on the right side of my face) (seriousness criterion medically significant) and MUSCLE SPASMS (spasms/still have permanent paralysis with spasms on the right side of my face). The patient was treated with ACYCLOVIR [ACICLOVIR] at an unspecified dose and frequency. At the time of the report, FACIAL PARALYSIS (facial paralysis/still have permanent paralysis with spasms on the right side of my face) and MUSCLE SPASMS (spasms/still have permanent paralysis with spasms on the right side of my face) had not resolved.            Concomitant information was not reported. Patient got the second dose on her left side.  Patient had visited 6 doctors and all doctors tell her that they'd never seen it on both sides. First date of medical clinic (doctor visits) visit was on 18-APR-2021. The patient was prescribed acyclovir and steroids at the clinic when patient visited all three times. It was reported that the spasms have not gone away, and they are pretty bad and the symptoms stayed the same. Company comment: This is a spontaneous case concerning a 66-year-old female patient, with medical history of Bell's Palsy 12 days before the first dose of mRNA-1273, diabetes, who experienced the serious, medically significant, expected AESI event of Facial paralysis, which occurred the day after the booster dose of mRNA-1273. The patient experienced Bell's Palsy on the left side of her face before the first dose and recovered on the next day. The day after the second dose she had the same event on the right side of her face and lasted three months. She reported that she had tests done and none confirmed a stroke and the event resolved again. The day after the booster dose, she had facial paralysis and spasms. At the time of the last observation, she still has permanent paralysis with spasms on the right side of her face. The rechallenge was positive since the patient experienced similar events after the 2nd dose, resolved and reappeared after the 3rd dose. Both mentioned medical history could be confounders for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-597755, MOD-2022-597762.; Sender's Comments: This is a spontaneous case concerning a 66-year-old female patient, with medical history of Bell's Palsy 12 days before the first dose of mRNA-1273, diabetes, who experienced the serious, medically significant, expected AESI event of Facial paralysis, which occurred the day after the booster dose of mRNA-1273. The patient experienced Bell's Palsy on the left side of her face before the first dose and recovered on the next day. The day after the second dose she had the same event on the right side of her face and lasted three months. She reported that she had tests done and none confirmed a stroke and the event resolved again. The day after the booster dose, she had facial paralysis and spasms. At the time of the last observation, she still has permanent paralysis with spasms on the right side of her face. The rechallenge was positive since the patient experienced similar events after the 2nd dose, resolved and reappeared after the 3rd dose. Both mentioned medical history could be confounders for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.