Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain, Viral infection
Clinical narrative: Red spot on leg, diagnosed with cellulitis; Viral infection; slurred speech; rash on both arms, both knees, and right side of cheek by eye; Bell's Palsy; sore arm; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Red spot on leg, diagnosed with cellulitis) and BELL'S PALSY (Bell's Palsy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gallbladder removal on 29-Oct-2021. Concurrent medical conditions included Gallstones.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced VACCINATION SITE PAIN (sore arm), FATIGUE (fatigue) and HEADACHE (headache). On 29-Oct-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). On 12-Nov-2021, the patient experienced CELLULITIS (Red spot on leg, diagnosed with cellulitis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced VIRAL INFECTION (Viral infection), DYSARTHRIA (slurred speech) and RASH (rash on both arms, both knees, and right side of cheek by eye). The patient was hospitalized from 12-Nov-2021 to 15-Nov-2021 due to CELLULITIS. The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) for Adverse event, at an unspecified dose and frequency and ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID) for Adverse event, at an unspecified dose and frequency. At the time of the report, CELLULITIS (Red spot on leg, diagnosed with cellulitis), VIRAL INFECTION (Viral infection), DYSARTHRIA (slurred speech), VACCINATION SITE PAIN (sore arm), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown and BELL'S PALSY (Bell's Palsy) and RASH (rash on both arms, both knees, and right side of cheek by eye) had not resolved.            No concomitant drugs were provided by reporter. Treatment medication include antibiotics and steroids.  Patient stated that when she comes off steroids and antibiotics the bells Palsy and rash symptoms re flare up. Patient had a neurologist appointment on 23December  due to slurred speech from Bells Palsy.  Company Comment: This case concerns a 43 year old female patient, with medical history of recent cholecystecomia, who experienced serious unexpected event of cellulitis and serious expected AESI of Bell´s palsy after second dose of mRNA-1273. The event cellulitis occurred 66 days after second dose and event Bell´s palsy occurred 52 days after second dose. The re-challenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-386032, MOD-2021-386032 (Patient Link).; Sender's Comments: This case concerns a 43 year old female patient, with medical history of recent cholecystecomia, who experienced serious unexpected event of cellulitis and serious expected AESI of Bell´s palsy after second dose of mRNA-1273. The event cellulitis occurred 66 days after second dose and event Bell´s palsy occurred 52 days after second dose. The re-challenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.