Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Blepharospasm, Eye disorder, Eye irritation, Eye swelling
Clinical narrative: Allergic reaction since getting the Moderna covid19; Face paralysis; Neck pain; Eye lid palpitations; Problems with the eyes; Swelling  of the eyes; Eyes burn; Face numbness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Face paralysis) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028k21a, 038a21a and 046b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced FACIAL PARALYSIS (Face paralysis) (seriousness criterion medically significant), NECK PAIN (Neck pain), BLEPHAROSPASM (Eye lid palpitations), EYE DISORDER (Problems with the eyes), EYE SWELLING (Swelling  of the eyes), EYE IRRITATION (Eyes burn), HYPOAESTHESIA (Face numbness) and HEADACHE (Headache). On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic reaction since getting the Moderna covid19). At the time of the report, FACIAL PARALYSIS (Face paralysis), NECK PAIN (Neck pain), BLEPHAROSPASM (Eye lid palpitations), EYE DISORDER (Problems with the eyes), EYE SWELLING (Swelling  of the eyes), EYE IRRITATION (Eyes burn), HYPOAESTHESIA (Face numbness), HEADACHE (Headache) and ALLERGY TO VACCINE (Allergic reaction since getting the Moderna covid19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: not provided Not provided.         She had no past medical history or allergies before vaccination and had not taken any other vaccines 1 month prior to Moderna. She went to doctor office every week for a month and took unspecified steroid that inflated her like a pig. Patient symptoms sometimes worsened and other times improved.   Concomitant medication was not provided Treatment information was not reported.  Company comment: This is a spontaneous case concerning a 41-year-old female patient with no medical history reported, who experienced the expected serious(Medically significant) and AESI  event of facial paralysis, as well as non serious events of neck pain, blepharospasm, eye disorder, eye swelling, eye irritation, hypoaesthesia, headache and allergy to vaccine after the first and booster dose of mRNA1273 vaccine. The events occurred approximately 24 days after the booster dose of mRNA1273 vaccine. Patient was treated with unspecified steroid. The outcome of the events was not recovered. Rechallenge was positive as events re occurred after the booster dose ( the patient stated that after first series and the booster she had face paralysis, headache, neck pain, face numbness, eye lid palpitations, problems with the eyes, swelling  of the eyes and  they burn. this also happened since the 31Jan2022). The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-483651, MOD-2022-483779 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 41-year-old female patient with no medical history reported, who experienced the expected serious(Medically significant) and AESI  event of facial paralysis, as well as non serious events of neck pain, blepharospasm, eye disorder, eye swelling, eye irritation, hypoaesthesia, headache and allergy to vaccine after the first and booster dose of mRNA1273 vaccine. The events occurred approximately 24 days after the booster dose of mRNA1273 vaccine. Patient was treated with unspecified steroid. The outcome of the events was not recovered. Rechallenge was positive as events re occurred after the booster dose ( the patient stated that after first series and the booster she had face paralysis, headache, neck pain, face numbness, eye lid palpitations, problems with the eyes, swelling  of the eyes and  they burn. this also happened since the 31Jan2022). The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.