Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vaccination site pain
Clinical narrative: she has not gotten 2nd dose yet; left arm soreness; Couldn't wink her right eye/has a hard time seeing out of her right eye/couldn't lift her right eyebrow; Bell's Palsy and it has been awful; Earache in her right ear; Face was swollen; Left arm and under that arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy and it has been awful) and OPHTHALMOPLEGIA (Couldn't wink her right eye/has a hard time seeing out of her right eye/couldn't lift her right eyebrow) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced AXILLARY PAIN (Left arm and under that arm soreness). On 25-Aug-2021, the patient experienced EAR PAIN (Earache in her right ear) and SWELLING FACE (Face was swollen). On 26-Aug-2021, the patient experienced BELL'S PALSY (Bell's Palsy and it has been awful) (seriousness criterion medically significant) and OPHTHALMOPLEGIA (Couldn't wink her right eye/has a hard time seeing out of her right eye/couldn't lift her right eyebrow) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (she has not gotten 2nd dose yet) and VACCINATION SITE PAIN (left arm soreness). The patient was treated with PARACETAMOL (TYLENOL) on 25-Aug-2021 for Earache, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bell's Palsy and it has been awful), EAR PAIN (Earache in her right ear), SWELLING FACE (Face was swollen), OPHTHALMOPLEGIA (Couldn't wink her right eye/has a hard time seeing out of her right eye/couldn't lift her right eyebrow), AXILLARY PAIN (Left arm and under that arm soreness) and VACCINATION SITE PAIN (left arm soreness) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she has not gotten 2nd dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Patient stated that she had a hard time seeing out of her right eye and did not receive the second dose.  Company Comment:  This case concerns a 59 year-old, female patient with no relevant medical history, who experienced the unexpected events of ear pain, swelling face, ophthalmoplegia, product dose omission and expected events of Bell's Palsy, axillary pain and vaccination site pain. The events ear pain and swelling face occurred approximately 27 days after the first dose while events ophthalmoplegia and Bell's palsy occurred 28 days after first dose of Spikevax. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 59 year-old, female patient with no relevant medical history, who experienced the unexpected events of ear pain, swelling face, ophthalmoplegia, product dose omission and expected events of Bell's Palsy, axillary pain and vaccination site pain. The events ear pain and swelling face occurred approximately 27 days after the first dose while events ophthalmoplegia and Bell's palsy occurred 28 days after first dose of Spikevax. The benefit-risk relationship of Spikevax is not affected by this report.