Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Diplopia, Dyspepsia, Fatigue
Clinical narrative: extreme heartburn on a daily basis; Migraine Headache; extreme brain fatigue; cranial nerve palsy in my left eye/Double vision switched to my right eye; severe headache; developed a fever; acidic vomiting; sweating; extreme nausea which would get worse in the evening; double vision returned after second dose; This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMOPLEGIA (cranial nerve palsy in my left eye/Double vision switched to my right eye) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced DIPLOPIA (double vision returned after second dose) and NAUSEA (extreme nausea which would get worse in the evening). In August 2021, the patient experienced HYPERHIDROSIS (sweating), HEADACHE (severe headache), PYREXIA (developed a fever) and VOMITING (acidic vomiting). On an unknown date, the patient experienced OPHTHALMOPLEGIA (cranial nerve palsy in my left eye/Double vision switched to my right eye) (seriousness criterion medically significant), DYSPEPSIA (extreme heartburn on a daily basis), MIGRAINE (Migraine Headache) and FATIGUE (extreme brain fatigue). The patient was treated with PROPRANOLOL for Migraine, at a dose of 20 milligram; PREDNISONE on 12-Aug-2021 at a dose of 6 days of Prednisone and PYRIDOSTIGMINE BROMIDE (MESTINON) on 17-Sep-2021 at a dose of 60 milligram. At the time of the report, OPHTHALMOPLEGIA (cranial nerve palsy in my left eye/Double vision switched to my right eye), DIPLOPIA (double vision returned after second dose), DYSPEPSIA (extreme heartburn on a daily basis), MIGRAINE (Migraine Headache), HYPERHIDROSIS (sweating), NAUSEA (extreme nausea which would get worse in the evening), FATIGUE (extreme brain fatigue), HEADACHE (severe headache), PYREXIA (developed a fever) and VOMITING (acidic vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) normal. On an unknown date, Thyroid function test: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported.  Company comment: This case concerns a 32-year-old, female patient with no relevant medical history, who experienced the unexpected serious (IME) event of OPHTHALMOPLEGIA, the unexpected events of DYPLOPIA, DYSPEPSIA, MIGRAINE, SWEATING, and the expected non-serious events NAUSEA, PYREXIA, VOMITING, FATIGUE and HEADACHE. The events occur between days and 6 months after the second dose of Spikevax. The events were considered related to the product per the reporter's assessment. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-323388 (Patient Link).; Sender's Comments: This case concerns a 32-year-old, female patient with no relevant medical history, who experienced the unexpected serious (IME) event of OPHTHALMOPLEGIA, the unexpected events of DYPLOPIA, DYSPEPSIA, MIGRAINE, SWEATING, and the expected non-serious events NAUSEA, PYREXIA, VOMITING, FATIGUE and HEADACHE. The events occur between days and 6 months after the second dose of Spikevax. The events were considered related to the product per the reporter's assessment. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.