Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Gaze palsy, Headache, Injection site pain
Clinical narrative: You have both of your eyes are drooping, but significantly more dropping on the right side; couldn't sit up, couldn't turn over, couldn't walk without assistance; voice got weaker; shortness of breath; severe muscle weakness ,pain; SORE ARM; excruciating headache; fever 102.1 F; CHILLS; injection site soreness; injection site swelling; rash; fatigue; joint pain; A spontaneous report was received from a nurse concerning a female patient who experienced arthralgia, fatigue, aphonia, muscle weakness, headache, pyrexia, chills, asthma, dyspnoea, injection site pain, injection site swelling, rash, gaze palsy, and gait disturbance.    The patient's medical history included asthma, two cataract surgeries in ??-DEC-2020, and Laryngoscopy in ??-DEC-2021. Concomitant product use was not provided/unknown by the reporter.    The patient received their first of two planned doses of mRNA-1273 (Batch number:025J20A) on 20-DEC-2020 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. The patient received their second of the two planned doses of mRNA-1273 (Batch number: 030L20A) on 29-JAN-2021 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.    The patient received the second dose of Moderna vaccine at 9:30 AM on Friday 29-Jan-2021. At 3:00 PM, she had arm soreness, fatigue, voice got weaker too, The patient had history of right vocal cord issues as it does not open clearly (history of 3years, had surgery two years ago but did not go well). At 6:00 PM, she had severe muscle weakness, pain. At 8:00 PM at night, she had excruciating headache, chills and fever, At 10:00 PM, she had chills, fever 102.1 F, headache, muscle pain, joint pain. The patient had history of asthma and her oxygen was 92-95, little shortness of breath from Friday to Sunday night and everything lasted 36 hours. On Sunday morning, she had headache and mild soreness at injection site, but muscle pain was still pronounced.   On 01-Feb-2021, the patient had mild headache, but extreme fatigue, no pain and no fever. She also had injection site reaction, swollen at site of injection, rash until that morning started on day of injection. The patient took Tylenol every 6 hours starting from 3:00 PM on day of injection. The patient reported to her Doctor and he said it was all injection reaction happening to her. The patient reported muscle weakness that lasted until 07-FEB-2021. She could not sit up, couldn't turn over, couldn't walk without assistance. She had a fever of 103, really bad headache, and just hasn't felt good since she got the vaccine, easily fatigued. On 08-FEB-2021, the patient saw her ophthalmologist who noticed right away that both of her eyes were drooping, but significantly more on the right side.   Treatment for the events included acetaminophen.    The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The events, arthralgia, fatigue, aphonia, muscle weakness, headache, pyrexia, chills, asthma, dyspnoea, injection site pain, injection site swelling, rash, gaze palsy, and gait disturbance, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.