Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Feeling abnormal, Insomnia, Myalgia
Clinical narrative: Trouble swallowing; Trouble sleeping; When she looks at or focus on an object it goes into her mouth; Hurting all over / Aching all over; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Trouble swallowing), INSOMNIA (Trouble sleeping), FEELING ABNORMAL (When she looks at or focus on an object it goes into her mouth) and MYALGIA (Hurting all over / Aching all over) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medial history information provided.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MYALGIA (Hurting all over / Aching all over). On 12-Mar-2021, the patient experienced DYSPHAGIA (Trouble swallowing), INSOMNIA (Trouble sleeping) and FEELING ABNORMAL (When she looks at or focus on an object it goes into her mouth). The patient was treated with ALPRAZOLAM (XANAX) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPHAGIA (Trouble swallowing) and INSOMNIA (Trouble sleeping) had not resolved and FEELING ABNORMAL (When she looks at or focus on an object it goes into her mouth) and MYALGIA (Hurting all over / Aching all over) outcome was unknown.            Patient called to report that she received her 1st dose of the Moderna vaccine 10FEB2021 and her 2nd dose 10MAR2021.  On 11MAR2021 patient stated that she was hurting and aching all over. On 12MAR2021 she was having hallucinations.  The patient said she had razor blades, screws and pots and pans in her mouth. The patient also had shoe laces in her gums and a gun in top of her mouth. Patient further stated that when she looks at or focus on an object it seems to go into her mouth and still had trouble swallowing or sleeping.  Patient further stated she was taking Lexapro before she took the Moderna vaccine and Xanax after she took the vaccine.  This case concerns a 68-year-old, female with not reported medical history, who experienced the unexpected events of Hallucinations, insomnia, dysphagia and the expected event of myalgia . The event occurred approximately between 29 and 30 days after the first dose and between 1 and 2 days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since no information regarding adverse events after the first dose were reported. The use of concomitant medication escitalopram could be a potentially co-suspect for the event hallucinations. Event hallucinations was automatically upgraded as a serious event as per IME list. However, based on the information available and as per medical judgment it is classified as Non-serious. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.; Sender's Comments: This case concerns a 68-year-old, female with not reported medical history, who experienced the unexpected events of Hallucinations, insomnia, dysphagia and the expected event of myalgia . The event occurred approximately between 29 and 30 days after the first dose and between 1 and 2 days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since no information regarding adverse events after the first dose were reported. The use of concomitant medication escitalopram could be a potentially co-suspect for the event hallucinations. Event hallucinations was automatically upgraded as a serious event as per Regulatory authority list. However, based on the information available and as per medical judgment it is classified as Non-serious. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.