Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Injection site erythema, Injection site swelling, Pyrexia, Rash
Clinical narrative: Seizures; bumps on her right arm; red big spots on her right arm; Fever; A spontaneous report was received from a caregiver concerning a 55-years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced seizures, fever, and red spots and bumps on her arm.  The patient's medical history, as provided by the reporter, included being non-verbal, unable to walk, and seizures that last 1-2 seconds.  No relevant concomitant medications were reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 041L20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   The reporter was a consumer who holds a foster care for older patients. This patient was under her care at the time of the report. The patient received the Moderna Covid-19 vaccine on 13 Jan 2021 at 10 A.M. at the foster care location. She did not notice any reaction after administration. That evening, she saw two big red spots and bumps on her right arm. She iced the patient's arm, but the redness was still visible and bumps were present. That night, the patient started a fever of 102 degrees Fahrenheit. The reporter iced her body down and gave her paracetamol, which helped. She reported that there was no vomiting.   On 14 Jan 2021, in the morning the patient had a seizure that lasted 30 mins. The reporter stated that she usually does not call 911 because she is familiar with the patient's seizures that last between 1-2 seconds, but this led her to call emergency services. The seizure was gone when they arrived, and she continued to care for the patient at the home.   On 16 Jan 2021, the seizure returned.   She had another seizure on 18 Jan 2021, which was concerning, per the reporter because of their frequency. She contacted the patient's health care provider who did not advise anything. She scheduled an appointment with a neurologist.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, seizures, fever, and red spots and bumps on her arm, was not reported.; Reporter's Comments: This case concerns a 55-year-old female patient with a significant medical history of seizures who experienced a medically significant and unexpected event of Seizure and non-serious unexpected event of Injection site papule along with non-serious expected events of Injection site erythema and Pyrexia. The event of Seizure occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (041L20A), which returned on day 3 and 5 after vaccination. The events of Injection site erythema, Injection site papule and Pyrexia occurred on the same day after receiving their first of two planned doses of mRNA-1273 (041L20A). Treatment for pyrexia included iced her body down and Tylenol. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. Of note, patient's prior history of seizures is considered a confounding factor for the event of seizure.