Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Flushing, Headache
Clinical narrative: face is flushed and still a bit red; sore arm; face is flushed and still a bit red; bad headache; nausea; muscle ache in patient's jaw; chilly; Patient felt tired; did not sleep; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (face is flushed and still a bit red), PAIN IN EXTREMITY (sore arm), ERYTHEMA (face is flushed and still a bit red), INSOMNIA (did not sleep) and HEADACHE (bad headache) in a 72-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (dose 5) in April 2024, COVID-19 vaccine (dose 1), COVID-19 vaccine (dose 4), COVID-19 vaccine (dose 2) and COVID-19 vaccine (dose 3). Past adverse reactions to the above products included No adverse effect with COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine and COVID-19 vaccine.    On 29-Aug-2024 at 11:00 AM, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In August 2024, the patient experienced INSOMNIA (did not sleep) and FATIGUE (Patient felt tired). On 29-Aug-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced FLUSHING (face is flushed and still a bit red), PAIN IN EXTREMITY (sore arm), ERYTHEMA (face is flushed and still a bit red), HEADACHE (bad headache), NAUSEA (nausea), MYALGIA (muscle ache in patient's jaw) and CHILLS (chilly). At the time of the report, FLUSHING (face is flushed and still a bit red), PAIN IN EXTREMITY (sore arm), ERYTHEMA (face is flushed and still a bit red), HEADACHE (bad headache), NAUSEA (nausea), MYALGIA (muscle ache in patient's jaw), CHILLS (chilly) and FATIGUE (Patient felt tired) had not resolved and INSOMNIA (did not sleep) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No allergies or medical condition as per patient. No concomitant medication was reported. The patient had the shot on 29-Aug-2024 at 11:00 in the morning. Patient stated that she had 6 shots so far. Patient felt tired and said that it was fine. And then, the patient went to bed and felt a very bad headache and this all happened sort of in the middle of the night. The patient stated that it was a really, really bad headache and some of it is still with the patient until the date of reporting. The patient also added the feeling of nausea, muscle ache in patient's jaw that was really weird (both sides). Patient face was flushed and still a bit red. The patient thought she had shivers which was extreme and felt very, very chilly. Patient basically stayed in bed and drunk lots of liquids and woke up not too long ago as patient kept getting up and down and did not sleep. As per patient, everything hurts and guessing that maybe it was a classic reaction but then experienced a severe headache and nausea. The patient said that it was fine before that and happened probably 12 hours later or 10 hours later after the shot. The patient also added of having a very sore arm which was immediate but stated that it was not such a big deal but it's a little unusual for the patient. Patient stated that her the last covid-19 vaccine was April of 2024. The patient's face was still red. No treatment medication was reported.