Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, Vaccination complication, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: felt hot and cold then hot again; she was having sleepless and restlessness nights; she was having sleepless and restlessness nights; Feeling awful, Hard to get up; At the injection site area she has redness; Also, at the injection site area she has redness, it's itchy and sore/Injection site is itchy; Also, at the injection site area she has redness, it's itchy and sore/Injection site is sore; Shivering; Had a slight headache; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (felt hot and cold then hot again), INSOMNIA (she was having sleepless and restlessness nights), RESTLESSNESS (she was having sleepless and restlessness nights), VACCINATION COMPLICATION (Feeling awful, Hard to get up) and VACCINATION SITE ERYTHEMA (At the injection site area she has redness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009121A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (felt hot and cold then hot again), INSOMNIA (she was having sleepless and restlessness nights), RESTLESSNESS (she was having sleepless and restlessness nights), VACCINATION COMPLICATION (Feeling awful, Hard to get up), VACCINATION SITE ERYTHEMA (At the injection site area she has redness), VACCINATION SITE PRURITUS (Also, at the injection site area she has redness, it's itchy and sore/Injection site is itchy), VACCINATION SITE PAIN (Also, at the injection site area she has redness, it's itchy and sore/Injection site is sore), CHILLS (Shivering), HEADACHE (Had a slight headache) and FATIGUE (Extremely tired). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (felt hot and cold then hot again), INSOMNIA (she was having sleepless and restlessness nights), RESTLESSNESS (she was having sleepless and restlessness nights), VACCINATION COMPLICATION (Feeling awful, Hard to get up), CHILLS (Shivering), HEADACHE (Had a slight headache) and FATIGUE (Extremely tired) outcome was unknown and VACCINATION SITE ERYTHEMA (At the injection site area she has redness), VACCINATION SITE PRURITUS (Also, at the injection site area she has redness, it's itchy and sore/Injection site is itchy) and VACCINATION SITE PAIN (Also, at the injection site area she has redness, it's itchy and sore/Injection site is sore) had not resolved. No concomitant medications were reported.  Treatment information was not provided.Patient was putting cold compress on the vaccination site. This case was linked to MOD-2021-382340 (Patient Link).