Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder, Tremor, Vaccination site pain
Clinical narrative: Sore arm; Body had tremors/mostly just shaking; Felt cold; Next day had a severe headache/slight headache was 50% of the intensity of the first vaccine; Injection site arm was sore; Had chills 6 hours after the vaccine/shivering; Had low grade nonclinical fever/slight half degree increase in temperature; Severe headache attribute to a poor nights sleep; This spontaneous case was reported by a patient and describes the occurrence of SLEEP DISORDER (Severe headache attribute to a poor nights sleep), PAIN IN EXTREMITY (Sore arm), TREMOR (Body had tremors/mostly just shaking), FEELING COLD (Felt cold) and HEADACHE (Next day had a severe headache/slight headache was 50% of the intensity of the first vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced SLEEP DISORDER (Severe headache attribute to a poor nights sleep), TREMOR (Body had tremors/mostly just shaking), FEELING COLD (Felt cold), HEADACHE (Next day had a severe headache/slight headache was 50% of the intensity of the first vaccine), VACCINATION SITE PAIN (Injection site arm was sore) and PYREXIA (Had low grade nonclinical fever/slight half degree increase in temperature). April 2021, the patient experienced CHILLS (Had chills 6 hours after the vaccine/shivering). In May 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). In April 2021, TREMOR (Body had tremors/mostly just shaking), FEELING COLD (Felt cold), VACCINATION SITE PAIN (Injection site arm was sore) and CHILLS (Had chills 6 hours after the vaccine/shivering) had resolved. At the time of the report, SLEEP DISORDER (Severe headache attribute to a poor nights sleep), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Next day had a severe headache/slight headache was 50% of the intensity of the first vaccine) outcome was unknown and PYREXIA (Had low grade nonclinical fever/slight half degree increase in temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: a half degree above normal. In May 2021, Body temperature: slight half degree increase in temperature. On an unknown date, Body temperature: slight half degree increase in temperature and slight half degree increase in temperature.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The symptoms after first dose lasted for vaccination day and the day after vaccination. Two days after the vaccination day felt fine. After second dose, patient had no shivering or chills. The symptoms after first dose lasted for vaccination day and the day after vaccination. Two days after the vaccination day felt fine. After second dose, patient had no shivering or chills. After second, third and fourth dose patient had a slight half degree increase in temperature, had a sore arm, slight headache was 50% of the intensity of the first vaccine. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728243 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728243:Bivalent dose case