Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept straight through the night and the next day), FEELING ABNORMAL (felt horrible), FEELING COLD (felt cold all day), PERIPHERAL SWELLING (arm was swollen) and TENDERNESS (arm is tender to touch) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 045B21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (received the monoclonal antibody treatment.) on 23-Dec-2021. Concurrent medical conditions included Sinus disorder. Concomitant products included CETIRIZINE for Sinus disorder. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced TENDERNESS (arm is tender to touch). On 24-Jan-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (slept straight through the night and the next day.). On 25-Jan-2022, the patient experienced FEELING ABNORMAL (felt horrible), FEELING COLD (felt cold all day), PERIPHERAL SWELLING (arm was swollen), DIARRHOEA (diarrhea), NAUSEA (very nauseated) and PYREXIA (fever/temperature spiked to 101.7 degrees F/fever of 100.4 degrees F). On 26-Jan-2022, the patient experienced NECK PAIN (soreness below the injection and site up through her clavicle and to her neck) and VACCINATION SITE PAIN (soreness below the injection site up through my clavicle). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 25-Jan-2022 for Fever, at an unspecified dose and frequency. On 25-Jan-2022, SOMNOLENCE (slept straight through the night and the next day.) had resolved. At the time of the report, FEELING ABNORMAL (felt horrible), FEELING COLD (felt cold all day), PERIPHERAL SWELLING (arm was swollen), TENDERNESS (arm is tender to touch), NECK PAIN (soreness below the injection and site up through her clavicle and to her neck), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (soreness below the injection site up through my clavicle), NAUSEA (very nauseated) and PYREXIA (fever/temperature spiked to 101.7 degrees F/fever of 100.4 degrees F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2022, Body temperature: 101.7 (High). Patient stated that her temperature spiked to 101.7 degrees F for most of the evening. On 26-Jan-2022, Body temperature: 100.4 (High) During the morning patient woke up with a fever of 100.4 degrees F.. The patient on 23-Dec-2021 was infected with COVID-19 and received monoclonal antibody treatment. The patient received their booster shot on 24-Jan-2022 at noon and on that day the patient slept straight through the night and the next day the patient felt horrible and felt cold all through the day, their arm was swollen, and their temperature spiked to 101.7 degrees F for most of the evening. The patient had taken Tylenol for the fever. On 26-Jan-2022, morning the patient woke up with a fever of 100.4 degrees F. The patient stated that they also experienced soreness below the injection site up through their clavicle and to their neck. The patient was also feeling very nauseated last night, had diarrhea and their arm was tender to the touch. The patient stated that they did go to the emergency center walk in clinic. This case was linked to MOD-2022-461970 (Patient Link).