Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Nausea, Pain in extremity, Peripheral swelling, Rash erythematous
Clinical narrative: Headache/headache that would not respond to anything; Sore arm/arm was sore to touch; Arm had red rash, raised; Arm had raised rash; Abdominal cramping; Got chills that were so severe she was involuntarily shaking/teeth were chattering; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm/arm was sore to touch), RASH ERYTHEMATOUS (Arm had red rash, raised), PERIPHERAL SWELLING (Arm had raised rash), ABDOMINAL PAIN (Abdominal cramping) and CHILLS (Got chills that were so severe she was involuntarily shaking/teeth were chattering) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 012M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm/arm was sore to touch), RASH ERYTHEMATOUS (Arm had red rash, raised), PERIPHERAL SWELLING (Arm had raised rash), ABDOMINAL PAIN (Abdominal cramping) and NAUSEA (Nausea). 26-Feb-2021, the patient experienced CHILLS (Got chills that were so severe she was involuntarily shaking/teeth were chattering). On 27-Feb-2021 at 2:00 AM, the patient experienced HEADACHE (Headache/headache that would not respond to anything). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ZOLPIDEM TARTRATE (AMBIEN) at a dose of 1 UNK and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 28-Feb-2021, HEADACHE (Headache/headache that would not respond to anything) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm/arm was sore to touch), RASH ERYTHEMATOUS (Arm had red rash, raised), PERIPHERAL SWELLING (Arm had raised rash), ABDOMINAL PAIN (Abdominal cramping), CHILLS (Got chills that were so severe she was involuntarily shaking/teeth were chattering) and NAUSEA (Nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 101.5 (High) Temperature went up to 101.5. On 27-Feb-2021, Blood pressure measurement: 140/88 (High) Blood pressure was elevated to 140/88. and 150/88 (High) Blood pressure was elevated to 150/88 in the other arm.. On 27-Feb-2021, Heart rate: 90 (High) Pulse was elevated to 90 all day long,normally its 68. On 28-Feb-2021, Heart rate: 80 (Inconclusive) Pulse went down to 80.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient experienced chills after 12 hours that were so severe she was involuntarily shaking, her teeth were shattering for 1 and half hour. The patient applied cold pack and drink of alcohol, but the events persisted.  The patient took Tylenol, Ambien, Motrin and muscle relaxant as treatment medications for the reported events. Action taken with mRNA-1273 in response to the events were not applicable.