Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Induration, Influenza like illness, Muscle spasms
Clinical narrative: Second dose experienced pain in feet and went to ER; Second dose experienced Red 2 inch round spot which felt lie hard to touch; Second dose experienced Red 2 inch round spot which felt hard to touch; Second dose experienced bad flu like symptoms; First dose experienced cramping in the feet; First Dose experienced with Nausea; First Dose experienced headache; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (First dose experienced cramping in the feet), NAUSEA (First Dose experienced with Nausea), HEADACHE (First Dose experienced headache), INFLUENZA LIKE ILLNESS (Second dose experienced bad flu like symptoms) and ERYTHEMA (Second dose experienced Red 2 inch round spot which felt lie hard to touch) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MAGNESIUM OXIDE, POTASSIUM GLUCONATE, PYRIDOXINE HYDROCHLORIDE (POTASSIUM 10 MEQ) and METOPROLOL for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced MUSCLE SPASMS (First dose experienced cramping in the feet), NAUSEA (First Dose experienced with Nausea) and HEADACHE (First Dose experienced headache). On 14-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Second dose experienced bad flu like symptoms). On 15-May-2021, the patient experienced ERYTHEMA (Second dose experienced Red 2 inch round spot which felt lie hard to touch) and INDURATION (Second dose experienced Red 2 inch round spot which felt hard to touch). On 17-May-2021, the patient experienced PAIN IN EXTREMITY (Second dose experienced pain in feet and went to ER). At the time of the report, MUSCLE SPASMS (First dose experienced cramping in the feet), NAUSEA (First Dose experienced with Nausea), HEADACHE (First Dose experienced headache), INFLUENZA LIKE ILLNESS (Second dose experienced bad flu like symptoms), ERYTHEMA (Second dose experienced Red 2 inch round spot which felt lie hard to touch), INDURATION (Second dose experienced Red 2 inch round spot which felt hard to touch) and PAIN IN EXTREMITY (Second dose experienced pain in feet and went to ER) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Ultrasound scan: normal (normal) Normal.         Results from  Electrolytes test was normal.  Treatment was not provided/ unknown.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   N/A   This case was linked to MOD-2021-177818, MOD-2021-177818 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up case received; Reporter's Comments: N/A; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.