Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Low grade fever; tenderness on the injection arm; slight headache; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), VACCINATION SITE PAIN (tenderness on the injection arm), HEADACHE (slight headache) and VACCINATION SITE ERYTHEMA (redness at injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included LISINOPRIL for an unknown indication.   On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PYREXIA (Low grade fever), VACCINATION SITE PAIN (tenderness on the injection arm), HEADACHE (slight headache) and VACCINATION SITE ERYTHEMA (redness at injection site). At the time of the report, PYREXIA (Low grade fever), VACCINATION SITE PAIN (tenderness on the injection arm), HEADACHE (slight headache) and VACCINATION SITE ERYTHEMA (redness at injection site) outcome was unknown. Not Related          No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), VACCINATION SITE PAIN (tenderness on the injection arm), HEADACHE (slight headache) and VACCINATION SITE ERYTHEMA (redness at injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included LISINOPRIL for an unknown indication.   On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PYREXIA (Low grade fever), VACCINATION SITE PAIN (tenderness on the injection arm), HEADACHE (slight headache) and VACCINATION SITE ERYTHEMA (redness at injection site). At the time of the report, PYREXIA (Low grade fever), VACCINATION SITE PAIN (tenderness on the injection arm), HEADACHE (slight headache) and VACCINATION SITE ERYTHEMA (redness at injection site) outcome was unknown. Not Related          No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.