Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Infection, Influenza like illness, Injection site infection
Clinical narrative: flu-like symptoms; feels like under the skin of site of injection there is an infection; hot to touch of injection; swelling, itchy, hot to touch and big bump on arm of injection; swelling, itchy, hot to touch and big bump on arm of injection; swelling, itchy, hot to touch and big bump on arm of injection; feels like under the skin of site of injection there is an infection; pain going down to the upper arm; sore throat; runny nose; swollen and hurt arm of injection; fatigue; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (swelling, itchy, hot to touch and big bump on arm of injection), INJECTION SITE MASS (swelling, itchy, hot to touch and big bump on arm of injection), INJECTION SITE INFECTION (feels like under the skin of site of injection there is an infection), PAIN IN EXTREMITY (pain going down to the upper arm) and OROPHARYNGEAL PAIN (sore throat) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN, ESTRADIOL (ESTROGEN) and PROGESTERONE for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), INJECTION SITE PAIN (swollen and hurt arm of injection), FATIGUE (fatigue), NAUSEA (nausea) and HEADACHE (headache). On 08-Apr-2021, the patient experienced PRURITUS (swelling, itchy, hot to touch and big bump on arm of injection), INJECTION SITE MASS (swelling, itchy, hot to touch and big bump on arm of injection), INJECTION SITE INFECTION (feels like under the skin of site of injection there is an infection), PAIN IN EXTREMITY (pain going down to the upper arm), INJECTION SITE WARMTH (hot to touch of injection) and INJECTION SITE SWELLING (swelling, itchy, hot to touch and big bump on arm of injection). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) and INFECTION (feels like under the skin of site of injection there is an infection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (swelling, itchy, hot to touch and big bump on arm of injection), INJECTION SITE MASS (swelling, itchy, hot to touch and big bump on arm of injection), INJECTION SITE INFECTION (feels like under the skin of site of injection there is an infection), PAIN IN EXTREMITY (pain going down to the upper arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), INFECTION (feels like under the skin of site of injection there is an infection), INJECTION SITE WARMTH (hot to touch of injection) and INJECTION SITE SWELLING (swelling, itchy, hot to touch and big bump on arm of injection) outcome was unknown and OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), INJECTION SITE PAIN (swollen and hurt arm of injection), FATIGUE (fatigue), NAUSEA (nausea) and HEADACHE (headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other treatment drugs include Antihistaminic.