Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pruritus, Vaccination site discolouration, Vaccination site erythema
Clinical narrative: It's so hot, so red, so itchy; Moderna arm; So red; The inside color changed and the outside circle is getting bigger; Injection area started to get itchy like hell and the size is getting bigger and bigger and still has the itch and now the size is 4 inches; A little bit itchy; Was a little bit sore; Injection site had a bump the size of a quarter/now the size is 4 inches; Little bit nausea; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (It's so hot, so red, so itchy), VACCINATION SITE REACTION (Moderna arm), VACCINATION SITE DISCOLOURATION (The inside color changed and the outside circle is getting bigger), PRURITUS (Injection area started to get itchy like hell and the size is getting bigger and bigger and still has the itch and now the size is 4 inches) and VACCINATION SITE PRURITUS (A little bit itchy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (oesophageal), TURMERIC [CURCUMA LONGA RHIZOME], PROBIOTICS NOS, VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]), VITAMIN E NOS and ZINC for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (A little bit itchy), VACCINATION SITE PAIN (Was a little bit sore), VACCINATION SITE SWELLING (Injection site had a bump the size of a quarter/now the size is 4 inches), NAUSEA (Little bit nausea) and FATIGUE (Felt tired). On 12-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (The inside color changed and the outside circle is getting bigger) and PRURITUS (Injection area started to get itchy like hell and the size is getting bigger and bigger and still has the itch and now the size is 4 inches). On an unknown date, the patient experienced VACCINATION SITE WARMTH (It's so hot, so red, so itchy), VACCINATION SITE REACTION (Moderna arm) and VACCINATION SITE ERYTHEMA (So red). The patient was treated with CETIRIZINE HYDROCHLORIDE (ALEGRA) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and SERTRALINE HYDROCHLORIDE (SERTAC) from 20-Apr-2021 to 21-Apr-2021 for Adverse event, at an unspecified dose and frequency. On 08-Apr-2021, FATIGUE (Felt tired) had resolved. At the time of the report, VACCINATION SITE WARMTH (It's so hot, so red, so itchy), VACCINATION SITE REACTION (Moderna arm), VACCINATION SITE DISCOLOURATION (The inside color changed and the outside circle is getting bigger), PRURITUS (Injection area started to get itchy like hell and the size is getting bigger and bigger and still has the itch and now the size is 4 inches), VACCINATION SITE PRURITUS (A little bit itchy), VACCINATION SITE PAIN (Was a little bit sore), VACCINATION SITE ERYTHEMA (So red), VACCINATION SITE SWELLING (Injection site had a bump the size of a quarter/now the size is 4 inches) and NAUSEA (Little bit nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.