Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: developed hives on both elbows one each; patient could not sleep; itching; rash at back of his right thigh like a bump &  crack of her buttock; low fever; nauseas; pain at injection site; lump appeared. "Bigger lump than 1st "; "feels like she had the flu"; itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump appeared. "Bigger lump than 1st "), INFLUENZA LIKE ILLNESS ("feels like she had the flu"), URTICARIA (developed hives on both elbows one each), INSOMNIA (patient could not sleep) and PRURITUS (itching) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol, Fruit allergy (Allergic to pineapple and acidic fruits.), Drug allergy (naproxen), Drug allergy (codeine) and Drug allergy (benadryl tablets). Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE) and ATORVASTATIN for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (itching at injection site). On 16-Mar-2021, the patient experienced VACCINATION SITE MASS (lump appeared. "Bigger lump than 1st "), INFLUENZA LIKE ILLNESS ("feels like she had the flu"), PRURITUS (itching), PYREXIA (low fever) and NAUSEA (nauseas). 16-Mar-2021, the patient experienced RASH (rash at back of his right thigh like a bump &  crack of her buttock). 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). On 19-Mar-2021, the patient experienced INSOMNIA (patient could not sleep). On 20-Mar-2021, the patient experienced URTICARIA (developed hives on both elbows one each). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LORATADINE (CLARITINE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (lump appeared. "Bigger lump than 1st "), INFLUENZA LIKE ILLNESS ("feels like she had the flu"), INSOMNIA (patient could not sleep), PRURITUS (itching), VACCINATION SITE PRURITUS (itching at injection site), RASH (rash at back of his right thigh like a bump &  crack of her buttock), PYREXIA (low fever), NAUSEA (nauseas) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown and URTICARIA (developed hives on both elbows one each) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 100.1f (Inconclusive) Had Temperature of 100.1F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-047836.  Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Events, first dose batch number and treatment information added.