Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PRURITUS (Itching/ pruritus/ itchy bumps), PYREXIA (Fever lasting about 24-30 hours), FATIGUE (Fatigue) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 0281_20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Penicillin allergy (reaction - hives), Food allergy (To all fish (regurgitation; requires hospitalization and IV's)), Food allergy (To Aspertine (Equal)  (regurgitation;   requires hospitalization and IV's)), Food allergy (To Pine nuts (swollen tongue and lips)), Drug allergy (To Mobic drug (Anti inflammatory drugs) -flu like symptoms), Drug allergy (To Advil (Anti inflammatory drugs) - flu like symptoms), Diverticulitis (Diverticulitis on Invanz infusion at time of first vaccination) since 18-Jan-2021, Hives and Diverticulitis (Treatment- Surgery Sigmoid colon resection) since 26-May-2021. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Nose congestion, LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS PROBIOTIC) for Probiotic therapy, LEVOTHYROXINE SODIUM (SYNTHROID) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021 at 12:14 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced FATIGUE (Fatigue) and HEADACHE (Headache). On 03-Mar-2021, the patient experienced URTICARIA (Hives). 03-Mar-2021, the patient experienced PRURITUS (Itching/ pruritus/ itchy bumps). On an unknown date, the patient experienced PYREXIA (Fever lasting about 24-30 hours) and HEADACHE (headache came back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Mar-2021, PRURITUS (Itching/ pruritus/ itchy bumps) had resolved. At the time of the report, URTICARIA (Hives), PYREXIA (Fever lasting about 24-30 hours), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved and HEADACHE (headache came back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement: 160/80 mmHg abnormal. On 11-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) Negative at 1:35 pm No antibodies were found.. On an unknown date, Blood pressure measurement: 150/143 mmHg abnormal. On an unknown date, Body temperature: normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medication included Calcitrate 600+D for CA.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Updated patient weight, height, race, ethnicity,  medical history, lab data, added concomitant medication, treatment medication and updated event term (Itching/ pruritus/ itchy bumps) it's onset date, stop date and outcome. On 22-Jul-2021: Contained no new information (NNI)