Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lethargy, Nausea, Pyrexia
Clinical narrative: hives are debilitating/this (hives) experience was worse; Nausea; feeling lethargic; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (feeling lethargic), URTICARIA (hives are debilitating/this (hives) experience was worse), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 0391K20A) for COVID-19 vaccination.     The patient's past medical history included Hives. Concurrent medical conditions included Drug allergy (Allergy to Erythromycin-, Reaction -  extreme vomiting), Drug allergy (Allergy to Codeine) and Essential tremor. Concomitant products included NADOLOL for Essential tremor, CANDESARTAN CILEXETIL (CANDESARTAN [CANDESARTAN CILEXETIL]) for Hypertension, AMITRIPTYLINE for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 09-Feb-2021, the patient experienced LETHARGY (feeling lethargic). On an unknown date, the patient experienced URTICARIA (hives are debilitating/this (hives) experience was worse) and NAUSEA (Nausea). The patient was treated with TRIAMCINOLONE ACETONIDE at a dose of 0.1 %; CLOBETASOL PROPIONATE at a dose of 0.5 %; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form once a day; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form once a day and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form once a day. At the time of the report, LETHARGY (feeling lethargic), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown and URTICARIA (hives are debilitating/this (hives) experience was worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 100 (High) 100 °F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she had possible neuropathy which was not diagnostically certain  Patient reported that felt better on 11 Feb 2021 Treatment medication include Compounded topical product: 1% hydrocortisone/menthol 1%/glycerin 10%/ vanicream 40%. Patient reported that she had taken ice packs  throughout the day Patient reported that she was going through Photo therapy Reported that hives have been more intense after the vaccine   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Non significant follow up received. Patient is asking for assistance with ADR form filling. On 19-Jul-2021: Non significant follow up received. Patient requested for post office mailing address. On 20-Jul-2021: Follow up document received  and contains significant information. Patient demographics, medical history, allergies and lab data  added. New event Nausea added. Event outcome updated for the event Urticaria from Unknown to Not Recovered/Resolved