Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Joint swelling, Paraesthesia, Product dose omission issue
Clinical narrative: missed 2 dose; my legs (below my knees) itched and ankles swelled; my legs (below my knees) itched and ankles swelled; hives; burning; prickling all over; itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BURNING SENSATION (burning), PARAESTHESIA (prickling all over), PRURITUS (itching), URTICARIA (hives) and PRURITUS (my legs (below my knees) itched and ankles swelled) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN, OMEPRAZOLE, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and ASCORBIC ACID, BORAGO OFFICINALIS OIL, FISH OIL, MAGNESIUM, NICOTINAMIDE, PYRIDOXINE, ZINC (OMEGA-3 & -6 COMPLEX) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced BURNING SENSATION (burning), PARAESTHESIA (prickling all over) and PRURITUS (itching). On 05-Mar-2021, the patient experienced URTICARIA (hives). On 07-Apr-2021, the patient experienced PRURITUS (my legs (below my knees) itched and ankles swelled) and JOINT SWELLING (my legs (below my knees) itched and ankles swelled). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 2 dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Burning skin, Prickling of hand and Itching, at a dose of bed time; LORATADINE (CLARITINE) for Hives, at a dose of 14 days at bed time; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) on 22-Mar-2021 for Itching and Burning skin, at a dose of 20 mg twice a day and FAMOTIDINE on 22-Mar-2021 for Hives and Itching, at a dose of 20 mg twice a day. At the time of the report, BURNING SENSATION (burning), PARAESTHESIA (prickling all over), PRURITUS (itching), URTICARIA (hives), PRURITUS (my legs (below my knees) itched and ankles swelled) and JOINT SWELLING (my legs (below my knees) itched and ankles swelled) had resolved and PRODUCT DOSE OMISSION ISSUE (missed 2 dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) negative. On an unknown date, SARS-CoV-2 antibody test: other IgG: Positive IgM: Positive IgA: Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is feeling good now.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Additional AE added, updated AE outcome, doctor's info updated