Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation
Clinical narrative: Scratched silly to the point of bleeding; Itching didn't stop; Hives got worse; Hives under neck and back but they had not come out; Hives started on her arms; Rash appeared on left hip which was itchy; Anaphylactic reaction; Itching; Rash is so bad/Rash on right hip; Ready to rip her skin off; Hive/Legs both front and back were covered in hives/Hives on legs; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bee sting (Reaction: Swelling at the site of sting) and Shellfish allergy (Reaction: Hives). Concomitant products included PRAVASTATIN SODIUM (PRAVACHOL) for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroiditis, unspecified.    On 21-Jan-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced SKIN EXFOLIATION (Ready to rip her skin off), URTICARIA (Hive/Legs both front and back were covered in hives/Hives on legs), PRURITUS (Itching) and RASH (Rash is so bad/Rash on right hip). On 21-Jan-2021 at 4:30 PM, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). On 22-Jan-2021, the patient experienced RASH PRURITIC (Rash appeared on left hip which was itchy). On 02-Feb-2021, the patient experienced URTICARIA CHRONIC (Hives got worse), URTICARIA (Hives under neck and back but they had not come out), URTICARIA (Hives started on her arms) and PRURITUS (Itching didn't stop). On an unknown date, the patient experienced SCRATCH (Scratched silly to the point of bleeding). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at a dose of 1 dosage form; CORTISONE for Itchy, at a dose of 1 dosage form; PREDNISONE for Hives, at a dose of 1 dosage form; OATMEAL at a dose of 1 dosage form; BAKING SODA at a dose of 1 dosage form; PREDNISONE (DELTASONE [PREDNISONE]) for Rash, at a dose of 40 mg and HYDROXYZINE HCL for Rash, at a dose of 25 mg. On 01-Mar-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved. At the time of the report, SCRATCH (Scratched silly to the point of bleeding), SKIN EXFOLIATION (Ready to rip her skin off), URTICARIA (Hive/Legs both front and back were covered in hives/Hives on legs), URTICARIA CHRONIC (Hives got worse), URTICARIA (Hives under neck and back but they had not come out), URTICARIA (Hives started on her arms), RASH PRURITIC (Rash appeared on left hip which was itchy), PRURITUS (Itching), PRURITUS (Itching didn't stop) and RASH (Rash is so bad/Rash on right hip) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 119/85 (abnormal) abnormal. On an unknown date, Body temperature: 36.4 (Inconclusive) Inconclusive. On an unknown date, Heart rate: 94 (Inconclusive) Inconclusive. On an unknown date, Oxygen saturation: 100% (Inconclusive) Inconclusive. On an unknown date, Respiratory rate: 18 (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient also took cold bath as treatment. On an unknown date, it was reported that the patient had a dermatologic examination where the dermatologist look at the patient's hives/rash; results were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16 Jun 2021, Added Patient's race, height, weight, lab details and information concomitant medications and new event details.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.