Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Ocular hyperaemia, Urticaria
Clinical narrative: anaphylaxis; Hives; bloodshot in eyes; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaxis) and URTICARIA (Hives) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dermatitis.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criterion medically significant), URTICARIA (Hives) (seriousness criterion medically significant) and OCULAR HYPERAEMIA (bloodshot in eyes). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (anaphylaxis), URTICARIA (Hives) and OCULAR HYPERAEMIA (bloodshot in eyes) outcome was unknown.            No concomitant medications were reported.  Reported that, Patient has been having hives since February 2021. Patient had both doses of the Moderna COVID-19 vaccine. Ever since then, the hives was not going away. Along with hives, Patient also had anaphylaxis as well, and bloodshot in eyes. If patient don't take antihistamine (Zyrtec), the hives will continue every night and patient will wake up in hives.  Company Comment: This spontaneous case concerns a 30 year old female with relevant medical history of dermatitis. who experienced Serious ( medically significant ) , expected event of anaphylactic reaction and non-serious , unexpected event of ocular hyperemia which occurred on an unknown date after vaccination with the 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine . This was accompanied by another serious ( medically significant ) , unexpected event of urticaria which occurred before vaccination with the 2nd but occurred after the 1st dose  of the vaccine relieved only with Cetirizine.  The re-challenge for this case is not applicable since the events outcome were unknown and  resolved only with medications. The history of dermatitis of this patient may be considered as a confounder for this case. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-435698 (Patient Link).; Sender's Comments: This spontaneous case concerns a 30 year old female with relevant medical history of dermatitis. who experienced Serious ( medically significant ) , expected event of anaphylactic reaction and non-serious , unexpected event of ocular hyperemia which occurred on an unknown date after vaccination with the 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine . This was accompanied by another serious ( medically significant ) , unexpected event of urticaria which occurred before vaccination with the 2nd but occurred after the 1st dose  of the vaccine relieved only with Cetirizine.  The re-challenge for this case is not applicable since the events outcome were unknown and  resolved only with medications. The history of dermatitis of this patient may be considered as a confounder for this case. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.