Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Ocular hyperaemia, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) and URTICARIA (Hives) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 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 15-Feb-2021, the patient experienced URTICARIA (Hives) (seriousness criterion medically significant). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant) and OCULAR HYPERAEMIA (Bloodshot in eyes). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) and OCULAR HYPERAEMIA (Bloodshot in eyes) outcome was unknown and URTICARIA (Hives) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. It was reported that If patient doesn't take antihistamine (Zyrtec), the hives will continue every night and she will wake up in hives.  Company comment: This spontaneous case concerns a 29 year old female, with relevant medical history of dermatitis, who experienced Serious ( Medically significant ) expected event of anaphylactic reaction which occurred on an unknown date after vaccination with the 1st dose of mRNA. This was accompanied by non-serious, unexpected event of ocular hyperemia. After 1- 1/2 month post vaccination with the 1st dose of mRNA-1273 vaccine (Moderna Covid-19 vaccine), she experienced Serious ( medically significant ), unexpected event of urticaria which was treated with cetirizine. The re-challenge for this case is not applicable since the events' outcome were either unknown, resolving and for the event urticaria she was given medications to be relieved. 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-2021-435730 (Patient Link). Sender's Comments: This spontaneous case concerns a 29 year old female, with relevant medical history of dermatitis, who experienced Serious (Medically significant) expected event of anaphylactic reaction which occurred on an unknown date after vaccination with the 1st dose of mRNA. This was accompanied by non-serious, unexpected event of ocular  hyperemia. After 1- 1/2 month post vaccination with the 1st dose of mRNA-1273 vaccine (Moderna Covid-19 vaccine), she experienced Serious (medically significant), unexpected event of urticaria which was treated with cetirizine. The re-challenge for this case is not applicable since the events' outcome were either unknown, resolving and for the event urticaria she was given medications to be relieved. 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.