Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Oral discomfort, Pruritus, Urticaria
Clinical narrative: itching as if there's no tomorrow; Allergic reaction/severe reaction; hives/hives have progressed/progressed to cover her whole body, with hives on the face/hives have been recurring/mostly on her torso, legs and arms; discomfort in the mouth; could hardly breath; This spontaneous case was reported by a nurse and describes the occurrence of ORAL DISCOMFORT (discomfort in the mouth), DYSPNOEA (could hardly breath), PRURITUS (itching as if there's no tomorrow), HYPERSENSITIVITY (Allergic reaction/severe reaction) and URTICARIA (hives/hives have progressed/progressed to cover her whole body, with hives on the face/hives have been recurring/mostly on her torso, legs and arms) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     Patient had no allergy related to medications, food and other products.  The patient's past medical history included COVID-19 (End of Apr-2022. Tested because of exposure, COVID-19 mild symptoms 5 days out of work.) in April 2022. Concurrent medical conditions included Anxiety and Regurgitation. Concomitant products included CLONAZEPAM (KLONOPIN) for Anxiety, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Regurgitation.    On 16-Sep-2022 at 9:30 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced ORAL DISCOMFORT (discomfort in the mouth) and DYSPNOEA (could hardly breath). 16-Sep-2022, the patient experienced HYPERSENSITIVITY (Allergic reaction/severe reaction) and URTICARIA (hives/hives have progressed/progressed to cover her whole body, with hives on the face/hives have been recurring/mostly on her torso, legs and arms). On 19-Sep-2022, the patient experienced PRURITUS (itching as if there's no tomorrow). The patient was treated with ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) on 16-Sep-2022 at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 16-Sep-2022 at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (oral) on 16-Sep-2022 at an unspecified dose and frequency. At the time of the report, ORAL DISCOMFORT (discomfort in the mouth), DYSPNOEA (could hardly breath), PRURITUS (itching as if there's no tomorrow), HYPERSENSITIVITY (Allergic reaction/severe reaction) and URTICARIA (hives/hives have progressed/progressed to cover her whole body, with hives on the face/hives have been recurring/mostly on her torso, legs and arms) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient had first dose of primary series with Moderna on 30-Dec-2020 with lot number 037K20A.  Patient had second dose of primary series with Moderna on 27-Jan-2021 with lot number 030L20A.  Patient had first booster dose with Moderna on 29-Oct-2021 with lot number 077C21B.  Patient stated that she got her fourth dose around 09:30 AM on 16-Sep-2022 and within as hour she developed hives. Patient reported that the right arm where she got vaccine had less hives than her left arm. Patient reported that her airway was not affected and hives were not on her face. Patient did not had similar event in past. Adverse events caused patient to visit Emergency Room.  Treatment medication included steroids and IV fluids and patient started taking oral steroids from 17-Sep-2022.   This case was linked to MOD-2022-647519 (Patient Link).