Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Swelling face, Throat tightness, Urticaria
Clinical narrative: his face was swollen and throat was closing; his face was swollen and throat was closing; he started getting hives; This spontaneous case was reported by a patient and describes the occurrence of SWELLING FACE (his face was swollen and throat was closing), THROAT TIGHTNESS (his face was swollen and throat was closing) and URTICARIA (he started getting hives) in a 75-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (on the late summer / early fall of 2022) in 2022, COVID-19 in June 2023, Infection (In recent years he got a bad infection that required surgery), Surgery (In recent years he got a bad infection that required surgery) and Cardiac operation (He had two stands put in his heart in 1998) in 1998. Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 1) in January 2021, Moderna covid-19 vaccine (Dose 2) in February 2021, Moderna covid-19 vaccine (Dose 3) in October 2021 and Moderna covid-19 vaccine (Dose 4) in May 2022; for Product used for unknown indication: FLU [INFLUENZA VACCINE]; for Drug use for unknown indication: MONTELUKAST [MONTELUKAST SODIUM]. Past adverse reactions to the above products included No adverse event with FLU [INFLUENZA VACCINE], MONTELUKAST [MONTELUKAST SODIUM], Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine. Concurrent medical conditions included Hypercholesteraemia (Patient was taking Atorvastatin during 25 years for high cholesterol). Concomitant products included ATORVASTATIN for Hypercholesteraemia.    On 13-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 18-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced URTICARIA (he started getting hives) (seriousness criterion hospitalization). On 20-Dec-2023, the patient experienced SWELLING FACE (his face was swollen and throat was closing) (seriousness criterion hospitalization) and THROAT TIGHTNESS (his face was swollen and throat was closing) (seriousness criterion hospitalization). The patient was treated with PREDNISONE at a dose of 20 milligram as required; ACRIVASTINE (BENADRYL [ACRIVASTINE]) at an unspecified dose and frequency and OMALIZUMAB (XOLAIR) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (his face was swollen and throat was closing), THROAT TIGHTNESS (his face was swollen and throat was closing) and URTICARIA (he started getting hives) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: found no allergies.         The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. On 13 Oct 2023, the patient was administered SPIKEVAX. Approximately five days after receiving the vaccine, he began experiencing hives. The hives progressively worsened over the following days, prompting him to seek medical attention at a walk-in clinic. The clinic prescribed a 10-day course of prednisone, which initially alleviated the hives. However, once the medication was completed, the hives returned even stronger. Seeking further treatment, he consulted a dermatologist who prescribed a 15-day regimen of prednisone. Unfortunately, the hives resurfaced shortly after completing this treatment as well. On 20 Dec 2023, due to facial swelling and throat constriction, he was urgently taken to the hospital. There, he was administered Benadryl and additional prednisone, which successfully halted the hives. The hospital also provided him with a prescription for 20 mg prednisone tablets to be used as needed. Subsequently, he visited his family doctor who prescribed 10 mg prednisone tablets for use as needed, along with an Epipen in case of facial and throat swelling until he could consult an Allergist, as recommended by his doctor. The Allergist conducted various allergy tests, but no allergies were detected. As a result, the Allergist prescribed a high dosage of antihistamines and advised the patient to continue using prednisone as necessary, with the hope of eventually tapering off the medication. However, this approach proved ineffective, leading the patient to commence a series of Xolair shots. Unfortunately, the hives worsened after the initial shots. The doctor explained that it may take 3-4 treatments before any improvement was observed. The patient's next round of Xolair shots was scheduled for 1st May.   This case was linked to MOD-2024-766116 (Patient Link).