Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: She had trouble breathing/Shortness of Breath; Throat closing up; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She had trouble breathing/Shortness of Breath) and THROAT TIGHTNESS (Throat closing up) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 030M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced DYSPNOEA (She had trouble breathing/Shortness of Breath) (seriousness criterion hospitalization) and THROAT TIGHTNESS (Throat closing up) (seriousness criterion hospitalization). The patient was hospitalized from 21-Sep-2021 to 22-Sep-2021 due to DYSPNOEA and THROAT TIGHTNESS. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (She had trouble breathing/Shortness of Breath) and THROAT TIGHTNESS (Throat closing up) was resolving.            No concomitant medication information provided  It was reported as within a few minutes after the first booster, the patient had a reaction. The patient had trouble breathing, shortness of breath and throat closing up. The PCP gave the patient a steroid shot and Benadryl. It did not help. EMT came and took patient vital signs and the patient felt better. The patient was transported to the hospital and stayed in the hospital overnight for observation. The patient was released at 10AM the next day. They did not find anything wrong. The reporter also stated that patient did not had any reaction to the first 2 Moderna COVID-19 vaccine doses.  Company comment: This spontaneous case concerns a 69-year-old female patient with no medical history reported, who experienced the unexpected serious (hospitalization) events of DYSPNEA and THROAT TIGHTNESS, which occurred a few minutes after receiving the 3rd dose of mRNA-1273 vaccine (booster). It was reported that within a few minutes after the first booster dose, the patient had trouble breathing, shortness of breath and throat closing up. The primary care physician gave a steroid shot and diphenhydramine which did not relieve the symptoms. Patient was admitted at the hospital for observation and was discharged the next day. The reporter also stated that patient did not had any reaction to the first 2 Moderna COVID-19 vaccine doses. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 69-year-old female patient with no medical history reported, who experienced the unexpected serious (hospitalization) events of DYSPNEA and THROAT TIGHTNESS, which occurred a few minutes after receiving the 3rd dose of mRNA-1273 vaccine (booster). It was reported that within a few minutes after the first booster dose, the patient had trouble breathing, shortness of breath and throat closing up. The primary care physician gave a steroid shot and diphenhydramine which did not relieve the symptoms. Patient was admitted at the hospital for observation and was discharged the next day. The reporter also stated that patient did not had any reaction to the first 2 Moderna COVID-19 vaccine doses. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.