Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dizziness, Dyspnoea, Rash
Clinical narrative: shortness breath/difficulty breathing; dizziness; feeling of tremendous pressure on chest; tightening on throat; cough; Swollen hot and red; left arm to top of scalp swollen hot and red; Red; rash all over; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness breath/difficulty breathing), DIZZINESS (dizziness), CHEST DISCOMFORT (feeling of tremendous pressure on chest), THROAT TIGHTNESS (tightening on throat) and COUGH (cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced DYSPNOEA (shortness breath/difficulty breathing) (seriousness criterion medically significant), DIZZINESS (dizziness) (seriousness criterion medically significant), CHEST DISCOMFORT (feeling of tremendous pressure on chest) (seriousness criterion medically significant), THROAT TIGHTNESS (tightening on throat) (seriousness criterion medically significant), COUGH (cough) (seriousness criterion medically significant), VACCINATION SITE WARMTH (Swollen hot and red), VACCINATION SITE SWELLING (left arm to top of scalp swollen hot and red), VACCINATION SITE ERYTHEMA (Red) and RASH (rash all over). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Difficulty breathing, at an unspecified dose and frequency and OXYGEN for Difficulty breathing, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness breath/difficulty breathing), DIZZINESS (dizziness), CHEST DISCOMFORT (feeling of tremendous pressure on chest), THROAT TIGHTNESS (tightening on throat), COUGH (cough), VACCINATION SITE WARMTH (Swollen hot and red), VACCINATION SITE SWELLING (left arm to top of scalp swollen hot and red), VACCINATION SITE ERYTHEMA (Red) and RASH (rash all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported.  Company comment: This case concerns a female patient with  no relevant medical history reported who experienced serious unexpected events dyspnoea, dizziness, chest discomfort, throat tightness and cough. The events occurred within 24 hours from the first dose of Spikevax. Rechallenge was not applicable due to action taken unknown and lack of information regarding the second dose of Spikevax. The events were consistent with the current understanding of the mechanism of action of the medication . The benefit-risk relationship of drug is not affected by this report; Sender's Comments: This case concerns a female patient with  no relevant medical history reported who experienced serious unexpected events dyspnoea, dizziness, chest discomfort, throat tightness and cough. The events occurred within 24 hours from the first dose of Spikevax. Rechallenge was not applicable due to action taken unknown and lack of information regarding the second dose of Spikevax. The events were consistent with the current understanding of the mechanism of action of the medication . The benefit-risk relationship of drug is not affected by this report