Reporte zur Charge B04021A

Symptomtext

Allergic Reaction; Tongue and throat swelled; Tongue and throat swelled; Feeling odd; Shortness of breath/not breathing as normal; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (Allergic Reaction), SWOLLEN TONGUE (Tongue and throat swelled) and PHARYNGEAL SWELLING (Tongue and throat swelled) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. B04021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. NO medical history was reported by reporter. Concomitant products included THIAMINE (VITAMIN B1 [THIAMINE]) for an unknown indication. On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jul-2021, the patient experienced HYPERSENSITIVITY (Allergic Reaction) (seriousness criterion hospitalization), SWOLLEN TONGUE (Tongue and throat swelled) (seriousness criterion hospitalization) and PHARYNGEAL SWELLING (Tongue and throat swelled) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEELING ABNORMAL (Feeling odd) and DYSPNOEA (Shortness of breath/not breathing as normal). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Allergic Reaction), SWOLLEN TONGUE (Tongue and throat swelled), PHARYNGEAL SWELLING (Tongue and throat swelled) and FEELING ABNORMAL (Feeling odd) outcome was unknown and DYSPNOEA (Shortness of breath/not breathing as normal) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2021, Blood pressure measurement: 147 (High) Blood pressure 147 high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was suffered with Shortness of breath , feeling better. patient doesn't have a main doctor but provides information of the hospital and Doctor that treat his allergic reaction after taking the vaccine, gives consent to safety follow up. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.