Reporte zur Charge 029A21AA

Symptomtext

Swelling throat / throat swelled; Itching over body; Dizziness; weak; Lip swelling; Tongue swelling; uvula swelling; Heart rate irregular; Throat discomfort; palpitations; larynx swelling; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swelling throat / throat swelled), PRURITUS (Itching over body), DIZZINESS (Dizziness), ASTHENIA (weak) and LIP SWELLING (Lip swelling) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21AA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hives and Hay fever. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication. On 03-Mar-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 11:45 AM, the patient experienced PHARYNGEAL SWELLING (Swelling throat / throat swelled), PRURITUS (Itching over body), DIZZINESS (Dizziness), ASTHENIA (weak), LIP SWELLING (Lip swelling), SWOLLEN TONGUE (Tongue swelling), ENLARGED UVULA (uvula swelling), HEART RATE IRREGULAR (Heart rate irregular), OROPHARYNGEAL DISCOMFORT (Throat discomfort), PALPITATIONS (palpitations) and LARYNGITIS (larynx swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 04-Mar-2021, PHARYNGEAL SWELLING (Swelling throat / throat swelled) and PRURITUS (Itching over body) had resolved. On 03-Jun-2021, DIZZINESS (Dizziness), ASTHENIA (weak), LIP SWELLING (Lip swelling), SWOLLEN TONGUE (Tongue swelling), ENLARGED UVULA (uvula swelling), HEART RATE IRREGULAR (Heart rate irregular), OROPHARYNGEAL DISCOMFORT (Throat discomfort), PALPITATIONS (palpitations) and LARYNGITIS (larynx swelling) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Heart rate: irregular Irregular. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant Follow up appended on 22-Jul-2021. Updated: Reporter, Patient (Allergies and Lab data), Product (For vaccine updated facility type and name and added concomitant drug), Event (added newevents and causality updated) and Narrative updated.