Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Throat tightness
Clinical narrative: Tight throat after booster 3rd shot; Swelling on the left side of neck (throat) after booster 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Tight throat after booster 3rd shot) and SWELLING (Swelling on the left side of neck (throat) after booster 3rd shot) 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.     Previously administered products included for Product used for unknown indication: Lisinopril (5 years ago). Past adverse reactions to the above products included Angioedema with Lisinopril.   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 THROAT TIGHTNESS (Tight throat after booster 3rd shot) (seriousness criterion hospitalization) and SWELLING (Swelling on the left side of neck (throat) after booster 3rd shot) (seriousness criterion hospitalization). The patient was hospitalized on 21-Sep-2021 due to SWELLING and THROAT TIGHTNESS. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 21-Sep-2021 for Throat tightness and Neck swelling, at a dose of 1 UNK and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 21-Sep-2021 for Throat tightness and Neck swelling, at a dose of 120 mg. On 21-Sep-2021, THROAT TIGHTNESS (Tight throat after booster 3rd shot) and SWELLING (Swelling on the left side of neck (throat) after booster 3rd shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient did not had any reactions after the first two shots. Five minutes after the booster shot, her throat was tight and started to swell on the left side of the neck. She was given some Benadryl shot and steroid shot and transported to the emergency room where she received additional Benadryl and Steroid shot (120 mg).  Company comment: A 69-year-old female was hospitalized with serious unexpected events of throat tightness and swelling. Latency 249 days after first dose, 221 days after second dose, and 5 minutes after third dose mRNA-1273. Events resolved with diphenhydramine and steroids. Rechallenge not applicable. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: A 69-year-old female was hospitalized with serious unexpected events of throat tightness and swelling. Latency 249 days after first dose, 221 days after second dose, and 5 minutes after third dose mRNA-1273. Events resolved with diphenhydramine and steroids. Rechallenge not applicable. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.