Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: was pressure around my head "like a rubber band around my head."; tired; Mild fever; around the lymph nodes were a little swollen and hurt the reaction from my lymph nodes; Angioedema attack/swollen lips; This spontaneous case was reported by a patient and describes the occurrence of ANGIOEDEMA (Angioedema attack/swollen lips) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Angioedema (prior history of Angioedema before receiving any Moderna Covid-19 vaccines).    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced ANGIOEDEMA (Angioedema attack/swollen lips) (seriousness criterion medically significant). On an unknown date, the patient experienced HEAD DISCOMFORT (was pressure around my head "like a rubber band around my head."), FATIGUE (tired), PYREXIA (Mild fever) and LYMPHADENOPATHY (around the lymph nodes were a little swollen and hurt the reaction from my lymph nodes). At the time of the report, ANGIOEDEMA (Angioedema attack/swollen lips) and PYREXIA (Mild fever) had resolved and HEAD DISCOMFORT (was pressure around my head "like a rubber band around my head."), FATIGUE (tired) and LYMPHADENOPATHY (around the lymph nodes were a little swollen and hurt the reaction from my lymph nodes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 100.4 degrees Fahrenheit.         No concomitant medication was reported.  The patient was tired but that was not as bad as usual. There was no headache. The reaction from lymph nodes and immune system was very weak. The patient told her Doctor that she was worried that she was not making antibodies after the first bivalent booster dose. Doctor said that the patient was probably making antibodies but maybe less than before. Patient saw the allergist and the allergist says that the Angioedema attack was probably an indirect reaction to the other things that are going on.  No treatment information was reported.  Company Comment: This is a spontaneous case concerning a 68-year-old, female patient with a relevant medical history of Angioedema who experienced the serious (due to medically significant) unexpected, event of Angioedema, the non-serious unexpected event of Head discomfort, and the listed events of Pyrexia, Fatigue and Lymphadenopathy. The event Angioedema occurred on the same day after a booster dose of mRNA-1273 vaccine, and the rest of the events occurred after a booster dose but latency cannot be provided as onset dates were not reported. It was reported that the patient received the vaccine in her left arm, and that she was tired but that was not as bad as usual; she also endorsed mild fever of 100.4 degrees Fahrenheit, pressure around her head and swollen lymph nodes. The outcome of the events Angioedema and Pyrexia was reported as recovered, and the outcome of the rest of the events was reported as unknown. The mentioned medical history of Angioedema remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact