Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 37 days; severe anaphylaxis/acute angioedema after bivalent shot; This spontaneous case was reported by a nurse and describes the occurrence of ANAPHYLACTIC REACTION (severe anaphylaxis/acute angioedema after bivalent shot) in a 41-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: mRNA-1273 (Dose Number: 1 Manufacturer: Moderna Lot number: 043C20A, Expiration date: Unknown Dose: 0.5 mL) on 30-Dec-2020, mRNA-1273 (Dose Number: 2 Manufacturer: Moderna Lot number: 025J20A, Expiration date: Unknown Dose: 0.5 mL) on 05-Feb-2021, mRNA-1273 (Dose Number: 3 Manufacturer: Moderna Lot number: 035C21A, Expiration date: 30DEC2021 Dose: 0.25 mL) on 03-Nov-2021 and Flu vaccine on 12-Oct-2022. Past adverse reactions to the above products included No adverse event with Flu vaccine, mRNA-1273, mRNA-1273 and mRNA-1273. Concurrent medical conditions included Fruit allergy (Patient has anaphylaxis to watermelon and cantaloupe to the point where even cutting a watermelon in the same room as her would require her to use an Epipen. She also has severe reaction to tomatoes. Additional allergies include banana, avocado, carrot, and kiwi.), Latex allergy (Additional allergies include latex.) and Allergy to antibiotic (Additional allergies include amoxicillin). Concomitant products included EPINEPHRINE (EPIPEN) for Anaphylaxis, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 19-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced ANAPHYLACTIC REACTION (severe anaphylaxis/acute angioedema after bivalent shot) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 37 days). At the time of the report, ANAPHYLACTIC REACTION (severe anaphylaxis/acute angioedema after bivalent shot) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 37 days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient  had a history of anaphylactic reactions to watermelon and cantaloupe, but she had never had such a severe anaphylactic reaction to any vaccine in the past.   Treatment 3 rounds of epinephrine plus IV histamine blocker, corticosteroids, and antihistamines.  Patient had received all previous COVID vaccinations without any acute allergic reactions.  Symptoms improved for event acute angioedema and severe anaphylaxis Patient was on steroid taper.  Angioedema is a common symptom of Anaphylactic reaction.  Company Comment: This is a spontaneous case, reported by a HCP, concerning a 41-year-old female patient with relevant medical history of Anaphylactic reaction to food and Latex and Drug Allergy, who experienced the expected serious (medically significant) event of Anaphylactic reaction, which occurred on the same day after receiving a dose of mRNA-1273.222 given as fourth/booster dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine with no reported adverse event, given at an interval of 37 days which did not fall within the recommended vaccine dosing schedule (Inappropriate schedule of vaccine administered), and the third dose mRNA-1273 vaccine given approximately 11 months and 2 weeks prior to the mRNA-1273.222 vaccination. It was reported that the patient had acute severe anaphylactic reaction with associated angioedema. Patient was sent to emergency room and was given with steroid therapy. No further details about the diagnostic procedures and specific treatments were provided. It was reported that the event was resolved. The medical history of Anaphylactic reaction to food and Latex and Drug Allergy could be the risk factors for the event. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a HCP, concerning a 41-year-old female patient with relevant medical history of Anaphylactic reaction to food and Latex and Drug Allergy, who experienced the expected serious (medically significant) event of Anaphylactic reaction, which occurred on the same day after receiving a dose of mRNA-1273.222 given as fourth/booster dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine with no reported adverse event, given at an interval of 37 days which did not fall within the recommended vaccine dosing schedule (Inappropriate schedule of vaccine administered), and the third dose mRNA-1273 vaccine given approximately 11 months and 2 weeks prior to the mRNA-1273.222 vaccination. It was reported that the patient had acute severe anaphylactic reaction with associated angioedema. Patient was sent to emergency room and was given with steroid therapy. No further details about the diagnostic procedures and specific treatments were provided. It was reported that the event was resolved. The medical history of Anaphylactic reaction to food and Latex and Drug Allergy could be the risk factors for the event. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.