Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19-2 | COVID19 (COVID19 (MODERNA BIVALENT)) | MODERNA | 5 | AS7146B | — |
she gets a reaction every time she has a booster; the first time it was really warm; She gets concerned every time she gets it because she has had something worse than others; the localized red, itchy symptoms; the localized red, itchy symptoms; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (she gets a reaction every time she has a booster), VACCINATION SITE WARMTH (the first time it was really warm), CONDITION AGGRAVATED (She gets concerned every time she gets it because she has had something worse than others), VACCINATION SITE ERYTHEMA (the localized red, itchy symptoms) and VACCINATION SITE PRURITUS (the localized red, itchy symptoms) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: sulfa and penicillin. Past adverse reactions to the above products included Allergy with penicillin and sulfa. Concurrent medical conditions included Allergy to antibiotic (she had a serious, though not anaphylactic, hemolytic reaction one time with cephalosporin. She just wants to be sure that it is not an allergy because she keeps getting the vaccine), Hypertension (She is healthy except that she sees a cardiologist, her hypertension is controlled), Hemolytic reaction, Mitral valve prolapse, Penicillin allergy and Sulfonamide allergy. On 20-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (she gets a reaction every time she has a booster), VACCINATION SITE WARMTH (the first time it was really warm), CONDITION AGGRAVATED (She gets concerned every time she gets it because she has had something worse than others), VACCINATION SITE ERYTHEMA (the localized red, itchy symptoms) and VACCINATION SITE PRURITUS (the localized red, itchy symptoms). At the time of the report, IMMUNISATION REACTION (she gets a reaction every time she has a booster) and CONDITION AGGRAVATED (She gets concerned every time she gets it because she has had something worse than others) outcome was unknown and VACCINATION SITE WARMTH (the first time it was really warm), VACCINATION SITE ERYTHEMA (the localized red, itchy symptoms) and VACCINATION SITE PRURITUS (the localized red, itchy symptoms) had resolved. 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. No concomitant medication was reported. It was stated that Patient had COVID arm. she was not on blood thinners and did not have any other conditions. She got concerned every time she got it because she had something worse than others. It was stated that she got a reaction every time she had a booster. Sometimes her reaction was more than others, the localized red, itchy symptoms. It was stated it was not dreadful, but she was concerned as to what was causing it. It was stated that it was warm sometimes, the first time it was really warm and then it just subsided. She took the antihistamines, and it was fine, "the next day it was a little bad". She did not want to take Benadryl again because she did not want to be tired. It was stated that her arm symptoms only last a couple of days. It was stated that she was pretty sure there was a time where her reaction was "really, really minimal" but the first time she got the vaccine it seemed to be the worst. It was stated there was another time, she did not remember exactly, might be the third one, that she had a pretty big reaction again. It was stated that there were always like something, so patient was careful." It was stated she'll get her flu shot first and then wait a month because she often reacted to the flu too with mild symptoms, no flu vaccine brand was mentioned. Patient had triple antibiotic allergies and once she had a serious hemolytic reaction to cephalosporin. It was stated this was a long time ago but that her immune system likes to overreact. She did not want to put herself at risk and wants the protection. It was unknown if the patient experienced any additional symptoms/events. This case was linked to MOD-2021-008609, MOD-2023-741990, MOD-2025-789715 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2025: Live Significant Follow-up information received: New event Condition worsened was added. Patient's historical condition was updated, and narrative was updated.
Allergy to antibiotic (she had a serious, though not anaphylactic, hemolytic reaction one time with cephalosporin. She just wants to be sure that it is not an allergy because she keeps getting the vaccine); Hemolytic reaction; Hypertension (She is healthy except that she sees a cardiologist, her hypertension is controlled); Mitral valve prolapse; Penicillin allergy; Sulfonamide allergy