Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
she gets a reaction every time she has a booster; it is warm sometimes-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 (it is warm sometimes-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 PRURITUS (the localized red, itchy symptoms) and VACCINATION SITE ERYTHEMA (the localized red, itchy symptoms) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: penicillin. Past adverse reactions to the above products included Allergy with penicillin. Concurrent medical conditions included Hypertension, Hemolytic reaction (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), Penicillin allergy (penicillin), Sulfonamide allergy (sulfa), Allergy to antibiotic (cephalosporin) and Mitral valve prolapse. On 30-Sep-2024, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 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 (it is warm sometimes-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 PRURITUS (the localized red, itchy symptoms) and VACCINATION SITE ERYTHEMA (the localized red, itchy symptoms). The patient was treated with Diphenhydramine hydrochloride (Benadryl) at an unspecified dose and frequency. 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 (it is warm sometimes-the first time it was really warm), VACCINATION SITE PRURITUS (the localized red, itchy symptoms) and VACCINATION SITE ERYTHEMA (the localized red, itchy symptoms) had resolved. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not reported. It was stated that she was a person who had COVID arm. She had a reaction every time she had a booster. Sometimes her reaction was more than others, the localized red, itchy symptoms. She states 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 didn't want to take Benadryl again because she didn't want to be tired. 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, minimal but the first time she got the vaccine it seemed to be the worst. There was another time, she didn't remember exactly, maybe the third one, that she had a pretty big reaction again. There was always something, so she was careful. Patient will get her flu shot first and then wait a month because she often reacts to the flu too with mild symptoms - no flu vaccine brand was mentioned. She states that she has triple antibiotic allergies and once she had a serious hemolytic reaction to cephalosporin. She states this was a long time ago but that her immune system likes to overreact. She was healthy except when she saw a cardiologist, her hypertension was controlled. Other than that, she was not on blood thinners and didn't have any other conditions. She gets concerned every time she gets it because she has had something worse than others. It was unknown if the patient experienced any additional symptoms/events. This case was linked to US-MODERNATX, INC.-MOD-2021-008609, US-MODERNATX, INC.-MOD-2023-741990, US-MODERNATX, INC.-MOD-2025-789714 (E2B Linked Report). 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, and narrative was updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-008609:Monovalent Dose US-MODERNATX, INC.-MOD-2023-741990:2023-2024 PFS Case (Dose 6) US-MODERNATX, INC.-MOD-2025-789714:Bivalent Dose (Dose 5)
Allergy to antibiotic (cephalosporin); Hemolytic reaction (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; Mitral valve prolapse; Penicillin allergy (penicillin); Sulfonamide allergy (sulfa)