Report #2889774

Overview

Sex

Female

Age

Age unknown

State

—

Recovered

Not recovered

Vaccinated

—

Onset

Oct 24, 2025

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

VACCINATION SITE ERYTHEMA; VACCINATION SITE SWELLING; Information has been received from Food and Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency# 2889774-1) This Spontaneous report was received from a non-health professional and describes the occurrence of VACCINATION SITE SWELLING (arm was very swollen and red) and VACCINATION SITE ERYTHEMA (arm was very swollen and red) in a 64-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052034) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052034) for COVID-19 prophylaxis and non-company product included Pneumococcal vaccine conj 21v (CRM197) (CAPVAXIVE) for an unknown indication. Previously administered products included for Drug use for unknown indication: cefuroxime, cleocin, montelukast, tramadol, Triamterene, levaquin, Morphine and Codeine. Past adverse reactions to the above products included Allergy to antibiotic with cefuroxime, cleocin and levaquin; and Drug allergy with Codeine, Morphine, Triamterene, montelukast and tramadol. Concurrent medical conditions included Drug hypersensitivity, Drug hypersensitivity, Drug hypersensitivity, Allergy to antibiotic, Allergy to antibiotic, Allergy to antibiotic, Drug hypersensitivity and Drug hypersensitivity. Concomitant products included guaifenesin (MUCINEX) and salbutamol sulfate (PROAIR) for an unknown indication. On 23-OCT-2025, the patient received first dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form in the right arm and first dose of Pneumococcal vaccine conj 21v (CRM197) (CAPVAXIVE) (unknown route) 1 dosage form in the left arm (lot number Z009681 has been verified to be valid, expiration date not provided but upon internal review was determined to be 10-OCT-2026. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 24-OCT-2025, the patient experienced vaccination site swelling (arm was very swollen and red) and vaccination site erythema (arm was very swollen and red). At the time of the report, vaccination site swelling (arm was very swollen and red) and vaccination site erythema(arm was very swollen and red) had not resolved. Related Patient was taking unspecified allergy medications. and also, in drug allergies it was mentioned as no treatment medication was reported. The action taken with Pneumococcal vaccine conj 21v (CRM197) (CAPVAXIVE) was not applicable. The action taken with mRNA-1283 (MNEXSPIKE PFS) was Unknown, The causality assessment between the event Vaccination site swelling, vaccination site erythema, Pneumococcal vaccine conj 21v (CRM197) (CAPVAXIVE), and mRNA-1283 (MNEXSPIKE PFS) was not reported. The Regulatory Authority considered the event Vaccination site swelling to be non-serious and the event Vaccination site erythema to be non-serious; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2026-05-27 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2889774 , Central date : 2026-05-26 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :

Current illness

Allergy to antibiotic; Drug hypersensitivity

Other medications

Guaifenesin (Mucinex); Salbutamol sulfate (Proair)