Sex: F
Vaccine: COVID19, FLU3, PNC21
Symptoms: Injection site rash, Investigation
Clinical narrative: Injection site rash; This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: 2232228. The previous case ID: 2412USA004514. As a consequence of migration, the follow-up report may indicate in the appropriate field that it is an initial report.  Information has been received from Food and Drug Administration (FDA) (VAERS ID: 2801462)  This spontaneous report has been received from regulatory authority, concerning to a 49-year-old female patient.   The patient's medical history included asthma, dermatitis atopic, cough, hypertension,  pain,  migraine, and respiratory disorder. The patient's concurrent conditions included drug hypersensitivity, drug hypersensitivity, drug hypersensitivity, drug hypersensitivity, allergic reaction to antibiotics, and penicillin allergy. Historical drugs included aspirine, codeine, erythromycin benzoyl peroxide, angiotensin converting enzyme (ACE) inhibitor, erythromicin, and penicillin nos. Concomitant therapies were not reported.  On 17-OCT-2024, the patient was vaccinated with pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE) injection, administered intramuscularly for prophylaxis (strength and dose were not provided; lot #Y011819 was verified to be valid for this vaccine and  expiration date was not reported, but confirmed as 01-OCT-2025); with covid-19 vaccine (COVID-19 VACCINE), lot #LM2216, administered intramuscularly (strength, dose, formulation, expiry date, and indication were not provided); and  with influenza vaccine inact split 3v (FLUARIX), lot #KM5GK, administered intramuscularly (strength, dose, formulation, expiry date, and indication were not provided). All vaccines were administered at the pharmacy.   On 18-OCT-2024, the patient had rash on her left arm near vaccine injection site (injection site rash), the patient stopped at our pharmacy and reported rash on that same day. On 22-OCT-2024, urgent care (emrgency room) and was prescribed antibiotic. At the time of reporting, the outcome of the event injection site rash was reported as unknown.     The causal relationship between injection site rash and pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE) was unknown.  This is one of several reports received from the same reporter.   Investigation Summary for pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE), Batch/Lot#: Y011819  Reviews performed as a result of this adverse event concluded that no unexpected events arose during the manufacture of Capvaxive Batch number 0001774623 material number 2017970 at MSD which could have impacted on product quality.  No deviations were deemed to have an impact on the batch prior to batch disposition. All acceptance criteria were met. All components utilized in the batch underwent QC inspection and release as per applicable quality standards and site procedures prior to use in the batch.  Sterility, Bioburden and endotoxin testing were performed as per approved site procedures and results met specification. Release testing conformed to all specifications. Based on this investigation of the adverse event, no systemic manufacturing inadequacy was identified at the MSD manufacturing facility that could impact the quality attributes of the product.  There have been no additional requests for information or additional testing relating to this Adverse Event.