Report #2877531

Overview

Sex

Unknown

Age

Age unknown

State

NY

Recovered

Recovered

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

stinging at injection site; particulate matter being difficult to resuspend when stored vertically (per package insert, should be stored horizontally); particulate matter being difficult to resuspend when stored vertically (per package insert, should be stored horizontally); particulate matter being difficult to resuspend when stored vertically (per package insert, should be stored horizontally); This is a spontaneous report received from a Pharmacist from a sales representative. An adult patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "stinging at injection site"; PRODUCT STORAGE ERROR (non-serious), PRODUCT RECONSTITUTION QUALITY ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "particulate matter being difficult to resuspend when stored vertically (per package insert, should be stored horizontally)". Therapeutic measures were not taken as a result of vaccination site pain, product storage error, product reconstitution quality issue, poor quality product administered. Additional information: Pharmacist describes particulate matter being difficult to resuspend when stored vertically (per package insert, should be stored horizontally). Notes some patients have also reported stinging at injection site. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.