Sex: F
Vaccine: PNC15
Symptoms: Product design confusion, Product label confusion, Product preparation issue, Product use complaint, Vaccination site erythema
Clinical narrative: Patient instructions for use in label confusing; induration, the grape size; swelling at vaccination site; redness at vaccination site; painful at the injection site (very painful per patient); do not know how to use the syringe due to two caps at the end and there were no directions in the PI on how to use it; Practice keep moving vaccine pre-filled syringe while it was in the pt's arm / vaccine admin did not know how to remove cap of "leur-lok  pre-filled syringe and attach a needle; didn't know that vaccine had to been shaken vigorously prior adminis; Vaccine administer had troubles prepping the vaccination/ medical assistant complained VAXNEUVANCE during previous administrations and reemphasized that drug preparation and administration was not intuitive like other pre-filled syringe; Vaccine administrator did not know how to remove cap of eur-lok pre-filled syringe and attach a needle; additionally, they did not know that the vaccine had to been shaken vigorously prior to administration; This spontaneous report was received from a nurse prescriber and refers to a 67-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 19-OCT-2022, the patient started therapy with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, pre-filled syringe, 0.5 milliliter, lot #U036156, expiration date: 25-MAY-2023, administered for prophylaxis (anatomical location, and route of administration were not provided). The vaccination was administered by medical assistant at practice who kept moving the vaccine pre-filled syringe while it was in the patient's arm. The lead nurse practitioner mentioned that the person who administered the vaccine had troubles prepping the vaccination (vaccine administrator did not know how to remove cap of leur-lok pre-filled syringe and attach a needle (Product preparation issue); additionally, they did not know that the vaccine had to been shaken vigorously prior to administration) and administering the injection (Wrong technique in product usage process). According to lead nurse practitioner, the medical assistant has complained pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) during previous administrations and reemphasized that drug preparation and administration was not intuitive like other pre-filled syringe vaccines on the market (Product use complaint).    On 20-OCT-2022 (reported also as: next after received), the patient experienced vaccination site induration, vaccination site swelling, vaccination site erythema, vaccination site pain. The patient reported that the next day she had induration (it was the size grape) the next after received. It was painful at the injection site (very painful per patient). Redness, swelling like the size of a grape (the site very hard). The Patient was a registered nurse who reported a red grape size painful induration at injection site. The patient was very upset she had never had any issues with any vaccine.   Nurse practitioner (NP) reported that they did not know how to use the pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE). That no one in the facility could figure out how to correctly use the product. NP reported that it was confusing to use since it looks like it had two caps the rubber one at the very end then you pull the rubber one off and it looked like it has another cap on the end. The Employee reported that she was not even sure how to use the product and that it was very confusing to her as well. The NP and employee made it seem like at the begging of the call that they had not been able to use the product due to no one at the facility understanding how to use the syringe. Towards the end of the call before the employee hung up she mentions that she would call back later to report an adverse event (AE). NP reported that no one in the facility knows how to use pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE). No products actually messed up per caller they do not know how to use the syringe due two the two caps at the end and there are no directions in the prescribing information (PI) on how to use it. Caller did not under why there are two caps and if they need to remove both. Caller thinks there should be something in the PI stating how to use the syringe or what the two caps are for per caller. Customer had issues that their was not something in the PI to tell how to use the syringe (Product design confusion). Customer reported they were all confused since it looked to have two caps on the syringe. Caller states there is nothing to tell them how to use the syringe (Product label confusion). No stating how to use the syringe it was confusing to them since it looked like there are two caps the rubber on and clear one. The reporter stated the healthcare provider feels like there needs to be direction on how to utilized the pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) pre-filled syringe and picture directions for administration should be included in the PI as you don't normally had to shake a pre-filled syringe vigorously until it was cloudy. The reporter stated that none of the nurses in the office realized it should be shaken in that manner.  At the time of reporting, the outcome of the events vaccination site induration, vaccination site swelling, vaccination site erythema, vaccination site pain was unknown.  The causal relationship between the events vaccination site induration, vaccination site swelling, vaccination site erythema, vaccination site pain and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was unknown.