Received Mar 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | — |
vials somethings cracked and broken; The initial case was missing the following minimum criteria: [specify criteria adverse event. Upon receipt of follow-up information on [19Feb2025], this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP from product quality group. A patient (age and gender not provided) 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: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "vials somethings cracked and broken". Additional information: It was stated, "I'm a Pfizer vaccine sales representative I'm calling because I have an office that received Prevanar 20 and one of the pens, vials somethings cracked and broken and I spoke with the doctor and he said all of the vaccine Is still intact inside but there's something that's cracked and he tried to explain to me and I said is it still something that you can administer and he said he would have to use another needle so I said let me get medical on because I was told by customer service that the medical department needs to make a decision on weather they can use it or not." The reporter considered "vials somethings cracked and broken" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "vials somethings cracked and broken" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.