Received Aug 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | — |
this vaccine broke as we were like administering it basically and the tip just came off where you would like to attach the needle.; 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 "this vaccine broke as we were like administering it basically and the tip just came off where you would like to attach the needle.". Additional information: The reporter stated, all the liquid was still in the vaccine. The vaccine was not administered to any patient, as they got another dose and we used that to administer the dose. The reporter considered "this vaccine broke as we were like administering it basically and the tip just came off where you would like to attach the needle." not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "this vaccine broke as we were like administering it basically and the tip just came off where you would like to attach the needle." was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Product Quality Group provided investigational results on 01Aug2025 for pneumococcal 20-val conj vac (dipht crm197 protein) (device constituent): No further investigation was required as no valid lot number or returned sample was available. This complaint will continue to be trended. If additional information becomes available, this complaint will be reopened. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.