Received Jul 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | — |
Prolonged Syncope; The baby was lethargic; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 08Jul2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Physician from medical information team. A 9-month-old male patient received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) at the age of 9 months for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant, life threatening), outcome "unknown", described as "Prolonged Syncope"; LETHARGY (life threatening), outcome "unknown", described as "The baby was lethargic". Clinical course: The pediatrician called regarding a 9-month baby, healthy, no allergies (referred a "perfectly fine") who was administered PCV 20. The pediatrician initially reported that the baby almost died right after giving the vaccine in their office and that they almost lost the baby. She mentioned that this is so very serious. This vaccine is causing problems and lots of reactions. She does not know if she should give this vaccine anymore. On 08Jul2025, the same pediatrician reported that the baby had a reaction that is not outlined in the PI. As soon as PCV 20 was administered, the baby went to sleep almost immediately, they thought they had lost him. They tried to wake him up, took about half an hour to know what's going on. The baby was lethargic, almost called the Emergency Services. The pediatrician stated that this is not normal. It was an instant reaction to the vaccine. The pediatrician is aware that the PI reported drowsiness, however she would referred it as Prolonged Syncope. The pediatrician also reported that she has seen other local reactions (redness, 1-inch knots that take 2-4 weeks) that she didn't see with PCV 13. The pediatrician wanted to know if she should continue to give the vaccine and if there are any more reports. The information on the batch/lot number for pneumococcal 20- valent conjugate vaccine (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Based on the close temporal relationship, the association between the events syncope and lethargy with PREVNAR 20 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.