Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | B532G | IM |
| HIBV | HIB (PEDVAXHIB) | MERCK & CO. INC. | 2 | Y013470 | IM |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | 2 | LK6650 | IM |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Y013470 | OT / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | LK6650 | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | B532G | OT |
Unresponsive to stimuli; The second dose of PEDVAXHIB was administered to a 3-month-old baby; 7 antigens, 3 syringes full of different adjuvants, preservatives and stabilizers. Too much pharma poisoned this little boy; . This spontaneous report was received from a consumer (patient's father) and refers to a 3-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions included Intussusception. Historical drugs included nirsevimab alip (BEYFORTUS). Concomitant therapies were not reported. On 13-MAR-2025, the patient was vaccinated with the second dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), lot #Y013470; which has been verified to be valid for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate), expiration date not reported but upon internal validation establish as 27-FEB-2027, administered by Intramuscular route in left thigh (strength and exact quantity volume were not provided) for prophylaxis (Inappropriate schedule of product administered) and also was vaccinated with the second dose of Pneumococcal vaccine conj 20v (CRM197) (PREVENAR 20), lot #LK6650, left thigh), administered by Intramuscular route in the left thigh (strength, exact quantity volume, indication and expiration date were not reported) and with the second dose of Diphtheria vaccine toxoid; Hepatitis b vaccine rHBsAg (yeast) (+) Pertussis vaccine acellular 3-component (+) Polio vaccine inact 3v (Vero) (+) Tetanus vaccine toxoid (PEDIARIX), lot #B532G, administered by Intramuscular route in the right thigh (strength, exact quantity volume, indication and expiration date were not reported). On the same date (13-MAR-2025) at 7p.m., the patient experienced unresponsive to stimuli; even with cardiopulmonary resuscitation (CPR) and other interventions at the hospital when he was admitted (he was stabilized and transferred to a facility with an available pediatric provider), he never regained consciousness. Instead, he slowly declined and was no longer responsive to treatments in intensive case unit (ICU). It was also reported that "7 antigens, 3 syringes full of different adjuvants, preservatives and stabilizers" "too much pharma poisoned this little boy" (Toxicity to various agents). On 15-MAR-2023 at 8:14 a.m., he was pronounced dead. It was unknown whether an autopsy was performed. The reporter considered the event of unresponsive to stimuli to be related to the suspect therapies meanwhile the event of toxicity to various agents was assessed as related to the suspect therapies. Upon internal review, the event of unresponsive to stimuli was determined to be medically significant for the treatment required (ICU).; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : (redacted)@merck.com , Index date : 2025-04-16 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : PV202500045176 , Central date : 2025-04-16 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Intussusception