Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| FLU3 | INFLUENZA (SEASONAL) (FLUARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| FLU3 | INFLUENZA (SEASONAL) (FLULAVAL) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| FLU4 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) | SANOFI PASTEUR | UNK | — | — |
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | UNK | — | — |
| HIBV | HIB (PEDVAXHIB) | MERCK & CO. INC. | UNK | — | — |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 3 | FX6077 | — |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | FX6077 | — |
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLULAVAL) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | OT |
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | UNK | — | OT |
| HIBV | HIB (PEDVAXHIB) | MERCK & CO. INC. | UNK | — | OT |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | UNK | — | OT |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | FX6077 | OT |
Passed away while napping; On 02-MAR-2023 vaccinated with hepatitis a vaccine inact (VAQTA); This spontaneous report was received from a Consumer or other non-health professional and refers to a 6-month-old male patient. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Prevnar (Pneumococcal vaccine conj 7v (CRM197)), and Prevnar (Pneumococcal vaccine conj 7v (CRM197)). On 02-Mar-2023, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) (Product administered to patient of inappropriate age), (lot # and expiration date were not reported); Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (lot # and expiration date were not reported); Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot #FX6077 (Lot #FX6077 is an invalid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent) (expiration date was not reported); 13 valent pneumococcal polysaccharide conjugate vaccine (Pneumococcal vaccine conj 13v (CRM197)) (PREVNAR 13) (lot #FX6077) (Dose number 3)(expiration date was not reported); influenza vaccine inact split 3v (FLULAVAL), (lot # and expiration date were not reported) influenza vaccine (FLUZONE) (lot # and expiration date were not reported); diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (INFANRIX), (lot # and expiration date were not reported); Hepatitis a vaccine inact (HAVRIX) (lot # and expiration date were not reported); Diphtheria vaccine toxoid; Hepatitis b vaccine rHBsAg (yeast);Pertussis vaccine acellular 3-component; Polio vaccine inact 3v (Vero);Tetanus vaccine toxoid) (PEDIARIX) (lot # and expiration date were not reported); Influenza vaccine (split virion), inactivated (Influenza vaccine inact split 3v) (FLUZONE) (lot # and expiration date were not reported). All the vaccines were administered as immunization. Route of administration and anatomical location were not reported for any vaccine. On 25-Mar-2025, when the patient was 2-year-old, he passed away while napping with no previous conditions. Autopsy performed, autopsy remarks as pending. No treatment received for event (as reported). The reported cause of death was Unknown. The causal relationship between the patient's death and the suspect vaccines was not provided.; Reported Cause(s) of Death: Unknown