Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / RL |
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | 4 | UNK | IM / RL |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | 1 | UNK | SC / RA |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 4 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | PO / MO |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | UNK | SC / LA |
Skull Fracture; This 20-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo co-administered with PCV and routine vaccines (intramuscular) on 29th May 2020, for prophylaxis. On 12th February 2021, 259 days after receiving Bexsero vs Placebo co-administered with PCV and routine vaccines, the subject developed severe - grade 3 skull fracture. Serious criteria included hospitalization. The subject was treated with paracetamol (Acetaminophen) and midazolam (Versed (Midazolam)). The outcome of skull fracture was recovered/resolved on 18th March 2021. The investigator considered that there was no reasonable possibility that the skull fracture may have been caused by Bexsero vs Placebo co-administered with PCV and routine vaccines. Relevant Tests: On 13Feb2021 CT Head Result showed Calvarium left paracentral occipital acute fracture. Diagnostic results (unless otherwise stated, normal values were not provided): On 13th February 2021, Computerised tomogram head result was see text. Investigator Text On 12Feb2021 subject sustained an occipital skull fracture after falling backwards in his booster chair. The fall was witnessed by the mother. There was no loss of consciousness and he cried right away. He was not as playful and took 2 naps and vomited 4 times before his arrival to the emergency department on 12Feb2021 at 2103. CT head showed Calvarium left paracentral occipital acute fracture. 13Feb2021 at 0127 admitted to Hospital (transferred to pediatric intensive care unit from emergency department) for overnight observation. He was given 2 doses of Midazolam (Versed) via IV route and one dose of IV Acetaminophen. Diet was advanced from clears to regular in the morning and he did not have further episodes of emesis or unusual irritability. After demonstrating an ability to tolerate solid foods and with resolved nausea and vomiting, he was discharged home on 13Feb2021 at 1356 with follow up by pediatric neurosurgery in 2 to 4 weeks. 18Mar2021: Follow up phone consultation with peds neurosurgery reported full recovery. Follow up information received on 11-Mar-2025 End of study Unblinding completed. Upon internal review the case was updated on 18-Mar-2025. Study drugs updated.; Sender's Comments: A case of skull fracture, 259 days after receiving 4th dose of Bexsero vs Placebo co-administered with PCV and routine vaccines, in a 20-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative etiology (H/O falling backwards in his booster chair).
Test Date: 20210213; Test Name: CT Head; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Comments: On 13Feb2021 CT Head Result showed Calvarium left paracentral occipital acute fracture.