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 | 3 | UNK | IM / RL |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 3 | 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 |
Malignant Neuroblastoma; This 12-month-old female subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular) on 19th August 2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 19th August 2019, for prophylaxis. The subject received the 1st dose of Rotarix lyophilized formulation (oral) on 26th June 2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 19th August 2019, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and Prevnar 13 (Non-GSK Comparator) (Prevnar 13) for prophylaxis. On 18th February 2020, 183 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix and 237 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 neuroblastoma. Serious criteria included hospitalization and GSK medically significant. Bexsero vs Placebo was discontinued. DTPa-HBV-IPV was discontinued. Hiberix was discontinued. The outcome of neuroblastoma was not recovered/not resolved. The investigator considered that there was no reasonable possibility that the neuroblastoma may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. Relevant Tests: On 18Feb2020 Abdominal ultrasound: 12 x 13 x 5 x 9cm abdominal mass and small pleural effusion on right. Diagnostic results (unless otherwise stated, normal values were not provided): On 18th February 2020, Ultrasound abdomen result was see text. On 21st February 2020, Biopsy result was Neuroblastoma (Tumor biopsy). Investigator text 18FEB2020 Subject brought to Emergency Room for emesis x2 and abdominal distention. Exam revealed right upper quadrant mass. Chemotherapy to begin 27FEB2020. Spoke with mother 26FEB2020 Subject has discontinued the study and no further information can be obtained. Additional Details: Investigator reported SAE as Malignant Neuroblastoma. Subject withdrawn from study due to this event. Follow up information received on 11-Mar-2025. End of study Unblinding completed.; Sender's Comments: A case of neuroblastoma, 183 days after receiving 3rd doses of Bexsero vs Placebo, DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe and Hiberix, and 237 days after receiving the 1st dose of Rotarix lyophilized formulation with Rotarix Oral Applicator Device, in a 12-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility.
Test Date: 20200221; Test Name: Tumor biopsy; Result Unstructured Data: (Test Result:Neuroblastoma (Tumor biopsy),Unit:unknown,Normal Low:,Normal High:); Test Date: 20200218; Test Name: Abdominal ultrasound; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Comments: On 18Feb2020 Abdominal ultrasound: 12 x 13 x 5 x 9cm abdominal mass and small pleural effusion on right.