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 |
New Onset Type 1 Diabetes Mellitus; DKA (Diabetic Keto Acidosis; This 19-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular) on 13th August 2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 4th February 2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous) on 13th August 2019, for prophylaxis. The subject received the 4th dose of Prevnar 13 (intramuscular) on 13th August 2019, for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis, Rota (Rotarix) for prophylaxis and MMR II for prophylaxis. Concomitant products included famotidine. On 5th March 2020, 205 days after receiving Bexsero vs Placebo, Varivax and Prevnar 13 and 395 days after receiving Hiberix, the subject developed severe - grade 3 diabetic ketoacidosis. Serious criteria included hospitalization. Additional event(s) included severe - grade 3 type i diabetes mellitus on 5th March 2020 20:25 with serious criteria of hospitalization. The subject was treated with insulin lispro (Humalog), glycerol (Glycerin Suppository), ondansetron (Zofran), human biosynthetic insulin (Novolin R), insulin detemir (Levemir), heparin (nos) (Heparin), glucose (Dextrose 10%), sodium chloride, potassium chloride, insulin glargine (Lantus) and insulin aspart (Novolog). The outcome of diabetic ketoacidosis was recovered/resolved on 7th March 2020. The outcome(s) of the additional event(s) included type i diabetes mellitus (not recovered/not resolved). The investigator considered that there was no reasonable possibility that the diabetic ketoacidosis and type i diabetes mellitus may have been caused by Bexsero vs Placebo, Hiberix, Varivax, Prevnar 13, DTPa-HBV-IPV (Pediarix), Rota (Rotarix) and MMR II. Diagnostic results (unless otherwise stated, normal values were not provided): On 6th March 2020, Anti-GAD antibody result was 8368.2 (Endocrinology)and Glycosylated haemoglobin result was 11.7. In March 2020, Blood glucose result was 421, Blood insulin result was 24 (Endocrinology), Full blood count result was not provided, Insulin C-peptide result was 0.3 (Endocrinology), Platelet count result was 587 (Hematology), Respiratory syncytial virus test result was Negative and White blood cell count result was 14.3 (Hematology). Investigator text: Subject's parent called CRC on 05 mar 2020. Child was struggling with constipation and had a fever. CRC discussed with mom all possible issues via phone and it was decided that child would be taken to ER. Mom called site to let CRC know that that he is constipated and that he was given a suppository and tested for RSV and sent home. Mom is still concerned. CRC discussed with mom that CRC would help monitor him through out the day. Contacted PI and let him know that child was still not feeling well. CRC spoke with mom of subject and PI multiple times on 05Mar2020. Per PI mom was supposed to push fluids and if necessary get another suppository for child if he still hadn't had a bowel movement. At 1810 CRC checked in on child, now child very lethargic, still running fever and drinking a lot and urinating a lot but still no Bowel movement. Mom then mentioned that child had "purplish color on his lips" CRC advised mom to take child back to the ER at this time. CRC called PI as well and he suggested possibly trying another suppository or enema at this time but if too lethargic, fever continues etc he would need to be seen. Mom decided to take child to hospital because she has never seen him like this. When child arrived at hospital, he was in DKA and it was determined that T1DM had developed and per mom first Blood glucose taken was 421. Subject stayed in hospital and was stabilized and treated until 10 Mar 2020. CRC has been in contact with subject each day. 07Apr2020 Subject has no blood cultures or genetic testing in history. 21Jul2021er the PI, constipation and fever would not be relevant or risk factors for the SAE. Additional Details: The Investigator reported SAE term as New Onset Type 1 Diabetes Mellitus, DKA (Diabetic Keto Acidosis. This case contains an event assessed by the investigator as a serious possible immune mediated disorder (pIMD). On 5th March 2020, 205 days after receiving 1st dose MMR II the subject developed severe - grade 3 diabetic ketoacidosis and i diabetes mellitus. On 5th March 2020, 395 days after receiving 3rd dose DTPa-HBV-IPV (Pediarix) the subject developed severe - grade 3 diabetic ketoacidosis and i diabetes mellitus. On 5th March 2020, 458 days after receiving 2nd Rota (Rotarix) the subject developed severe - grade 3 diabetic ketoacidosis and i diabetes mellitus. 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 diabetic ketoacidosis and Type 1 diabetes mellitus, 205 days after receiving 4th dose of Bexsero vs Placebo and 1st doses of Varivax and Prevnar 13, and 395 days after receiving the 3rd dose of Hiberix, in a 19-month-old male subject. Insufficient information for causality assessment (no information available on genetic tests).
FAMOTIDINE
Test Date: 20200306; Test Name: GAD-65 (Endocrinology); Result Unstructured Data: (Test Result:8368.2 (Endocrinology),Unit:unknown,Normal Low:,Normal High:); Test Date: 202003; Test Name: First Blood Glucose; Result Unstructured Data: (Test Result:421,Unit:unknown,Normal Low:,Normal High:); Test Date: 202003; Test Name: Insulin Antibody (Endocrinology); Result Unstructured Data: (Test Result:24 (Endocrinology),Unit:unknown,Normal Low:,Normal High:); Test Date: 202003; Test Name: CBC; Result Unstructured Data: (Test Result:not provided,Unit:unknown,Normal Low:,Normal High:); Test Date: 20200306; Test Name: A1C; Result Unstructured Data: (Test Result:11.7,Unit:unknown,Normal Low:,Normal High:); Test Date: 202003; Test Name: C-Peptide (Endocrinology); Result Unstructured Data: (Test Result:0.3 (Endocrinology),Unit:unknown,Normal Low:,Normal High:); Test Date: 202003; Test Name: Platelet (Hematology); Result Unstructured Data: (Test Result:587 (Hematology),Unit:unknown,Normal Low:,Normal High:); Test Date: 202003; Test Name: Completed Swab for RSV; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 202003; Test Name: WBC (Hematology); Result Unstructured Data: (Test Result:14.3 (Hematology),Unit:unknown,Normal Low:,Normal High:)