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 |
Intestinal infection due to clostridium difficile; This 7-month-old female subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular) on 2nd January 2020, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 2nd January 2020, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 29th October 2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 2nd January 2020, 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 7th February 2020, 36 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix and 101 days after receiving Rotarix lyophilized formulation, the subject developed moderate - grade 2 intestinal infection due to clostridium difficile. Serious criteria included hospitalization. The subject was treated with vancomycin hydrochloride, famotidine and metronidazole. Bexsero vs Placebo was continued with no change. Prevnar 13 was continued with no change. The outcome of intestinal infection due to clostridium difficile was recovered/resolved on 10th March 2020. The investigator considered that there was no reasonable possibility that the intestinal infection due to clostridium difficile may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. Diagnostic results (unless otherwise stated, normal values were not provided): On 21st February 2020, Alanine aminotransferase result was 110 u/L (normal low: 10.00, normal high: 65.00), Aspartate aminotransferase result was 56 u/L (normal low: 20.00, normal high: 60.00), Blood albumin result was 4.4 g/dL (normal low: 3.90, normal high: 5.60), Blood alkaline phosphatase result was 189 u/L (normal low: 72.00, normal high: 307.00), Blood bilirubin result was 0.3mcv40 mg/dL (normal low: 0.00, normal high: 1.90), Blood bilirubin result was 10 mg/dL (normal low: 0.00, normal high: 1.90), Blood calcium result was 10.3 mg/dL (normal low: 8.50, normal high: 10.60), Blood chloride result was 114 mmol/L (normal low: 99.00, normal high: 109.00), Blood creatine result was 0.29 mg/dL (normal low: 0.10, normal high: 0.58), Blood potassium result was 4.0 mmol/L (normal low: 3.60, normal high: 6.80), Blood sodium result was 139 mmol/L (normal low: 135.00, normal high: 145.00), Carbon dioxide result was 12 mmol/L (normal low: 20.00, normal high: 28.00), Clostridium test result was positive, Clostridium test result was positive (Tox Ag), Escherichia test result was negative (Shiga toxin), Giardia test result was negative (Giardia Antigen Stool), Haemoglobin result was 13.0 g/dL (normal low: 11.50, normal high: 13.50), Mean cell volume result was 84.8 fL (normal low: 70.00, normal high: 86.00), Platelet count result was 405 K/uL (normal low: 250.00, normal high: 600.00) and White blood cell count result was 9.59 K/uL (normal low: 6.00, normal high: 17.50). INVESTIGATOR TEXT Subject is a 7 month old female who presented to the ED with intermittent bloody stools and chronic diarrhea. Mother stated the diarrhea has been intermittent and waxing and waning over the past month. She occasionally has soft stools, but throughout the day her stools become more watery. Her mother first noted dark red blood and mucous in the stool about 3 weeks ago, this self-resolved. The PCP switched the patient's formula over to nutramigen, but the patient did not tolerate this (possibly due to flavor). She continued to have intermittent diarrhea. In hospital it was felt milk protein allergy was most likely, but that infectious cause should be ruled out. Stool cultures for yersina, giardia, and C. Diff were sent in addition to CMP and CBC. In all, patient was found to be positive for C Diff NAAT and toxin. Her inital electrolytes improved as well. She was discharged on oral metronidazole for 10 day course. Subject was admitted to the hospital on 21FEB2020 and discharged on22FEB2020 at 15:50pm. No history of C-Diff Lab 02/21/20 1228 WBC 9.59 HGB 13.0 MCV 84.8 PLT 405 Lab 02/21/20 1228 NA 139 K 4.0 CL 114 CO2 12 ANIONGAP 13 BUN 10 CREA 0.29 GLU 66 Lab 02/21/20 1228 CALCIUM 10.3 Recent Labs Lab 02/21/20 1228 ALBUMIN 4.4 ALT 110 AST 56 ALKPHOS 189 BILITOT 0.3 Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Clostridium difficile colitis, 36 days after receiving 3rd doses of Bexsero vs Placebo, DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device and Hiberix and 101 days after receiving the 2nd dose of Rotarix lyophilized formulation with Rotarix Oral Applicator Device, in a 7-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility.
Test Date: 20200221; Test Name: Alanine Amino Transferase; Result Unstructured Data: (Test Result:110,Unit:u/L,Normal Low:10.00,Normal High:65.00); Test Date: 20200221; Test Name: Aspartate Aminotransferase; Result Unstructured Data: (Test Result:56,Unit:u/L,Normal Low:20.00,Normal High:60.00); Test Date: 20200221; Test Name: Albumin; Result Unstructured Data: (Test Result:4.4,Unit:g/dL,Normal Low:3.90,Normal High:5.60); Test Date: 20200221; Test Name: Alkaline phosphatase; Result Unstructured Data: (Test Result:189,Unit:u/L,Normal Low:72.00,Normal High:307.00); Test Date: 20200221; Test Name: Bilirubin; Test Result: 10 mg/dl; Test Date: 20200221; Test Name: Bilirubin total; Result Unstructured Data: (Test Result:0.3mcv40,Unit:mg/dL,Normal Low:0.00,Normal High:1.90); Test Date: 20200221; Test Name: Calcium; Test Result: 10.3 mg/dl; Test Date: 20200221; Test Name: Chloride; Result Unstructured Data: (Test Result:114,Unit:mmol/L,Normal Low:99.00,Normal High:109.00); Test Date: 20200221; Test Name: Creatine; Test Result: 0.29 mg/dl; Test Date: 20200221; Test Name: Potassium; Result Unstructured Data: (Test Result:4.0,Unit:mmol/L,Normal Low:3.60,Normal High:6.80); Test Date: 20200221; Test Name: Sodium; Result Unstructured Data: (Test Result:139,Unit:mmol/L,Normal Low:135.00,Normal High:145.00); Test Date: 20200221; Test Name: Carbon dioxide; Result Unstructured Data: (Test Result:12,Unit:mmol/L,Normal Low:20.00,Normal High:28.00); Test Date: 20200221; Test Name: c. diffile; Result Unstructured Data: (Test Result:positive,Unit:unknown,Normal Low:,Normal High:); Test Date: 20200221; Test Name: C-difficile Tox Ag; Result Unstructured Data: (Test Result:positive (Tox Ag),Unit:unknown,Normal Low:,Normal High:); Test Date: 20200221; Test Name: Shiga toxin; Result Unstructured Data: (Test Result:negative (Shiga toxin),Unit:unknown,Normal Low:,Normal High:); Test Date: 20200221; Test Name: Giardia Antigen Stool; Result Unstructured Data: (Test Result:negative (Giardia Antigen Stool),Unit:unknown,Normal Low:,Normal High:); Test Date: 20200221; Test Name: Hemoglobin; Result Unstructured Data: (Test Result:13.0,Unit:g/dL,Normal Low:11.50,Normal High:13.50); Test Date: 20200221; Test Name: Mean corpuscular volume; Test Result: 84.8 fL; Test Date: 20200221; Test Name: Platelet count; Result Unstructured Data: (Test Result:405,Unit:K/uL,Normal Low:250.00,Normal High:600.00); Test Date: 20200221; Test Name: White blood cell count; Result Unstructured Data: (Test Result:9.59,Unit:K/uL,Normal Low:6.00,Normal High:17.50)