Age: 0.33
Sex: F
Vaccine: HIBV, MEN, PNC13, UNK, UNK
Symptoms: Alanine aminotransferase increased, Anion gap, Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase normal
Clinical narrative: 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.