Age: 0.33
Sex: M
Vaccine: HIBV, MEN, MMR, PNC13, UNK, UNK, VARCEL
Symptoms: Haematochezia, Haematocrit normal, Haemoglobin normal, Helicobacter test negative, Lymphocyte count normal
Clinical narrative: Viral Gastroenteritis; This 12-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular) on 5th March 2020, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 10th September 2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 9th July 2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 10th September 2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous) on 5th March 2020, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous) on 5th March 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 10th March 2020 14:45, 5 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 182 days after receiving DTPa-HBV-IPV and Hiberix and 245 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 viral gastroenteritis. Serious criteria included clinically significant/intervention required. The subject was treated with sodium chloride (Sodium Chloride 0.9% Bolus) and ondansetron (Zofran (Ondansetron)). The outcome of viral gastroenteritis was recovered/resolved on 17th March 2020.   The investigator considered that there was no reasonable possibility that the viral gastroenteritis may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II and Varivax.   Relevant Tests: On 12Mar2020 Stool tests was ordered and resulted on 16Mar2020:  Test: Giardia Cryptosporidium Direct antigen Results: Giardia Antigen - Negative Cryptosporidium Antigen - Negative Test: Stool Pathogen Screen Result: No Salmonella or Shigella Isolated Test: Shigatoxin Screen Results: Shigatoxin 1 - Negative,Shigatoxin 2 - Negative Test: Campylobacter Antigen Result: Negative Test: Comprehensive Ova and Parasite Exam Result: No Parasites Seen   Diagnostic results (unless otherwise stated, normal values were not provided):  On 11th March 2020, Basophil percentage result was 0 % (normal low: 0.00, normal high: 2.00), Blood calcium result was 10.5 mg/dL (normal low: 8.80, normal high: 10.60), Blood chloride result was 103.00 mmol/L (normal low: 99.00, normal high: 108.00), Blood creatine result was 0.28 mg/dL (normal low: 0.26, normal high: 0.77), Blood glucose result was 140 mg/dL (normal low: 55.00, normal high: 199.00), Blood potassium result was 4.6 mmol/L (normal low: 3.50, normal high: 5.10), Blood sodium result was 141 mmol/L (normal low: 136.00, normal high: 145.00), Blood urea result was 19 (nitrogen) mg/dL (normal low: 7.00, normal high: 25.00), Carbon dioxide result was 19 mmol/L (normal low: 21.00, normal high: 31.00), Eosinophil percentage result was 0 % (normal low: 0.00, normal high: 9.00), Haematocrit result was 34 % (normal low: 32.00, normal high: 42.00), Haemoglobin result was 11.4 g/dL (normal low: 10.50, normal high: 14.00), Lymphocyte percentage result was 19 % (normal low: 49.00, normal high: 70.00), Mean cell haemoglobin concentration result was 29 pg (normal low: 24.00, normal high: 30.00), Mean platelet volume result was 7.1 fL (normal low: 6.00, normal high: 9.50), Monocyte percentage result was 5 % (normal low: 1.00, normal high: 12.00), Neutrophil percentage result was 76 % (normal low: 23.00, normal high: 44.00), Platelet count result was 511 K/uL (normal low: 150.00, normal high: 450.00), Red blood cell count result was 3.99 M/uL (normal low: 3.80, normal high: 5.40), Red cell distribution width result was 12.6 % (normal low: 11.50, normal high: 16.00) and White blood cell count result was 17.1 K/uL (normal low: 6.00, normal high: 14.00). On 12th March 2020, Stool analysis result was see text. In March 2020, Anion gap result was 19 (normal low: 3.00, normal high: 11.00), Basophil count result was 0.1 (Absolute) K/uL (normal low: 0.00, normal high: 0.20), Blood osmolarity result was 286 unit mOsm/kg (normal low: 270, normal high: 295), Culture stool result was Positive(A), Eosinophil count result was 0.00 (Absolute) K/uL (normal low: 0.00, normal high: 1.10), Lymphocyte count result was 3.2 (Absolute) K/uL (normal low: 2.90, normal high: 9.80), Mean cell volume result was 85 fL (normal low: 72.00, normal high: 88.00), Monocyte count result was 0.9 (Absolute) K/uL (normal low: 0.00, normal high: 1.40), Neutrophil count result was 12.8 (Absolute) K/uL (normal low: 1.40, normal high: 6.20), Occult blood result was Positive(A) POCT, Red blood cell nucleated morphology result was 0 range /100WBC, Rotavirus test result was Negative, Ultrasound abdomen result was No evidence of Intussusception is identified and White blood cells stool result was Rare WBC's.                                                                                              INVESTIGATOR TEXT Patient presented to Wake Med ED on 3/10/2020 for vomiting that started that day. In the ED he had several episodes that were blood streaked- non bilious. HE received Zofran and boluses of IV fluids. His lab work was reassuring. Prior to departure from the ED he had a large bowel movement that appeared to have blood and mucus. An ultrasound was obtained to rule out obstruction and /or intussusception, and that was negative. Stool studies were sent out and pending at the time of discharge 3/11/20 morning. His vomiting and diarrhea were suspected to be secondary to viral gastroenteritis. At followup office visit on 3/12/20 additional stool studies were obtained (Giardia, Cryptosporidium, Ova and parasite, Shigella, stool pathogen panel, salmonella, campylobacter) and all resulted negative. The diagnosis was presumed to be a viral gastroenteritis.        Additional deatils: On 30Jun2021 SAE Diarrhea was deleted.  Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of gastroenteritis viral, 5 days after receiving the 4th dose of Bexsero vs Placebo, M-M-R II, Varivax, 182 days after receiving 3rd dose of DTPa-HBV-IPV vaccine pre-filled syringe device injection syringe, 182 days after receiving 3rd dose of Hiberix  and 245 days after receiving 2nd dose of Rotarix vaccine oral applicator device in a 12 month old male subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility.