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 | — | 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 |
Abdominal Pain; This 12-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular) on 9th January 2020. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 24th June 2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 23rd April 2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 24th June 2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous) on 9th January 2020, for prophylaxis. The subject received the 4th dose of Prevnar 13 (intramuscular) on 9th January 2020, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. On 17th January 2020, 8 days after receiving Bexsero vs Placebo, M-M-R II and Prevnar 13, 207 days after receiving DTPa-HBV-IPV and Hiberix and 269 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 abdominal pain. Serious criteria included hospitalization. The subject was treated with phosphoric acid, sodium salt (Sodium Phosphate Enema), morphine, macrogol (Polyethylene Glycol) and paracetamol (Acetaminophen). The outcome of abdominal pain was recovered/resolved on 21st January 2020. The investigator considered that there was no reasonable possibility that the abdominal pain may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II and Prevnar 13. Diagnostic results (unless otherwise stated, normal values were not provided): On 20th January 2020, C-reactive protein result was 6.8 mg/dL (normal low: less than equal to 0.9), Red blood cell sedimentation rate result was 84 (normal low: 0, normal high: 15), Ultrasound scan result was negative for intussusception and White blood cell count result was normal no fever. KUB without air fluid levels. On 29th January 2020, Faecal calprotectin result was less than 16 ug/g (normal low: less than equal to 50), Occult blood result was Negative, Ultrasound scan result was see text and Urine analysis result was Negative. GSK Receipt Date - 21-JAN-2020 12 Month old male presented to emergency department on 20JAN2020 at 1449 with intermittent abdominal pain (the pain started 17JAN2020). Also reported decreased po, decreased activity and fussier than usual. Mom noted that something similar happened a few months ago but seemed to get better on its own. In the emergency room he was noted to have intermittent bouts of pain, given morphine and normal saline bolus that helped a bit with the pain. Ultrasound negative for intussusception. Elevated inflammatory markers (Erythrocyte sedimentation rate and C-reactive Protein) present. Admitted from Emergency room to Hospital 20JAN2020 at 2155. Negative urinalysis, normal white blood cell count, no fever. KUB without air fluid levels but lots of people looking stool in rectum and stool in ascending and descending colon. Stool removed with enema and Miralax. Discharged home from hospital on 21JAN2020 at 1140. I phoned mom at 1400. Baby sleeping. Without abdominal pain. Response to query from 24FEB2020. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of abdominal pain 8 days after receiving 4th dose of Bexsero vs Placebo and Prevnar 13, 207 days after receiving 3rd dose of DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device and Hiberix, 269 days after receiving 2nd dose of Rotarix lyophilized formulation with Rotarix Oral Applicator Device, 8 days after receiving 1st dose of M-M-R II and Varivax co-administered with PCV and routine vaccines in a 12-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility. Causal relation is indeterminate considering insufficient definitive evidence for Rotarix lyophilized formulation with Rotarix Oral Applicator Device causing the temporaly related AE.
Test Date: 20200120; Test Name: C-Reactive Protein; Test Result: 6.8 mg/dl; Test Date: 20200129; Test Name: Calprotectin Stool; Result Unstructured Data: (Test Result:less than 16,Unit:ug/g,Normal Low:less than equal to 50,Normal High:); Test Date: 20200129; Test Name: Occult Blood Stool Guaiac; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20200120; Test Name: Erythrocyte Sedimentation Rate; Result Unstructured Data: (Test Result:84,Unit:unknown,Normal Low:0,Normal High:15); Test Date: 20200120; Test Name: Ultrasound; Result Unstructured Data: (Test Result:negative for intussusception,Unit:unknown,Normal Low:,Normal High:); Test Date: 20200129; Test Name: Ultrasound; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Date: 20200129; Test Name: urinalysis; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20200120; Test Name: white blood cell count; Result Unstructured Data: (Test Result:normal no fever. KUB without air fluid levels,Unit:unknown,Normal Low:,Normal High:)