Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | IM / RL |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 1 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | IM / RL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | PO / MO |
Urinary Tract Infection; Respiratory Viral Syndrome; This 3-month-old female subject was enrolled in a blinded study. The subject received the 1st dose of Bexsero vs Placebo (intramuscular, right thigh) on 04-JAN-2019, for prophylaxis. The subject received the 1st dose of DTPa-HBV-IPV (intramuscular, right thigh) on 04-JAN-2019, for prophylaxis. The subject received the 1st dose of Rotarix lyophilized formulation (oral) on 04-JAN-2019, for prophylaxis. The subject received the 1st dose of Hiberix (intramuscular, right thigh) on 04-JAN-2019, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 27-FEB-2019, 54 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix, the subject developed moderate - grade 2 respiratory tract infection viral (Verbatim: Respiratory Viral Syndrome). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 urinary tract infection (Verbatim: Urinary Tract Infection) on 04-MAR-2019 with serious criteria of hospitalization. The subject was treated with cefdinir, ceftriaxone, dextrose, acetaminophen and sodium chloride. The action taken with Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix was no change. The outcome of respiratory tract infection viral was resolved on 12-MAR-2019. The outcome(s) of the additional event(s) included urinary tract infection (resolved on 13-MAR-2019). Relevant Tests: On 27-FEB-2019: Rapid antigen test was done in ER (Emergency Room). Results = POSITIVE abnormal On 27-FEB-2019 XR (X-ray) Abdomen single view Indications = increasing emesis Conclusion = multiple loops of dilated small bowel in the mid abdomen. Gas-filled colon appears decompressed. Findings are worrisome for small bowel obstruction. In this age group, etiologies may include intussusception and Meckel's divericulitis On 27-FEB-2019: US (Ultrasound) abdomen limited Indication = recent imaging suspicious for intussusception Conclusion = Concentric target appearance of bowel in the left lower quadrant is highly suspicious for an intussusception. It is favored to be small bowel. No ascites. On 03-FEB-2019: Urine culture tested positive for E. Coli. Presumed to be caused by untreated UTI.. The investigator considered that there was no reasonable possibility that the respiratory tract infection viral and urinary tract infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. The company considered that there was no reasonable possibility that the respiratory tract infection viral and urinary tract infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. Linked case(s) involving the same subject: US2019056671, US2019059404 GSK receipt date: 28-MAR-2019 2/27/19: subject was seen by a colleague of PI who sent her directly to the ER for RSV. ER did some tests and transferred her to a larger ER across down. Subject was admitted for RSV and suspicion of intussusception. 2/28/19: Intussusception clinically resolved without intervention or surgery. 3/4/19 Hospital progress note: Urine culture from 3/2/19 resulted positive for E. Coli and subject was given ceftriaxone. Was thought to possibly be contaminant as it was from a bagged specimen. Given age and presumed duration of untreated UTI, subject was kept an additional 24 hours for observation. 3/5/19: Subject discharged and given prescription for 8 days of cefdinir. Will need RBUS near the completion of antibiotic therapy. 3/5/19: subject discharged 3/8/19: LAR/Mom brought subject for 4 mos WCC and study visit 2. At this time informed site that subject had been hospitalized and discharged 3 days prior. Visit is rescheduled for 3/22/19. On 23 Apr 2019, case US2019056671 and US2019059404 were identified as duplicate of US2019056670. All future correspondence will be added US2019056670. Reported medication name was Sodium chloride nasal Upon internal review the case was updated on 23-Jan-2025 FU GSK Receipt Date was updated and Narrative updated. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Respiratory tract infection viral and urinary tract infection, 54 days after receiving 1st doses of Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device, Hiberix and Rotarix lyophilized formulation with Rotarix Oral Applicator Device, in a 3-month-old female subject . Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility. US-GLAXOSMITHKLINE-US2019056671: US-GLAXOSMITHKLINE-US2019059404:
Comments: On 27-FEB-2019: Rapid antigen test was done in ER (Emergency Room). Results POSITIVE abnormal On 27-FEB-2019 XR (X-ray) Abdomen single view Indications = increasing emesis Conclusion = multiple loops of dilated small bowel in the mid abdomen. Gas-filled colon appears decompressed. Findings are worrisome for small bowel obstruction. In this age group, etiologies may include intussusception and Meckel's divericulitis On 27-FEB-2019: US (Ultrasound) abdomen limited Indication = recent imaging suspicious for intussusception Conclusion = Concentric target appearance of bowel in the left lower quadrant is highly suspicious for an intussusception. It is favored to be small bowel. No ascites. On 03-FEB-2019: Urine culture tested positive for E. Coli. Presumed to be caused by untreated UTI.