Report #2831855

Overview

Sex

Female

Age

0.3 yrs

State

—

Recovered

Recovered

Vaccinated

Jul 31, 2019

Onset

May 20, 2020

Days to onset

294

Hospital days

—

Symptoms (17)

Symptom narrative

SERUM SICKINESS; This 13-month-old female subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 01-APR-2020, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 02-OCT-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 02-OCT-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 31-JUL-2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 01-APR-2020, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 01-APR-2020, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis and amoxicillin trihydrate (Amoxicillin) for systemic antibacterial therapy. Concurrent medical conditions included penicillin allergy (Allergic to Amoxicillin). On 20-MAY-2020, 49 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 231 days after receiving DTPa-HBV-IPV and Hiberix and 294 days after receiving Rotarix lyophilized formulation, the subject developed moderate - grade 2 serum sickness (Verbatim: SERUM SICKINESS). Serious criteria included clinically significant/intervention required. The subject was treated with clindamycin palmitate hydrochloride, hydroxyzine, sodium chloride (Normal Saline), ibuprofen, cetirizine and diphenhydramine. Bexsero vs Placebo was continued with no change. The outcome of serum sickness was resolved on 04-JUL-2020. Relevant Tests: On 22-May-2020 CBC (Complete blood count) with Automated Differential showed Abnormal On 22-May-2020 WBC (White blood cell) with Automated Differential Abnormal. Diagnostic results (reference ranges are provided in parenthesis if available): Blood sodium- 22-MAY-2020 134 mEq/L, (135.00-145.00). C-reactive protein- 22-MAY-2020 3.5 (0.00-0.90). Platelet count- 22-MAY-2020 623 K/uL, (140.00-400.00). The investigator considered that there was no reasonable possibility that the serum sickness may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, Rotarix lyophilized formulation, M-M-R II and Varivax. The company considered that there was no reasonable possibility that the serum sickness may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, Rotarix lyophilized formulation, M-M-R II and Varivax. GSK Receipt Date: 19-DEC-2024 Thirteen-month-old infant who presented with fevers and fussiness at her doctors appointment on 13MAY2020. She was diagnosed with right otitis media and was prescribed amoxicillin to be taken for 10 days. On day7 21MAY2020 of her amoxicillin course she developed a rash that started on her ear and spread to the body. Per mom the infants fingers began to swell and the rash became itchy. The amoxicillin was stopped. The child started to had a low-grade fever and became extremely fussy on 21MAY2020. By that same afternoon, mom noticed that the child had an abnormal gait, imbalance when walking. She was seen in the Emergency Department on 22MAY2020. Labs were drawn, a normal saline bolus was given along with antihistamines that were ordered. Mom reported that the child seemed significantly weaker and more lethargic upon review of the systems. She was positive for fevers, leg swelling, joint swelling and color change, with no change in her rashes. She was stable for discharge from the Emergency Department on 22MAY2020. After the ED (emergency department) visit the child had multiple telephone appointments with different pediatricians and on 24MAY2020 was diagnosed with Serum Sickness. Parent continued to give antihistamines as needed as her symptoms slowly improved, per mom all symptoms ended on 04JUL2020. This case contains an event assessed by the investigator as a serious possible immune mediated disorder (pIMD). On 20 May 2020, 7 days after starting Amoxicillin (GSK product, taken for Antibiotic), subject experienced Serum sickness. Follow up information received on 11-MAR-2022. This follow up was considered non-significant. Summary of changes: No new information updated. Follow up information was received on 19-DEC-2024 Summary of changes: Treatment medication name updated from Clindamycin Palmitate to Clindamycin Palmitate Hydrochloride Upon internal review the case was updated on 23-Dec-2024 Device causality updated from no to unknown. Upon internal review the case was updated on 07-FEB-2025. Authorization Number updated for Products Hiberix, DTPa-HBV-IPV-HIB from World-MKT to World-INV, Rotarix lyophilized formulation from BB-9,231 to World-INV. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of serum sickness, 49 days after receiving the 4th doses of Bexsero vs Placebo, Prevnar 13, 1st doses of M-M-R II and Varivax, 231 days after receiving the 3rd doses of Hiberix and DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device, and 294 days after receiving the 2nd dose of Rotarix lyophilized formulation with Rotarix Oral Applicator Device, in a 13-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering alternative etiology (event occurred after a 7 day course of amoxicillin).

Current illness

Penicillin allergy (Allergic to Amoxicillin)

Other medications

Amoxicillin

Lab data

Test Date: 20200522; Test Name: Sodium; Test Result: 134 {DF}; Test Date: 20200522; Test Name: C-reactive protein; Result Unstructured Data: (Test Result:3.5,Unit:unknown,Normal Low:0.00,Normal High:0.90); Test Date: 20200522; Test Name: Platelet count; Result Unstructured Data: (Test Result:623,Unit:K/uL,Normal Low:140.00,Normal High:400.00); Comments: On 22-May-2020 CBC (Complete blood count) with Automated Differential showed Abnormal On 22-May-2020 WBC (White blood cell) with Automated Differential Abnormal