Report #2832110

Overview

Sex

Male

Age

0.3 yrs

State

—

Recovered

Recovered

Vaccinated

Mar 4, 2019

Onset

Jan 21, 2020

Days to onset

323

Hospital days

3

Symptoms (15)

Symptom narrative

lymphadenitis; Cellulitis; This 14-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular) on 18th November 2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 20th May 2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 4th March 2019, for prophylaxis. The subject received the 1st dose of Hiberix (intramuscular) on 20th May 2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous) on 18th November 2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous) on 18th November 2019, for prophylaxis. The subject received the 4th dose of Prevnar 13 (intramuscular) on 18th November 2019, 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. Concomitant products included fentanyl and salbutamol (Albuterol Inhaler). On 21st January 2020 06:45, 64 days after receiving Bexsero vs Placebo, M-M-R II, Varivax and Prevnar 13, 246 days after receiving DTPa-HBV-IPV and Hiberix and 323 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 cellulitis. Serious criteria included hospitalization. Additional event(s) included severe - grade 3 lymphadenitis on 22nd January 2020 with serious criteria of hospitalization. The subject was treated with ibuprofen, paracetamol (Tylenol), sodium chloride, glucose (Dextrose) and clindamycin. The outcome of cellulitis was recovered/resolved on 10th February 2020 15:46. The outcome(s) of the additional event(s) included lymphadenitis (recovered/resolved on 10th February 2020 15:46). The investigator considered that there was no reasonable possibility that the cellulitis and lymphadenitis may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II, Varivax and Prevnar 13. Diagnostic results (unless otherwise stated, normal values were not provided):In January 2020, Culture result was no strict anaerobic growth and Culture result was moderate staphylococcus aureus (MRSA) . On 22nd January 2020, Blood chloride result was 102 mmol/L (normal low: 99.00, normal high: 111.00), Blood potassium result was 3.8 mmol/L (normal low: 3.40, normal high: 4.70), Blood sodium result was 136 mmol/L (normal low: 136.00, normal high: 145.00), C-reactive protein result was 3.30 mg/dL, Carbon dioxide result was 19.00 mmol/L (normal low: 20.00, normal high: 36.00), Lymphocyte count result was 4.70 x10e9/L (normal low: 1.50, normal high: 7.00) and White blood cell count result was 14.3 x10e9/L (normal low: 6.00, normal high: 11.00). Investigator Text: Subject's mom/LAR called CRC on 21 Jan 2020 at 0645 to let CRC know that subject had a fever of 100.5. Mom was giving him Tylenol and was not overly concerned as child did not have other symptoms at this time. CRC educated mom that if other symptoms did develop or if fever spiked or if she had concerns to let CRC know. Mom of subject agreed to do that. At 2025 on 21 Jan 2020 LAR/Mom called CRC after hours to express concern about a bump in his groin area that "popped" but nothing came out except blood. Mom stated also that child is still running a fever of 101.3 with Tylenol given. CRC consulted with Sub I. Per Sub I, instructed Mom to not push or squeeze area (area is right groin area, not injection site) any more, place warm compress for comfort, keep on Tylenol and site will schedule child to be seen first thing in the morning. Also instructed parent that if subject spikes a fever or is inconsolable, or any other emergent situation than he should be taken into ER before morning. Mom of subject expressed understanding. 1000 22 Jan 2020 subject was brought to site and seen by Sub I. Per mom child had ran a high fever most of the night. She did attempt to take him to ER overnight but it was so "crazy and busy" that they finally gave up and went home. Sub I and PI consulted on the situation and the infant was direct admitted to the hospital due to fever in office (102.5 and appearance of area of bump-raised, hard, warm to touch). Subject was admitted to hospital at 1157 for cellulitis and Lymphadenitis. CELLULITIS WAS NO AT THE INJECTION SITE. THE SITE WAS IN THE RIGHT GROIN AREA AND RESULTED FROM ABSCESS. THE CULTURE WAS POSITIVE FOR MRSA. SUBJECT HAS A HISTORY OF MULTIPLE URI'S; TORTICOLLIS; INFANTILE ECZEMA; RSV; THEN THE ABSCESS OCCURRED. Subject was discharged on 25 Jan 2020 Investigator Comment: The subject had concomitant medication Decadron from 22 Jan 2020 to 22 Jan 2020, once only intravenously for indication anesthesia stop. The subject had concomitant medication Culturelle Capsule from 24 Jan 2020 to 25 Jan 2020, 1 capsule, bid orally for indication preventative/supplement. Follow-up information received on 25-MAR-2022. This follow-up was considered significant. Investigator Comment The investigator considered that there was no reasonable possibility that the cellulitis may have been caused by Prevnar 13. The relationship of the lymphadenitis to treatment with Prevnar 13 was not reported. Summary of Changes: Vaccination and event onset time, Seriousness criteria. Follow up information received on 05-Oct-2022. This follow-up was considered Non.significant. Summary of changes: The Unit of Concomitant drug fentanyl changed from mcg/mg to ml. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of lymphadenitis and cellulitis, 64 days after receiving 4th dose of Bexsero vs Placebo and Prevnar 13, 246 days after receiving 3rd dose of DTPa-HBV-IPV vaccine pre-filled syringe device injection syringe, 323 days after receiving 2nd dose of Rotarix vaccine oral applicator device in a Rotarix Oral Applicator Device, 246 days after receiving 1st dose of Hiberix, 64 days after receiving 1 st dose of M-M-R II and Varivax co-administered with PCV and routine vaccines in a 14-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and infantile eczema as a risk factor based on medical history.

Other medications

FENTANYL; ALBUTEROL

Lab data

Test Date: 20200122; Test Name: Chloride; Result Unstructured Data: (Test Result:102,Unit:mmol/L,Normal Low:99.00,Normal High:111.00); Test Date: 20200122; Test Name: Potassium; Result Unstructured Data: (Test Result:3.8,Unit:mmol/L,Normal Low:3.40,Normal High:4.70); Test Date: 20200122; Test Name: Sodium; Result Unstructured Data: (Test Result:136,Unit:mmol/L,Normal Low:136.00,Normal High:145.00); Test Date: 20200122; Test Name: Carbone dioxide; Result Unstructured Data: (Test Result:19.00,Unit:mmol/L,Normal Low:20.00,Normal High:36.00); Test Date: 20200122; Test Name: C-reactive protein; Test Result: 3.30 mg/dl; Test Date: 202001; Test Name: Aerobic Culture; Result Unstructured Data: (Test Result:moderate staphylococcus aureus (MRSA),Unit:unknown,Normal Low:,Normal High:); Test Date: 202001; Test Name: Anaerobic culture; Result Unstructured Data: (Test Result:no strict anaerobic growth,Unit:unknown,Normal Low:,Normal High:); Test Date: 20200122; Test Name: Lymphocytes; Result Unstructured Data: (Test Result:4.70,Unit:x10e9/L,Normal Low:1.50,Normal High:7.00); Test Date: 20200122; Test Name: White blood cell count; Result Unstructured Data: (Test Result:14.3,Unit:x10e9/L,Normal Low:6.00,Normal High:11.00)