Report #2831659

Overview

Sex

Male

Age

0.3 yrs

State

—

Recovered

Recovered

Vaccinated

Mar 7, 2019

Onset

Dec 11, 2019

Days to onset

279

Hospital days

—

Symptoms (12)

Symptom narrative

Bilateral tonsillar hypertrophy; This 13-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular) on 13th November 2019. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 15th May 2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 7th March 2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 15th May 2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous) on 13th November 2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous) on 13th November 2019, 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 Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 11th December 2019, 28 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 210 days after receiving DTPa-HBV-IPV and Hiberix and 279 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 tonsillar hypertrophy. Serious criteria included clinically significant/intervention required. The subject was treated with sodium chloride, iohexol, ibuprofen and dexamethasone (Decadron (Dexamethasone)). The outcome of tonsillar hypertrophy was recovered/resolved on 18th December 2019 15:45. The investigator considered that there was no reasonable possibility that the tonsillar hypertrophy may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix and Varivax. The investigator considered that there was a reasonable possibility that the tonsillar hypertrophy may have been caused by M-M-R II. Other possible cause(s) of the tonsillar hypertrophy included concurrent medication M-M-R II vaccine. Relevant Tests: On 14Dec2019, CT scan, Impression was Mild cervical lymph node enlargement, probably reactive. No abscess. Diagnostic results (unless otherwise stated, normal values were not provided): On 14th December 2019, Computerised tomogram result was See text and White blood cell count result was 5.4 K/uL (normal low: 6.00, normal high: 14.00). Investigator Text: 13 month old male presents to ED on 14 Dec 2019 for decreased PO intake, drooling, fever. Pt had a fever for about 2 days, starting 4 days prior to ED visit. Pt had shown improvement on 13 DEC 2019 but on 14 Dec had almost no PO intake, pt had been drooling and mother stated the pt. does not open his mouth to eat drink or talk. no fever, vomiting or diarrhea on 14 Dec 2019.On exam: patient was awake, alert, non toxic appearing, keeping his mouth closed w/ occasional drooling. No trismus, no obvious neck masses or facial masses. Exam of posterior pharynx revealed moist mucous membranes w. bilateral tonsillar hypertrophy and erythema, no asymmetry, lungs clear, abd, soft. Rotates neck normally but resistant on extension; breathing w/o distress. Assessment and plan: CT scan, CBC and BMPCT scan and labs fairly unremarkable. No indication of retropharyngeal abscess or other serious etiologies of the symptoms. CT scan impression: mild cervical lymph node enlargement, probably reactive, no abscess. WBC consistent w/ viral process. BMP unremarkable Pt. Was treated with IV Decadron, IV Sodium Chloride 0.9% (NS) bolus, and Oral Ibuprofen. symptoms improved and pt was discharged home with mother. PI Narrative note for possible :relationship between bilateral hypertrophy of tonsils and the MMRII vaccine: There is a low likelihood that these symptoms are related to the MMR vaccine given, as they occurred nearly 4 weeks after administration. They are most likely related to a viral pharyngitis. However, given the severity of the symptoms requiring both a CT, IV decadron and IV Fluids, he cannot definitely say they were not vaccine related. Additional details: Investigator reported SAE term as Bilateral tonsillar hypertrophy. The investigator considered that there was no reasonable possibility that the tonsillar hypertrophy may have been caused by Prevenar 13. On 11Dec2019, 28 days after 4th dose of Prevenar 13 (Non-GSK product, taken as prophylaxis), the subject experienced Bilateral tonsillar hypertrophy. Case US2019229557 and US2019229558 is a duplicate of case US2019229555. Case US2019229557 and US2019229558 was deleted. All further information will be entered in case US2019229555. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Tonsillar hypertrophy, 28 days after receiving Placebo, 210 days after receiving 3rd dose of Hiberix and DTPa-HBV-IPV, 279 days after receiving 2nd dose of Rotarix, 28 days after receiving 1st dose of M-M-R II and Varivax co-administered with PCV and routine vaccine, Hiberix and Rotarix lyophilized formulation in a 13-month-old male subject. Placebo case following unblinding, causality assessment non applicable. Report is inconsistent with causal relation to the vaccine product, considering alternate etiology (concurrent MMR II vaccine) based on medical history. US-GLAXOSMITHKLINE-US2019229557:

Lab data

Test Date: 20191214; Test Name: CT scan, Impression; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Date: 20191214; Test Name: White blood cell count; Result Unstructured Data: (Test Result:5.4,Unit:K/uL,Normal Low:6.00,Normal High:14.00); Comments: On 14Dec2019, CT scan, Impression was Mild cervical lymph node enlargement, probably reactive. No abscess.