Report #2904729

Overview

Sex

Female

Age

1 yrs

State

—

Recovered

Not recovered

Vaccinated

Jun 26, 2026

Onset

Jul 15, 2026

Days to onset

19

Hospital days

3

Symptoms (43)

Symptom narrative

worsening of lymphadenitis; worsening of lymphadenitis; This 12-month-old female subject was enrolled in a blinded study. The subject received the 1st dose of Varicella VNS Vs Varivax (subcutaneous, left deltoid) on 26-JUN-2026 10:55, for Prophylaxis. The subject received the 1st dose of MMR vaccine (subcutaneous, right deltoid) on 26-JUN-2026 10:57, for Prophylaxis. The subject received the 1st dose of Hepatitis A vaccine (intramuscular, right thigh) on 26-JUN-2026 10:56, for Prophylaxis. The subject received the 1st dose of Prevnar 13 (intramuscular, left thigh) on 26-JUN-2026 10:56, for Prophylaxis. On 15-JUL-2026, 19 days after receiving Varicella VNS Vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13, the subject developed severe - grade 3 lymphadenitis (Verbatim: worsening of lymphadenitis). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 condition aggravated (Verbatim: worsening of lymphadenitis) on 15-JUL-2026 with serious criteria of hospitalization. The subject was treated with paracetamol (Acetaminophen), clindamycin, fluconazole, ibuprofen, ampicillin;sulbactam, iohexol, lidocaine, midazolam, dexamethasone, dexmedetomidine, fentanyl, epinephrine;lidocaine hydrochloride (Lidocaine-Epinephrine), propofol and cefalexin (Cephalexin). The outcome of lymphadenitis was not resolved. The outcome(s) of the additional event(s) included condition aggravated (not resolved). Relevant Tests: On an unknown date, initial labs were remarkable for acute inflammation with moderate transaminitis of unclear origin. On an unknown date, imaging confirmed abscesses of the left supraclavicular and submental lymph nodes. On an unknown date, cultures grew methicillin-susceptible staphylococcus aureus.. Diagnostic results (reference ranges are provided in parenthesis if available): Alanine aminotransferase- 15-JUL-2026 230 u/L, (10-32): 16-JUL-2026 153 u/L, (10-32): 18-JUL-2026 94 u/L, (10-32) and Mildly increased. Aspartate aminotransferase- 15-JUL-2026 86 u/L, (18-63): 16-JUL-2026 64 u/L, (18-63): 18-JUL-2026 31 u/L, (18-63) and Normal. Basophil percentage- 15-JUL-2026 0 percent: 16-JUL-2026 0 percent and 16-JUL-2026 0 percent. Bilirubin conjugated- 15-JUL-2026 0 mg/dL, (0-0.2) and 18-JUL-2026 0 mg/dL, (0-0.2). Blood albumin- 15-JUL-2026 5 g/dL, (2.9-4.2): 16-JUL-2026 4 g/dL, (2.9-4.2) and 18-JUL-2026 4 g/dL, (2.9-4.2). Blood alkaline phosphatase- 15-JUL-2026 307 u/L, (60-321): 16-JUL-2026 264 u/L, (60-321) and 18-JUL-2026 252 u/L, (60-321). Blood bilirubin- 15-JUL-2026 0 mg/dL, (0.3-1): 16-JUL-2026 1 mg/dL, (0.3-1) and 18-JUL-2026 0 mg/dL, (0.3-1). Blood calcium- 15-JUL-2026 11 mg/dL, (8.6-10.3) and 16-JUL-2026 10 mg/dL, (8.6-10.3). Blood chloride- 15-JUL-2026 101 mmol/L, (98-116) and 16-JUL-2026 112 mmol/L, (98-116). Blood creatinine- 15-JUL-2026 0 mg/dL, (0.4-0.7) and 16-JUL-2026 0 mg/dL, (0.4-0.7). Blood glucose- 15-JUL-2026 106 mg/dL, (60-110) and 16-JUL-2026 101 mg/dL, (60-110). Blood potassium- 15-JUL-2026 5 mmol/L, (3.5-5.1) and 16-JUL-2026 4 mmol/L, (3.5-5.1). Blood sodium- 15-JUL-2026 138 mmol/L, (134-143) and 16-JUL-2026 145 mmol/L, (134-143). Blood urea- 15-JUL-2026 14 mg/dL, (8-30) and 16-JUL-2026 10 mg/dL, (8-30). C-reactive protein- 15-JUL-2026 4 mg/dL, (0-0.5) and 16-JUL-2026 8 mg/dL, (0.5). Carbon dioxide- 15-JUL-2026 23 mmol/L, (17-29) and 16-JUL-2026 22 mmol/L, (17-29). Eosinophil percentage- 15-JUL-2026 1 percent. Haematocrit- 15-JUL-2026 34 percent, (33-39) and 16-JUL-2026 31 percent, (33-39). Haemoglobin- 15-JUL-2026 11 g/dL, (10.5-13.5) and 16-JUL-2026 11 g/dL, (10.5-13.5). Lymphocyte count- 15-JUL-2026 5200 micro litre, (3000-9500) and 16-JUL-2026 4200 micro litre, (3000-9500). Lymphocyte percentage- 15-JUL-2026 24 percent and 16-JUL-2026 22 percent. Mean cell haemoglobin- 15-JUL-2026 26 pg, (23-31) and 16-JUL-2026 28 pg, (23-31). Mean cell haemoglobin concentration- 15-JUL-2026 32 g/dL, (30-36) and 16-JUL-2026 34 g/dL, (30-36). Mean cell volume- 15-JUL-2026 82 fL, (70-86) and 16-JUL-2026 82 fL, (70-86). Monocyte count- 15-JUL-2026 2000 micro litre, (50-1100) and 16-JUL-2026 2100 micro litre, (50-1100). Monocyte percentage- 15-JUL-2026 9 percent and 16-JUL-2026 11 percent. Neutrophil count- 15-JUL-2026 14400 micro litre, (1500-8500) and 16-JUL-2026 12600 micro litre, (1500-8500). Neutrophil percentage- 15-JUL-2026 66 percent and 16-JUL-2026 66 percent. Platelet count- 15-JUL-2026 558000 micro litre, (150000-350000) and 16-JUL-2026 538000 micro litre, (150000-350000). Protein total- 15-JUL-2026 8 g/dL, (5.2-7.4): 16-JUL-2026 7 g/dL, (5.2-7.4) and 18-JUL-2026 8 g/dL, (5.2-7.4). Red blood cell count- 15-JUL-2026 4160000 micro litre, (370000-530000) and 16-JUL-2026 3790000 micro litre, (370000-530000). White blood cell count- 15-JUL-2026 21790 micro litre, (6000-17000) and 16-JUL-2026 18970 micro litre, (6000-17000). The investigator considered that there was no reasonable possibility that the lymphadenitis and condition aggravated may have been caused by Varicella VNS Vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13. Other possible cause(s) of the lymphadenitis included Hepatitis A vaccine PRE-FILLED SYRINGE DEVICE and MMR vaccine PRE-FILLED SYRINGE DEVICE. Other possible cause(s) of the condition aggravated included Hepatitis A vaccine PRE-FILLED SYRINGE DEVICE and MMR vaccine PRE-FILLED SYRINGE DEVICE. The company considered that there was no reasonable possibility that the lymphadenitis and condition aggravated may have been caused by Varicella VNS Vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13. Additional Information: Prior to ED (Emergency department) Subject with 24-day history of a rash on subject neck. First seen for this on 26-JUN-2026 and diagnosed as intertrigo, prescribed nystatin. Subject went to the ED (Emergency department) on 03-JUL-2026 for worsening rash and fever and was sent home with miconazole powder and keflex. On 13-JUL-2026 subject was seen by study SUB-I for unscheduled visit and found to had supraclavicular vs deep cervical lymphadenitis on the left. Subject was sent to her PCP (Primary Care Physician) that same day where it was noted subject was taking keflex bid instead of 4x daily. At the PCP (Primary Care Physician), they noted subject had L subclavicular lymphadenitis and was prescribed an extended course of keflex and hydrocortisone due to concern for dermatitis. Subject was scheduled for an US (Ultrasound) of her neck on 13-JUN-2026 but was unable to go. On 15-JUL-2026 subject followed up with her PCP (Primary Care Physician) and was sent to the ED (Emergency department), as it was noted subject had a hard/immobile lymph node with worsening erythema and edema as well as a new submental indurated area. At ED (Emergency department) Subject was started on IV antibiotics and underwent an uncomplicated incision and drainage on 16-JUL-2026. Subject had excellent clinical improvement and was discharged on cephalexin to complete a treatment course. Transaminases were resolving at discharged. Subject was hospitalized on 15-JUL-2026 and discharged on 18-JUL-2026 Initial GSK receipt date: 16-JUL-2026, 17-JUL-2026, 20-JUL-2026 and 21-JUL-2026 Subject received D5 percent and 0.9 percent sodium chloride infusion (43 mL/h, qid, intravenous) from 15-JUL-2026 to 17-JUL-2026 for worsening of lymphadenitis.; Sender's Comments: A case of Lymphadenitis and Condition aggravated, 19 days after receiving 1st dose of Varicella VNS Vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13, in a 12-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility for Varicella VNS Vs Varivax, Hepatitis A vaccine and Prevnar 13 and alternative risk factors (cultures grew methicillin-susceptible staphylococcus aureus).

Lab data

Test Name: ALT; Result Unstructured Data: (Test Result:Mildly increased,Unit:unknown,Normal Low:,Normal High:); Test Date: 20260715; Test Name: Clinical Chemistry - Alanine Aminotransferase; Result Unstructured Data: (Test Result:230,Unit:u/L,Normal Low:10,Normal High:32); Test Date: 20260716; Test Name: Clinical Chemistry - Alanine Aminotransferase; Result Unstructured Data: (Test Result:153,Unit:u/L,Normal Low:10,Normal High:32); Test Date: 20260718; Test Name: Clinical Chemistry - Alanine Aminotransferase; Result Unstructured Data: (Test Result:94,Unit:u/L,Normal Low:10,Normal High:32); Test Name: AST; Result Unstructured Data: (Test Result:Normal,Unit:unknown,Normal Low:,Normal High:); Test Date: 20260715; Test Name: Clinical Chemistry - Aspartate Aminotransferase; Result Unstructured Data: (Test Result:86,Unit:u/L,Normal Low:18,Normal High:63); Test Date: 20260716; Test Name: Clinical Chemistry - Aspartate Aminotransferase; Result Unstructured Data: (Test Result:64,Unit:u/L,Normal Low:18,Normal High:63); Test Date: 20260718; Test Name: Clinical Chemistry - Aspartate Aminotransferase; Result Unstructured Data: (Test Result:31,Unit:u/L,Normal Low:18,Normal High:63); Test Date: 20260715; Test Name: Hematology - Basophils; Test Result: 0 %; Test Date: 20260716; Test Name: Hematology - Basophils; Test Result: 0 %; Test Date: 20260716; Test Name: Hematology - Basophils; Test Result: 0 %; Test Date: 20260715; Test Name: Clinical Chemistry - Direct Bilirubin; Test Result: 0 mg/dl; Test Date: 20260718; Test Name: Clinical Chemistry - Direct Bilirubin; Test Result: 0 mg/dl; Test Date: 20260715; Test Name: Clinical Chemistry - Albumin; Result Unstructured Data: (Test Result:5,Unit:g/dL,Normal Low:2.9,Normal High:4.2); Test Date: 20260716; Test Name: Clinical Chemistry - Albumin; Result Unstructured Data: (Test Result:4,Unit:g/dL,Normal Low:2.9,Normal High:4.2); Test Date: 20260718; Test Name: Clinical Chemistry - Albumin; Result Unstructured Data: (Test Result:4,Unit:g/dL,Normal Low:2.9,Normal High:4.2); Test Date: 20260715; Test Name: Clinical Chemistry - Alkaline Phosphatase; Result Unstructured Data: (Test Result:307,Unit:u/L,Normal Low:60,Normal High:321); Test Date: 20260716; Test Name: Clinical Chemistry - Alkaline Phosphatase; Result Unstructured Data: (Test Result:264,Unit:u/L,Normal Low:60,Normal High:321); Test Date: 20260718; Test Name: Clinical Chemistry - Alkaline Phosphatase; Result Unstructured Data: (Test Result:252,Unit:u/L,Normal Low:60,Normal High:321); Test Date: 20260715; Test Name: Clinical Chemistry - Bilirubin; Test Result: 0 mg/dl; Test Date: 20260716; Test Name: Clinical Chemistry - Bilirubin; Test Result: 1 mg/dl; Test Date: 20260718; Test Name: Clinical Chemistry - Bilirubin; Test Result: 0 mg/dl; Test Date: 20260715; Test Name: Clinical Chemistry - Calcium; Test Result: 11 mg/dl; Test Date: 20260716; Test Name: Clinical Chemistry - Calcium; Test Result: 10 mg/dl; Test Date: 20260715; Test Name: Clinical Chemistry - Chloride; Result Unstructured Data: (Test Result:101,Unit:mmol/L,Normal Low:98,Normal High:116); Test Date: 20260716; Test Name: Clinical Chemistry - Chloride; Result Unstructured Data: (Test Result:112,Unit:mmol/L,Normal Low:98,Normal High:116); Test Date: 20260715; Test Name: Clinical Chemistry - Creatinine; Test Result: 0 mg/dl; Test Date: 20260716; Test Name: Clinical Chemistry - Creatinine; Test Result: 0 mg/dl; Test Date: 20260715; Test Name: Clinical Chemistry - Glucose; Test Result: 106 mg/dl; Test Date: 20260716; Test Name: Clinical Chemistry - Glucose; Test Result: 101 mg/dl; Test Date: 20260715; Test Name: Clinical Chemistry - Potassium; Result Unstructured Data: (Test Result:5,Unit:mmol/L,Normal Low:3.5,Normal High:5.1); Test Date: 20260716; Test Name: Clinical Chemistry - Potassium; Result Unstructured Data: (Test Result:4,Unit:mmol/L,Normal Low:3.5,Normal High:5.1); Test Date: 20260715; Test Name: Clinical Chemistry - Sodium; Result Unstructured Data: (Test Result:138,Unit:mmol/L,Normal Low:134,Normal High:143); Test Date: 20260716; Test Name: Clinical Chemistry - Sodium; Result Unstructured Data: (Test Result:145,Unit:mmol/L,Normal Low:134,Normal High:143); Test Date: 20260715; Test Name: Clinical Chemistry - Urea Nitrogen; Test Result: 14 mg/dl; Test Date: 20260716; Test Name: Clinical Chemistry - Urea Nitrogen; Test Result: 10 mg/dl; Test Date: 20260715; Test Name: Clinical Chemistry - Carbon Dioxide; Result Unstructured Data: (Test Result:23,Unit:mmol/L,Normal Low:17,Normal High:29); Test Date: 20260716; Test Name: Clinical Chemistry - Carbon Dioxide; Result Unstructured Data: (Test Result:22,Unit:mmol/L,Normal Low:17,Normal High:29); Test Date: 20260716; Test Name: Clinical Chemistry - C Reactive Protein; Test Result: 8 mg/dl; Test Date: 20260715; Test Name: Clinical Chemistry - C Reactive Protein; Test Result: 4 mg/dl; Test Date: 20260715; Test Name: Hematology - Eosinophils; Test Result: 1 %; Test Date: 20260715; Test Name: Hematology - Hematocrit; Test Result: 34 %; Test Date: 20260716; Test Name: Hematology - Hematocrit; Test Result: 31 %; Test Date: 20260715; Test Name: Hematology - Hemoglobin; Result Unstructured Data: (Test Result:11,Unit:g/dL,Normal Low:10.5,Normal High:13.5); Test Date: 20260716; Test Name: Hematology - Hemoglobin; Result Unstructured Data: (Test Result:11,Unit:g/dL,Normal Low:10.5,Normal High:13.5); Test Date: 20260715; Test Name: Hematology - Lymphocytes; Test Result: 5200 uL; Test Date: 20260716; Test Name: Hematology - Lymphocytes; Test Result: 4200 uL; Test Date: 20260715; Test Name: Hematology - Lymphocytes; Test Result: 24 %; Test Date: 20260716; Test Name: Hematology - Lymphocytes; Test Result: 22 %; Test Date: 20260715; Test Name: Hematology - Ery. Mean Corpuscular Hemoglobin; Test Result: 26 pg; Test Date: 20260716; Test Name: Hematology - Ery. Mean Corpuscular Hemoglobin; Test Result: 28 pg; Test Date: 20260715; Test Name: Hematology - Ery. Mean Corpuscular Hemoglobin concentration; Result Unstructured Data: (Test Result:32,Unit:g/dL,Normal Low:30,Normal High:36); Test Date: 20260716; Test Name: Hematology - Ery. Mean Corpuscular Hemoglobin concentration; Result Unstructured Data: (Test Result:34,Unit:g/dL,Normal Low:30,Normal High:36); Test Date: 20260715; Test Name: Hematology - Ery. Mean Corpuscular Volume; Test Result: 82 fL; Test Date: 20260716; Test Name: Hematology - Ery. Mean Corpuscular Volume; Test Result: 82 fL; Test Date: 20260715; Test Name: Hematology - Monocytes; Test Result: 2000 uL; Test Date: 20260716; Test Name: Hematology - Monocytes; Test Result: 2100 uL; Test Date: 20260715; Test Name: Hematology - Monocytes; Test Result: 9 %; Test Date: 20260716; Test Name: Hematology - Monocytes; Test Result: 11 %; Test Date: 20260715; Test Name: Hematology - Neutrophils; Test Result: 14400 uL; Test Date: 20260716; Test Name: Hematology - Neutrophils; Test Result: 12600 uL; Test Date: 20260715; Test Name: Hematology - Neutrophils; Test Result: 66 %; Test Date: 20260716; Test Name: Hematology - Neutrophils; Test Result: 66 %; Test Date: 20260715; Test Name: Hematology - Platelets; Test Result: 558000 uL; Test Date: 20260716; Test Name: Hematology - Platelets; Test Result: 538000 uL; Test Date: 20260715; Test Name: Clinical Chemistry - Protein; Result Unstructured Data: (Test Result:8,Unit:g/dL,Normal Low:5.2,Normal High:7.4); Test Date: 20260716; Test Name: Clinical Chemistry - Protein; Result Unstructured Data: (Test Result:7,Unit:g/dL,Normal Low:5.2,Normal High:7.4); Test Date: 20260718; Test Name: Clinical Chemistry - Protein; Result Unstructured Data: (Test Result:8,Unit:g/dL,Normal Low:5.2,Normal High:7.4); Test Date: 20260715; Test Name: Hematology - Erythrocytes; Test Result: 4160000 uL; Test Date: 20260716; Test Name: Hematology - Erythrocytes; Test Result: 3790000 uL; Test Date: 20260715; Test Name: Hematology- Leukocytes; Test Result: 21790 uL; Test Date: 20260716; Test Name: Hematology- Leukocytes; Test Result: 18970 uL; Comments: On an unknown date, initial labs were remarkable for acute inflammation with moderate transaminitis of unclear origin. On an unknown date, imaging confirmed abscesses of the left supraclavicular and submental lymph nodes. On an unknown date, cultures grew methicillin-susceptible staphylococcus aureus.