Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | UNK | IM |
Atrial Fibrillation; This 63-year-old male subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, unknown deltoid) on 15-APR-2021, for prophylaxis. Concurrent medical conditions included hypertension. On 15-OCT-2021, 183 days after receiving RSVPreF3 vaccine + AS01E, the subject developed severe - grade 3 atrial fibrillation (Verbatim: Atrial Fibrillation). Serious criteria included hospitalization. The subject was treated with diltiazem, salicylic acid and metoprolol. The outcome of atrial fibrillation was resolved on 17-OCT-2021. Diagnostic results (reference ranges are provided in parenthesis if available): Alanine aminotransferase- 15-OCT-2021 98 u/L, (0.00-55.00). Aspartate aminotransferase- 15-OCT-2021 55 u/L, (5.00-34.00). Basophil percentage- 15-OCT-2021 5 percent, (0.20-1.20). Blood albumin- 15-OCT-2021 4.5 g/dL, (3.20-4.60). Blood alkaline phosphatase- 15-OCT-2021 140 u/L, (40.00-150.00). Blood bilirubin- 15-OCT-2021 1.2 mg/dL, (0.20-1.20). Blood calcium- 15-OCT-2021 10.1 mg/dL, (7.70-10.10). Blood chloride- 15-OCT-2021 106 mmol/L, (98.00-107.00). Blood creatine- 15-OCT-2021 266.4 mg/dL, (0.00-108.00). Blood creatinine- 15-OCT-2021 1.6 mg/dL, (0.70-1.30). Blood potassium- 15-OCT-2021 4.9 mmol/L, (3.50-5.10). Blood sodium- 15-OCT-2021 142 mmol/L, (131.00-143.00). Blood urea- 15-OCT-2021 24 mmol/L, (7.00-21.00). Carbon dioxide- 15-OCT-2021 22 mmol/L, (17.00-31.00). Eosinophil percentage- 15-OCT-2021 0.1 percent, (0.80-7.00). Granulocyte percentage- 15-OCT-2021 0.4 percent, (0.00-0.40). Haematocrit- 15-OCT-2021 46.8 percent, (40.10-51.00). Haemoglobin- 15-OCT-2021 15.8 g/dL, (11.20-15.70). Lymphocyte percentage- 15-OCT-2021 21.8 percent, (21.80-53.10). Mean cell haemoglobin- 15-OCT-2021 29.4 pg, (25.70-32.20). Mean cell haemoglobin concentration- 15-OCT-2021 33.8 g/dL, (32.30-36.50). Mean cell volume- 15-OCT-2021 87.0 fL, (79.00-92.20). Mean platelet volume- 15-OCT-2021 9.3 fL, (9.00-12.00). Monocyte percentage- 15-OCT-2021 6.5 percent, (5.30-12.20). Neutrophil count- 15-OCT-2021 10.4 x10e3/mm3, (1.78-5.38). Neutrophil percentage- 15-OCT-2021 70.7 percent, (34.00-67.90). Platelet count- 15-OCT-2021 378 x10e3/mm3, (157.00-380.00). Protein total- 15-OCT-2021 39 mg/dL, (0.00-174.00). Red blood cell count- 15-OCT-2021 5.38 x10E6/mm3, (4.63-6.08). Red cell distribution width- 15-OCT-2021 13.2 percent, (11.60-14.40). Troponin I- 15-OCT-2021 .05 ng/mL, (0.00-0.03). White blood cell count- 15-OCT-2021 14.7 x10e3/mm3, (4.20-9.10). pH urine- 15-OCT-2021 6.0 (4.50-8.00). The investigator considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. Linked case(s) involving the same subject: US2022GSK148515 GSK Receipt Date: 19-OCT-2021 Subject called office and told coordinator at work he lost vision in his eye and fell. Subject drove to hospital where they admitted him from 15OCT2021 to 17OCT2021. Upon arrival, he was in Atrial Fibrillation. Subject was admitted to IMCU (Intermediate Care unit) in which Cardizem was given intravenously but a dose was not given in the medical record. Subject would follow up with his Dr. Subject had a history of smoking cigarettes from 19991-1996. No other information received for this event. This was an AESI. Follow-up information received on 18-APR-2022. This follow-up was considered non-significant. Summary of Changes: No new information. Follow-up information received on 10-JUL-2024 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI) Summary of changes: General narrative comments were updated. Follow-up information received on 18-JUL-2024 Summary of changes: General narrative comments were updated. Follow-up information received on 15-AUG-2024 Summary of changes Lab test added.; Sender's Comments: A case of Atrial fibrillation, 183 days after receiving 1st dose ofRSVPreF3 vaccine + AS01E, in a 63-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factor (known case of hypertension). US-GSK-US2022GSK148515:
Hypertension
Test Date: 20211015; Test Name: Alanine Amino Transferase; Result Unstructured Data: (Test Result:98,Unit:u/L,Normal Low:0.00,Normal High:55.00); Test Date: 20211015; Test Name: Aspartate Amino Transferase; Result Unstructured Data: (Test Result:55,Unit:u/L,Normal Low:5.00,Normal High:34.00); Test Date: 20211015; Test Name: Basophils; Test Result: 5 %; Test Date: 20211015; Test Name: Albumin; Result Unstructured Data: (Test Result:4.5,Unit:g/dL,Normal Low:3.20,Normal High:4.60); Test Date: 20211015; Test Name: Alkaline phosphatase; Result Unstructured Data: (Test Result:140,Unit:u/L,Normal Low:40.00,Normal High:150.00); Test Date: 20211015; Test Name: Bilirubin total; Test Result: 1.2 mg/dl; Test Date: 20211015; Test Name: Calcium; Test Result: 10.1 mg/dl; Test Date: 20211015; Test Name: Chloride; Result Unstructured Data: (Test Result:106,Unit:mmol/L,Normal Low:98.00,Normal High:107.00); Test Date: 20211015; Test Name: Creatine; Test Result: 266.4 mg/dl; Test Date: 20211015; Test Name: Creatinine; Test Result: 1.6 mg/dl; Test Date: 20211015; Test Name: Potassium; Result Unstructured Data: (Test Result:4.9,Unit:mmol/L,Normal Low:3.50,Normal High:5.10); Test Date: 20211015; Test Name: Sodium; Result Unstructured Data: (Test Result:142,Unit:mmol/L,Normal Low:131.00,Normal High:143.00); Test Date: 20211015; Test Name: Blood urea nitrogen; Result Unstructured Data: (Test Result:24,Unit:mmol/L,Normal Low:7.00,Normal High:21.00); Test Date: 20211015; Test Name: Carbone dioxide; Result Unstructured Data: (Test Result:22,Unit:mmol/L,Normal Low:17.00,Normal High:31.00); Test Date: 20211015; Test Name: Eosinophils; Test Result: 0.1 %; Test Date: 20211015; Test Name: Granulocyte count; Test Result: 0.4 %; Test Date: 20211015; Test Name: Hematocrit; Test Result: 46.8 %; Test Date: 20211015; Test Name: Hemoglobin; Result Unstructured Data: (Test Result:15.8,Unit:g/dL,Normal Low:11.20,Normal High:15.70); Test Date: 20211015; Test Name: Lymphocytes; Test Result: 21.8 %; Test Date: 20211015; Test Name: Mean corpuscular hemoglobin; Test Result: 29.4 pg; Test Date: 20211015; Test Name: Mean cell hemoglobin concentration; Result Unstructured Data: (Test Result:33.8,Unit:g/dL,Normal Low:32.30,Normal High:36.50); Test Date: 20211015; Test Name: Mean corpuscular volume; Test Result: 87.0 fL; Test Date: 20211015; Test Name: Mean Platelet Volume; Test Result: 9.3 fL; Test Date: 20211015; Test Name: Monocytes; Test Result: 6.5 %; Test Date: 20211015; Test Name: Neutrophils; Test Result: 70.7 %; Test Date: 20211015; Test Name: Neutrophils; Result Unstructured Data: (Test Result:10.4,Unit:x10e3/mm3,Normal Low:1.78,Normal High:5.38); Test Date: 20211015; Test Name: Urine pH; Result Unstructured Data: (Test Result:6.0,Unit:unknown,Normal Low:4.50,Normal High:8.00); Test Date: 20211015; Test Name: Platelet count; Result Unstructured Data: (Test Result:378,Unit:x10e3/mm3,Normal Low:157.00,Normal High:380.00); Test Date: 20211015; Test Name: Protein total; Test Result: 39 mg/dl; Test Date: 20211015; Test Name: Red blood cell count; Result Unstructured Data: (Test Result:5.38,Unit:x10E6/mm3,Normal Low:4.63,Normal High:6.08); Test Date: 20211015; Test Name: Red Cell Distribution Width; Test Result: 13.2 %; Test Date: 20211015; Test Name: Troponin I; Result Unstructured Data: (Test Result:.05,Unit:ng/mL,Normal Low:0.00,Normal High:0.03); Test Date: 20211015; Test Name: White blood cell count; Result Unstructured Data: (Test Result:14.7,Unit:x10e3/mm3,Normal Low:4.20,Normal High:9.10)