Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | — | IM |
Atrial Fibrillation; This 64-year-old female subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 13-JUL-2021, for prophylaxis. Co-suspect products included losartan potassium for hypertension. The subject's past medical history included ex-smoker (Previous). Concurrent medical conditions included hypertension and obesity. Concomitant products included amlodipine, losartan and warfarin. On 24-JUL-2021, 11 days after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 atrial fibrillation (Verbatim: Atrial Fibrillation). Serious criteria included hospitalization. The subject was treated with bisacodyl, acetylsalicylic acid (Aspirin), potassium chloride, sodium chloride, diltiazem hydrochloride (Cardizem) and metoprolol. The outcome of atrial fibrillation was resolved on 26-JUL-2021. Relevant Tests: On 24-Jul-2021 Echo was done, no diagnostical findings On 24-Jul-2021 and 25-Jul-2021 Subject received a ecg On 24-Jul-2021 subject received an chest xray On Unk-Jul-2021 ECG showed NSR with PVC On Unk-Jul-2021 XRAY was normal. Diagnostic results (reference ranges are provided in parenthesis if available): Alanine aminotransferase- 24-JUL-2021 17 intlUnit/l (15.00-37.00). Aspartate aminotransferase- 24-JUL-2021 12 intlUnit/l (15.00-37.00). Basophil percentage- 24-JUL-2021 0.8 percent and 25-JUL-2021 0.6 percent. Blood albumin- 24-JUL-2021 2.9 g/dL, (3.40-5.00). Blood alkaline phosphatase- 24-JUL-2021 62 unit/litre, (46.00-116.00). Blood bilirubin- 24-JUL-2021 0.3 mg/dL, (0.20-1.00). Blood calcium- 24-JUL-2021 8.0 mg/dL, (8.50-10.10) and 25-JUL-2021 8.5 mg/dL, (8.50-10.10). Blood chloride- 24-JUL-2021 108 mmol/L, (98.00-107.00) and 25-JUL-2021 109 mmol/L, (98.00-107.00). Blood creatinine- 24-JUL-2021 1.20 mg/dL, (0.55-1.02) and 25-JUL-2021 0.87 mg/dL, (0.55-1.02). Blood glucose- 24-JUL-2021 142 mg/dL, (65.00-99.00) and 25-JUL-2021 99 mg/dL, (65.00-99.00). Blood magnesium- 24-JUL-2021 2.0 mg/dL, (1.60-2.40). Blood potassium- 24-JUL-2021 3.3 mmol/L, (3.50-5.10) and 25-JUL-2021 4.1 mmol/L, (3.50-5.10). Blood sodium- 24-JUL-2021 141 mmol/L, (136.00-145.00) and 25-JUL-2021 138 mmol/L, (136.00-145.00). Blood urea- 24-JUL-2021 15 mg/dL, (7.00-18.00) and 25-JUL-2021 11 mg/dL, (7.00-18.00). Carbon dioxide- 24-JUL-2021 21.9 mmol/L, (21-32) and 25-JUL-2021 21.3 mmol/L, (21-32). Eosinophil percentage- 24-JUL-2021 2.5 percent and 25-JUL-2021 2.6 percent. Haematocrit- 24-JUL-2021 42.7 percent, (31.70-42.50) and 25-JUL-2021 39.4 percent, (31.70-42.50). Haemoglobin- 24-JUL-2021 14.0 g/dL, (11.10-14.40) and 25-JUL-2021 12.6 g/dL, (11.10-14.40). International normalised ratio- 24-JUL-2021 1.25 (0.90-1.10): 25-JUL-2021 1.39 (0.90-1.10) and 26-JUL-2021 1.62 (0.90-1.10). Lipase- 24-JUL-2021 104 intlunit/l (73.00-393.00). Lymphocyte percentage- 24-JUL-2021 40.0 percent and 25-JUL-2021 40.2 percent. Mean cell haemoglobin- 24-JUL-2021 30.0 pg, (26.90-33.20) and 25-JUL-2021 29.9 pg, (26.90-33.20). Mean cell haemoglobin concentration- 24-JUL-2021 32.8 g/dL, (31.80-36.00) and 25-JUL-2021 32.0 g/dL, (31.80-36.00). Mean cell volume- 24-JUL-2021 91.4 fL, (79.50-98.90) and 25-JUL-2021 93.6 fL, (79.50-98.90). Mean platelet volume- 24-JUL-2021 9.2 fL, (7.40-12.30) and 25-JUL-2021 9.4 fL, (7.40-12.30). Monocyte percentage- 24-JUL-2021 9.2 percent and 25-JUL-2021 10.5 percent. Neutrophil percentage- 24-JUL-2021 47.2 percent and 25-JUL-2021 45.9 percent. PO2- 24-JUL-2021 Less than 40 mmHg, (38.00-42.00). Platelet count- 24-JUL-2021 300 x10e3/mcL, (159.00-386.00) and 25-JUL-2021 246 x10e3/mcL, (159.00-386.00). Protein total- 24-JUL-2021 6.4 g/dL, (6.40-8.20). Prothrombin time- 24-JUL-2021 13.5 seconds, (9.40-11.50): 25-JUL-2021 13.8 seconds, (9.40-11.50) and 26-JUL-2021 17.3 seconds, (9.40-11.50). Red blood cell count- 24-JUL-2021 4.67 X10e6/uL, (3.64-5.00) and 25-JUL-2021 4.21 X10e6/uL, (3.64-5.00). Red cell distribution width- 24-JUL-2021 13.1 percent, (12.10-17.20) and 25-JUL-2021 13.2 percent, (12.10-17.20). Troponin I- 24-JUL-2021 22.8 pg/mL, (0-51.40): 24-JUL-2021 13.0 pg/mL, (0-51.40) and 25-JUL-2021 19.1 pg/mL, (0-51.40). White blood cell count- 24-JUL-2021 7.3 x10e3/mcL, (3.60-11.30) and 25-JUL-2021 6.2 x10e3/mcL, (3.60-11.30). The investigator considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. Other possible cause(s) of the atrial fibrillation included concurrent medication. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. Subject contacted site to notify of hospitalization that occurred 7/24-26/2021. Subject states around noon on 7/24/2021 she felt suddenly dizzy an sweaty. Subject contacted 911 and was transported via ambulance to Emergency room. Subject states the doctor believes she was on too much Losartan which caused the Atrial Fibrillation. Subject notified site of medication changes and discharged home in stable condition on 7/26/2021. Site has mailed ROR to subject and will update report upon receipt of new information. Subject went to the hospital on 7/24/21 due to feeling dizzy, chest tightness and shortness of air. EMS noted subject to be in A-Fib with RVR rate in the 170's. Subject was given Cardizem and normal sinus was noted. Subject also started metoprolol which caused subject to be bradycardic. The medication was stopped due to the bradycardia and the dizziness. Subject received PT and OT as well as medication changes before being discharged to home on 7/26/21 once the SOA, chest tightness and dizziness had resolved. The subject is not a part of reactogenicity and immunoigenicity subset. The event was unanticipated and unexpected. This event was not related or possibly related to reasearch. This event does not suggest that research places subject or others at new or increased risk of harm. Follow-up information received on 23-Nov-2022 Investigator comment: On 24th July 2021, more than 2 years after 1st dose of Losartan potassium (non GSK product, taken for hypertension), the subject experienced Atrial fibrillation. Summary of changes: The medication details were updated. Follow-up information received on 14-Dec-2022. Summary of changes: Only lab data X-ray and ECG updated. Follow-up information received on 22-DEC-2022. Summary of changes: co-suspect medication (Amlodipine) has been updated to concomitant medication. Follow-up information received on 03-NOV-2023 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Summary of changes: Event term Mitral valve calcification, Tricuspid regurgitation, Aortic valve regurgitation, Hiatal hernia, Cen tribular Emphysema, Chest pain NOS, Bradycardia, Hypotension deleted, AESI sentence updated. Follow up information receive don 08-Nov-2023. Summary of changes: Medical history added. Narrative updated. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of atrial fibrillation, 11 days after receiving 1st dose of RSVPreF3 vaccine, in a 64-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering alternative risk factors (h/o hypertension, obesity, ex-smoker) based on medical history.
Hypertension; Obesity
Medical History/Concurrent Conditions: Ex-smoker (Previous)
AMLODIPINE; LOSARTAN; WARFARIN
Test Date: 20210724; Test Name: Alanine Amino Transferase; Result Unstructured Data: (Test Result:17 intlUnit/l,Unit:unknown,Normal Low:15.00,Normal High:37.00); Test Date: 20210724; Test Name: Aspartate Amino Transferase; Result Unstructured Data: (Test Result:12 intlUnit/l,Unit:unknown,Normal Low:15.00,Normal High:37.00); Test Date: 20210724; Test Name: Basophils; Test Result: 0.8 %; Test Date: 20210725; Test Name: Basophils; Test Result: 0.6 %; Test Date: 20210724; Test Name: Albumin; Result Unstructured Data: (Test Result:2.9,Unit:g/dL,Normal Low:3.40,Normal High:5.00); Test Date: 20210724; Test Name: Alkaline phosphatase; Result Unstructured Data: (Test Result:62,Unit:unit/litre,Normal Low:46.00,Normal High:116.00); Test Date: 20210724; Test Name: Bilirubin total; Test Result: 0.3 mg/dl; Test Date: 20210724; Test Name: Calcium; Test Result: 8.0 mg/dl; Test Date: 20210725; Test Name: Calcium; Test Result: 8.5 mg/dl; Test Date: 20210724; Test Name: Chloride; Result Unstructured Data: (Test Result:108,Unit:mmol/L,Normal Low:98.00,Normal High:107.00); Test Date: 20210725; Test Name: Chloride; Result Unstructured Data: (Test Result:109,Unit:mmol/L,Normal Low:98.00,Normal High:107.00); Test Date: 20210724; Test Name: Creatinine; Test Result: 1.20 mg/dl; Test Date: 20210725; Test Name: Creatinine; Test Result: 0.87 mg/dl; Test Date: 20210724; Test Name: Blood glucose; Test Result: 142 mg/dl; Test Date: 20210725; Test Name: Blood glucose; Test Result: 99 mg/dl; Test Date: 20210724; Test Name: Magnesium; Test Result: 2.0 mg/dl; Test Date: 20210724; Test Name: Potassium; Result Unstructured Data: (Test Result:3.3,Unit:mmol/L,Normal Low:3.50,Normal High:5.10); Test Date: 20210725; Test Name: Potassium; Result Unstructured Data: (Test Result:4.1,Unit:mmol/L,Normal Low:3.50,Normal High:5.10); Test Date: 20210724; Test Name: Sodium; Result Unstructured Data: (Test Result:141,Unit:mmol/L,Normal Low:136.00,Normal High:145.00); Test Date: 20210725; Test Name: Sodium; Result Unstructured Data: (Test Result:138,Unit:mmol/L,Normal Low:136.00,Normal High:145.00); Test Date: 20210724; Test Name: Blood urea nitrogen; Test Result: 15 mg/dl; Test Date: 20210725; Test Name: Blood urea nitrogen; Test Result: 11 mg/dl; Test Date: 20210724; Test Name: Carbone dioxide; Result Unstructured Data: (Test Result:21.9,Unit:mmol/L,Normal Low:21,Normal High:32); Test Date: 20210725; Test Name: Carbone dioxide; Result Unstructured Data: (Test Result:21.3,Unit:mmol/L,Normal Low:21,Normal High:32); Test Date: 20210724; Test Name: Eosinophils; Test Result: 2.5 %; Test Date: 20210725; Test Name: Eosinophils; Test Result: 2.6 %; Test Date: 20210724; Test Name: Hematocrit; Test Result: 42.7 %; Test Date: 20210725; Test Name: Hematocrit; Test Result: 39.4 %; Test Date: 20210724; Test Name: Hemoglobin; Result Unstructured Data: (Test Result:14.0,Unit:g/dL,Normal Low:11.10,Normal High:14.40); Test Date: 20210725; Test Name: Hemoglobin; Result Unstructured Data: (Test Result:12.6,Unit:g/dL,Normal Low:11.10,Normal High:14.40); Test Date: 20210724; Test Name: INR; Result Unstructured Data: (Test Result:1.25,Unit:NA,Normal Low:0.90,Normal High:1.10); Test Date: 20210725; Test Name: INR; Result Unstructured Data: (Test Result:1.39,Unit:NA,Normal Low:0.90,Normal High:1.10); Test Date: 20210726; Test Name: INR; Result Unstructured Data: (Test Result:1.62,Unit:NA,Normal Low:0.90,Normal High:1.10); Test Date: 20210724; Test Name: Lipase; Result Unstructured Data: (Test Result:104 intlunit/l,Unit:unknown,Normal Low:73.00,Normal High:393.00); Test Date: 20210724; Test Name: Lymphocytes; Test Result: 40.0 %; Test Date: 20210725; Test Name: Lymphocytes; Test Result: 40.2 %; Test Date: 20210724; Test Name: Mean corpuscular hemoglobin; Test Result: 30.0 pg; Test Date: 20210725; Test Name: Mean corpuscular hemoglobin; Test Result: 29.9 pg; Test Date: 20210724; Test Name: Mean cell hemoglobin concentration; Result Unstructured Data: (Test Result:32.8,Unit:g/dL,Normal Low:31.80,Normal High:36.00); Test Date: 20210725; Test Name: Mean cell hemoglobin concentration; Result Unstructured Data: (Test Result:32.0,Unit:g/dL,Normal Low:31.80,Normal High:36.00); Test Date: 20210724; Test Name: Mean corpuscular volume; Test Result: 91.4 fL; Test Date: 20210725; Test Name: Mean corpuscular volume; Test Result: 93.6 fL; Test Date: 20210724; Test Name: Mean Platelet Volume; Test Result: 9.2 fL; Test Date: 20210725; Test Name: Mean Platelet Volume; Test Result: 9.4 fL; Test Date: 20210724; Test Name: Monocytes; Test Result: 9.2 %; Test Date: 20210725; Test Name: Monocytes; Test Result: 10.5 %; Test Date: 20210724; Test Name: Neutrophils; Test Result: 47.2 %; Test Date: 20210725; Test Name: Neutrophils; Test Result: 45.9 %; Test Date: 20210724; Test Name: Platelet count; Result Unstructured Data: (Test Result:300,Unit:x10e3/mcL,Normal Low:159.00,Normal High:386.00); Test Date: 20210725; Test Name: Platelet count; Result Unstructured Data: (Test Result:246,Unit:x10e3/mcL,Normal Low:159.00,Normal High:386.00); Test Date: 20210724; Test Name: pO2; Result Unstructured Data: (Test Result:Less than 40,Unit:mmHg,Normal Low:38.00,Normal High:42.00); Test Date: 20210724; Test Name: Protein total; Result Unstructured Data: (Test Result:6.4,Unit:g/dL,Normal Low:6.40,Normal High:8.20); Test Date: 20210724; Test Name: Prothrombin time; Test Result: 13.5 s; Test Date: 20210725; Test Name: Prothrombin time; Test Result: 13.8 s; Test Date: 20210726; Test Name: Prothrombin time; Test Result: 17.3 s; Test Date: 20210724; Test Name: Red blood cell count; Result Unstructured Data: (Test Result:4.67,Unit:X10e6/uL,Normal Low:3.64,Normal High:5.00); Test Date: 20210725; Test Name: Red blood cell count; Result Unstructured Data: (Test Result:4.21,Unit:X10e6/uL,Normal Low:3.64,Normal High:5.00); Test Date: 20210724; Test Name: Red Cell Distribution Width; Test Result: 13.1 %; Test Date: 20210725; Test Name: Red Cell Distribution Width; Test Result: 13.2 %; Test Date: 20210724; Test Name: Troponin I; Result Unstructured Data: (Test Result:22.8,Unit:pg/mL,Normal Low:zero,Normal High:51.40); Test Date: 20210724; Test Name: Troponin I; Result Unstructured Data: (Test Result:13.0,Unit:pg/mL,Normal Low:zero,Normal High:51.40); Test Date: 20210725; Test Name: Troponin I; Result Unstructured Data: (Test Result:19.1,Unit:pg/mL,Normal Low:zero,Normal High:51.40); Test Date: 20210724; Test Name: White blood cell count; Result Unstructured Data: (Test Result:7.3,Unit:x10e3/mcL,Normal Low:3.60,Normal High:11.30); Test Date: 20210725; Test Name: White blood cell count; Result Unstructured Data: (Test Result:6.2,Unit:x10e3/mcL,Normal Low:3.60,Normal High:11.30); Comments: On 24-Jul-2021 Echo was done, no diagnostical findings On 24-Jul-2021 and 25-Jul-2021 Subject received a ecg On 24-Jul-2021 subject received an chest xray On Unk-Jul-2021 ECG showed NSR with PVC On Unk-Jul-2021 XRAY was normal