Received Sep 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU4 | INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) | SANOFI PASTEUR | 1 | UNK | IM |
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | UNK | IM |
Tachycardia/bradycardia syndrome; Diverticulitis intestinal hemorrhage; This 74-year-old female subject was enrolled in an open label study. The subject received the 1st dose of Fluzone Quadrivalent (intramuscular, unknown deltoid) .7 ml on 01-NOV-2022, for prophylaxis. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, unknown deltoid) .5 ml on 06-DEC-2022, for prophylaxis. The subject's past medical history included arrhythmia. On 27-MAY-2023 08:00, 207 days after receiving Fluzone Quadrivalent and 172 days after receiving RSVPreF3 vaccine + AS01E, the subject developed severe - grade 3 diverticulitis intestinal hemorrhagic (Verbatim: Diverticulitis intestinal hemorrhage). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 bradycardia-tachycardia syndrome (Verbatim: Tachycardia/bradycardia syndrome) on 29-MAY-2023 08:00 with serious criteria of hospitalization. The outcome of diverticulitis intestinal hemorrhagic was resolved on 07-JUN-2023. The outcome(s) of the additional event(s) included bradycardia-tachycardia syndrome (resolved on 11-JUN-2023). Relevant Tests: On 30May2023 CT angio showed possible active arterial extravasation in sigmoid colon. Diagnostic results (reference ranges are provided in parenthesis if available): Laparoscopy- 07-JUN-2023 sigmoid colectomy. The investigator considered that there was no reasonable possibility that the diverticulitis intestinal hemorrhagic and bradycardia-tachycardia syndrome may have been caused by Fluzone Quadrivalent and RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the diverticulitis intestinal hemorrhagic and bradycardia-tachycardia syndrome may have been caused by Fluzone Quadrivalent and RSVPreF3 vaccine + AS01E. Linked case(s) involving the same subject: US2023085179 GSK receipt date: 16-Jun-2023 required interventional radiology and surgical intervention; outside medical records requested; subject was admitted to hospital 27May2023 and was discharged after pacemaker placed, exact date unknown as medical records were not released. Regarding tachycardia/bradycardia syndrome: PCP records reviewed which indicate pacemaker placed 11Jun2023. Will consider that to be end date as it is date it was effectively treated. Reqarding diverticulitis intestinal bleeding: hospital records will not be released. Review of PCP/oncology records indicates the diagnosis of "diverticulosis of colon with hemorrhage" Also notes CT angio 30May2023 showing possible active arterial extravasation in sigmoid colon. It notes laparscopic sigmoid colectomy performed on 07Jun2023. Will list recovery date as surgery date as that is date bleeding stopped. No pre-existing gastrointestinal conditions and no known contributing cardiac or gastrointestinal medications Follow-up information received on 26-JUN-2023 The case US2023085179 was identified as a duplicate of US2023085180. All correspondence will be added in the case US2023085180(case of record) Summary of changes: event Tachycardia/bradycardia syndrome and narrative updated, deletion merging case performed. Follow-up information received on 25-JUL-2023. Summary of changes: SAE term (From diverticular bleeding to Diverticulitis intestinal hemorrhage) updated. Follow-up information received on 28-AUG-2023 Summary of changes: Event outcome and event outcome date, lab data and narrative updated. Follow-up information received on 31-AUG-2023 Summary of changes: Narrative and historical condition updated.; Sender's Comments: A case of Diverticulitis intestinal haemorrhagic and Sinus node dysfunction, 207 days after receiving the 1st dose of Fluzone Quadrivalent and 172 days after receiving the 1st dose of RSVPreF3 vaccine + AS01E, in a 74-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factor for Sinus node dysfunction (past medical history included arrhythmia). US-GSK-US2023085179:
Medical History/Concurrent Conditions: Arrhythmia
Test Date: 20230607; Test Name: laparscopic; Result Unstructured Data: (Test Result:sigmoid colectomy,Unit:unknown,Normal Low:,Normal High:); Comments: On 30May2023 CT angio showed possible active arterial extravasation in sigmoid colon