Received Jul 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU4 | INFLUENZA (SEASONAL) (QIV DRESDEN) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / LA |
Stroke; This 59-year-old male subject was enrolled in a blinded study titled A phase 2a randomized, observer-blind, dose-finding study to evaluate the immunogenicity and safety of mRNA-based multivalent seasonal influenza vaccine candidates in adults 18 years of age and older. The subject received the 1st dose of Flu Seasonal mRNA vaccine vs Flu D-QIV or Fluzone HD (intramuscular, left deltoid) on 03-JUN-2024 11:08, for prophylaxis. The subject's past medical history included lumbar pain (severe) and spinal laminectomy. Concurrent medical conditions included hypercholesterolemia, type ii diabetes mellitus, myopia (Bilateral), sciatica, numbness in hand (right (mild)), back pain (Generalized) and drug allergy (to Lisinopril). Concomitant products included atorvastatin, sitagliptin phosphate (Januvia), pregabalin (Lyrica), meloxicam (Mobic), dulaglutide (Trulicity), tizanidine hydrochloride (Zanaflex), valsartan and ezetimibe. On 22-JUL-2024, 49 days after receiving Flu Seasonal mRNA vaccine vs Flu D-QIV or Fluzone HD, the subject developed moderate - grade 2 stroke (Verbatim: Stroke). Serious criteria included life threatening. The outcome of stroke was resolved on 22-JUL-2024. Relevant Tests: On an unknown date in 2024, MRI(magnetic resonance imaging) brain scan done, which did indicate that he had had a stroke. On 21-SEP-2024 MRI (magnetic resonance imaging) was obtained and impression were as follows: No acute territorial ischemia, acute intra-axial hemorrhage or focal intra-axial mass. However, there was extensive deep white matter and periventricular chronic microangiopathy changes and these were also seen in the posterior fossa.. Diagnostic results (reference ranges are provided in parenthesis if available): Blood pressure measurement-In 2024 Elevated. Computerised tomogram-In 2024 did not show evidence of stroke at that time.. The investigator considered that there was no reasonable possibility that the stroke may have been caused by Flu Seasonal mRNA vaccine vs Flu D-QIV or Fluzone HD. The company considered that there was no reasonable possibility that the stroke may have been caused by Flu Seasonal mRNA vaccine vs Flu D-QIV or Fluzone HD. GSK Receipt date: 04-DEC-2024 Subject went to his physical therapist for a pre-existing leg weakness (no known diagnosis or information on this), who told him he was having a stroke and sent him to the ER(Emergency room). At the ER, subject was told he did not have the signs of a stroke and discharged him- recommended to follow up at PCP (primary care physician), office. Subject went to PCP, who also told him he was not having a stroke. Later the subject went to his optometrist, who informed him he did have a stroke. Subject had no stroke in the past, no any family history. Subject only had left leg weakness and elevated blood pressure as symptoms. No other information received to date. Serious adverse event (SAE) was not related to study participation activities other than study treatment. SAE was not related to study treatment Date event became serious: 22-JUL-2024 The subject was given concomitant medication Januvia (sitagliptin). Follow up information received on 09-DEC-2024 Summary of changes: Event outcome and date updated. Follow up information received on 10Dec2024 Summary of changes: General narrative comments updated. Lab data updated. Follow up information received on 31-JAN-2025 Summary of changes: The event start date and end date was updated from 10-JUL-2024 to 22-JUL-2024. TTO updated. Date event became serious was updated from 10-JUL-2024 to 22-JUL-2024. Lab data section, general narrative comment updated. Follow up information received on 05-FEB-2025. Summary of changes: General narrative comments updated, Lab data updated. Follow up information received on 27-Jun-2025 End of study Unblinding completed.; Sender's Comments: A case of Cerebrovascular accident, 49 days after receiving 1st dose of Flu D-QIV or Fluzone HD in a 59-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factors ( Hypercholesterolemia, Type II Diabetes mellitus) based on medical history.
Back pain (Generalized); Drug allergy (to Lisinopril); Hypercholesterolemia; Myopia (Bilateral); Numbness in hand (right (mild)); Sciatica; Type II diabetes mellitus
Medical History/Concurrent Conditions: Lumbar pain (severe); Spinal laminectomy
ATORVASTATIN; JANUVIA; LYRICA; MOBIC; TRULICITY; ZANAFLEX; VALSARTAN; EZETIMIBE
Test Date: 2024; Test Name: Bloodpressure; Result Unstructured Data: (Test Result:Elevated,Unit:unknown,Normal Low:,Normal High:); Test Date: 2024; Test Name: CT scan; Result Unstructured Data: (Test Result:did not show evidence of stroke at that time.,Unit:unknown,Normal Low:,Normal High:); Comments: On an unknown date in 2024, MRI(magnetic resonance imaging) brain scan done, which did indicate that he had had a stroke. On 21-SEP-2024 MRI (magnetic resonance imaging) was obtained and impression were as follows: No acute territorial ischemia, acute intra-axial hemorrhage or focal intra-axial mass. However, there was extensive deep white matter and periventricular chronic microangiopathy changes and these were also seen in the posterior fossa.