Fifty-nine people suffered adverse reactions similar to that experienced by a young Waterford man who died five days after receiving the single-shot Janssen Covid-19 vaccine, an inquest has heard.
Dr Luis Humberto Anaya-Velarde, a medical safety officer with Janssen, told a hearing at Cork City Coroner’s Court into the death of Roy Butler (23) that not all 60 cases were fatal and they arose in the context of the company distributing 660 million vaccine doses worldwide up to February 29th last.
Mr Butler, from O’Reilly Road, Cork Road, Waterford, felt ill in the days after receiving the vaccine at a local pharmacy on August 12th, 2021 and died at Cork University Hospital (CUH) five days later.
The inquest opened on Tuesday and heard Mr Butler suffered “a catastrophic intercranial bleed” resulting from a large and spontaneous haematoma in the tissue of his brain leaking. The coroner was told that the cause of the haematoma remains unexplained, with scans showing no sign of any trauma or injury to his skull.
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Mr Butler’s mother described him as being “a perfectly healthy boy” until he received the vaccine in order to go on a holiday overseas with friends.
Dr Logesvaran Yogendran, vice-president of global strategy and risk management at Janssen Research and Development, told the inquest the company had received reports on adverse reactions among people who received its Covid-19 vaccine, but it did not have data on the number who died globally after receiving it.
He said this was because not every country reported deaths linked to the vaccine and each recorded case of death included in the company’s global safety database had to be of an identified person and reported by an identified person with medical qualifications.
Following a request from Cork city coroner Philip Comyn, Janssen reviewed data on its Covid-19 vaccine and found two previously “healthy” patients worldwide had died after suffering spontaneous intercranial haemorrhages similar to Mr Butler within seven days of vaccination.
Dr Anaya told Ciara Davin BL, for the Butler family, that 60 people of all ages, including Mr Butler, suffered spontaneous intercranial haemorrhages within 10 days of having the vaccine.
When this was broadened to more general central nervous system vascular haemorrhages within 10 days of receiving the vaccine, the number reported and recorded in Janssen’s database was 311, with the cases ranging in age from 17 to 103 years. Janssen was unable to say how many of the 660 million doses distributed were ultimately administered.
Dr Anaya, who said he learned of Mr Butler’s death via social media, told Ms Davin he did not agree with the view that Mr Butler’s death was associated with taking the vaccine. He said the symptoms Mr Butler exhibited in the days immediately after taking the vaccine – headaches, nausea and fatigue – were normal symptoms of vaccine reactogenicity.
Asked if he was concerned by the evidence heard on Tuesday about Mr Butler collapsing, suffering convulsions and suffering a spontaneous intercranial bleed, Dr Anaya said he was.
Ms Davin said that, by a process of elimination, Mr Butler’s brain bleed was probably caused by the vaccine given it happened within days of him receiving the injection and he had been a healthy young man before that.
However, Dr Anaya disagreed and said he did not believe that was the case, although he later accepted that the possibility could not be ruled out.
“A single case is not sufficient evidence to confirm an association,” he said. “A single case may be tragic, it may be compelling – we take every case seriously, particularly this case where a healthy man of a young age dies, but from a scientific point of view, a single case is not sufficient for proof.”
The inquest continues.
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