The revelation came as the firm that made the one-shot Janssen vaccine, Johnson & Johnson, insisted there was “insufficient evidence” to link the brain bleeds with the jab – and that the European Medicines Agency (EMA) agreed with their findings.
Two senior executives with Johnson & Johnson also said they did not have an overall global figure for how many people had died within 28 days of taking the vaccine.
Roy became unresponsive four days after receiving the one-shot Janssen-Johnson & Johnson Covid-19 vaccine and died the following day from a catastrophic brain bleed despite desperate efforts by doctors in Waterford and Cork to help him.
The intracranial bleed left him with a massive 8.1cm haematoma which caused devastating brain injuries.
His inquest has now heard that 60 people worldwide – including Roy Butler – who received the Janssen-Johnson & Johnson vaccine suffered intercranial brain bleeds.
The pharmaceutical company – which said it learned of Mr Butler’s death via social media – launched an investigation in 2022 after multiple reports of haemorrhage incidents.
More than 400 reports were examined, before the number of incidents of cerebral haemorrhage within 28 days of the vaccine were noted at 36 after the original jab and two more after the booster jab.
Janssen-Johnson & Johnson said it reported its findings to the EMA, and it concurred that there was “insufficient evidence to establish a causal link between the spontaneous bleeds and the vaccine.”
The footballer’s parents, Martin and Angela, and his older brother, Aaron, insisted they just want the truth over the young man’s death to be known.
Roy died five days after receiving the vaccine on August 12, 2021.
The Cork Coroner’s Court inquest heard that he was reluctant to get the jab, but did so because he needed to be vaccinated to accompany a group of friends travelling on holidays to Dubai.
Cork Coroner Philip Comyn heard evidence from Janssen-Johnson & Johnson medical safety director Dr Luis Humberto Anaya Velarde and vice-president of medical safety strategy Dr Logesvaran Yogendran.
It was confirmed that two women had died in similar circumstances to the Waterford footballer.
Both women died in the US – one suffered a massive stroke on the day she received the vaccine and the second, a 45 year old woman, died in hospital from a brain bleed after attending with symptoms of a severe headache.
Both died within seven days of receiving the vaccine.
Dr Anaya, a former Mexican Government health official who joined Johnson & Johnson to aid their Covid-19 vaccine programme, said the company had investigated after receiving reports of up to 400 haemorrhage cases.
More than 660 million doses of the Janssen vaccine were distributed globally but not all were administered.
In Ireland, over 281,000 doses were delivered with 241, 743 being administered.
Later in the roll-out of the Covid-19 vaccine programme, various European and North American governments recommended alternative MRNA vaccines rather than the adeno-virus Janssen type.
Dr Anaya said that an investigation was launched by the company amid reports of haemorrhage incidents.
“(It was found) there was insufficient evidence to establish a causal link between the spontaneous bleeds and the vaccine.
“We submitted it to the European Medicines Agency (EMA) and they confirmed it. They agreed with our assessment that there was insufficient evidence.
“There was nothing to link the intracerebral bleed and the vaccine,” he said.
Ciara Davin BL, for the Butler family, insisted such a catastrophic brain bleed in a fit and healthy young man had to be linked to the vaccine given that he complained of feeling unwell immediately after the jab.
“Isn’t it probable that Roy Butler suffered a rare side effect from the vaccine – isn’t that what happened here,” she said?
Dr Anaya insisted that all such cases are taken very seriously.
“A single case cannot be sufficient enough proof. There needs to be a formal process of evaluation. We have considered a review of cerebral haemorrhage – we have come to the conclusion that there is insufficient evidence to show a link with the vaccine. We have considered that it is unlikely.”
Dr Anaya, who listened to all the evidence from the Butler family on Tuesday, admitted he was concerned by what he heard.
Dr Yogendran said no figure was available for known fatalities involving people who had received the vaccine over the previous 28 days.
When pressed on the fact other Covid-19 vaccines appeared to have much lower adverse effects, Dr Yogendran warned that great care has to be taken when comparing different medicines.
Roy Butler of O’Reilly Road, Cork Road, Waterford had received the one-shot Janssen-Johnson & Johnson vaccine in Mulligan’s Pharmacy in Waterford on August 12 2021.
He returned home shortly after leaving for the gym on August 16 and said he felt unwell and feared he might collapse.
“Roy was getting sick. I called him but I got no response,” she said after going up to her son’s bedroom.
The family called for an ambulance and tried to comfort Roy.
“I kept talking to him. He was getting sick and then he started getting convulsions,” Mr Butler said.
The father-of-two broke down as he told the inquest of the family’s desperate attempts to assist their son as his condition rapidly deteriorated.
“He was just jerking from the convulsions. I held his hand. I kept talking to him. He was totally unresponsive when the second ambulance arrived.”
He was rushed to University Hospital Waterford (UHW) and the decision was later made that, given his age, health and general fitness, he would be transferred to Cork University Hospital (CUH) for specialist neurological care.
On August 17, the family were informed at CUH that nothing more could be done for Roy and the decision was made to turn off his life support machine.
“We went in to say goodbye to Roy. The machine was switched off and five minutes later Roy had passed.”
HIs mother said that: “He was perfect, he got the injection and then he wasn’t (perfect).”
Roy’s brother, Aaron, warned that: “I just want the truth about what happened.”
Aaron said his brother’s text messages to friends and family in the days before his death revealed how he immediately felt unwell after receiving the jab.
“I don’t want it (the jab) but I am going to Dubai and I need it to go there,” Roy messaged one friend.
On August 12, after receiving the vaccine, he messaged another friend that: “I feel f***ed. I have to go back to work.”
Another friend received a message: “Good bro – got my jab yesterday. Bit shook at the moment.”
“I don’t take any (Paracetamol) bro – hopefully I will be grand. I don’t like taking tablets,” he messaged another friend, indicating he also did not want to ring in sick at work.
“I’m old school like that,” he messaged another friend.
“I’m f***ed after the vaccine. I’m just not well.”
Later he indicated to friends that he was suffering from grogginess, headaches, the sweats as well as a sore jaw and neck.
Just 48 hours before his death, Roy messaged one friend that: “I’m not dying – I’m just not well. The vaccine has me shook.”
The inquest is due to conclude on Thursday.
