A mum-of-three has died aged 43 after she suffered blood clots having had the AstraZeneca coronavirus vaccine.
Tanya Smith booked a Covid jab after she was contacted by her GP to arrange her first dose. Her partner Kenneth Edwards said she felt "pretty rough" for a couple of days after the jab - and then woke one morning with painful stomach cramps, so NHS 111 was called.
She was visited by a paramedic who prescribed painkillers, according to the family, but her pain did not ease and Ms Smith was taken to Derriford Hospital where it was later found she had suffered multiple blood clots. She soon suffered a heart attack and a cardiac arrest and after a short period of stability, her condition got "progressively worse" before she tragically died in hospital on April 3.
Described as an "amazing" and "selfless" partner, mum and childminder, Tanya Smith moved to Plymouth from Portsmouth as a child and had worked as both a self-employed childminder and a childminder for Plymouth City Council for more than 19 years, while also being a dedicated mum to her three children, reports Plymouth Live.
Mr Edwards believes she would not have passed away if she hadn't had the Covid-19 AstraZeneca vaccine, but this can not be verified until a full investigation and inquest into her death has taken place.
After taking some time to grieve for his partner, Mr Edwards has decided to speak out as he has seen similar reports of people suffering blood clots following the AstraZeneca vaccine - like the report of the death of BBC journalist Ms Lisa Shaw.
The European Medicines Agency says the benefits of the vaccine in combating the widespread threat of Covid-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risk of side effects.
A spokesperson for the MHRA (the Medicines and Healthcare products Regulatory Agency) said: "As with any serious suspected adverse reaction, reports with a fatal outcome are fully evaluated by the MHRA, including an assessment of post-mortem details if available."
The death has been reported to the coroner but no inquest has been opened and the cause of death is awaited, HM Coroners Office in Plymouth has confirmed.
Paying tribute to his partner of eight years, Mr Edwards said: "She was just amazing, selfless. She was a childminder - a really good childminder for 19 years. She leaves three children behind, two grown up children and a 12-year-old little girl with disabilities. She was the only woman, apart from my mum, who really looked after me. She loved her family, she was really family-orientated and she'd go above and beyond. We're all pretty lost without her, I've never experienced anything like this."
Ms Smith was invited to have her jab early as she was a key worker and a carer for her daughter who has disabilities. She had her vaccine and felt "pretty rough" for a few days but was beginning to feel better - until she awoke one morning with intense stomach cramps, which the family initially thought was caused by food poisoning.
Later that day, Ms Smith started "screaming in agony" so her son Harvey rang NHS 111. A paramedic/responder soon attended and the family say she was given stronger painkillers to tackle the cramps, but after the awful pain persisted, her son rang for an ambulance.
After being taken to hospital, medics performed multiple ECGs over several hours and later phoned Mr Edwards to tell him Ms Smith had suffered a heart attack and a cardiac arrest.
After meeting doctors in the hospital, Mr Edwards said medics "didn't understand" how Ms Smith could have had a heart attack, and soon sent her down to theatre. She was found to have blood clots in her arteries, which had caused the heart attack, Mr Edwards said, but her condition appeared to be improving shortly after surgery.
Sadly, Ms Smith later complained of bleeding and doctors noticed her platelet levels were "through the floor" as her condition got progressively worse. By Good Friday, just over a week since Ms Smith had received her vaccine, doctors told Mr Edwards that she was "gravely poorly but she's a fighter".
The following day, Mr Edwards and Ms Smith's parents and children rushed to the hospital to see her before medics advised they went home to rest. Sadly, Mr Edwards had a phone call from hospital staff just a few hours later and was advised to rush back to the hospital to see his wife. On returning to the hospital, he was told he had 'just missed' his partner's passing,
"It's been horrendous," he said. "I'm devastated by all this but people need to know. The [BBC journalist Lisa Shaw's] story struck a chord. I know it's a small percent [of people that have blood clots after the vaccine] but my partner was healthy. Within four days she had passed away.
"I would not stop anyone getting the jab, but people need to know [what happened] to make their own decision."
Mr Edwards said Ms Smith had no underlying health conditions he was aware of, aside from a heart arrhythmia (abnormal heart rhythm) and "a bit" of IBS.
PlymouthLive has reported that it understands Ms Smith's death will be investigated by University Hospitals Plymouth NHS Trust and the MHRA (Medicines and Healthcare products Regulatory Agency), an executive agency in the government's Department of Health and Social Care that authorises the vaccine for use.
NHS Devon has explained that Ms Smith had the vaccine recommended for her age group.
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Guidance on the government website explains: "Older adults (including health and social care workers aged 40 years or older, care home residents and adults of any age with certain medical conditions) are at high risk of the complications of Covid-19. The Medicines and Healthcare products Regulatory Agency (MHRA) and the JCVI advises that you should still receive any of the available Covid-19 vaccines. The benefits of vaccination in protecting you against the serious consequences of Covid-19 outweigh any risk of this extremely rare condition.
"In the current situation the JCVI has advised that it is preferable for people in [the age 30 to 39 age group] to have a vaccine other than AZ."
An inquest into Ms Smith's death is expected to take place later this year.
What does the NHS/MHRA say?
NHS England declined to comment on the matter, instead recommending PlymouthLive contact the MHRA (the Medicines and Healthcare products Regulatory Agency, part of the Department of Health and Social Care) as it is the Agency that authorises the vaccine for use.
A spokesperson for the MHRA said: "We are saddened to hear about the death of Tanya Smith and our thoughts are with the family. As with any serious suspected adverse reaction, reports with a fatal outcome are fully evaluated by the MHRA, including an assessment of post-mortem details if available. Our detailed and rigorous review into reports of blood clots occurring together with thrombocytopenia is ongoing.”
What does the government say about the side effects from a Covid-19 vaccine?
The MHRA publishes a report every week which outlines the total number of people in the UK who have passed away within 28 days of a positive test for Covid-19 and provides information and data on the vaccines currently in circulation and their known side-effects.
Regarding the vaccine Ms Smith received, AstraZeneca, the Agency has confirmed that the evidence to date does not suggest that the AstraZeneca vaccine causes venous thromboembolism (blood clots) without a low platelet count.
The latest report, as of June 2, 2021, reads: "At the time of this report, over 127,500 people across the UK have died within 28 days of a positive test for coronavirus (Covid-19). Vaccination is the single most effective way to reduce deaths and severe illness from Covid-19. A national immunisation campaign has been underway since early December 2020. Three Covid-19 vaccines, Pfizer/BioNTech, Covid-19 Vaccine AstraZeneca and Covid-19 Vaccine Moderna, are currently being used in the UK. All have been authorised for supply by the Medicines and Healthcare products Regulatory Agency (MHRA) following a thorough review of safety, quality and efficacy information from clinical trials.
"In clinical trials, the vaccines showed very high levels of protection against symptomatic infections with COVID-19. Data are now available on the impact of the vaccination campaign in reducing infections and illness in the UK.
"All vaccines and medicines have some side-effects. These side-effects need to be continuously balanced against the expected benefits in preventing illness. The Pfizer/BioNTech vaccine was evaluated in clinical trials involving more than 44,000 participants.
"The most frequent adverse reactions in trials were pain at the injection site, fatigue, headache, myalgia (muscle pains), chills, arthralgia (joint pains), and fever; these were each reported in more than 1 in 10 people. These reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Adverse reactions were reported less frequently in older adults (over 55 years) than in younger people.
"The Covid-19 Vaccine AstraZeneca was evaluated in clinical trials involving more than 23,000 participants. The most frequently reported adverse reactions in these trials were injection-site tenderness, injection-site pain, headache, fatigue, myalgia, malaise, pyrexia (fever), chills, arthralgia, and nausea; these were each reported in more than 1 in 10 people.
"The majority of adverse reactions were mild to moderate in severity and usually resolved within a few days of vaccination. Adverse reactions reported after the second dose were milder and reported less frequently than after the first dose. Adverse reactions were generally milder and reported less frequently in older adults (65 years and older) than in younger people.
"The Covid-19 Vaccine Moderna was evaluated in clinical trials involving more than 30,000 participants. The most frequent adverse reactions in these trials were pain at the injection site, fatigue, headache, myalgia (muscle pains), arthralgia (joint pains), chills, nausea/vomiting, axillary swelling/tenderness (swelling/tenderness of glands in the armpit), fever, injection site swelling and redness; these were each reported in more than 1 in 10 people.
"These reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Adverse reactions were reported less frequently in older adults (over 65 years) than in younger people.
"The MHRA’s role is to continually monitor safety during widespread use of a vaccine. We have in place a proactive strategy to do this. We also work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side-effects.
"Part of our monitoring role includes reviewing reports of suspected side-effects. Any member of the public or health professional can submit suspected side-effects through the Yellow Card scheme.
"The nature of Yellow Card reporting means that reported events are not always proven side-effects. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated, and especially when most vaccines are being given to the most elderly people and people who have underlying illness."
