Health investigates death of Paranapanema resident after Butantan dengue vaccine The daughter of the 48-year-old woman who died on March 1, about a month after taking the dengue vaccine developed by the Butantan Institute, claims that her mother was a victim of medical negligence. The case is being investigated as a suspicious death by the Ministry of Health. The application of the vaccine was temporarily suspended across the country on Monday (8). Daiane Diniz, 31, told g1 and TV TEM that her mother, Ângela Diniz Marques, took the vaccine on January 29th, as she was a cleaning employee at the Leonardo Van Melis Municipal Hospital, in Paranapanema (SP), the city where she lived. 📲 Join the g1 Itapetininga e Região channel on WhatsApp The first symptoms began to appear around February 13, when Angela made a call to her daughter saying that she and others were feeling unwell. "She called me saying that everyone was 'blistered', with scattered spots, headaches and body aches, unable to walk properly. I told her to see a doctor, because these are the symptoms of dengue. I know that the vaccine is made based on the live virus in a low percentage, however, the batch could have the wrong dosage", he recalls. Daiane says that her mother even went to the hospital where she worked. However, she was discharged after receiving a dose of bromopride - a medicine used to control nausea and vomiting. At the time, Angela was already vomiting, with constant sweating and a pale complexion. "She told me that 'the doctor didn't hold her'. Soon after, my mother sent me a photo and I saw that she wasn't really well. We called the ambulance and the nurse refused to help her, because my mother was an employee at the hospital and she hadn't gone to work on her shift. We called my aunt, who also works there. When they arrived at her house, they found my mother unconscious", he says. Family alleges that Angela was a victim of medical negligence Personal file The daughter states that, after being rescued again and taken to the municipal hospital in Paranapanema, Ângela had to be transferred to Santa Casa de Avaré (SP), where she was admitted with suspected meningitis and a stroke. For Daiane, the lack of communication about the possibility of a reaction to the vaccine affected the care provided to the mother. "She was transferred to Avaré (SP) and, during the transfer, no one who was there said: 'Look, we took the vaccine and many people had reactions, whether mild or severe'. The doctor who carried out several tests reported that she did not find any convulsive symptoms in her and that they did not match the suspicion presented", points out Daiane. "No zero vacancy transfer document was notified or placed [which obliges a hospital to receive a patient in a serious condition or at risk of death], nor was there any suspicion of a dengue vaccine. Only meningitis and stroke were placed. Apart from that, there were other patients, from the same city, who were civil servants and had the same reactions, but it was not notified to any body", he adds. At Santa Casa de Misericórdia de Avaré (SP), Ângela's condition was investigated as suspected post-vaccination encephalitis and peripheral vasculitis with thrombosis Personal file Daughter went to the police Before her mother's death, Daiane had gone to the city police station to file a police report and report the alleged medical negligence, which is being investigated as bodily injury by the Civil Police. "The police chief told me that there was a bodily injury because she was in the ICU at the time. I notified the city hall and spoke to the mayor three times, but he told me that the hiring was done outsourced. If there is any risk of presenting symptoms, those vaccinated need to be monitored frequently", he says. Ângela's body underwent a necropsy before being buried, with the report expected to be released in July. According to the daughter, her mother was always in favor of vaccination. "In addition to enjoying the health sector, she had been working at city hall for some time. She was always in favor of the vaccine and, regardless, she did not have any comorbidity, rare or serious illness that could worsen a vaccination. This is being investigated even through the conduct itself of what happened to her", he adds. What those involved say In a note sent to TV TEM, the City of Paranapanema informed that it follows the guidelines of the Ministry of Health and the National Health Surveillance Agency (Anvisa) regarding the suspension of the application of the vaccine. The municipality also reported that, as reported by the aforementioned bodies, there is no confirmation of a causal relationship between the immunizer and the cases investigated. According to the note, the municipal management states that it opened an investigation to investigate the family's allegations, a process that is being carried out under secrecy. The Ministry of Health informed that it will temporarily discontinue the Butantan Institute's current vaccination strategy against dengue. The measure was adopted after recording 42 cases with warning signs. The ministry highlighted that it cannot be said that the deaths identified were caused by the Butantan-DV vaccine. "The National Health Surveillance Agency (Anvisa) will establish a panel of experts, with representatives from academia and the scientific community, to deepen the investigation into possible comorbidities, risk factors and other situations that may have contributed to the deaths. The discontinuation of the vaccination strategy was adopted as a precaution until the conclusion of the investigation and does not invalidate the effectiveness of the vaccine nor alter the evidence of protection observed to date", says the note. TV TEM production also contacted the São Paulo Public Security Secretariat (SSP-SP), but did not receive a response until the publication of this report. Butantan dengue vaccine. Government of São Paulo/Disclosure Cases The suspension of the application of immunizers occurred this Monday (8), after two suspicious deaths were recorded. The Butantan Institute said that, following the guidelines of the Ministry of Health and Anvisa, vaccination against dengue will be temporarily interrupted to reevaluate the vaccination strategy. And that the measure seeks to guarantee the safety of the population in the next stages of vaccination. According to the Ministry of Health, 500,000 doses were administered, 417,000 of which were administered to health professionals alone. Among those vaccinated, 42 cases of severe adverse reactions were recorded, representing 0.008% of the total. Of these, three were classified as serious, including two deaths that are under investigation. According to the Ministry of Health, one of the cases investigated involves a resident of the interior of São Paulo. Death occurred nineteen days after she received the vaccine. She developed severe dengue symptoms associated with neurological impairment, diagnosed as meningoencephalitis. According to the ministry, the condition had an unfavorable evolution and resulted in death. Another case investigated involves the death of a 58-year-old man from Santo André, Greater SP. Investigations still do not allow establishing a causal relationship between vaccination and death. The vaccine and tests The vaccine developed by the Butantan Institute was developed to prevent infection by the four serotypes of the virus and offers protection for at least five years, in addition to significantly reducing the risk of severe forms of the disease. The institute explains that the vaccine uses attenuated virus technology, popularly called weakened virus. In this type of vaccine, all the characteristics of the virus are maintained, but with a low replication capacity, that is, at a dose that is not capable of causing the disease. As a result, the vaccine induces the immune system to produce antibodies to combat this infectious agent, in addition to generating cellular memory, responsible for storing information that will activate defense cells in the event of contact with the virus already known to the body. According to the institute, Butantan-DV proved to be effective both in people who have already had dengue fever and in those who had never been infected. In addition to protection, it significantly reduces the risk of serious forms of the disease. The study on the vaccine was published in the journal "Nature Medicine" in March, and showed that serious adverse events occurred in similar proportions between those vaccinated and participants who received a placebo, with no signs of safety problems related to the vaccine. In the study, more than 16 thousand volunteers were followed over five years, with an overall effectiveness of up to 80.5% protection against severe dengue (a condition that leads to hospitalization or death). Throughout this research, no serious adverse effects or deaths linked to the vaccine were recorded. From this analysis, the efficacy and safety were proven To g1, experts explain that no clinical study can anticipate adversities or complications. Rare adverse effects are unlikely to appear in phases 1, 2 or 3 of a clinical trial because there are not enough participants to make them visible. Despite the announcement of the temporary discontinuation of the use of the vaccine, it is still not possible to establish a causal relationship between the application of the vaccine and deaths. Who has been vaccinated, what should they do? Within 21 days after immunization, it is necessary to observe: Fever; Intense and continuous abdominal pain; Persistent vomiting; Dizziness; Bleeding; Intense drowsiness; Irritability; Signs of dehydration; Worsening of the general condition. If symptoms intensify, the immunized person should seek a health unit. Given this scenario, the ministry recommends that anyone who took the vaccine in the last 21 days should be followed up at a local health unit to observe whether or not there will be adverse reactions. From Tuesday (9), the Ministry of Health will also begin to guide active monitoring for cases in the hospital network of dengue in people with recent vaccination, cases with alarm signs and deaths. The guideline is to follow up with clusters by lot, unit or territory. Dengue vaccine is suspended Butantan Institute/ Disclosure Initial plugin text See more news on g1 Itapetininga and Region VIDEOS: watch TV TEM reports