Tweets mislead that Pfizer vaccine caused ‘many deaths’

A string of seven tweets misleads that deaths and miscarriages and other side effects from Pfizer’s Covid-19 vaccine were covered up.

The content responsible for the content misinforms by writing that “in the first three months alone, thousands of serious side effects and 1,223 deaths were hidden from the public”, which would show that “Pfizer has more than lived up to its infamous reputation as one of the most criminals the planet has known”.

As verified by Project Comprova, the document used as the source of the tweets — although the drugmaker doesn’t confirm its authenticity, the Food and Drug Administration (FDA) claimed it was from Pfizer — considers 42,086 post-immunization reports in the US and other countries since the authorization of the emergency use of the vaccine by the health agency of the North American country, on December 10, 2020, until February 28, 2021. In it, there are reports of 1,223 deaths and 520 people who recovered with sequelae (no “thousands”, nor “serious side effects”), but, as informed in the document, there is no relation of cause and effect linked to the vaccine.

Contacted by the report, Pfizer said that “the information from the tweets is unfounded”, that “there are no serious safety warnings related to the immunizing agent” and that “the company reinforces that the benefits of vaccination outweigh the potential adverse events”. The WHO (World Health Organization) and Anvisa (National Health Surveillance Agency) also have this understanding of the benefits of Pfizer’s immunizing agent.

The article contacted the author of the tweets, but did not receive a response until the publication of this text. This content was considered misleading because it uses inaccurate data, which induces a misinterpretation.

How do we check?

The first step was to look for the document that the author of the tweets used as a source. Searching the file, entitled, in free translation, “BNT162b2 — Cumulative analysis of post-authorization adverse event reports” BNT162b2 is the code that identifies the Pfizer vaccine”, it was possible to find it on the internet with the title in English on websites unofficial.

Even without the pharmacist confirming the authenticity of the document, from it it was possible to deny the data used in the tweets. In addition, the report contacted Pfizer’s press office, who responded via email.

Still on the source of the information, the FDA was also contacted by email and confirmed that it “is part of a larger document sent by Pfizer-BioNTech”.

Finally, the article contacted the author of the content (@ThaisConexao) via a private message on Twitter, but she did not respond.

Verification

Deaths and other occurrences

The document used as the source of the tweets is, according to the FDA, a biological license application (BLA) sent to the agency by Pfizer. The text does state that 1,223 people who were vaccinated died between the authorization of the emergency use of the vaccine by the FDA in the United States (which occurred on December 10, 2020) and February 28, 2021, but it does not relate these deaths to vaccine. Thus, the document does not serve as proof that the vaccine killed 1,200 people, as the verified sequence of tweets alleges.

In the table “Overview: selected characteristics of all cases received during the reporting interval”, the document informs that, of the 42,086 people vaccinated considered:

• 19,582 recovered or were recovering;
• 520 recovered with sequelae;
• 11,361 had not recovered at the time of publication of the survey;
• 1,223 had died;
• 9,400 cases without knowledge.

In other words, differently from what the sequence of tweets verified here states, the data do not show that there were “thousands of [pessoas com] serious side effects.” There were 520 cases of people who recovered with sequelae, or 1.2 percent of the total—not to mention whether it was severe or not.

As previously reported, the document analyzed 42,086 cases of people vaccinated in the United States and other countries. For comparison, as of February 28, the US country had immunized 49.7 million citizens with at least one dose, according to the website Our World in Data.

Abortions

The author of the content also misleads when stating that, of 116 women who breastfed after being vaccinated, “17 cases (of sequelae) would have been registered, 3 of which had serious consequences for the babies”. The document is clear in stating that, among these 116 mothers, there was no “occurrence of any adverse clinical events”.

In fact, the document says that three babies exposed to the vaccine through breastfeeding had symptoms such as: fever, rash, irritability, vomiting, diarrhea, insomnia, poorly fed child, lethargy, abdominal discomfort, vaccine allergy, increased appetite, anxiety , crying, poor sleep, belching, restlessness, pain and hives.

Contacted by the report, the FDA points out that “there were no safety signs that emerged from the analysis of these cases during pregnancy and during breastfeeding”.

The verified content also invents that the document speaks of “270 pregnancies with spontaneous abortions and premature births”. In fact, the text informs that, of 270 cases of pregnancies, in 23 there was a miscarriage – noting that the cases have no cause and effect relationship with the vaccine.

limitations

In the item on “Methodology”, the document mentions presenting a “spontaneous notification system” with “external factors” that influence “adverse events”, or side effects. “The spontaneous reporting system produces reporting ratios, not incidence rates,” the text states. He continues: “As a result, it is generally not appropriate to make drug comparisons using these ratios; the spontaneous reporting system should be used for signal detection rather than hypothesis testing.”

Another limitation presented is that, in some cases, “clinical information is lacking (such as medical history, diagnostic validation, time from drug use to disease onset, dose and concomitant drug use)”.

It goes on to state that an “adverse event report does not necessarily indicate that a particular adverse event was caused by the drug,” which may be due to an existing illness or medical history.

Out-of-context use of data from pharmacovigilance systems is a common tactic to misinform vaccine safety. Only a careful case-by-case analysis – carried out by the health authorities – can determine the relationship with the immunizing agent.

Side effects

Pfizer’s vaccine package insert lists the reactions it can cause in people 12 years of age and older. Are they:

• Very common reactions (in 10% of patients): pain and swelling at the injection site, tiredness, headache, diarrhea, muscle pain, joint pain, chills and fever.
• Common reactions (between 1% and 10% of patients): redness at the injection site, nausea and vomiting.
• Uncommon reactions (between 0.1% and 1% of patients): enlarged lymph nodes, hypersensitivity reactions such as itching, decreased appetite, limb pain, insomnia, lethargy, excessive sweating, night sweat, asthenia (weakness, tiredness intense physical), feeling unwell and itching at the injection site.
• Rare reaction (between 0.01% and 0.1% of patients): acute facial palsy.
• Not known (cannot be estimated from the available data): severe allergic reaction (anaphylaxis), erythema multiforme (skin reaction causing red patches or plaques that look like a target or “buffalo eye” and have a red center dark surrounded by red and pale halos), extensive swelling of the vaccinated limb, swelling of the face (swelling of the face may occur in patients who have received dermatological facial fillers).

The package insert also mentions adverse reactions after the third dose:

• Very common reactions (in 10% of patients): headache, joint pain, muscle pain, injection site pain, tiredness and chills.
• Common reactions (between 1% and 10% of patients): swollen lymph nodes, diarrhea, vomiting, fever, injection site swelling and injection site redness.
• Uncommon reactions (occur in between 0.1% and 1% of patients): rash, decreased appetite, nausea and limb pain.
• Not known (cannot be estimated from the available data): severe allergic reaction (anaphylaxis).

Secrecy

Contrary to what the tweet says, the FDA did not require 55 years of secrecy on documents related to Pfizer. This allegation takes out of context an FDA response to a request for information through the Foia (Freedom of Information Act).

The request was made by the group Doctors of Public Health Professionals for Transparency. They asked for the release of all documentation reviewed by the FDA to authorize the application of Pfizer’s immunizers. And set March 3, 2022 as the deadline.

However, the regulatory body, which was against the decision, claims that it would take 55 years until all documentation is available. According to the agency, there are not enough personnel and/or resources to fulfill the request within the stipulated period. The FDA also claims that this is an order for more than 329,000 pages of documents and that it would need to process 80,000 pages per month.

In addition, the North American regulatory body states that all documents need to be analyzed before they are made available, because some of them contain confidential business information from Pfizer/BioNTech, and others contain personal data of those involved in the clinical trials. The FDA believes it is possible to analyze an average of 500 pages of documents per month, to separate which ones are exempted by Foia from being made public. The requesting physicians, however, claim that the information about Pfizer is of public interest and ask for the deadline to be met by March 2022.

Although the FDA says it’s impossible to meet the deadline, US District Judge Mark Pittman has already set a conference, scheduled for Dec. 14 in Fort Worth, Texas, to consider the timetable for processing the requested documents.

On August 23 of this year, the FDA granted definitive registration for Pfizer’s Covid-19 vaccine to persons aged 16 and over in the country. According to information from Reuters, the immunizing agent is the first against the coronavirus approved by the agency.

The author of the tweets

The deceptive content was posted by @ThaisConexao’s Twitter profile. The author identifies herself as an “international correspondent in Europe” for the Political Connection website and, in a post at the very beginning of her posting panel, she says, without saying why, that she had an old account taken down by Twitter.

The report contacted her via a private message on Twitter, but has not responded until this text was published.

The Political Connection, the site on which she claims to work, has been checked by Comprova since 2019, also for misleading by publishing denial content such as the one relating the murder of a Chinese-American scientist to his research work on the new coronavirus, the who used a title exaggerating a German doctor’s lines about strict measures against the disease and what linked, without evidence, the death of a German girl to the wearing of masks.

Why do we investigate?

In its fourth phase, Comprova checks suspicious content that has gone viral about the pandemic, public policies of the federal government and elections. The content verified here had more than 4,700 likes and was shared 1,500 times until December 8th.

Disinformation pieces like this, involving vaccines, put the population at risk by trying to discredit them. Without the correct application of doses, citizens are more vulnerable to Covid and are more likely to develop the most severe symptoms of the disease.

Similar content was verified by the North American website Lead Stories. Since last year, Comprova has been checking content on immunization, such as the doctor who distorted a study to attack vaccines and was denied by the author, and the doctor who spread an unfounded thesis that vaccinated people are dangerous and should be isolated.

Misleading, for Comprova, is content taken from the original context and used in another so that its meaning changes; that it uses inaccurate data or that it induces an interpretation different from its author’s intention; or even one who confuses, with or without the deliberate intention of causing harm.

Comprova performed this verification based on information available on December 13th of 2021.