Vaccine Safety Update – The Daily Sceptic

This is the 30th of the round-ups of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate (find the 29th one here). By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from getting inoculated. It should be read in conjunction with the Daily Sceptic‘s other posts on vaccines, which include both encouraging and not so encouraging developments. At the Daily Sceptic we report all the news about the vaccines whether positive or negative and give no one advice about whether they should or should not take them. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as reporting the facts, not advocating for or against a particular policy. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This was done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. (Dr. Tess Lawrie in June wrote an open letter to Dr. June Raine, head of the MHRA, arguing that: “The MHRA now has more than enough evidence on the Yellow Card system to declare the COVID-19 vaccines unsafe for use in humans,” a claim that has been ‘fact checked’ here.) Boris Johnson said in October that being double vaccinated “doesn’t protect you against catching the disease, and it doesn’t protect you against passing it on”. We publish information and opinion to inform public debate and help readers reach their own conclusions about what is best for them, based on the available data.

The first batch of documents from the Pfizer vaccine trial released by the U.S. FDA on March 1st includes a nine-page list of 1,291 different types of adverse event reported post-authorisation.
An additional Pfizer trial document released separately shows immunosuppression in the first seven days following vaccination and evidence supporting natural immunity.
A study suggests the Pfizer vaccine can damage brain cells and the immune system.
U.S. army doctor Pete Chambers gave an informed consent briefing to 3,000 soldiers, setting out in full the risks and benefits of the vaccine, following which 99.8% declined to get vaccinated. Dr. Chambers was subsequently dismissed.
Data from Rambam hospital in Haifa, Israel reveal a stillbirth, miscarriage and abortion (SBMA) rate of 6% among women who never received a COVID-19 vaccine, compared to 8% among women who were.
Case report in journal Brain Hemorrhages of intracerebral bleeding following vaccination.
A study shows that more than two-thirds of adolescents with COVID-19 vaccine-related myopericarditis had persistent heart abnormalities months after their initial diagnosis.
The Miami Open tennis tournament saw 15 withdrawals or retirements. While all players were required to be vaccinated to enter the U.S., it’s not clear how many of the withdrawals were vaccine related.
Eudravigilance – the European version of the Yellow Card Reporting system – as of April 3rd has reported 4,039,333 reactions from 1,670,823 reports of which 1,862,987 were deemed as serious. 42,782 fatal reactions were reported with an approximate actual number of deaths being 14,438. This is due to a 2.96 reporting rate in fatalities across multiple reactions. Of these reports, 30,764 injuries have been recorded in the 0-17 years age group.
VAERS – the American version of the Yellow Card reporting system – as of March 25th reports a total of 1,205,755 reports of adverse events following Covid vaccines, including 26,396 deaths and 214,521 serious injuries.
DAEN Australia – the equivalent of the Yellow Card reporting system – has logged (up to March 22nd) 118,035 reports of adverse events, including 809 deaths.
Children (Under 18) Adverse Events U.K. – up to March 23rd, the MHRA reports a total of 3,674 adverse event reports, comprising 3,366 Pfizer, 262 AstraZeneca, 24 Moderna and 22 unspecified from 3,314,700 children vaccinated. This includes 70 reported cases with Pfizer of myocarditis/pericarditis, suggesting a current reported risk of 14 cases per million first doses and 12 per million second doses for this age group.
Booster Doses – 47,418 adverse events have been reported across all vaccines up to March 23rd from 38,701,747 people vaccinated, suggesting a reporting rate of one adverse event per 816 doses.

Summary of Adverse Events in the U.K.

According to an updated report, as of March 23rd the MHRA Yellow Card reporting system has recorded a total of 1,475,298 events based on 450,567 reports. The total number of fatalities reported is 2,075.

Pfizer (26.2 million first doses, 23.7 million second doses, 29.6 million third doses) now has one Yellow Card in 156 people vaccinated. Deaths: one in 35,501 people vaccinated (738).
AstraZeneca (24.9 million first doses, 24.2 million second doses, 55,500 third doses) has one Yellow Card in 102 people vaccinated. Deaths: one in 19,904 people vaccinated (1,251).
Moderna (1.6 million first doses, 1.5 million second doses, 9.0 million third doses) has one Yellow Card in 44 people vaccinated. Deaths: one in 37,209 people vaccinated (43).

Overall, one in every 117 people vaccinated (0.85%) have experienced a Yellow Card adverse event. The MHRA has previously estimated that the Yellow Card reporting rate may be approximately 10% of actual figures. Note that sometimes in Yellow Card reporting, the numbers of adverse events (including fatalities) will be lower than the previous week. The Yellow Card system is a passive reporting system, so in theory this should not happen as all reports should be cumulative. However, the MHRA says it analyses the data prior to publication, with deaths and pregnancy conditions being notably investigated. It does not state criteria by which reports would be removed and to date has not clarified why these data vary. It is therefore unclear how many reported adverse events have been removed from the reports since reporting began in February 2021.