A study published in the peer-reviewed journal Acta Médica Portuguesa has found the rate of anaphylactic shock in response to the COVID vaccines is 400% higher compared to the normal rate for vaccines. And in the case of the UK's Oxford/Astra-Zeneca COVID vaccine, the rate is at least 1,000% higher than the normal level.
According to the study, the FDA's data released since January 18, 2021 shows an allergic reaction rate of 4.7 anaphylactic shock reactions per million vaccinations for the Pfizer vaccine and 2.5 anaphylactic shock reactions per million for the Moderna vaccine. This is significantly higher than the average safety threshold of less than one reaction per million vaccinations.
This is important because, according to the study on page 544, this reaction could be life-threatening because some who experience anaphylactic shock could stop breathing if their airways close and the proper medical procedures are not administered in time to open up the airways.
Anaphylaxis, as a life-threatening reaction, is worthy of particular emphasis. According to the Safety Surveillance Manual and the Causality Assessment of AEFI Manual, anaphylaxis is considered an adverse event of special interest (an event which requires rapid medical intervention, monitoring and mandatory reporting to the regulatory agency). Data from the COVID-19 vaccines approved in the European Union to this date indicate that vaccine safety was overall similar to that of other viral vaccines. Anaphylaxis has not been reported in the trials and has not been reported either in trials of vaccines under review or in advanced stages of development.16-19 However, it is not surprising given the exclusion of individuals with a history of severe adverse reactions associated with the vaccines or any component of their vaccines.
After the start of the vaccination program rollout, several reports suggested a risk of allergic reactions greater than that of the conventional vaccines. Anaphylaxis occurs at a rate of less than one per million doses for most vaccines and for the mentioned COVID-19 vaccines it is estimated at two to 8.5 times higher. Based on information since January 18th 2021, the U.S. Food and Drug Administration (US-FDA) reported anaphylaxis/anaphylactoid reactions at a rate of 4.7 cases/million doses administered of the Pfizer-BioNTech® and a rate of 2.5 cases/million doses administered of the Moderna® vaccine. On the 30th January 2021, the U.K. Medicines and Healthcare Products Regulatory agency reported a rate between 10 to 20 cases/million doses administered of the Oxford University/Astra-Zeneca® vaccine.40 Despite the higher rates, anaphylaxis following vaccination was a rare event. For all vaccines, no anaphylaxis-related deaths were reported.
The study does state that no anaphylactic deaths were reported for those who took the vaccine and had this severe allergic reaction. However, for those who know others with a peanut allergy, anaphylactic shock is no walk in the park, and it is, indeed, life threatening in certain cases.
The study lists a wide range of anaphylactic reactions to the vaccine. However, for 57% of patients who had a severe anaphylactic reaction, the result was swelling of the airways or tongue, which could be dangerous. Additionally, 10% of all anaphylactic cases required the use of an Epipen to alleviate the allergic reaction.
To put these numbers into perspective, unless you are one of the people who have allergic reactions to vaccines, your odds of getting an anaphylactic reaction are around 0.002%. However, the amount of anaphylactic reactions to the vaccine is still much higher than normal. The study states on page 545 that "most patients with confirmed anaphylaxis to mRNA vaccines had a prior allergy history and a third had a prior history of anaphylaxis. Despite the higher rates, it is still a rare event among patients with an allergy history."
According to data out of PHE, the vaccine is effective at protecting against COVID-19 for those who are aged 50 and older. However, a study out of Poland has found the adverse reaction rate for the COVID vaccines is much higher than reported, including severe reactions such as seizures.
Additionally, the Polish study states that more than 1 in 10 people reportedly contracted COVID-19 after vaccination.
The Polish study states:
For the largest number, 78% (1253), of respondents who received the first dose of the vaccine, the most common side effect was soreness at the injection site. Limb pain was reported to a lesser extent with 46.6% (746). In contrast, less than 50% of respondents after the first dose of the COVID-19 vaccine experienced fatigue 30% (490), injection site swelling 24.5% (392), malaise 21.3% (342), injection site redness (295), headache (268), muscle and joint pain (240), elevated body temperature up to 38 °C (220) and chills (186). Other possible side effects after the first dose include injection site pruritus (89), lymph node pain and enlargement (68), fever above 38 °C (60), seizures (26), insomnia (69), nausea (64), vomiting (13), allergic reactions (11), migraine (43), diarrhea (22), cough (16), fainting (10) and hair loss (13).
After the second dose of the COVID-19 vaccine, the majority of respondents also experienced soreness at the injection site—64.7% (1008), in a smaller group, fatigue—45.7% (712), malaise (671), pain in the limb (604), muscle and joints (515), chills (483), headache (481), body temperature elevated up to 38 °C (446), injection site swelling (317), injection site redness (259), fever above 38 °C (223), lymph node soreness and enlargement (147), insomnia (109), nausea (106), injection site pruritus (76), migraine (54), seizures (50), cough (30), diarrhea (27), fainting (20), vomiting (18), hair loss (15) and allergic reaction (9), but 187 people had no adverse effects. In the next question, the respondents rated the severity of the side effects after receiving the first and second doses of the COVID-19 vaccine. They found that almost 60% of people (906) had more vaccine symptoms after taking the second dose, and 23% (350) had weaker symptoms after taking the second dose. However, no differences were found in 17.4% (265) of respondents.
Side effects after the second dose of the COVID-19 vaccine were mainly fatigue—31.8% (452), malaise (442), muscle and joint pain (345), chills (330), and body temperature increased to 38 °C (323), headache (307), injection site soreness (268), pain in a limb (240), fever above 38 °C (186), lymph node soreness and enlargement (87), injection site swelling (73), nausea (71), insomnia (61), injection site redness (51), seizures (45), migraine (43), injection site pruritus (24), cough (18), diarrhea (17), vomiting (15), fainting (13) and allergic reactions (5).
The range of side effects after vaccination is wide and affects 80% of vaccinated people. According to the results of the questionnaire, only 4.6% (73) of vaccinated people reported an adverse reaction after receiving the COVID-19 vaccine to the Sanitary Inspection. However, 1503 people, i.e., as much as 95.4%, did not report any side effects after taking the vaccine. This question was answered in the survey by 1576 people, while the number of completed questionnaires was 1657, which indicates that 81 respondents did not answer this question.
There has been more and more information coming out that this experimental form of vaccination for COVID-19 is not as safe as originally reported. However, it appears the statistics show it is effective at preventing death from COVID-19 in the elderly. But some questions about long-term immune system function as a result of the vaccine remain. If you choose to get the vaccine, talk it over with your doctor to make sure it is safe for you.
The Washington Gazette does not recommend making any personal health decisions without talking with your primary care physician about your specific circumstances and whether the vaccine is right for you. This information is not intended to diagnose, treat, cure, or prevent any disease.
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