Severe Allergic Reactions Reported After Pfizer/BioNTech COVID-19 Vaccinations

Severe Allergic Reactions Reported After Pfizer/BioNTech COVID-19 Vaccinations

Last week the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a strong warning to those who have a history of significant allergic reactions to medicines, foods or vaccines or who carry an epi-pen that they may be at increased individual risk for suffering a serious allergic reaction after receiving the Pfizer/BioNTech COVID-19 vaccine.1 2 The warning came after two British National Health Service health professionals with a history of severe allergic reactions requiring them to carry an epi-pen experienced a serious allergic reaction to the new coronavirus vaccine released on Dec. 9, 2020 for public use in the U.K.

U.K. Health officials stated:

Any person with a history of a significant allergic reaction to a vaccine, medicine or food (such as previous history of anaphylactoid reaction or those who have been advised to carry an adrenaline autoinjector) should not receive the Pfizer/BioNtech vaccine.3

The U.K. is the first country to approve use of the experimental mRNA COVID-19 vaccine under Emergency Use Authorization (EUA). Several thousand people were vaccinated in one day, and the new vaccine will be administered first at 50 hospitals with frontline health professionals, as well as to home health care workers and to individuals over 80 years of age in the U.K.4 5

Not Known Which Ingredients in Pfizer-BioNTech COVID-19 Vaccine Caused Allergic Reactions

 A list of ingredients in the Pfizer/BioNTech COVID-19 vaccine was released by the U.S. Food and Drug Administration (FDA) on Dec. 11 in a letter to Pfizer authorizing emergency use of the COVID-19 vaccine in the U.S. for individuals 16 years of age or older.6 The FDA issued the EUA 24 hours after a nine hour meeting of the Vaccines and Related Biological Products Advisory Committee Advisory Committee (VRBPAC) when the committee voted 17 to 4 with 1 abstention that the vaccine’s that “based on the totality of scientific evidence available, the benefits of the Pfizer/BioNTech COVID-19 vaccine outweigh its risks for individuals 16 years of age and older.”7

Listed ingredients of the Pfizer/BioNTech COVID-19 vaccine include:

  • 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2
  • lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)
  • .05 mg 2[polyethylene glycol)-2000]-N,N-ditetradecylacetamide
  • .09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol)
  • .01 potassium chloride
  • .01 mg monobasic potassium phosphate
  • .36 mg sodium chloride
  • .07 mg dibasic sodium phosphate dehydrate
  • 6 mg sucrose
  • the diluent (.09 percent Sodium Chloride Injection) contributes an additional 2.16 mg sodium chloride per dose

However, it is not known which ingredients in the vaccine caused allergic reactions in the two U.K. health care workers or which unique genetic, epigenetic, environmental or other biological host factors potentially increases individual susceptibility8 for an allergic response in vaccine recipients. The vaccine does not contain common triggers found in other vaccines such as eggs, gelatin and preservatives.

In the Pfizer/BioNTech COVID-19 vaccine trials conducted in the United States, there were more allergic reactions reported in the vaccine group than in the placebo control group.9 While allergic reactions occurred in less than one percent of those receiving the COVID vaccine, it is important to note that individuals with a “history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)” were excluded from Pfizer’s clinical trials.10 11

FDA EUA Fact Sheet for Pfizer/BioNTech COVID-19 Vaccine Does Not List History of Severe Allergic Reactions to Drugs, Foods or Other Vaccines as Contraindication

According to a Dec. 9 USA Today article, Moncef Slaoui, MD, co-head of Operation Warp Speed (OWS) said that he assumed that the U.S. Food and Drug Administration (FDA) would advise those with severe allergies that they, “should not take the vaccine until we know exactly what happened.”12

However, on Dec. 11 when the FDA issued its EUA giving Pfizer the go-ahead to distribute its COVID-19 vaccine in the U.S. for persons aged 16 and older, the FDA Fact Sheet for Vaccine Recipients and Caregivers included only one contraindication (reason to not get the vaccine) that was confined to an allergic reaction to a previous dose of Pfizer’s COVID-19 vaccine or an ingredient in the vaccine: “You should not get the Pfizer/BioNTech COVID-19 vaccine if you had a severe allergic reaction after a previous dose of this vaccine [or] had a severe allergic reaction to any ingredients of this vaccine.”13

The only other mention in the FDA Fact Sheet about allergic reactions was a recommendation to “tell the vaccination provider about all your medical conditions, including if you have any allergies” and this warning:14

There is a remote chance that the Pfizer/BioNTech COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Pfizer/BioNTech COVID-19 Vaccine. Signs of a severe allergic reaction can include: • Difficulty breathing • Swelling of your face and throat • A fast heartbeat • A bad rash all over your body • Dizziness and weakness. These may not be all the possible side effects of the Pfizer/BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer/BioNTech COVID-19 Vaccine is still being studied in clinical trials.

Pfizer and Moderna mRNA COVID-19 Vaccines Have “Significantly Noticeable” Side Effects Greater Than for Most Flu Vaccines

About 10-15 percent of volunteers in clinical trials of both of the Pfizer/BioNTech and Moderna experimental mRNA COVID-19 vaccines experienced “significantly noticeable” side effects. Arnold Monto, MD professor of epidemiology at the University of Michigan School of Public Health concluded about the COVID vaccine trials, “This is higher reactogenicity than is ordinarily seen with most flu vaccines, even the high-dose ones.”15

In anticipation of numerous adverse events following a mass COVID vaccination campaign, U.K. health officials at the MHRA recently spent £1.5 million on a software tool “to process the expected high volume of COVID-19 adverse drug reactions [ADRs] and ensure that no details from the ADRs’ reaction text are missed”.16

The MHRA has issued the warning that individuals with a history of allergic reactions should not receive the COVID vaccine while further investigation of the two reported cases of allergic reaction takes place.17

FDA Says All Covid Vaccine “Side Effects” Should Be Reported to VAERS

Under EUA authorization, COVID-19 vaccines remain experimental vaccines until formally licensed. The FDA’s EUA Fact Sheet states, “The Pfizer/BioNTech COVID-19 vaccine is an unapproved vaccine,” and directs directs vaccine recipients to call 9-1-1 or go to the nearest hospital “if you experience an allergic reaction” and to “call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.”18

FDA also emphasizes in the Fact Sheet that vaccine side effects should be reported to the FDA/CDC’s Vaccine Adverse Event Reporting System (VAERS), a open-access vaccine safety monitoring system that was created by Congress under the 1986 National Childhood Vaccine Injury Act.

Report vaccine side effects to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html and include ‘Pfizer/BioNTech COVID-19 Vaccine EUA’ in the first line of box #18 of the report form.19

Vaccine providers are supposed to report adverse events that occur after vaccinations to VAERS but vaccinated persons who experienced the reaction or a family member also can file a report if a health care provider does not do it. According to one government funded study in 2011, fewer than one percent of all vaccine reactions are reported to VAERS.20


Click here to view References:

1 Triggle N, Scraer R. Covid-19 vaccine: Allergy warning over new jab. BBC News Dec. 9, 2020.
2 Reynolds E, Braithwaite S, Cassidy A. Allergy warning for Pfizer/BioNTech vaccine after UK health workers with allergy history suffer reaction. CNN Dec. 9, 2020.
3 Ellyatt H. People With a History of ‘Significant’ Allergic Reactions Shouldn’t Have Pfizer Vaccine, UK Regulator Warns. CNBC Dec. 9, 2020.
4 See Footnote 1.
5 Ellyat H. UK begins rollout of Pfizer’s coronavirus vaccine: Here’s what you need to know. CNBC Dec. 8, 2020.
6 FDA. Approval letter to Pfizer, Inc. authorizing emergency use of Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age or older. Dec. 11, 2020.
7 FDA. Question for VRBPAC Vote. Dec. 10, 2020.
8 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Evaluation of Biologic Mechanisms of Adverse Effects: Increased Susceptibility. Chapter 3 (p. 82). Washington, DC The National Academies Press 2012.
9 FDA. FDA Briefing Document: Pfizer-BioNTech COVID-19 Vaccine. VRBPAC Committee Meeting Dec. 10, 2020.
10 Pfizer. Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Adults. Exclusion Criteria. Sept. 28, 2020.
11 Weintraub K. ‘Very inconsistent’: 2 allergic reactions in the UK to COVID-19 vaccine puzzle researchers. USA Today Dec. 9, 2020.
12 Ibid.
13 FDA. Fact Sheet for Recipients and Caregivers. Emergency Use Authorization (EUA) of the Phizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) in Individuals 16 Years of Age and Older.
14 Ibid.
15 Cáceres M. Pfizer, Moderna COVID-19 Vaccines Produce ‘Significantly Noticeable’ Side Effects. The Vaccine Reaction Dec. 6, 2020.
16 NHS told not to give Covid vaccine to those with history of allergic reactions. The Guardian Dec. 9, 2020.
17 Ibid.
18 See Footnote 13.
19 Ibid.
20 Harvard Pilgrim Health Care, Inc. Electronic System for Public Health Vaccine Adverse Event Reporting System. AHRQ 2011.

19 Responses to "Severe Allergic Reactions Reported After Pfizer/BioNTech COVID-19 Vaccinations"

  1. Maverick   December 14, 2020 at 4:43 pm

    So yeah just the top 3 ingredients……a RNA modifier to mess around with your DNA, Antifreeze i mean after all they need to keep it stable a -94 and hexane which is petroleum stuff which messes up your brain your CNS destroys your heart causes paralysis etc. Yeah i would say this is attempted murder.

    Anyone who sees this and thinks this is a good idea needs their heads tested. The problem is 90% of the population do not research and even if they did they would be like ‘oh but it is only a little amount it wont be an issue.’ Guess what cyanide would be a very small dose especially if it is injected….wonder how many people would line up for that if it was labelled a ‘vaccine’. This is not a vaccine though this is gene therapy and you add to that stuff like antifreeze and carcinogens and mutational crap you just know you are gonna have severe problems. Watch this space ‘cancer is now 1 in 1 and we are desperately seeking a cure and we need your help, please donate whatever you can for our lifesaving work.’

    Reply
  2. Redpill   December 15, 2020 at 2:47 pm

    Pfizer just released a Peer Review study on the NEJM:
    Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
    https://www.nejm.org/doi/full/10.1056/NEJMoa2034577?query=featured_home

    Anyone know who paid for the study?
    Does it have all the data that other scientist have been asking for?

    Reply
    • J   December 17, 2020 at 2:03 pm

      (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728. opens in new tab.)

      Reply
  3. Tom   December 16, 2020 at 1:05 pm

    So they even put sugar in the darn thing (sucrose)? How about the aluminum which is an ingredients nearly always used in vaccines? I do not for one second believe this list is complete. You need degrees in chemistry and biology, at least, to understand the make up and what it might do to you.

    Reply
  4. CATRYNA WHITE   December 16, 2020 at 1:15 pm

    I don’t know why they didn’t suspect there would be significant problems with these mRNA vaccines. There have been severe reactions and death in animal testing for decades, so why would humans be any different? The listing of ingredients is always subject to question, but it is the vaccine ingredients that pharmaceutical companies do not have to list that would be more disconcerting. Also, the Pfizer COVID vaccine has used two aborted cell lines in its production (HEK293) and PER.C6), along with horseshow crab blood.

    https://www.thepublicdiscourse.com/2020/11/72753/

    Reply
  5. Jay   December 16, 2020 at 2:16 pm

    BioNtech sponsored the ph1,2,3 trial short report that was released recent! Hmmm conflict anyone? Where are the 6 deaths that occured so far with Phizer? No mention in this article. 2 in vaccine group, 4 in placebo! This begs the question, is this a saline placebo? Astrozenica had a death or 2 I believe also and many serious events (Hospitalization) in their trials that shut down after. Thank you for publishing the ingredients! My question also is, who will ensure more serious adverse events and deaths are tracked and reported to the ignorant fauci-ist public? My family knew nothing of these deaths until I I formed them..

    Reply
  6. Augusta   December 16, 2020 at 2:22 pm

    For Redpill… below is pasted within the body of the article you sited above:

    CONCLUSIONS
    A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728. opens in new tab.)

    Reply
    • Redpill   December 17, 2020 at 11:53 pm

      Safety over a median of 2 months was similar to that of other viral vaccines.

      We know from the Flu Vaccines thousands of people have experienced adverse reactions. It’s convenient that they did not say what viral vaccine.

      Reply
  7. Adolf   December 16, 2020 at 2:36 pm

    We should inject Dr. Faucci and Bill Gates: They are very precious to keep around.

    Reply
  8. Colorado   December 16, 2020 at 2:38 pm

    This is good news. My wife works at the hospital and has had a previous severe allergic reaction to other pharmaceutical medicines, specifically flowmax which is used to dilate urinary tracts and kidney vessels to deal with kidney stones. This will be our primary reason for a legitimate opt out from this vaccine, for my wife at least. I’ll just claim we have all had similar allergic reactions to food and various medicines, but simply took benadryl at home and never presented to the doctors for official diagnosis and record keeping. Everyone in the world whom does not want this vaccine should immediately claim something similar. No means no. We are not lab experiments.

    Reply
  9. Adolf   December 16, 2020 at 2:55 pm

    Folks, I think it is important that you be aware of the two following acronyms:

    – COVID-19 : Certificate Of Vaccination IDentification – 19 (19 refers to the year 2019 but also to the extent of time that went between 2001 9/11 events and the Plandemic in 2020).

    – MODERNA : Modification Of Endogenous RNA – It has nothing to do with being “Modern”. Endogenous refers to the capability to destroy from inside.

    Reply
  10. Cathy   December 16, 2020 at 6:13 pm

    I agree with Colorado. When you consider this is literally phase 4 of the trials and they’re experimenting with unsuspecting people’s lives. Pfizer didn’t mention publicly the occurrence of Bell’s Palsy, the numerically greater number of appendicitis cases occurring in the vaccine group and they admit “Available data do not indicate a risk of vaccine-enhanced disease, and conversely suggest effectiveness against severe disease within the available follow-up period. However, risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in ongoing clinical trials and in observational studies that could be conducted following authorization and/or licensure.” All mentioned in the FDA reporting document https://www.fda.gov/media/144245. It’s all a big gamble and Pfizer et.al are protected from liability.

    Reply
  11. jean   December 17, 2020 at 12:48 am

    I do not understand how science can develop any reliable vaccine as fast as this one, but have been looking decades for a cure for Cancer…ahh not to mention the common cold? Is it really all about the money?

    Reply
  12. Mort   December 17, 2020 at 5:45 pm

    This article is referring to life-threatening anaphylactic reactions. Claiming you had one and stayed home and took Benadryl (diphenhydramine) will not be believed. Anaphylactic shock has to be treated with epinephrine injected IM (like an Epipen). Otherwise, your breathing will be impeded and you will die most likely.

    More serious reactions will come, as with any new vaccination series given to so many people. Unfortunately, neurological adverse reactions such as Guillain-Barre syndrome and Bell’s palsy can occur when you get a vaccine.

    Reply
  13. Brian James   December 17, 2020 at 6:59 pm

    Dec. 17, 2020 2 Alaska Health Workers Got Emergency Treatment After Receiving Pfizer’s Vaccine

    One of the workers, who did not have a history of allergies, remained in the hospital on Wednesday night. Some reactions to the vaccine were also reported last week in Britain.

    https://www.nytimes.com/2020/12/16/health/covid-pfizer-vaccine-allergic-reaction.html

    Reply
  14. Markb   December 19, 2020 at 12:48 am

    I believe the “placebo” for the control group for the Pfizer vaccine was a meningitis vaccine – that could mask some of the side-effects in the Pfizer test, as this placebo may have had some of its own.

    Reply
  15. Cecile Gunset   December 19, 2020 at 10:23 pm

    InfoWars.com & Banned.video — (Alex Jones) had on Dr. Francis Boyle, who has not only three degrees from Harvard University (including medical degree & law degree), plus he is an expert on Biological Warfare, and he prosecuted several war criminals as well— Dr. Boyle has stated that anyone can ( and SHOULD) say to the “authorized” vaccine-pushers: “These vaccines violate the Nurembourg Code on Medical Experimentation, and would violate basic international law. (I/We) have a human right under this law, not to take these ‘frankenshots’ – and I refuse to take them!”

    Reply
  16. miller   January 12, 2021 at 8:12 am

    Jean, 100%. Over 40 years and millions of dollars on HIV & CANCER research. Only Pills and Chemo poison; side effects that last and last. NO sure for the common cure. The pharmaceuticals and their “investors” expect the brain washed society to trust a man made virus, to inject the poison of vaccine. The billionaires really want control and for poor peasants to suffer and die.

    Reply

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