37. Covid 19 G.p vaccination consent form


Due to the new introduction of the Covid Vaccinations, we feel it is imperative that all patients understand the risks involved and receive the full information in which they are entitled to before receiving the vaccine.  All doctor's have a code of practice in which they have to work by and this includes giving full information to all those patients who intend on receiving the vaccine.

We have included a Vaccination consent form for those wishing to avail themselves of the vaccine.  This allows you to ask your doctor these questions and receive the full correct information prior to accepting the vaccine.  If after your doctor has confirmed this information then with full informed details on the risks and alternative treatment that is available to you, you can make an informed choice which is your human right to consent or remove consent.

**Remember to include your details in the relevant (Bracket) areas to personalise it**  *Please note this letter is available in a choice of downloadable formats to include Microsoft Doc, PDF or ODT below the letter.


Available in copy and paste:


                  UK MFA COVID-19 Vaccine Consent Form www.ukmedfreedom.org 1


COVID-19 VACCINATION CONSENT FORM 

Purpose: 

This form has been designed to support the Informed Consent process for Covid-19 vaccinations. 

FOR THE LEGAL ADMINISTRATION OF ANY CV19 VACCINE, BOTH PARTIES MUST READ AND SIGN THIS DOCUMENT

 Audience:

 • Doctors (or their delegated Health Care Professionals)

 • Patients receiving Covid-19 Vaccine 

Background

This document is based on the Montgomery Judgement and GMC Guidelines. 

The Montgomery Judgement and Informed Consent 

https://www.themdu.com/guidance-and-advice/guides/montgomery-and-informed-consent

 This Supreme Court judgement of Montgomery v Lanarkshire (2015) changed the standards of consent. The key passages from Montgomery Judgement state:           “…The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended                          treatment, and of any reasonable alternative or variant treatments….”

      “The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient's position would be likely to attach                          significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.”

 Before Montgomery, a doctor's duty to warn patients of risks was based on whether they had acted in line with a responsible body of medical opinion - known as the “Bolam test”. Now, doctors must provide information about all material risks to which a reasonable person in the patient's position would attach significance. This puts the patient at the centre of consent process, as their understanding of material risk must be considered. Both patient and doctor need to sign this document.

 If doctors fail to properly discuss the risks and alternative treatments with the patient, this renders them personally responsible for damages. This document therefore protects the patient and the doctor. 

General Medical Council Guidance - Decision Making and Consent (2020)

 https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/decision-making-and-consent) 

This states that doctors MUST attempt to find out what matters to patients, so they can share information about the benefits and harms of proposed options and reasonable alternatives. Note the word MUST makes this a legally binding directive.

 GMC Guidance states doctors MUST address the following information:

      a) Recognise risks of harm that you believe anyone in the patient’s position would want to know. You’ll know these already from your professional knowledge           and experience.

      b) The effect of the patient’s individual clinical circumstances on the probability of a benefit or harm occurring. If you know the patient’s medical history, you’ll           know some of what you need to share already, but the dialogue could reveal more.

      c) Risks of harm and potential benefits that the patient would consider significant for any reason. These will be revealed during your discussion with the                     patient about what matters to them.

      d) Any risk of serious harm, however unlikely it is to occur. 

     e) Expected harms, including common side effects and what to do if they occur

References: 

 Vitamin D 

     1. https://www.researchsquare.com/article/rs21211/v1 

     2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC751 3835 

     3. https://www.grassrootshealth.net/wpcontent/uploads/2020/04/Grant-GRH-Covid-paper2020.pdf 

     4. https://www.bmj.com/content/356/bmj.i6583 

Vitamin C 

     1. http://orthomolecular.org/resources/omns/v16n25.s html

      2. https://orthomolecular.activehosted.com/index.php

      3. https://ccforum.biomedcentral.com/articles/10.1186 /s13054-020-03249-y 

     4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC759 2143/

 Iodine 

     1. https://papers.ssrn.com/sol3/papers.cfm?abstract_id =3563092

      2. https://www.medrxiv.org/content/10.1101/2020.05. 25.20110239v1 

     3. https://www.researchgate.net/publication/34076984 4_Iodine_Intake_to_Reduce_Covid19_Transmission_and_Mortality

      4. https://www.medrxiv.org/content/10.1101/2020.09. 07.20180448v1


Vaccine development & testing timeframes:

      “The discovery and research phase is normally two-to-five years, according to the Wellcome Trust. In total, a vaccine can take more than 10 years to fully develop

” https://www.weforum.org/agenda/2020/06/vaccine-development-barriers-coronavirus

Vaccines trigger post viral syndromes

     “We present epidemiological, clinical and experimental evidence that ME/CFS constitutes a major type of adverse effect of vaccines” (2019 paper)      https://www.sciencedirect.com/science/article/abs/pii/S1568997219301090 

Allergy and autoimmunity effects of vaccines: 

1. Shoenfeld Y et al - Vaccination and autoimmunity - Vaccinosis: A dangerous liaison? J Autoimun 2000;14:1-10. 

2. Nossal GJV - Vaccination and autoimmunity. JAI 2000;14:15-22.

 3. Shoenfeld Y et al - Vaccination as an additional player in the mosaic of autoimmunity. Clin Exp Rheumatol 2000;18 4.

 4. Rogerson SJ. Nye FJ - Hepatitis B vaccine associated with erythema nodosum and polyarthritis. BMJ 1990;301:345. 

5. Haschulla E et al - Reactive arthritis after hepatitis B vaccination. J Rheumatol 1990;17:1250-1251.

 6. Biasi D et al - A new case of reactive arthritis after hepatitis B vaccination. Clin Exp Rheumatol 1993;11:215. 

7. Gross K et al - Arthritis after hepatitis B vaccination. Report of three cases. Scand J Rheumatol 1995;24:50-52. 

8. Maillefert JF et al - Rheumatic disorders developed after hepatitis B vaccination. Rheumatology (Oxford) 1999;38:978-983. 

9. Grasland A et al - Adult-onset Still's disease after hepatitis A and B vaccination (article in French). Rev Med Interne 1998;19:134-136. 

10. Pope JE et al - The development of rheumatoid arthritis after recombinant hepatitis B vaccination. J Rheumatol 1998;25:1687-1693. 

11. Guiseriz J - Systemic lupus erythematosus following hepatitis B vaccine. Nephron 1996;74:441. 

12. Grezard P et al - Lupus erythematosus and buccal aphthosis after hepatitis B vaccination in a 6-yearold child. Ann Dermatol Vener 1996;123:657-659. 

13. Weibel RE et al - Chronic arthropathy and musculoskeletal symptoms associated with rubella vaccines. A review of 124 claims submitted to the National                Vaccine Injury Compensation Program. Arthritis Rheum 1996;39:1529-1534.

 14. Ray P et al - Risk of chronic arthropathy among women after rubella vaccination. Vaccine Safety Datalink Team. JAMA 1997;278:551-556.

 15. Howson CP et al - Adverse events following pertussis and rubella vaccines. Summary of a report of the Institute of Medicine. JAMA 1992;267;392-396. 

16. Howson CP et al - Chronic arthritis after rubella vaccination. Clin Infect Dis 1992;15:307-312. 

17. Mitchell LA et al - HLA-DR class II associations with rubella vaccine-induced joint manifestations. J Infect Dis 1998;177:5-12. 

18. Nussinovitch M, Harel L, Varsano I. Arthritis after mumps and measles vaccination. Arch Dis Child 1995;72:348-349. 

19. Thurairajan G et al Polyarthropathy, orbital myositis and posterior scleritis: an unusual adverse reaction to influenza vaccine. Br J Rheumatol 1997;36:120-                123. 

20. Maillefert JF et al - Arthritis following combined vaccine against diphtheria, polyomyelitis and tetanus toxoid. Clin Exp Rheumatol 2000;18:255-256.

 21. Adachi JA et al - Reactive arthritis associated with typhoid vaccination in travellers: report of two cases with negative HLA-B27. J Travel Med 2000;7:35-36. 22. Older SA et al - Can immunization precipitate connective tissue disease? Report of five cases of systemic lupus erythematosus and review of the literature.                Sem Arthritis Rheum 1999;29:131-139. 

U.K MFA COVID-19 - Vaccine Consent Form 

www.ukmedfreedom.org 3 With Respect to the new COVID-19 vaccinations the Doctor MUST inform the patient of the following and tick the box to indicate such: 

Montgomery Judgement & GMC Guidance                                   

  Facts                                                             

2015 Montgomery Judgement on Informed Consent.  The doctor is therefore under a duty of reasonable care to ensure that the patient is aware of any reasonable alternative or variant treatments.

Notes                                                                                                                                                                                                                               Discussed 

Vitamin D, 5,000iu daily has proven benefit to prevent and treat Covid-19

 Vitamin C, 5 grams daily has proven benefit to prevent and treat Covid-19 

Topical antiseptics (such as iodine) are of proven benefit to reduce the loading dose, and hence disease severity, of Covid-19                   Yes/No 

GMC Guidelines to Doctors                                                          

  a. Recognised risks of harm that you believe anyone in 

the patient’s position would want to know. 

You’ll know these already from your professional 

knowledge and experience.                                                   


Facts

Limited short-term safety data: NO long-term safety data available on current CV-19 vaccines, including potential impacts on fertility.  mRNA vaccines are a completely novel technology - essentially  experimental, with the possibility of unanticipated/unpredictable long term/late onset health effects

 Risk of Antibody Dependent Enhancement causing more severe Covid-19 illness on exposure to virus post-vaccination 

Notes                                                                                                                                                                                                                                            Discussed

CV-19 vaccine development accelerated. Vaccine safety testing normally c.10 years. Current CV-19 vaccines trialled for a                                        Yes / No

few months with little/no animal testing. PHASE 3 trials won’t complete for 2 years

 https://www.bmj.com/content/370/bmj.m3096/rr https://www.bulatlat.com/2020/08/21/hazards-of-the-covid-19-vaccine/ 

CV-19 vaccines may sensitize recipients to more severe disease https://doi.org/10.1111/ijcp.13795 Potential cross-reactivity

 of vaccine-induced antibodies to virus spike protein, with the placental protein syncytin-1, could cause infertility 

https://2020news.de/en/dr-wodarg-and-dr-yeadon-request-a-stop-of-allcorona-vaccination-studies-and-call-for-co-signing-the-petition/                      Yes/No 

 Facts

There have been reports of some serious side effects including 2 cases of transverse myelitis and neurological conditions in the Astra Zeneca 

vaccine trial.

Notes                                                                                                                                                                                                                                                Discussed

 Astra Zeneca Transverse Myelitis report

 https://www.nature.com/articles/d41586-020-02594-w

 https://www.nytimes.com/2020/09/19/health/astrazeneca-vaccinesafety-blueprints.html?auth=login-email&login=email                                            Yes/No 

 Facts

  The CDC identified 6 case reports of anaphylaxis following Pfizer-BioNtech vaccine meeting Brighton Collaboration criteria for 

anaphylaxis CDC updated advice on equipment necessary at all vaccination sites to deal with anaphylaxis

Notes                                                                                                                                                                                                                                              Discussed

 Anaphylaxis reports:

 https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020- 12/slides-12-19/05-COVID-CLARK.pdf 

Preparations to manage anaphylaxis vaccine recipients:

 https://www.cdc.gov/vaccines/covid-19/info-byproduct/pfizer/anaphylaxis-management.html                                                                                         Yes/No


Guidelines to Doctors 

b. The effect of the patient’s individual clinical circumstances on the probability of a benefit or harm occurring. 

If you know the patient’s medical history, you’ll know some of what you need to share already, but the dialogue 

could reveal more.  

 Facts

 It is known that vaccines can switch on allergy and autoimmunity.   May be contraindicated with pre-existing autoimmune

 conditions or CFS/ME, or previous vaccine injury/reactions. MHRA 09 December 2020: Any person with a history of anaphylaxis

 to a vaccine, medicine or food should not receive the Pfizer/BioNTech vaccine. 

 A second dose should not be given to anyone who has experienced anaphylaxis following administration of the first dose of this vaccine

Notes                                                                                                                                                                                                                                           Discussed

Any patient with a history or strong family history of allergies or autoimmune conditions may choose to refuse a CV-19 vaccine.

 Doctors working with CFS/ME patients already advise them to avoid vaccination as this may trigger a relapse. https://www.gov.uk/government/news/confirmation-of-guidance-tovaccination-centres-on-managing-allergic-reactions

-following-covid-19- vaccination-with-the-pfizer-biontech-vacciine                                                                                                                                          Yes/No

Guidelines to Doctors 

. c. Risks of harm and potential benefits that the patient would consider significant for any reason. 

These will be revealed during your discussion with the patient about what matters to them.

Facts

 Patient’s individual risk from Covid-19 MUST be discussed – IFR <0.05% for <70 years to weigh up against risk from vaccine. 

Patient expectation of vaccine benefit i.e. reducing risk of severe illness, hospitalisation and preventing infection with and transmission

 of SARS-Cov-2 Patients MUST be made aware of the full list of vaccine ingredients 

Notes                                                                                                                                                                                                                                     Discussed

Covid-19 IFR estimate by age (Table 2): https://spiral.imperial.ac.uk:8443/bitstream/10044/1/83545/8/2020-10- 29-COVID19-Report-34.pdf

 Make patient aware that current trials are not designed to show if CV-19 vaccine will reduce their risk of hospitalisation or death or 

will prevent infection and transmission of virus as may affect risk v benefit profile 

https://www.bmj.com/content/371/bmj.m.com/content/371/bmj.m4037

 Ethical/religious considerations e.g. animal products - vegetarianism/veganism WI-38 human diploid cells (aborted fetus source)

 - pro-life/religious belief4037                                                                                                                                                                                                   Yes/No 


Guidelines to Doctors

d. Any risk of serious harm, however unlikely it is to occur. 

Facts

The Doctor MUST consider the significance that the Patient may place on risk of material harm Patient MUST be made aware

 that the vaccine manufacturers have demanded and been granted immunity from liability for injury or death caused by the vaccines

Notes                                                                                                                                                                                                                                 Discussed

 One example may be if a patient has first-hand knowledge of a relative who has suffered serious harm following vaccination. https://www.gov.uk/government/consultations/distributing-vaccinesand-treatments-for-covid-19-and-flu/outcome/government-

responseconsultation-on-changes-to-the-human-medicines-regulations-tosupport-the-rollout-of-covid-19-vaccines#extending-

immunity-from-civi lliability                                                                                                                                                                                                    Yes/No 

Guidelines to Doctors

e. Expected harms, including common side effects and what to do if they occur. 

Facts

Full list of adverse reactions in insert to be shared. Common side-effects include:

 chills, fever, myalgia, fatigue, arthralgia, headache, and pain at the injection site.

Notes                                                                                                                                                                                                                            Discussed 

Moderna vaccine -100% of high-dose participants report systemic side effects after second dose, some severe https://www.nejm.org/doi/full/10.1056/NEJMoa2022483                                                                                                                                        Yes/No 

Facts

A reaction to the first dose increases risk of a major reaction to a second dose

Notes                                                                                                                                                                                                                                 Discussed

 Before a second dose, the patient must be asked about their reaction to the first dose.                                                                                      Yes/No 


 5 To be signed by both parties and a copy held by both parties for at least 7 years. 

Doctor confirmation:

 I confirm that I have discussed the above issues at length with the patient below, in accordance with the 2015 Montgomery Judgement and GMC Guidelines. 

I understand that failure to correctly and fully inform my patient renders me personally and legally responsible for any damages 

Date                                                                                 time 

Name of doctor or nurse administering:

Professional number of doctor (GMC) or nurse (GNC):

Name of vaccine, batch number and date of administration 

Signature


Patient consent:

 I confirm that I have discussed the above issues at length with the doctor or health professional above. The Doctor/Health professional accepts total and all responsibility for all personal injury, illness, conditions, side effects and including death sustained as a result of receiving the Covid-19 vaccine.

Date,                                                                                 time 

Name of patient:

Name of parent or guardian if consenting on behalf of a child:

Contact phone number or email:

Signature:


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