Picking out the parts that are of interest in the product monograph from the Canadian drug database.
Note: Every citizen should think for themselves. That’s one of the main concerns, right, whether or not you get to do that! I am quoting statements from the official product monograph. I don’t automatically accept these statements as facts. I am concerned about avoiding the potential dangers of this brand new technology, promoted by Gates since the spring, considering the track record of the Gates Foundation in India and Africa with experimental vaccines and the extensive agenda Gates presents in his 2009 Ted Talk on the subject of population.
Also note that this product apparently has no human fetal cell tissue from what I can tell. That is an ingredient in some of the other COVID-19 vaccines being developed, and also in some existing vaccines.
PFIZER-BIONTECH COVID-19 VACCINE
COVID-19 mRNA Vaccine, Suspension for Intramuscular Injection
Notice it is an mRNA vaccine. It is a special genetic technology.
HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS COVID-19 Vaccine UNDER AN INTERIM ORDER
PFIZER-BIONTECH COVID-19 VACCINE is indicated for:
Active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
The use of PFIZER-BIONTECH COVID-19 VACCINE is permitted under an interim authorization delivered in accordance with section 5 of the COVID-19 Interim order (IO)*. Patients should be advised of the nature of the authorization. The interim authorization is associated with Terms and Conditions that need to be met by the Market Authorization Holder to ascertain the continued quality, safety and efficacy of the product. For further information on authorization under this pathway, please refer to Health Canada’s IO Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
Notice the age restriction: “16 years of age and older.”
Notice that there is a special “interim authorization delivered in accordance with section 5 of the COVID-19 Interim order (IO).” All of this is the federal government.
Quoting from the linked document “Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19”:
Whereas the Minister of Health believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment;
Therefore, the Minister of Health, pursuant to subsection 30.1(1)Footnote 1 of the Food and Drugs Act Footnote 2, makes the annexed Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
Ottawa, September 16, 2020
Minister of Health
Date of Initial Authorization: December 9, 2020
I am just going to quote parts of the document. Please read the whole thing.
Pfizer-BioNTech COVID-19 Vaccine (COVID-19 mRNA Vaccine) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
The safety and efficacy of Pfizer-BioNTech COVID-19 Vaccine in children under 16 years of age have not yet been established (see ADVERSE REACTIONS and CLINICAL TRIALS sections)
Pfizer-BioNTech COVID-19 Vaccine is contraindicated in individuals who are hypersensitive to the active substance or to any ingredient in the formulation. …
4.2 Recommended Dose and Dosage Adjustment
Vaccination Schedule for Individuals 16 Years of Age and Older
Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly after dilution as a series of two doses (0.3 mL each) 21 days apart …
Preparation for Administration
*The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial contains a frozen suspension that does not contain preservative and must be thawed and diluted prior to administration.
Prior to dilution, the thawed suspension may contain white to off-white opaque amorphous particles.
After dilution, the vaccine will be an off-white suspension. Inspect vials to confirm there are no particulates and no discolouration is observed
If using a frozen vial of Pfizer-BioNTech COVID-19 Vaccine, thaw for 30 minutes at room temperature.
Vials at room temperature must be diluted within 2 hours.
Before dilution, invert gently 10 times to mix. Do not shake.
Equalize vial pressure before removing the needle from the vial by withdrawing 1.8m L air into the empty diluent syringe.
Record the date and time of dilution on the Pfizer-BioNTech COVID-19 Vaccine vial label.
Store between 2°C to 25°C (35°F to 77°F). Discard any unused vaccine 6 hours after dilution …
Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3mL of the Pfizer-BioNTech COVID-19 Vaccine.
Administer immediately, and no later than 6 hours after dilution.
ALC-0315 = (4-hydroxybutyl) azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)
ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
dibasic sodium phosphate dihydrate
monobasic potassium phosphate
water for injection
Follow-up: What are those used for?
Pfizer-BioNTech COVID-19 Vaccine is a white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection. Pfizer-BioNTech COVID-19 Vaccine contains a nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2 and the non-medicinal ingredients listed in Table 1 above.
Pfizer-BioNTech COVID-19 Vaccine is packaged in a clear glass 2 mL vial with a rubber stopper (not made with natural rubber latex), aluminum overseal, and flip-off cap. To help ensure the traceability of vaccines for patient immunization record-keeping as well as safety monitoring, health professionals should record ….
7 WARNINGS AND PRECAUTIONS
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of this vaccine.
Notice the claim “rare” even though there were two severe reactions in the UK the first week. There are tables referring to “severe” reactions among test subjects (see below).
The administration of Pfizer-BioNTech COVID-19 Vaccine should be postponed in individuals suffering from acute severe febrile illness.
Note: so, if you are sick with a fever, you’re not supposed to take it.
As with any vaccine, vaccination with Pfizer-BioNTech COVID-19 Vaccine may not protect all recipients.
Individuals may not be optimally protected until at least 7 days after their second dose of vaccine . . .
Individuals receiving anticoagulant therapy or those with a bleeding disorder that would contraindicate intramuscular injection should not be given the vaccine unless the potential benefit clearly outweighs the risk of administration.
Notice how there is some decision being made about benefits and risks. Why don’t you do that? And why doesn’t everybody do that???? How could the benefit outweigh the risk in that case? The previous statement said it may not even work for some people..
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine.
Weigh the benefits and risks
7.1 Special Populations
7.1.1 Pregnant Women
The safety and efficacy of Pfizer-BioNTech COVID-19 Vaccine in pregnant women have not yet been established.
It is unknown whether Pfizer-BioNTechCOVID-19 Vaccine is excreted in human milk. A risk to the newborns/infants cannot be excluded.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for immunization against COVID-19.
More to consider! Weigh the risks. And it would be good if people had an accurate idea of the risks of COVID-19 because all the official numbers even show that the seriousness of it has been hyped beyond imagination by government and media false impressions. “Cases” are just positive test results with mild symptoms in most cases if any. Look at the official numbers for those “hospitalized” and compare the huge numbers presented for “cases” (government website and list of related points).
The safety and efficacy of Pfizer-BioNTech COVID-19 Vaccine in children under 16 years of age have not yet been established.
So much for children, pregnant women and nursing mothers.
8 ADVERSE REACTIONS
8.1 Adverse Reaction Overview
The safety of Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 16 years of age and older in two clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. Study BNT162-01 (Study 1) enrolled 60 participants, 18 through 55 years of age. Study C4591001 (Study 2) enrolled approximately 44,000 participants, 12 years of age or older.
Maybe “12” is a typo?
In Study 2, a total of 21,720 participants 16 years of age or older received at least one dose of Pfizer-BioNTech COVID-19 Vaccine and a total of 21,728 participants 16 years of age or older received placebo
Need information about what the “placebo” actually is
At the time of the analysis of Study 2, a total of 19,067 (9,531 Pfizer-BioNTech COVID-19 Vaccine and 9,536 placebo) participants 16 years of age or older were evaluated for safety 2 months after the second dose of Pfizer-BioNTech COVID-19 Vaccine.
The safety evaluation of participants in Study 2 is still ongoing. Participants were monitored for solicited local and systemic events,and use of antipyretic medication after each vaccination. Participants continue to be monitored for unsolicited adverse events, including serious adverse events up to six months after the last vaccine dose . . .
The most frequent adverse reactions in a subset (n=8183) of participants 18 years of age and older, who received the vaccine and comprised a subset of the safety population monitored for reactogenicity with an electronic diary were:, injection site pain ( 84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%),joint pain (23.6%) and fever (14.2%) and were usually mild or moderate in intensity and resolved within a few days after vaccination
Notice the numbers:
muscle pain: 38.3%
Joint pain: 23.6%
Those numbers seem surprisingly high. Sound like there is a lot of activity going on in the body.
Were you trying to avoid symptoms like that in yourself or family members–from avoiding COVID-19?
Does that mean elderly recipients will also suffer symptoms like that? Do you expect to receive those reactions from a vaccine?
8.2 Clinical Trial Adverse Reactions
Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice . . .
My understanding is that the participants in clinical trials are healthier than average. The actual description of who was selected for the study indicates it is excluding people with certain conditions – see section 14.1 and my comments below. Are people going to follow the warnings even in this official documentation when they administer the vaccine or is everyone just going to be bullied into pushing it without any thought?
Going over the tables for Study 2:
“Frequency of Solicited Local Reactions Within 7 Days After Each Dose –Participants 18-55 Years of Age”
I’ll just focus on the numbers for Dose 2 and for the COVID-19 vaccine to keep things brief, so there are 2098 subjects reporting either yes or no repsonses, and I’ll translate the percentages into numbers of people (focusing mainly on the severe reactions):
Redness: any: 5.9%, severe: 0.5% (“>10cm”) (of 2098 = 10 people)
Swelling: any: 6.3% (132 people), severe (“>10cm”): 0.3% (of 2098 = 6 people)
Pain at the injection site: any: 77.8%, severe (“prevents daily activity”): 1.2% (of 2098 = 25 people)
Any local reaction (for second dose): 78.1% (1638 people) For placebo: 12.2%
“Frequency of Solicited Systemic Events Within 7 Days After Each Dose –Participants 18-55 Years of Age”
(just focusing on Dose 2)
Fever: ≥38.0°C: 15.8% (331 people), >38.9°C: 1.2% (25 people)
Fatigue: Any: 59.4% (1246 people), Severe (“prevents daily activity”): 4.6% (96 people)
Headache: Any: 51.7% (1085 people), Severe (“prevents daily activity”): 3.2% (67 people)
Chills: Any: 35.1% (734 people), Severe (“prevents daily activity”): 2.1% (44 people)
Vomiting: Any: 1.9% (40 people), Severe (“requires intravenous hydration”): 0.2% (4 people)
Diarrhea: Any: 10.4% (218 people), Severe (“requires intravenous hydration”): 0.2% (4 people)
New or worsened muscle pain: Any: 37.3% (782 people), Severe (“prevents dailiy activity”): 2.2% (46)
New or worsened joint pain: Any: 21.9% (459 people), Severe (“prevents daily activity”): 1% (21 people)
Any systemic event: 74.2% (1557 people), For placebo: 38.2% (801 people)
Use of antipyretic or pain medication: 45% (944 people), For placebo: 12.6%
The reactions for the “placebo” are always lower numbers, but there seem to be a significant number of people reacting to it if you look through the charts? What is it?
The next two tables are the same format, except they are for participants 56 years of age or older:
So picture these results for seniors getting the vaccine in the coming weeks. Just listing dose 2 where there are 1660 people replying yes or no:
Redness: Any: 7.2%, Severe: 0.5% (8 people)
Swelling: Any: 7.5%, Severe: 0.2% (3 people)
Pain at the injection site: Any: 66.1%, Severe: 0.5% (8 people)
Any local reaction: 66.9% (1110 people) For Placebo: 8.5%
Fever: ≥38.0°C: 10.9% (181 people), >38.9°C: 0.3% (5%)
Fatigue: Any: 50.5% (838 people), Severe: 2.8% (46 people). “Placebo”: Any: 16.8%, severe: 0.1%
Headache: Any: 39% (647 people), Severe: 0.5% (8 people)
Chills: Any: 22.7% (377 people), Severe: 1.0% (16 people). Compare dose 1: Any: 6.3%, Severe: 0%
Vomiting: Any: 0.7% (11 people), Severe: 0.1% (2 people)
Diarrhea: Any: 8.3% (138 people), Severe: 0.1% (2 people)
New or worsened muscle pain: Any: 28.7% (476 people), Severe: 1.0% (16 people). For dose 1: 13.9% & 0.1%
New or worsened joint pain: Any: 18.9% (313 people), Severe: 0.4% (6 people). For dose 1: 8.6% & 0.1%
Any systemic event: 64.5% (1070 people). For placebo: 28.2%
Use of antipyretic or pain medication: 37.7% For placebo: 9.8% (dose 1: 19.9%, placebo: 11.9%)
I notice that for both age groups there was a drop in the number of participants from dose 1 to dose 2.
Unsolicited Adverse Events
No deaths related to the vaccine were reported in the study.
Serious Adverse Events
In Study 2, in participants 16 to 55 years of age (Pfizer-BioNTech COVID-19 Vaccine = 10,841, placebo = 10,851), serious adverse events from Dose 1 through 30 days after Dose 2 were reported by 0.4% of participants and by 0.3% of participants who received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine or placebo, respectively.
0.4 % of those from 16 to 55 taking both doses, if I just count the participants who were given the COVID-19 the vaccine (10,841), not the placebo, that’s 43 people. For both groups combined, the total would be 86 people.
In Study 2, in participants 56 years of age and older (Pfizer-BioNTech COVID-19 Vaccine = 7960, placebo = 7934), serious adverse events were reported by 0.8% of participants and by 0.6% of participants who received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine or placebo, respectively.
For those 56 or over, for those who received both doses, out of the total participants (15,894), 0.8% would be 127 people.
This is referring to “unsolicited” events. It doesn’t explain what these are in this section.
Non-Serious Adverse Events
Overall in Study 2, in which 10,841 participants 16 to 55 years of age received Pfizer-BioNTech COVID-19Vaccine and 10,851 participants received placebo, non-serious adverse events from Dose 1 through 30 days after Dose 2 were reported in 29.3% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 13.2% of participants in the placebo group, for participants who received at least 1 dose. Overall in Study 2, in which 7960 participants 56 years of age and older received Pfizer-BioNTech COVID-19 Vaccine, non-serious adverse events within 30 days were reported in 23.8% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 11.7% of participants in the placebo group, for participants who received at least 1 dose.
It was reported in the study that lymphadenopathy had occurred. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy were imbalanced with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine
This paragraph is confusing to me because it considers lymphadenopathy to be “non-serious” but it seems like the sort of thing that should require treatment. Also, “other neurologic or neuro-inflammatory, and thrombotic events” are mentioned, but those don’t sound non-serious.
Notice that it’s denying there was an imbalance between the placebo and the COVID-19 vaccine for other “non-serious adverse events.” That means that the “placebo” (what is it?) could be causing just as many of them as the COVID-19 vaccine.
10 CLINICAL PHARMACOLOGY
10.1 Mechanism of Action
The nucleoside-modified messenger RNA in Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid nanoparticles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S)antigen, which may contribute to protection against COVID-19 disease.
So these nanoparticles are delivering RNA into host cells. Is that a legitimate thing to be doing inside one’s body? Does it make mistakes? Does it have consequences? Is that all it does? And it “may” “contribute” to “protection against COVID-19 disease.” So is it really worth allowing this to happen?
“These mRNA vaccinations have never been approved before, so there is no reliable track record of safety. We should expect to set the bar higher for safety,” said Jeffrey A. Hirschfield, a pediatrician in St. Petersburg, Fla., who has discussed his reservations on Twitter. “It typically takes five to 10 years to successfully develop and vet vaccine candidates, especially those relying on new technologies.”. . .
Vaccines that use mRNA, or messenger RNA, work by carrying a genetic message into the body that signals cells to produce the novel coronavirus’s distinctive spike protein, triggering an immune response that creates specific antibodies. Traditional vaccines depend on inactivated virus to accomplish that mission, or some use a viral vector such as a harmless cold virus engineered to contain the genetic instructions for the spike protein.
So it is turning your cells into little factories.
The media story uses the term “harmless cold virus” as if the cold virus doesn’t cause problems for some people.
Continuing with the COVID-19 Vaccine document:
Frozen Vials Prior to Use
Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials (after dilution each vial contains 5 doses of 0.3 mL) arrive in thermal containers with dry ice. To ensure all appropriate safeguards are in place, refer to the Dry Ice Safety Data Sheet and the Pfizer-BioNTech COVID-19 Vaccine Storage and Handling Reference Guide provided (also available at CVDvaccine.ca). Once received, remove the vial cartons immediately from the thermal container and store in the freezer between -80°C to -60°C(-112°F to -76°F). Vials must be kept frozen between -80°C to -60°C (-112°F to-76°F) and protected from light, in the original cartons, until ready to use.
If an ultra-low temperature freezer is not available, the thermal container in which the Pfizer-BioNTech COVID-19 Vaccine arrives may be used as temporary storage when consistently re-filled to the top of the container with dry ice . . .
Then there is other information about thawing the vaccine, diluting it and how you shouldn’t freeze the diluted vaccine, etc.
PART II: SCIENTIFIC INFORMATION
13 PHARMACEUTICAL INFORMATION
Drug Substance: Proper name: COVID-19 mRNA Vaccine
Pfizer-BioNTech COVID-19 Vaccine (COVID-19 mRNA Vaccine)is highly purified single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.
This vaccine is a white to off-white frozen suspensionprovidedasa multiple dose vial and must be diluted before use. One vial contains 5 doses of 30 micrograms of COVID-19 mRNA Vaccine (embedded in lipid nanoparticles)
14 CLINICAL TRIALS
14.1 Trial Design and Study Demographics
There is a description of the clinical trials.
Who was excluded and not in terms of illness:
The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19 disease. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, were included as were participants with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).
The primary endpoint was defined as any symptomatic* COVID-19 case confirmed by Reverse Transcription-Polymerase Chain Reaction (RT-PCR). . . .
There are issues with that test we have mentioned and there is a lot of critical information about the use of it with COVID-19.
14.2 Study Results
There were 8 confirmed COVID-19 cases identified in the Pfizer-BioNTech COVID-19 Vaccine and 162 in placebo groups, respectively, for the first primary efficacy analysis. In this analysis, compared to placebo, efficacy of Pfizer-BioNTech COVID-19 Vaccine in participants with first COVID-19 occurrence from 7 days after Dose 2 (participants without evidence of prior infection with SARS-CoV-2)was 95.0% (95% credible interval of 90.3% to 97.6%). In participants 65 years of age and older without evidenceof prior infections with SARS-CoV-2, efficacy of Pfizer-BioNTech COVID-19 Vaccine was 94.7% (two-sided 95% confidence interval of 66.7% to 99.9%). In the second primary efficacy analysis (participants 16 years of age and older with or without evidenceof prior infection with SARS-CoV-2), compared to placebo, efficacy of Pfizer-BioNTech COVID-19 Vaccine in participants with first COVID-19 occurrence from 7 days after Dose 2 was 94.6% (95% credible interval of 89.9% to 97.3%).
*Case definition: (at least 1 of) fever, new or increased cough, new or increased shortness of breath, chills, new or increased muscle pain, new loss of taste or smell, sore throat, diarrhoea or vomiting
So it doesn’t claim to be 100% effective. In the first line above, it says, for the first efficacy anlaysis, there were 8 cases with the new vaccine and 162 in placebo groups. Also, people have raised questions about the testing process.
No microbiological information is required for this product.
16 NON-CLINICAL TOXICOLOGY
Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose toxicity.
Carcinogenic potential was not assessed, as carcinogenicity studies were not considered relevant to this vaccine.
Genotoxicity: Genotoxic potential was not assessed, as genotoxicity studies were notconsidered relevant to this vaccine.
The following is very important:
Reproductive and Developmental Toxicology
Reproduction and developmental toxicology studies in animals have not been completed.
Then there is a leaflet at the end for patients with incomplete information:
PATIENT MEDICATION INFORMATION
READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE
PFIZER-BIONTECH COVID-19 VACCINE
COVID-19 mRNA Vaccine, Suspension for Intramuscular Injection
Health Canada has authorized the sale of this COVID-19 vaccine under an Interim Order.
This leaflet is a summary and will not tell you everything about this vaccine. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about Pfizer-BioNTech COVID-19 Vaccine. . . .
Demand this full document from your health professional or download it yourself from the government website and read it!
The vaccine causes our body to produce protection (such as antibodies) that prevent the COVID-19 virus from entering our cells to make us sick. The vaccine uses a new method (messenger RNA -mRNA, the genetic code for a piece of the virus) to help our bodies make protection against the virus. . . . will require two doses given 21 days apart.
As with any vaccine, Pfizer-BioNTech COVID-19 Vaccine may not fully protect all those who receive it. Even after you have had both doses of the vaccine, continue to follow the recommendations of local public health officials to prevent spread of COVID-19.
So it doesn’t change anything about how they want you to live!
What are the ingredients in Pfizer-BioNTech COVID-19 Vaccine?
Medicinal ingredient: mRNA
ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
dibasic sodium phosphate dihydrate
monobasic potassium phosphate
water for injection
They warn you about the following!
You should not receive Pfizer-BioNTech COVID-19 Vaccine if:
you are allergic to any of the ingredients in this vaccine (see What are the ingredients in Pfizer-BioNTech COVID-19 Vaccine?)
have any symptoms that could be due to COVID-19. Talk with your healthcare professional about your symptoms and getting a COVID-19 test. Your healthcare professional will advise you when you are able to receive the vaccine.
What would happen to someone who did have symptoms (mild or not) and took it anyway?
Notice that some people have had severe reactions as explained above (see the full document).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you receive Pfizer-BioNTech COVID-19 Vaccine. Talk about any health conditions or problems you may have, including if you:
have had any problems following previous administration of Pfizer-BioNTech COVID-19 Vaccine such as an allergic reaction or breathing problems.
have a weakened immune system due to a medical condition or are on a medicine that affects your immune system.
have a bleeding problem, bruise easily or use a blood thinning medication
are pregnant, think you may be pregnant or plan to become pregnant
Other warnings you should know about:
It may take until 7 days after the second dose of Pfizer-BioNTech COVID-19 Vaccine to develop protection against COVID-19. As with any vaccine, Pfizer-BioNTech COVID-19 Vaccine may not fully protect all those who receive it.
So it may not work. You may get COVID-19 anyway. And as it also says, keep following the new, invented social behaviour restrictions and lockdowns. Shutting down your business is good for everyone’s health, right?
Opportunity for them to pry a lot of information out of you about your health beliefs and habits:
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
There is no information on the use of Pfizer-BioNTech COVID-19 vaccine with other vaccines.
Tell your healthcare professional if you have recently received any other vaccine
You will receive 2 injections, given 21 days apart. It is very important that you return for the second injection, or the vaccine may not work as well.
Take another look at the reactions tables–for dose 1 and dose 2 Some of the reactions were severe.
IMPORTANT: Note the “very common” side effects. 1 in 10 people it says. See my discussion above and the tables in the full document:
What are possible side effects from using Pfizer-BioNTech COVID-19 Vaccine?
Like all vaccines, Pfizer-BioNTech COVID-19 Vaccine can cause side effects.
Side effects may occurat the following frequencies:
Very common: may affect more than 1 in 10 people
pain at injection site
Uncommon: may affect up to 1 in 100 people enlarged lymph nodes
These are not all the possible side effects you may have when taking Pfizer-BioNTech COVID-19 Vaccine. If you experience any side effects not listed here, tell your healthcare professional.
Should you develop any serious symptoms or symptoms that could be an allergic reaction, seek medical attention right away. Symptoms of an allergic reaction include:
hives (bumps on the skin that are often very itchy)
swelling of the face, tongue or throat
If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
Remember that you have the right to informed consent!! You ask for all the information and you decide!
Your health care provider should inform your local public health department of any serious side effects after vaccination.
Reporting Suspected Side Effects for Vaccines
For the general public: Should you experience a side effect following immunization, please report it to your health care professional.
Should you require information related to the management of the side effect, please contact your healthcare professional. The Public Health Agency of Canada, Health Canada and Pfizer Canada ULC cannot provide medical advice.
For healthcare professionals: If a patient experiences a side effect following immunization, please complete the Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory (https://www.canada.ca/en/public-health/services/immunization/reporting-adverse-events-following-immunization/form.html) and send it to your local Health Unit
If you want more information about Pfizer-BioNTech COVID-19 Vaccine:
Talk to your healthcare professional.
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website:(https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html;the manufacturer’s website[www.pfizer.ca], or by calling 1-800-463-6001(Pfizer Medical Information).
Last Revised December 9, 2020
Use that database to locate the full product monograph.
Copy here of the current one.