Pfizer-BioNTech
COVID-19 Vaccine Information
The official name for this Vaccine is the COVID-19 mRNA Vaccine BNT162b2 produced by Pfizer and BioNTech. To make reading easier this will be referred to here as the COVID Vaccine.
This will cover:
1. What the COVID Vaccine is and what it is used for
2. What you need to know before you receive the COVID Vaccine
3. How the COVID Vaccine is given
4. Possible side effects
5. COVID Vaccine contents and other information
1. What the COVID Vaccine is and what it is used for
The COVID Vaccine is a vaccine used for active immunisation to prevent COVID19 disease caused by SARS-CoV-2 virus.
The COVID Vaccine is given to adults and adolescents from 16 years.
The vaccine triggers the body’s natural production of antibodies and stimulates immune cells to protect against COVID-19 disease.
2. What you need to know before you receive the COVID Vaccine
You should NOT receive the COVID Vaccine if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 5 below).
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency department right away if you have an allergic reaction. It can be life-threatening.
Please discuss with the clinic staff if you have:
– had any problems following previous administration of The COVID Vaccine such as allergic reaction or breathing problems
– a severe illness with high fever. However, a mild fever or upper airway infection, like a cold, are not reasons to delay vaccination.
– a weakened immune system, such as due to HIV infection, or are on a medicine that affects your immune system
– a bleeding problem, bruise easily or use a medicine to inhibit blood clotting
As with any vaccine, The COVID Vaccine may not fully protect all those who receive it. No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses.
The COVID Vaccine is not recommended for children under 16 years.
Other medicines and the COVID Vaccine
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines or have recently received any other vaccine.
Pregnancy and breast-feeding
There is currently limited data available on the use of this vaccine in pregnant women. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you receive this vaccine. As a precaution, you should avoid becoming pregnant until at least 2 months after the vaccine.
Driving and using machines
The COVID Vaccine has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4 ‘Possible side effects’ may temporarily affect the ability to drive or use machines. Do not drive or operate machinery until you are sure that you are not affected.
3. How the COVID Vaccine is given
The COVID Vaccine is given after dilution as an injection of 0.3 mL into a muscle of your upper arm.
You will receive 2 injections, given up to 12 weeks apart.
If you receive one dose of The COVID Vaccine, you should receive a second dose of the same vaccine within 12 weeks to complete the vaccination series.
Protection against COVID-19 disease may not be effective until at least 7 days after the second dose.
If you have any further questions on the use of the COVID Vaccine you can ask at the time of your vaccination itself.
4. Possible side effects
Like all vaccines, The COVID Vaccine can cause side effects, although not everybody gets them.
Most side effects are mild or moderate and go away within a few days of appearing. If side effects such as pain and/or fever are troublesome, they can be treated by medicines for pain and fever such as paracetamol.
Side effects may occur with following frequencies:
Very common: may affect more than 1 in 10 people
• pain at injection site
• tiredness
• headache
• muscle pain
• chills
• joint pain
• fever
Common: may affect up to 1 in 10 people
• injection site swelling
• redness at injection site
• nausea
Uncommon: may affect up to 1 in 100 people
• enlarged lymph nodes
• feeling unwell
5. What the COVID Vaccine contains
The active substance is BNT162b2 RNA
The other ingredients are:
– ALC-0315 = (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)
– ALC-0159 = 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
– 1,2-Distearoyl-sn-glycero-3-phosphocholine
– cholesterol
– potassium chloride
– potassium dihydrogen phosphate
– sodium chloride
– disodium hydrogen phosphate dihydrate
– sucrose
Spikevax (Moderna)
COVID-19 Vaccine Information
Spikevax dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified). This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get.
To make reading easier this will be referred to here as the COVID Vaccine.
This will cover:
1. What Spikevax is and what it is used for
2. What you need to know before you are given Spikevax
3. How Spikevax is given
4. Possible side effects
5. Contents of the vaccine
1. What Spikevax is and what it is used for
Spikevax is a vaccine used to prevent COVID-19 caused by SARS-CoV-2. It is given to adults and children aged 6 years and older. The active substance in Spikevax is mRNA encoding the SARS-CoV-2 Spike protein. The mRNA is embedded in SM-102 lipid nanoparticles.
As Spikevax does not contain the virus, it cannot give you COVID-19.
How the vaccine works
Spikevax stimulates the body’s natural defences (immune system). The vaccine works by causing the body to produce protection (antibodies) against the virus that causes COVID-19. Spikevax uses a substance called messenger ribonucleic acid (mRNA) to carry instructions that cells in the body can use to make the spike protein that is also on the virus. The cells then make antibodies against the spike protein to help fight off the virus. This will help to protect you against COVID-19.
2. What you need to know before you are given Spikevax
The vaccine must not be given if:
- you are allergic to the active substance or any of the other ingredients of this vaccine, listed below.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Spikevax if you:
- have previously had a severe, life-threatening allergic reaction after any other vaccine injection or after you were given Spikevax in the past
- have a very weak or compromised immune system
- have ever fainted following any needle injection.
- have a bleeding disorder
- have a high fever or severe infection; however, you can have your vaccination if you have a mild fever or upper airway infection like a cold
- have any serious illness
- have anxiety related to injections
There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after have been vaccination with Spikevax (see section 4).
These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often after the second dose, and more often in younger males.
Following vaccination, you should be alert to signs of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek immediate medical attention should these occur.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Spikevax.
Capillary leak syndrome (CLS) flare-ups
A few cases of capillary leak syndrome flare-ups (causing fluid leakage from small blood vessels (capillaries) resulting in rapid swelling of the arms and legs, sudden weight gain and feeling faint, low blood pressure) have been reported following vaccination with Spikevax. If you have previously had episodes of CLS, talk to a doctor before you are given Spikevax.
Duration of protection
As with any vaccine, the primary 2-dose vaccination course of Spikevax may not fully protect all those who receive it and it is not known how long you will be protected.
Children
Spikevax is not recommended for children aged under 6 years.
Other medicines and Spikevax
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Spikevax may affect the way other medicines work, and other medicines may affect how Spikevax works.
Immunocompromised individuals
If you are immunocompromised, you may receive a third dose of Spikevax. The third dose may still not provide full immunity to COVID-19 in people who are immunocompromised, and you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your doctor.
Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant, tell your doctor, nurse or pharmacist before you receive this vaccine. Spikevax can be used during pregnancy. A large amount of information from pregnant women vaccinated with Spikevax during the second and third trimester have not shown negative effects on the pregnancy or the newborn baby. While information on effects on pregnancy or the newborn baby after vaccination during the first trimester is limited, no change to the risk for miscarriage has been seen.
Spikevax can be given during breastfeeding.
Driving and using machines
Do not drive or use machines if you are feeling unwell after vaccination. Wait until any effects of the vaccine have worn off before you drive or use machines.
Spikevax contains sodium
Spikevax contains less than 1 mmol (23 mg) sodium per dose and, that is to say, essentially ‘sodium-free’.
3. How you will be given Spikevax
Individuals 12 years of age and older
Spikevax will be given to you as two 0.5 mL injections.
Children 6 through 11 years of age
Spikevax will be given to you as two 0.25 mL injections.
It is recommended to get the second dose 28 days after the first dose to complete the vaccination course.
If you miss an appointment for your primary 2nd dose of Spikevax
- If you miss an appointment, arrange another visit as soon as possible with your doctor, nurse, or pharmacist.
- If you miss a scheduled injection, you may not be fully protected against COVID-19.
A booster dose (0.25 mL) of Spikevax may be given at least 3 months after the second dose in individuals 18 years of age and older.
If you are immunocompromised, you may receive a third dose (0.5 mL for individuals 12 years of age and older; 0.25 mL for children 6 through 11 years) of Spikevax at least 1 month after the second dose.
Your doctor, pharmacist or nurse will inject the vaccine into a muscle (intramuscular injection) in your upper arm.
During and after each injection of the vaccine, your doctor, pharmacist or nurse will watch over you for at least 15 minutes to monitor for signs of an allergic reaction.
If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them. Most side effects go away within a few days of appearing. If side effects such as pain and/or fever are troublesome, they can be treated by medicines for pain and fever such as paracetamol.
Get urgent medical attention if you get any of the following signs and symptoms of an allergic reaction:
- feeling faint or light-headed
- changes in your heartbeat
- shortness of breath
- wheezing
- swelling of your lips, face, tongue or throat
- hives or rash
- nausea or vomiting
- stomach pain
Talk to your doctor or nurse if you develop any other side effects. These can include:
Very common (may affect more than 1 in 10 people):
- Swelling/tenderness of the underarm glands on the same side as the injection site
- Headache
- Nausea
- Vomiting
- Muscle ache, joint aches, and stiffness
- Pain or swelling at the injection site
- redness at the injection site (some of which may occur approximately 9 to 11 days after the injection)
- Feeling very tired
- Chills
- Fever
Common (may affect up to 1 in 10 people):
- Diarrhoea
- Rash
- Rash or hives at the injection site (some of which may occur at a median of 4 to 11 days after the injection)
Uncommon (may affect up to 1 in 100 people):
- Itchiness at the injection site
- dizziness
- stomach pain
Rare (may affect up to 1 in 1000 people)
- Temporary one sided facial drooping (Bell’s palsy)
- Swelling of the face (Swelling of the face may occur in patients who have had facial cosmetic injections.)
- decreased sense of touch or sensation
- unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)
Very rare (may affect up to 1 in 10,000 people)
- Inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis) which can result in breathlessness, palpitations or chest pain
Frequency unknown
- Severe allergic reactions with breathing difficulties (anaphylaxis)
- Reaction of increased sensitivity or intolerance by the immune system (hypersensitivity)
- a skin reaction that causes red spots or patches on the skin that may look like a target or “bulls eye” with a dark red centre surrounded by paler red rings (erythema multiforme).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. If you are concerned about a side-effect it can be reported directly via the Coronavirus Yellow Card reporting site or search for MHRA Yellow Card in the Google Play or Apple App Store and include the vaccine brand and batch/Lot number if available. By reporting side effects you can help provide more information on the safety of this vaccine.
5. Contents of the vaccine
This vaccine contains polyethylene glycol/macrogol (PEG) as part of PEG2000-DMG.
- This is a multidose vial that contains 10 doses of 0.5 mL each or a maximum of 20 doses of 0.25mL each.
- One dose (0.5 mL) contains 100 micrograms of messenger RNA (mRNA) (embedded in SM-102 lipid nanoparticles).
- One dose (0.25mL) contains 50 micrograms of messenger RNA (mRNA) (embedded in SM-102 lipid nanoparticles).
- 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.
- The other ingredients are:
- Lipid SM-102 (heptadecan-9-yl 8-{(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino}octanoate)
- Cholesterol
- 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC)
- 1,2-Dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 (PEG2000 DMG)
- Trometamol
- Trometamol hydrochloride
- Acetic acid
- Sodium acetate trihydrate
- Sucrose
- Water for injections.
AstraZeneca
COVID-19 Vaccine Information
The official name for this Vaccine is the COVID-19 Vaccine ChAdOx1-S produced by AstraZeneca. To make reading easier this will be referred to here as the COVID Vaccine.
This will cover:
1. What COVID-19 Vaccine AstraZeneca is and what it is used for
2. What you need to know before you receive COVID-19 Vaccine AstraZeneca
3. How COVID-19 Vaccine AstraZeneca is given
4. Possible side effects
5. Contents of the vaccine
1. What COVID-19 Vaccine AstraZeneca is and what it is used for
COVID-19 Vaccine AstraZeneca is a vaccine used to protect people aged 18 years and older against COVID-19.
COVID-19 is caused by a virus called coronavirus (SARS-CoV-2).
COVID- 19 Vaccine AstraZeneca stimulates the body’s natural defences (immune system). It causes the body to produce its own protection (antibodies) against the virus. This will help to protect you against COVID-19 in the future. None of the ingredients in this vaccine can cause COVID-19.
2. What you need to know before you receive COVID-19 Vaccine AstraZeneca
Do not have the vaccine:
If you have ever had a severe allergic reaction to any of the active substances or any of the other ingredients listed in section 5. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you have an allergic reaction. It can be life-threatening.
If you are not sure, talk to your doctor, pharmacist or nurse.
Warnings and precautions
Tell your doctor, pharmacist or nurse before vaccination:
If you have ever had a severe allergic reaction (anaphylaxis) after any other vaccine injection;
If you currently have a severe infection with a high temperature (over 38°C). However, a mild fever or infection, like a cold, are not reasons to delay vaccination;
If you have a problem with bleeding or bruising, or if you are taking a blood thinning medicine (anticoagulant);
If your immune system does not work properly (immunodeficiency) or you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines).
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before you are given the vaccine.
As with any vaccine, COVID -19 Vaccine AstraZeneca may not protect everyone who is vaccinated from COVID-19. It is not yet known how long people who receive the vaccine will be protected for. No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses.
Children and adolescents
No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age.
Other medicines and COVID-19 Vaccine AstraZeneca
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, tell your doctor, pharmacist or nurse. There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. Your doctor, pharmacist or nurse will discuss with you whether you can be given the vaccine.
Driving and using machines
COVID-19 Vaccine AstraZeneca has no known effect on the ability to drive and use machines. However, side effects listed in section 4 may impact your ability to drive and use machines. If you feel unwell, do not drive or use machines.
COVID-19 Vaccine AstraZeneca contains sodium and alcohol (ethanol)
This medicine contains less than 1 mm of sodium (23 mg) per dose of 0.5 ml. This means that it is essentially ‘sodium-free’.
This medicine contains a very small amount of alcohol (0.002 mg of alcohol (ethanol) per dose of 0.5 ml). This is not enough to cause any noticeable effects.
3. How COVID-19 Vaccine AstraZeneca is given
COVID-19 Vaccine AstraZeneca is injected into a muscle (usually in the upper arm).
You will receive 2 injections. You will be told when you need to return for your second injection of COVID-19 Vaccine AstraZeneca.
The second injection can be given between 4 and 12 weeks after the first injection.
When COVID-19 Vaccine AstraZeneca is given for the first injection, COVID -19 Vaccine AstraZeneca (and not another vaccine against COVID-19) should be given for the second injection to complete vaccination course.
If you miss your second injection
If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. It is important that you return for your second injection of COVID-19 Vaccine AstraZeneca.
4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them. In clinical studies with the vaccine, most side effects were mild to moderate in nature and resolved within a few days with some still present a week after vaccination.
If side effects such as pain and/or fever are troublesome, medicines containing paracetamol can be taken.
Side effects that occurred during clinical trials with COVID-19 Vaccine AstraZeneca were as follows:
Very Common (may affect more than 1 in 10 people)
– tenderness, pain, warmth, redness, itching, swelling or bruising where the injection is given
– generally feeling unwell
– feeling tired (fatigue)
– chills or feeling feverish
– headache
– feeling sick (nausea)
– joint pain or muscle ache
Common (may affect up to 1 in 10 people)
– a lump at the injection site
– fever
– being sick (vomiting)
– flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills
Uncommon (may affect up to 1 in 100 people)
– feeling dizzy
– decreased appetite
– abdominal pain
– enlarged lymph nodes
– excessive sweating, itchy skin or rash
In clinical trials there were very rare reports of events associated with inflammation of the nervous system, which may cause numbness, pins and needles, and/or loss of feeling. However, it is not confirmed whether these events were due to the vaccine.
If you notice any side effects not mentioned in this leaflet, please inform your doctor, pharmacist or nurse.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
If you are concerned about a side-effect it can be reported directly via the Coronavirus Yellow Card reporting site https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store and include the vaccine brand and batch/Lot number if available. By reporting side effects you can help provide more information on the safety of this vaccine.
5. What the COVID-19 Vaccine AstraZeneca contains
One dose (0.5 ml) contains:
COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 × 1010 viral particles
*Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. Produced in genetically modified human embryonic kidney (HEK) 293 cells.
This product contains genetically modified organisms (GMOs).
The other excipients are L-histidine, L-histidine hydrochloride monohydrate, magnesium chloride hexahydrate, polysorbate 80, ethanol, sucrose, sodium chloride, disodium edetate dihydrate, water for injections.
