FACT SHEET FOR RECIPIENTS OF PFIZER COVID-19 VACCINE AND THEIR CAREGIVERS
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
FACT SHEET FOR RECIPIENTS OF PFIZER COVID-19
VACCINE AND THEIR CAREGIVERS
Home Forward has adapted an FAQ from Pfizer to help inform res idents
about the COVID-19 vaccine av ailable at the temporary c linic s at their
property .
This Fact Sheet contains inf orm ation to help you understan d the risk s and
benef its of the Pf izer-BioNTech COVID-19 Vac c ine (The rest of this
doc um ent will ref er to it as “the v ac c ine”). It is adm inistere d as a 2-dose
series, 3 weeks apart, and m ay prev ent y ou f rom getting COVID-19. The
v ac c ine m ay not protect everyone. Currently , there is no U.S. Food and
Drug Adm inistrati on (FDA) approv ed vacc ine guaranteed to prev ent
COVID-19. Talk to the vaccination prov ider if y ou hav e questions. Getting
the v acc ine is your choice and is entirely optional.
Frequently Asked Questions
WHAT IS COVID-19?
COVID-19 is caused by a coronav irus c alled SARS-CoV-2. This ty pe of
c oronav irus has not been seen bef ore. You c an get COVID-19 through
c ontac t with another person who has the v irus. It is predom inant ly a
respiratory illness that can af f ec t other organs. People with COVID-19
hav e had a wide range of sym ptom s reported, ranging f rom m ild sy m ptom s
to sev ere illness. Sym ptom s m ay appear 2 to 14 day s af ter ex posure to
the v irus. Sym ptom s m ay include: f ev er or c hills; c ough; shortness of
breath; f atigue; m uscle or body ac hes; headac he; new loss of taste or
sm ell; sore throat; congestion or runny nose; nausea or vom iting; diarrhea.
WHAT IS T HE PFIZER-BIONT ECH COVID-19 VACCINE?
The v ac c ine is a shot that m ay prev ent COVID-19. There is no FDA-
approv ed vaccine to prevent COVID-19.
The FDA has authorized the em ergenc y use of the v ac c ine to prevent
COVID-19 in individuals 16 years of age and older under an Em ergenc y
Use Authorizati o n (EUA).
For m ore inf orm ation on EUA, see the “What is an Emergency Use
1 Revised: January 2021Authoriz ation (EUA)?” section at the end of this Fac t Sheet.
WHAT SHOULD YOU M ENT ION T O YOUR VACCINAT ION PROVIDER
BEFORE YOU GET T HE VACCINE?
Tell the v accination provider about all of y our m edic al c onditions,
including if you:
• hav e any allergies
• hav e a f ever
• hav e a bleeding disorder or are on a blood thinner
• are im m unocom prom ised or are on a m edic ine that af f ec ts y our
im m une system
• are pregnant or plan to bec om e pregnant
• are breastf eedin g
• hav e received another COVID-19 v ac c ine
WHO SHOULD GET T HE VACCINE?
The FDA has authorized the em ergenc y v ac c ination of people who are 16
and older.
WHO SHOULD NOT GET T HE VACCINE?
You should not get the vaccine if y ou:
• had a severe allergic reac tion af ter a prev ious dose of this v ac c ine
• hav e ever had a severe allergic reac tion to any ingredien t of this
v ac c ine
WHAT ARE T HE INGREDIENT S IN T HE VACCINE?
Ingredients: m RNA, lipids ((4-hy drox y buty l) az a ne diy l) bi s( hex an e- 6, 1-
diy l)bis(2-h exyl dec an oa te ), 2 [(poly ethyle ne gly c ol)-2000]-N ,N-
ditetradec y lac et am i de , 1,2-Distear oy l- s n-g lycer o- 3- phosphoc h ol in e, and
cholesterol ), potassium chloride, m onobasic potassium phosphate , sodium
chloride, dibasic sodium phosphat e dihy drate, and suc rose.
HOW IS T HE VACCINE GIVEN?
The v ac c ine will be given to you as an injec tion into the m usc le. There are
2 Revised: January 20212 doses giv en 3 weeks apart.
HAS T HE VACCINE BEEN USED BEFORE?
In c linic al trials, approxim ately 20,000 indiv iduals 16 years of age and older
hav e rec eiv ed at least 1 dose of the Pf izer-BioNTec h COVID-19 Vac c ine.
WHAT ARE T HE BENEFIT S OF T HE VACCINE?
In an ongoing clinical trial, the vac c ine has been shown to prev ent COVID-
19 f ollowing 2 doses given 3 week s apart. The duration of protec tion
against COVID-19 is currently unk nown.
WHAT ARE T HE RISKS OF T HE VACCINE?
Side ef f ec ts that have been reported with the vac c ine inc lude:
• injec tion site pain
• tiredness
• headache
• m usc le pain
• c hills
• joint pain
• f ev er
• injec tion site swelling
• injec tion site redness
• nausea
• f eeling unwell
• swollen lym ph nodes
There is a rem ote chance that the vac c ine c ould c ause a sev ere allergic
reac tion which would usually occ ur within a f ew m inutes to one hour af ter
getting a dose of the vaccine. Signs of a sev ere allergic reac tion c an
inc lude:
• dif f ic ulty breathing
• swelling of your f ace and throat
• a f ast heartbeat
• a bad rash all over your body
• dizziness and weakness
3 Revised: January 2021These m ay not be all the possible side ef f ec ts of the vac c ine. Serious and
unex pec ted side ef f ects m ay occ ur. The vac c ine is still being studied in
clinic al trials.
WHAT SHOULD I DO ABOUT SIDE EFFECT S?
If y ou ex perience a severe allergic reac tion, c all 9-1-1, or go to the nearest
hospital. Call the vaccination prov ider or y our healthc are prov ider if y ou
hav e any side ef f ects that bother y ou or do not go away .
You c an Report vaccine side ef f ec ts to FDA/CDC Vaccine Adverse Event
Reporting System (VAERS) toll-f ree num ber at 1-800-822-7 96 7. You c an
report side ef f ects online at https://v aer s. hh s. g ov /r ep or teve nt .h tm l . Please
include “Pf izer-BioNTech COVID-19
Vac c ine EUA” in the f irst line of box #18 of the report f orm .
In addition, you can report side ef f ec ts to Pf izer Inc . at:
Website Fax number T elephone number
www.pf izersaf etyre po rt in g.c om 1-866-635-8 3 37 1-800-438-1 9 85
WHAT IF I DECIDE NOT T O GET T HE VACCINE?
It is y our c hoice to receive the vac c ine or not. If y ou dec ide not to, it will
not c hange your standard m edical c are.
ARE OT HER CHOICES AVAILABLE FOR PREVENT ING COVID-19
BESIDES PFIZER-BIONT ECH COVID-19 VACCINE?
Currently , there is no approved alternativ e vac c ine av ailable f or prev ention
of COVID-19. The FDA has allowed the em ergenc y use of other v ac c ines
that m ay prevent COVID-19.
CAN I RECEIVE T HE VACCINE WIT H OT HER VACCINES?
There is no inf orm ation on the use of the v ac c ine with other v ac c ines.
WHAT IF I AM PREGNANT OR BREAST FEEDING?
If you are pregnant or breastf eedi ng , disc uss y our options with y our
healthc are provider.
WILL T HE VACCINE GIVE M E COVID-19?
No. Additionally , the vaccine does not c ontain the COVID-19 v irus.
4 Revised: January 2021KEEP YOUR VACCINAT ION CARD
When y ou get your f irst dose, you will get a v ac c ination c ard to show y ou
when to return f or your second dose of the vac c ine. Rem em ber to bring
your c ard when you return.
ADDIT IONAL INFORM AT ION
If y ou hav e questions, v isit www.cvdvaccine.com or c all 1-877-829-2 61 9.
To ac c ess the m ost recent Fact Sheets, please sc an this QR c ode
HOW CAN I LEARN M ORE?
• Ask the vaccination provider about y our c onc erns
• Visit CDC at https://www.cdc. gov /c or on av i ru s/ 2 01 9- nc ov / in dex .h tm l.
• Visit FDA at https://www.f da. gov /em erg e nc y -pr ep ar ed n es s- a nd-
response/m cm - legal-regu la to ry-a nd -p ol ic y-f ram ew ork / em e rg enc y -
use-author i za ti on .
• Contact your local or state public health departm ent.
WHERE WILL M Y VACCINAT ION INFORM AT ION BE RECORDED?
The v ac c ination provider m ay inc lude y our v ac c ination inf orm ation in y our
state/local jurisdictio n’ s Im m unizatio n Inf orm ation Sy stem (IIS) or other
designate d system . This will ensure that y ou rec eiv e the sam e v ac c ine
when y ou return f or the second dose. For m ore inf orm ation about IISs, v isit
https://www.cdc. gov /vacci ne s/ pr og ram s/ ii s/ a bo ut .h tm l.
WHAT IS T HE COUNT ERM EASURES INJURY COM PENSAT ION
PROGRAM ?
The Counterm easu re s Injury Com pensatio n Program (CICP) is a f ederal
program that m ay help pay f or costs of m edic al c are and other spec if ic
ex penses f or certain people who hav e been seriously injured by c ertain
m edic ines or vaccines, including this v ac c ine. Generally , a c laim m ust be
subm itted to the CICP within one (1) y ear f rom the date of rec eiv ing the
vac c ine. To learn m ore about this program , v isit www.hrsa.gov /c ic p/ or c all
1-855-266-2 4 27 .
WHAT IS AN EM ERGENCY USE AUT HORIZAT ION (EUA)?
The United States FDA has m ade the vac c ine av ailable under an
em ergenc y access m echanism c alled an EUA. The EUA is supported by a
Sec retary of Health and Hum an Serv ices (HHS) dec laration that
5 Revised: January 2021circum stanc es exist to justif y the em ergenc y use of drugs and biologic al
produc ts during the COVID-19 pandem ic .
The Pf izer-BioNTech COVID-19 Vac c ine has not undergone the sam e ty pe
of rev iew as an FDA-approved or c leared produc t. FDA m ay issue an EUA
when c ertain criteria are m et, whic h inc ludes that there are no adequate,
approv ed, available alternative s. In addition, the FDA dec ision is based on
the totality of scientif ic evidence av ailable showing that the produc t m ay
be ef f ec tiv e to prevent COVID-19 during the COVID-19 pandem ic and that
the k nown and potential benef its of the produc t outweigh the k nown and
potential risks of the product. All of these c riteria m ust be m et to allow f or
the produc t to be used in the treatm ent of patients during the COVID-19
pandem ic .
The EUA f or the Pf izer-BioNTech COVID-19 Vac c ine is in ef f ect f or the
duration of the COVID-19 EUA dec laration justif y ing em ergenc y use of
these products, unless term inated or rev oked (af ter which the produc ts m ay
no longer be used).
6 Revised: January 2021You can also read
