Pfizer Biontech COVID-19 Vaccine

Last reviewed on RxList: 1/6/2021
Pfizer Biontech COVID-19 Vaccine Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Pfizer-BioNTech COVID-19 Vaccine?

Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19.

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19 in individuals 18 years of age and older.

What Are Side Effects of Pfizer-BioNTech COVID-19 Vaccine?

Side effects of Pfizer-BioNTech COVID-19 Vaccine include:

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.

Dosage for Pfizer-BioNTech COVID-19 Vaccine

The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection administered as a series of two doses (0.3 mL each) 3 weeks apart.

Pfizer-BioNTech COVID-19 Vaccine In Children

Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine in adolescents 16 and 17 years of age is based on extrapolation of safety and effectiveness from adults 18 years of age and older.

Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine does not include use in individuals younger than 16 years of age.

What Drugs, Substances, or Supplements Interact with Pfizer-BioNTech COVID-19 Vaccine?

Pfizer-BioNTech COVID-19 Vaccine may interact with other medicines.

Tell your doctor all medications and supplements you use and all other vaccines you recently received.

Pfizer-BioNTech COVID-19 Vaccine During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Pfizer-BioNTech COVID-19 Vaccine; it is unknown how it could affect a fetus. There is no information available about Pfizer-BioNTech COVID-19 Vaccine effects on the breastfed infant or on milk production/excretion. Consult your doctor before breastfeeding.

Additional Information

Our Pfizer-BioNTech COVID-19 Vaccine Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pfizer Biontech COVID-19 Vaccine Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching; confusion, dizziness, fainting; vomiting, diarrhea; fast heartbeats, wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

An allergic reaction is more likely to occur within 30 minutes after you receive the vaccine. You will be treated quickly if you have a reaction.

You should not receive the second vaccine if the first shot caused an allergic reaction. Your healthcare provider will determine if you can safely receive the second dose.

Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine. Serious side effects other than an allergic reaction may include:

  • pale or clammy skin, sweating, feeling warm or cold;
  • feeling anxious, nauseated, weak, or light-headed;
  • slow heartbeats, rapid breathing; or
  • changes in vision or hearing.

Fever may be a normal symptom as your body begins to develop immunity to COVID-19. However, you should call your doctor right away if you have any side effects that concern you.

Common side effects may include:

  • fever, chills, swollen glands;
  • pain, redness, or swelling where the shot was given;
  • nausea, not feeling well;
  • feeling tired; or
  • headache, muscle pain, joint pain.

You may be able to treat these effects with an over-the-counter pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others). Follow the label directions or your vaccination provider's instructions.

Other side effects, mild or serious, may occur with more widespread use of COVID-19 vaccine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

You may also use a smartphone-based program called V-safe to communicate with the Centers for Disease Control and Prevention (CDC) about any health problems you have after receiving a COVID-19 vaccine: www.cdc.gov/vsafe.

Read the entire detailed patient monograph for Pfizer Biontech COVID-19 Vaccine (COVID-19 Vaccine)

Pfizer Biontech COVID-19 Vaccine Professional Information

SIDE EFFECTS

Overall Safety Summary

It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and hospitalized or fatal cases of COVID-19 following vaccination with the Pfizer-BioNTech COVID-19 Vaccine. To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and Pfizer Inc.

In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%).

Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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) was a Phase ½, two-part, dose-escalation trial that enrolled 60 participants, 18 through 55 years of age. Study C4591001 (Study 2) is a Phase 1/2/3, multicenter, multinational, randomized, saline placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection (Phase 1) and efficacy (Phase 2/3) study that has enrolled approximately 44,000 participants, 12 years of age or older. Of these, approximately 43,448 participants (21,720 Pfizer-BioNTech COVID-19 Vaccine; 21,728 placebo) in Phase 2/3 are 16 years of age or older (including 138 and 145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively).

At the time of the analysis of Study 2 for the EUA, 37,586 (18,801 Pfizer-BioNTech COVID-19 Vaccine and 18,785 placebo) participants 16 years of age or older have been followed for a median of 2 months after the second dose of Pfizer-BioNTech COVID-19 Vaccine.

The safety evaluation in Study 2 is ongoing. The safety population includes participants enrolled by October 9, 2020, and includes safety data accrued through November 14, 2020. Participants 18 years and older in the reactogenicity subset are monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination in an electronic diary. Participants are being monitored for unsolicited adverse events, including serious adverse events, throughout the study [from Dose 1 through 1 month (all unsolicited adverse events) or 6 months (serious adverse events) after the last vaccination].

Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among participants who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. Overall, among the total participants who received either the Pfizer-BioNTech COVID-19 Vaccine or placebo, 50.6% were male and 49.4% were female, 83.1% were White, 9.1% were Black or African American, 28.0% were Hispanic/Latino, 4.3% were Asian, and 0.5% were American Indian/Alaska Native.

Local And Systemic Adverse Reactions Solicited In The Study 2

Table 1 and Table 2 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of Pfizer-BioNTech COVID-19 Vaccine and placebo in the subset of participants 18 to 55 years of age included in the EUA safety population who were monitored for reactogenicity with an electronic diary.

Table 3 and Table 4 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of each dose of Pfizer-BioNTech COVID-19 Vaccine and placebo for participants 56 years of age and older.

Across both age groups, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days), for redness 2.6 days (range 1 to 34 days), and for swelling 2.3 days (range 1 to 34 days) for participants in the Pfizer-BioNTech COVID-19 Vaccine group.

Solicited reactogenicity data in 16 and 17 year-old participants are limited.

Table 1: Study 2 – Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose – Participants 18-55 Years of Age‡ – Reactogenicity Subset of the Safety Population*

Pfizer-BioNTech COVID-19 Vaccine Dose 1
Na=2291 nb (%)
Placebo Dose 1
Na=2298 nb (%)
Pfizer-BioNTech COVID-19 Vaccine Dose 2
Na=2098 nb (%)
Placebo Dose 2
Na=2103 nb (%)
Rednessc
Any (>2 cm)104 (4.5)26 (1.1)123 (5.9)14 (0.7)
Mild70 (3.1)16 (0.7)73 (3.5)8 (0.4)
Moderate28 (1.2)6 (0.3)40 (1.9)6 (0.3)
Severe6 (0.3)4 (0.2)10 (0.5)0 (0.0)
Swellingc
Any (>2 cm)132 (5.8)11 (0.5)132 (6.3)5 (0.2)
Mild88 (3.8)3 (0.1)80 (3.8)3 (0.1)
Moderate39 (1.7)5 (0.2)45 (2.1)2 (0.1)
Severe5 (0.2)3 (0.1)7 (0.3)0 (0.0)
Pain at the injection sited
Any1904 (83.1)322 (14.0)1632 (77.8)245 (11.7)
Mild1170 (51.1)308 (13.4)1039 (49.5)225 (10.7)
Moderate710 (31.0)12 (0.5)568 (27.1)20 (1.0)
Severe24 (1.0)2 (0.1)25 (1.2)0 (0.0)
Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination.
a N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose.
b n = Number of participants with the specified reaction.
c Mild: >2.0 to ≤5.0 cm; Moderate: >5.0 to ≤10.0 cm; Severe: >10.0 cm.
d Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.
Eight participants were between 16 and 17 years of age.
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.

Table 2: Study 2 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose – Participants 18-55 Years of Age‡ – Safety Population*

Pfizer-BioNTech COVID-19 Vaccine Dose 1
Na=2291 nb (%)
Placebo Dose 1
Na=2298 nb (%)
Pfizer-BioNTech COVID-19 Vaccine Dose 2
Na=2098 nb (%)
Placebo Dose 2
Na=2103 nb (%)
Fever
≥38.0°C85 (3.7)20 (0.9)331 (15.8)10 (0.5)
≥38.0°C to 38.4C64 (2.8)10 (0.4)194 (9.2)5 (0.2)
>38.4C to 38.9C15 (0.7)5 (0.2)110 (5.2)3 (0.1)
>38.9°C to 40.0C6 (0.3)3 (0.1)26 (1.2)2 (0.1)
>40.0°C0 (0.0)2 (0.1)1 (0.0)0 (0.0)
Fatiguec
Any1085 (47.4)767 (33.4)1247 (59.4)479 (22.8)
Mild597 (26.1)467 (20.3)442 (21.1)248 (11.8)
Moderate455 (19.9)289 (12.6)708 (33.7)217 (10.3)
Severe33 (1.4)11 (0.5)97 (4.6)14 (0.7)
Headachec
Any959 (41.9)775 (33.7)1085 (51.7)506 (24.1)
Mild628 (27.4)505 (22.0)538 (25.6)321 (15.3)
Moderate308 (13.4)251 (10.9)480 (22.9)170 (8.1)
Severe23 (1.0)19 (0.8)67 (3.2)15 (0.7)
Chillsc
Any321 (14.0)146 (6.4)737 (35.1)79 (3.8)
Mild230 (10.0)111 (4.8)359 (17.1)65 (3.1)
Moderate82 (3.6)33 (1.4)333 (15.9)14 (0.7)
Severe9 (0.4)2 (0.1)45 (2.1)0 (0.0)
Vomitingd
Any28 (1.2)28 (1.2)40 (1.9)25 (1.2)
Mild24 (1.0)22 (1.0)28 (1.3)16 (0.8)
Moderate4 (0.2)5 (0.2)8 (0.4)9 (0.4)
Severe0 (0.0)1 (0.0)4 (0.2)0 (0.0)
Diarrheae
Any255 (11.1)270 (11.7)219 (10.4)177 (8.4)
Mild206 (9.0)217 (9.4)179 (8.5)144 (6.8)
Moderate46 (2.0)52 (2.3)36 (1.7)32 (1.5)
Severe3 (0.1)1 (0.0)4 (0.2)1 (0.0)
New or worsened muscle painc
Any487 (21.3)249 (10.8)783 (37.3)173 (8.2)
Mild256 (11.2)175 (7.6)326 (15.5)111 (5.3)
Moderate218 (9.5)72 (3.1)410 (19.5)59 (2.8)
Severe13 (0.6)2 (0.1)47 (2.2)3 (0.1)
New or worsened joint painc
Any251 (11.0)138 (6.0)459 (21.9)109 (5.2)
Mild147 (6.4)95 (4.1)205 (9.8)54 (2.6)
Moderate99 (4.3)43 (1.9)234 (11.2)51 (2.4)
Severe5 (0.2)0 (0.0)20 (1.0)4 (0.2)
Use of antipyretic or pain medicationf638 (27.8)332 (14.4)945 (45.0)266 (12.6)
Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose.
a N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose.
b n = Number of participants with the specified reaction.
c Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity.
d Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration.
e Mild: 2 to 3 loose stools in 24 hours; Moderate: 4 to 5 loose stools in 24 hours; Severe: 6 or more loose stools in 24 hours.
f Severity was not collected for use of antipyretic or pain medication.
‡ Eight participants were between 16 and 17 years of age.
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.

Table 3: Study 2 – Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose – Participants 56 Years of Age and Older – Safety Population*

Pfizer-BioNTech COVID-19 Vaccine Dose 1
Na=1802 nb (%)
Placebo Dose 1
Na=1792 nb (%)
Pfizer-BioNTech COVID-19 Vaccine Dose 2
Na=1660 nb (%)
Placebo Dose 2
Na=1646 nb (%)
Rednessc
Any (>2 cm)85 (4.7)19 (1.1)120 (7.2)12 (0.7)
Mild55 (3.1)12 (0.7)59 (3.6)8 (0.5)
Moderate27 (1.5)5 (0.3)53 (3.2)3 (0.2)
Severe3 (0.2)2 (0.1)8 (0.5)1 (0.1)
Swellingc
Any (>2 cm)118 (6.5)21 (1.2)124 (7.5)11 (0.7)
Mild71 (3.9)10 (0.6)68 (4.1)5 (0.3)
Moderate45 (2.5)11 (0.6)53 (3.2)5 (0.3)
Severe2 (0.1)0 (0.0)3 (0.2)1 (0.1)
Pain at the injection sited
Any (>2 cm)1282 (71.1)166 (9.3)1098 (66.1)127 (7.7)
Mild1008 (55.9)160 (8.9)792 (47.7)125 (7.6)
Moderate270 (15.0)6 (0.3)298 (18.0)2 (0.1)
Severe4 (0.2)0 (0.0)8 (0.5)0 (0.0)
Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination.
a N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose.
b n = Number of participants with the specified reaction.
c Mild: >2.0 to ≤5.0 cm; Moderate: >5.0 to ≤10.0 cm; Severe: >10.0 cm.
d Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.

Table 4: Study 2 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose – Participants 56 Years of Age and Older – Reactogenicity Subset of the Safety Population*

Pfizer-BioNTech COVID-19 Vaccine Dose 1
Na=1802 nb (%)
Placebo Dose 1
Na=1792 nb (%)
Pfizer-BioNTech COVID-19 Vaccine Dose 2
Na=1660 nb (%)
Placebo Dose 2
Na=1646 nb (%)
Fever
≥38.0°C26 (1.4)7 (0.4)181 (10.9)4 (0.2)
≥38.0°C to 38.4C23 (1.3)2 (0.1)131 (7.9)2 (0.1)
>38.4°C to 38.9C1 (0.1)3 (0.2)45 (2.7)1 (0.1)
>38.9°C to 40.0C1 (0.1)2 (0.1)5 (0.3)1 (0.1)
>40.0°C1 (0.1)0 (0.0)0 (0.0)0 (0.0)
Fatiguec
Any615 (34.1)405 (22.6)839 (50.5)277 (16.8)
Mild373 (20.7)252 (14.1)351 (21.1)161 (9.8)
Moderate240 (13.3)150 (8.4)442 (26.6)114 (6.9)
Severe2 (0.1)3 (0.2)46 (2.8)2 (0.1)
Headachec
Any454 (25.2)325 (18.1)647 (39.0)229 (13.9)
Mild348 (19.3)242 (13.5)422 (25.4)165 (10.0)
Moderate104 (5.8)80 (4.5)216 (13.0)60 (3.6)
Severe2 (0.1)3 (0.2)9 (0.5)4 (0.2)
Chillsc
Any113 (6.3)57 (3.2)377 (22.7)46 (2.8)
Mild87 (4.8)40 (2.2)199 (12.0)35 (2.1)
Moderate26 (1.4)16 (0.9)161 (9.7)11 (0.7)
Severe0 (0.0)1 (0.1)17 (1.0)0 (0.0)
Vomitingd
Any9 (0.5)9 (0.5)11 (0.7)5 (0.3)
Mild8 (0.4)9 (0.5)9 (0.5)5 (0.3)
Moderate1 (0.1)0 (0.0)1 (0.1)0 (0.0)
Severe0 (0.0)0 (0.0)1 (0.1)0 (0.0)
Diarrheae
Any147 (8.2)118 (6.6)137 (8.3)99 (6.0)
Mild118 (6.5)100 (5.6)114 (6.9)73 (4.4)
Moderate26 (1.4)17 (0.9)21 (1.3)22 (1.3)
Severe3 (0.2)1 (0.1)2 (0.1)4 (0.2)
New or worsened muscle painc
Any251 (13.9)149 (8.3)477 (28.7)87 (5.3)
Mild168 (9.3)100 (5.6)202 (12.2)57 (3.5)
Moderate82 (4.6)46 (2.6)259 (15.6)29 (1.8)
Severe1 (0.1)3 (0.2)16 (1.0)1 (0.1)
New or worsened joint painc
Any155 (8.6)109 (6.1)313 (18.9)61 (3.7)
Mild101 (5.6)68 (3.8)161 (9.7)35 (2.1)
Moderate52 (2.9)40 (2.2)145 (8.7)25 (1.5)
Severe2 (0.1)1 (0.1)7 (0.4)1 (0.1)
Use of antipyretic or pain medication358 (19.9)213 (11.9)625 (37.7)161 (9.8)
Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose.
a N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose.
b n = Number of participants with the specified reaction.
c Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity.
d Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration.
e Mild: 2 to 3 loose stools in 24 hours; Moderate: 4 to 5 loose stools in 24 hours; Severe: 6 or more loose stools in 24 hours.
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.

Unsolicited Adverse Events

Serious Adverse Events

In Study 2, among participants 16 to 55 years of age who had received at least 1 dose of vaccine or placebo (Pfizer-BioNTech COVID-19 Vaccine = 10,841; placebo = 10,851), serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.3% of placebo recipients. In a similar analysis, 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 Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.6% of placebo recipients who received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine or placebo, respectively. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. Appendicitis was reported as a serious adverse event for 12 participants, and numerically higher in the vaccine group, 8 vaccine participants and 4 placebo participants. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.

Non-Serious Adverse Events

Overall in Study 2 in which 10,841 participants 16 to 55 years of age received Pfizer-BioNTech COVID-19 Vaccine and 10,851 participants received placebo, non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up 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 a similar analysis 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. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. The higher frequency of reported unsolicited non-serious adverse events among Pfizer BioNTech COVID-19 Vaccine recipients compared to placebo recipients was primarily attributed to local and systemic adverse events reported during the first 7 days following vaccination that are consistent with adverse reactions solicited among participants in the reactogenicity subset and presented in Tables 3 and 4. 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. Throughout the safety follow-up period to date, Bell’s palsy (facial paralysis) was reported by four participants in the Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of Bell’s palsy were reported in the placebo group. Currently available information is insufficient to determine a causal relationship with the vaccine. 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.

Requirements And Instructions For Reporting Adverse Events And Vaccine Administration Errors

See Overall Safety Summary (Section 6) for additional information.

The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for MANDATORY reporting of the listed events following Pfizer-BioNTech COVID-19 Vaccine to the Vaccine Adverse Event Reporting System (VAERS):

  • Vaccine administration errors whether or not associated with an adverse event
  • Serious adverse events* (irrespective of attribution to vaccination)
  • Cases of Multisystem Inflammatory Syndrome (MIS) in children and adults
  • Cases of COVID-19 that result in hospitalization or death

*Serious adverse events are defined as:

  • Death
  • A life-threatening adverse event
  • Inpatient hospitalization or prolongation of existing hospitalization
  • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
  • A congenital anomaly/birth defect
  • An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above
Instructions For Reporting To VAERS

The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using one of the following methods:

  • Complete and submit the report online: https://vaers.hhs.gov/reportevent.html, or
  • If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-721-0366. If you need additional help submitting a report you may call the VAERS toll-free information line at 1-800-822-7967 or send an email to [email protected]

IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS, please complete the entire form with detailed information. It is important that the information reported to FDA be as detailed and complete as possible. Information to include:

  • Patient demographics (e.g., patient name, date of birth)
  • Pertinent medical history
  • Pertinent details regarding admission and course of illness
  • Concomitant medications
  • Timing of adverse event(s) in relationship to administration of the Pfizer-BioNTech COVID-19 Vaccine
  • Pertinent laboratory and virology information
  • Outcome of the event and any additional follow-up information if it is available at the time of the VAERS report. Subsequent reporting of follow-up information should be completed if additional details become available.

The following steps are highlighted to provide the necessary information for safety tracking:

  1. In Box 17, provide information on Pfizer-BioNTech COVID-19 Vaccine and any other vaccines administered on the same day; and in Box 22, provide information on any other vaccines received within one month prior.
  2. In Box 18, description of the event:
    1. Write “Pfizer-BioNTech COVID-19 Vaccine EUA” as the first line.
    2. Provide a detailed report of vaccine administration error and/or adverse event. It is important to provide detailed information regarding the patient and adverse event/medication error for ongoing safety evaluation of this unapproved vaccine. Please see information to include listed above.
  3. Contact information:
    1. In Box 13, provide the name and contact information of the prescribing healthcare provider or institutional designee who is responsible for the report.
    2. In Box 14, provide the name and contact information of the best doctor/healthcare professional to contact about the adverse event.
    3. In Box 15, provide the address of the facility where vaccine was given (NOT the healthcare provider’s office address).
Other Reporting Instructions

Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above.

To the extent feasible, report adverse events to Pfizer Inc. using the contact information below or by providing a copy of the VAERS form to Pfizer Inc.

WebsiteFax numberTelephone number
www.pfizersafetyreporting.com1-866-635-83371-800-438-1985

Read the entire FDA prescribing information for Pfizer Biontech COVID-19 Vaccine (COVID-19 Vaccine)

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