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Comirnaty (COVID-19 Vaccine, mRNA) Adverse Reactions (Pfizer-BioNTech COVID-19 Vaccine)

Adverse Reactions

6 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. 6 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%).

In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%).

Severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials.

Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials.


6
Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.

6.1 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 12 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 1/2, 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 46,000 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) and 2,260 adolescents are 12 through 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively).

In Study 2, all participants 12 to <16 years of age, and participants 16 years of age and older in the reactogenicity subset, were 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]. Tables 1 through 6 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.

Participants 16 Years of Age and Older

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 had 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 16 years and older enrolled by October 9, 2020, and includes safety data accrued through November 14, 2020.

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.

Solicited Local and Systemic Adverse Reactions

Across both age groups, 18 through 55 years of age and 56 years and older, 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 Through 55 Years of Age* – Reactogenicity Subset of the Safety Population
Pfizer-BioNTech COVID-19 Vaccine
Dose 1
N=2291
n§ (%)
Placebo
Dose 1
N=2298
n§ (%)
Pfizer-BioNTech COVID-19 Vaccine
Dose 2
N=2098
n§ (%)
Placebo
Dose 2
N=2103
n§ (%)
Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination.
*
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.
N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose.
§
n = Number of participants with the specified reaction.
Mild: >2.0 to ≤5.0 cm; Moderate: >5.0 to ≤10.0 cm; Severe: >10.0 cm.
#
Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.
Redness
  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)
Swelling
  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 site#
  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)
Table 2: Study 2 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose – Participants 18 Through 55 Years of Age* – Reactogenicity Subset of the Safety Population
Pfizer-BioNTech COVID-19 Vaccine
Dose 1
N=2291
n§ (%)
Placebo
Dose 1
N=2298
n§ (%)
Pfizer-BioNTech COVID-19 Vaccine
Dose 2
N=2098
n§ (%)
Placebo
Dose 2
N=2103
n§ (%)
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.
*
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.
N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose.
§
n = Number of participants with the specified reaction.
Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity.
#
Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration.
Þ
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.
ß
Severity was not collected for use of antipyretic or pain medication.
Fever
  ≥38.0°C85 (3.7)20 (0.9)331 (15.8)10 (0.5)
  ≥38.0°C to 38.4°C64 (2.8)10 (0.4)194 (9.2)5 (0.2)
  >38.4°C to 38.9°C15 (0.7)5 (0.2)110 (5.2)3 (0.1)
  >38.9°C to 40.0°C6 (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)
Fatigue
  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)
Headache
  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)
Chills
  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)
Vomiting#
  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)
DiarrheaÞ
  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 pain
  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 pain
  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 medicationß638 (27.8)332 (14.4)945 (45.0)266 (12.6)
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 – Reactogenicity Subset of the Safety Population*
Pfizer-BioNTech COVID-19 Vaccine
Dose 1
N=1802
n (%)
Placebo
Dose 1
N=1792
n (%)
Pfizer-BioNTech COVID-19 Vaccine
Dose 2
N=1660
n (%)
Placebo
Dose 2
N=1646
n (%)
Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination.
*
Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose.
n = Number of participants with the specified reaction.
§
Mild: >2.0 to ≤5.0 cm; Moderate: >5.0 to ≤10.0 cm; Severe: >10.0 cm.
Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.
Redness§
  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)
Swelling§
  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 site
  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)
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
N=1802
n (%)
Placebo
Dose 1
N=1792
n (%)
Pfizer-BioNTech COVID-19 Vaccine
Dose 2
N=1660
n (%)
Placebo
Dose 2
N=1646
n (%)
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.
*
Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose.
n = Number of participants with the specified reaction.
§
Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity.
Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration.
#
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.
Fever
  ≥38.0°C26 (1.4)7 (0.4)181 (10.9)4 (0.2)
  ≥38.0°C to 38.4°C23 (1.3)2 (0.1)131 (7.9)2 (0.1)
  >38.4°C to 38.9°C1 (0.1)3 (0.2)45 (2.7)1 (0.1)
  >38.9°C to 40.0°C1 (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)
Fatigue§
  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)
Headache§
  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)
Chills§
  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)
Vomiting
  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)
Diarrhea#
  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 pain§
  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 pain§
  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)

From an independent report (Kamar N, Abravanel F, Marion O, et al. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. N Engl J Med), in 99 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 97±8 months previously who received a third vaccine dose, the adverse event profile was similar to that after the second dose and no grade 3 or grade 4 events were reported in recipients who were followed for one month following post Dose 3.

Unsolicited Adverse Events

Serious Adverse Events

In Study 2, among participants 16 through 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 = 7,960, placebo = 7,934), 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

In Study 2 in which 10,841 participants 16 through 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.

Adolescents 12 Through 15 Years of Age

In an analysis of Study 2, based on data up to the cutoff date of March 13, 2021, 2,260 adolescents (1,131 Pfizer-BioNTech COVID-19 Vaccine; 1,129 placebo) were 12 through 15 years of age. Of these, 1,308 (660 Pfizer-BioNTech COVID-19 Vaccine and 648 placebo) adolescents have been followed for at least 2 months after the second dose of Pfizer-BioNTech COVID-19 Vaccine. The safety evaluation in Study 2 is ongoing.

Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among adolescents who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. Overall, among the adolescents who received the Pfizer-BioNTech COVID-19 Vaccine, 50.1% were male and 49.9% were female, 85.9% were White, 4.6% were Black or African American, 11.7% were Hispanic/Latino, 6.4% were Asian, and 0.4% were American Indian/Alaska Native.

Solicited Local and Systemic Adverse Reactions

The mean duration of pain at the injection site after Dose 1 was 2.4 days (range 1 to 10 days), for redness 2.4 days (range 1 to 16 days), and for swelling 1.9 days (range 1 to 5 days) for adolescents in the Pfizer-BioNTech COVID-19 Vaccine group.

Table 5: Study 2 – Frequency and Percentages of Adolescents With Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose – Adolescents 12 Through 15 Years of Age – Safety Population*
Pfizer-BioNTech COVID-19 Vaccine
Dose 1
N=1127
n (%)
Placebo
Dose 1
N=1127
n (%)
Pfizer-BioNTech COVID-19 Vaccine
Dose 2
N=1097
n (%)
Placebo
Dose 2
N=1078
n (%)
Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination.
*
Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose.
n = Number of participants with the specified reaction.
§
Mild: >2.0 to ≤5.0 cm; Moderate: >5.0 to ≤10.0 cm; Severe: >10.0 cm.
Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.
Redness§
  Any (>2 cm)65 (5.8)12 (1.1)55 (5.0)10 (0.9)
    Mild44 (3.9)11 (1.0)29 (2.6)8 (0.7)
    Moderate20 (1.8)1 (0.1)26 (2.4)2 (0.2)
    Severe1 (0.1)0 (0.0)0 (0.0)0 (0.0)
Swelling§
  Any (>2 cm)78 (6.9)11 (1.0)54 (4.9)6 (0.6)
    Mild55 (4.9)9 (0.8)36 (3.3)4 (0.4)
    Moderate23 (2.0)2 (0.2)18 (1.6)2 (0.2)
    Severe0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Pain at the injection site
  Any971 (86.2)263 (23.3)866 (78.9)193 (17.9)
    Mild467 (41.4)227 (20.1)466 (42.5)164 (15.2)
    Moderate493 (43.7)36 (3.2)393 (35.8)29 (2.7)
    Severe11 (1.0)0 (0.0)7 (0.6)0 (0.0)
Table 6: Study 2 – Frequency and Percentages of Adolescents with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose – Adolescents 12 Through 15 Years of Age – Safety Population*
Pfizer-BioNTech COVID-19 Vaccine
Dose 1
N=1127
n (%)
Placebo
Dose 1
N=1127
n (%)
Pfizer-BioNTech COVID-19 Vaccine
Dose 2
N=1097
n (%)
Placebo
Dose 2
N=1078
n (%)
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.
*
Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose.
n = Number of participants with the specified reaction.
§
Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity.
Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration.
#
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.
Þ
Severity was not collected for use of antipyretic or pain medication.
Fever
  ≥38.0°C114 (10.1)12 (1.1)215 (19.6)7 (0.6)
  ≥38.0°C to 38.4°C74 (6.6)8 (0.7)107 (9.8)5 (0.5)
  >38.4°C to 38.9°C29 (2.6)2 (0.2)83 (7.6)1 (0.1)
  >38.9°C to 40.0°C10 (0.9)2 (0.2)25 (2.3)1 (0.1)
  >40.0°C1 (0.1)0 (0.0)0 (0.0)0 (0.0)
Fatigue§
  Any677 (60.1)457 (40.6)726 (66.2)264 (24.5)
    Mild278 (24.7)250 (22.2)232 (21.1)133 (12.3)
    Moderate384 (34.1)199 (17.7)468 (42.7)127 (11.8)
    Severe15 (1.3)8 (0.7)26 (2.4)4 (0.4)
Headache§
  Any623 (55.3)396 (35.1)708 (64.5)263 (24.4)
    Mild361 (32.0)256 (22.7)302 (27.5)169 (15.7)
    Moderate251 (22.3)131 (11.6)384 (35.0)93 (8.6)
    Severe11 (1.0)9 (0.8)22 (2.0)1 (0.1)
Chills§
  Any311 (27.6)109 (9.7)455 (41.5)73 (6.8)
    Mild195 (17.3)82 (7.3)221 (20.1)52 (4.8)
    Moderate111 (9.8)25 (2.2)214 (19.5)21 (1.9)
    Severe5 (0.4)2 (0.2)20 (1.8)0 (0.0)
Vomiting
  Any31 (2.8)10 (0.9)29 (2.6)12 (1.1)
    Mild30 (2.7)8 (0.7)25 (2.3)11 (1.0)
    Moderate0 (0.0)2 (0.2)4 (0.4)1 (0.1)
    Severe1 (0.1)0 (0.0)0 (0.0)0 (0.0)
Diarrhea#
  Any90 (8.0)82 (7.3)65 (5.9)43 (4.0)
    Mild77 (6.8)72 (6.4)59 (5.4)38 (3.5)
    Moderate13 (1.2)10 (0.9)6 (0.5)5 (0.5)
    Severe0 (0.0)0 (0.0)0 (0.0)0 (0.0)
New or worsened muscle pain§
  Any272 (24.1)148 (13.1)355 (32.4)90 (8.3)
    Mild125 (11.1)88 (7.8)152 (13.9)51 (4.7)
    Moderate145 (12.9)60 (5.3)197 (18.0)37 (3.4)
    Severe2 (0.2)0 (0.0)6 (0.5)2 (0.2)
New or worsened joint pain§
  Any109 (9.7)77 (6.8)173 (15.8)51 (4.7)
    Mild66 (5.9)50 (4.4)91 (8.3)30 (2.8)
    Moderate42 (3.7)27 (2.4)78 (7.1)21 (1.9)
    Severe1 (0.1)0 (0.0)4 (0.4)0 (0.0)
Use of antipyretic or pain medicationÞ413 (36.6)111 (9.8)557 (50.8)95 (8.8)

Unsolicited Adverse Events

In the following analyses of Study 2 in adolescents 12 through 15 years of age (1,131 of whom received Pfizer-BioNTech COVID-19 Vaccine and 1,129 of whom received placebo), 98.3% of study participants had at least 30 days of follow-up after Dose 2.

Serious Adverse Events

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 0.1% of placebo recipients. There were no notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.

Non-Serious Adverse Events

Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 5.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 5.8% of placebo recipients. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy plausibly related to the study intervention were imbalanced, with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (7) vs. the placebo group (1). There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.

6.2 Post Authorization Experience

The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

Cardiac Disorders: myocarditis, pericarditis

Gastrointestinal Disorders: diarrhea, vomiting

Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema)

Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm)

Nervous System Disorders: syncope


8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS7

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

7
Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.

Indications and Usage

1 AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused...

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 Preparation for Administration

...
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Dosage Forms and Strengths

3 DOSAGE FORMS AND STRENGTHS

Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. After preparation, a single dose is 0.3 mL.

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Contraindications

4 CONTRAINDICATIONS

Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech...

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Warnings and Precautions

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment used to manage immediate allergic...

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Adverse Reactions

6 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...

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Drug Interactions

10 DRUG INTERACTIONS

There are no data to assess the concomitant administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.

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Use in Specific Populations

11 USE IN SPECIFIC POPULATIONS

11.1 Pregnancy

Risk...

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Description

13 DESCRIPTION

The Pfizer-BioNTech COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials; each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to...

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Clinical Pharmacology

14 CLINICAL PHARMACOLOGY

14.1 Mechanism of Action

The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles,...

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Clinical Studies

18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA

18.1 Efficacy in Participants 16 Years of Age and Older

Study 2 is a multicenter,...

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How Supplied/Storage and Handling

19 HOW SUPPLIED/STORAGE AND HANDLING

Pfizer-BioNTech COVID-19 Vaccine Suspension for Intramuscular Injection, Multiple Dose Vials are supplied in a carton containing 25 multiple...

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Patient Counseling Information

20 PATIENT COUNSELING INFORMATION

Advise the recipient or caregiver to read the Vaccine Information Fact Sheet for Recipients and Caregivers.

The vaccination provider must include...

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Emergency Use Authorization Fact Sheet for Recipients and Caregivers

VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT COMIRNATY (COVID-19 VACCINE, mRNA) AND PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE...

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Fact Sheet For Healthcare Providers Administering Vaccine (Vaccination Providers)

FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS)

EMERGENCY...

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Contact Information

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION

21 CONTACT INFORMATION

For...

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Report Adverse Event