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Prevnar

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Prevnar

Prevnar Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (PCV) is used to prevent infection caused by pneumococcal bacteria. PCV is for use only in children between the ages of 6 weeks and 10 years. PCV contains 7 different types of pneumococcal bacteria. Common side effects include injection site reactions (e.g., pain, redness, swelling, hard lump), muscle/joint aches, or fever. Drowsiness, irritability, loss of appetite, nausea, or diarrhea may also occur.

The dose of Prevnar is 0.5 mL given intramuscularly. Consult your doctor for the vaccination schedule. Prevnar may interact with steroids, medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, or medicines to treat or prevent organ transplant rejection. Tell your doctor all medications or supplements your child uses, and all vaccines they recently received. This product is not usually used in adults. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have questions.

Our Prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Prevnar in Detail - Patient Information: Side Effects

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if you or your child has a serious side effect such as:

  • high fever (103 degrees or higher);
  • seizure (convulsions);
  • wheezing, trouble breathing;
  • easy bruising or bleeding; or
  • severe pain, itching, irritation, or skin changes where the shot was given.

Less serious side effects may include:

  • mild redness, swelling, tenderness, or a hard lump where the shot was given;
  • weakness, tired feeling;
  • crying, fussiness;
  • drowsiness, restless sleep;
  • low fever (102 degrees or less);
  • vomiting, diarrhea, loss of appetite; or
  • mild skin rash.

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.

Read the entire detailed patient monograph for Prevnar (Pneumococcal 7-valent Conjugate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Prevnar Overview - Patient Information: Side Effects

SIDE EFFECTS: Injection site reactions (e.g., pain, redness, swelling, hard lump), muscle/joint aches, or fever may occur. Ask your doctor about taking a fever/pain reducer (e.g., acetaminophen) to help treat these symptoms. Drowsiness, irritability, loss of appetite, nausea, or diarrhea may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Infrequently, temporary symptoms such as fainting/dizziness/lightheadedness, vision changes, numbness/tingling, or seizure-like movements have happened after vaccine injections. Tell your health care provider right away if you have any of these symptoms soon after receiving an injection. Sitting or lying down may relieve symptoms.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Prevnar (Pneumococcal 7-valent Conjugate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Prevnar FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Pre-Licensure Clinical Trial Experience

The majority of the safety experience with Prevnar (pneumococcal 7-valent conjugate) ® comes from the NCKP Efficacy Trial in which 17,066 infants received 55,352 doses of Prevnar (pneumococcal 7-valent conjugate) ®, along with other routine childhood vaccines through April 1998 (see CLINICAL PHARMACOLOGY section). The number of Prevnar (pneumococcal 7-valent conjugate) ® recipients in the safety analysis differs from the number included in the efficacy analysis due to the different lengths of follow-up for these study endpoints. Safety was monitored in this study using several modalities. Local reactions and systemic events occurring within 48 hours of each dose of vaccine were ascertained by scripted telephone interview on a randomly selected subset of approximately 3,000 children in each vaccine group. The rate of relatively rare events requiring medical attention was evaluated across all doses in all study participants using automated databases. Specifically, rates of hospitalizations within 3, 14, 30, and 60 days of immunization, and of emergency room visits within 3, 14, and 30 days of immunization were assessed and compared between vaccine groups for each diagnosis. Seizures within 3 and 30 days of immunization were ascertained across multiple settings (hospitalizations, emergency room or clinic visits, telephone interviews). Deaths and SIDS were ascertained through April 1999. Hospitalizations due to diabetes, autoimmune disorders, and blood disorders were ascertained through August 1999. (See also Postmarketing Experience.)

In Table 6 the rate of local reactions at the Prevnar (pneumococcal 7-valent conjugate) ® injection site is compared at each dose to the DTaP injection site in the same children.

TABLE 6: Percentage of Subjects Reporting Local Reactions Within 2 Days Following Immunization With Prevnar (pneumococcal 7-valent conjugate) ®* and DTaP Vaccines at 2, 4, 6, and 12-15 Months of Age20,21

Reaction Dose 1 Dose 2 Dose 3 Dose 4
Prevnar ® Site DTaP Site Prevnar ®Site DTaP Site Prevnar ® Site DTaP Site Prevnar ® Site DTaP Site
N=693 N=693 N=526 N=526 N=422 N=422 N=165 N=165
Erythema
  Any 10.0 6.7§ 11.6 10.5 13.8 11.4 10.9 3.6§
   > 2.4 cm 1.3 0.4§ 0.6 0.6 1.4 1.0 3.6 0.6
Induration
  Any 9.8 6.6§ 12.0 10.5 10.4 10.4 12.1 5.5§
   > 2.4 cm 1.6 0.9 1.3 1.7 2.4 1.9 5.5 1.8
Tenderness
  Any 17.9 16.0 19.4 17.3 14.7 13.1 23.3 18.4
  Interfered with limb movement 3.1 1.8§ 4.1 3.3 2.9 1.9 9.2 8.0
* HbOC was administered in the same limb as Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Prevnar (pneumococcal 7-valent conjugate) ®. If reactions occurred at either or both sites on that limb, the more severe reaction was recorded.
If Hep B vaccine was administered simultaneously, it was administered into the same limb as DTaP. If reactions occurred at either or both sites on that limb, the more severe reaction was recorded.
Subjects may have received DTP or a mixed DTP/DTaP regimen for the primary series. Thus, this is the 4th dose of a pertussis vaccine, but not a 4th dose of DTaP.
§ p < 0.05 when Prevnar (pneumococcal 7-valent conjugate) ® site compared to DTaP site using the sign test.

Table 7 presents the rates of local reactions in previously unvaccinated older infants and children.

TABLE 7: Percentage of Subjects Reporting Local Reactions Within 3 Days of Immunization With Prevnar (pneumococcal 7-valent conjugate) ® in Infants and Children from 7 Months Through 9 Years of Age31

Age at 1st Vaccination 7 - 11 Mos. 12 -23 Mos. 24 - 35 Mos. 36 - 59 Mos. 5 - 9 Yrs.
Study No. 118-12 118-16 118 - 9* 118-18 118 - 18 118 - 18 118 - 18
Dose Number 1 2 3 1 2 3 1 1 2 1 1 1
Number of Subjects 54 51 24 81 76 50 60 114 117 46 48 49
Reaction
Erythema  
  Any 16.7 11.8 20.8 7.4 7.9 14.0 48.3 10.5 9.4 6.5 29.2 24.2
  >2.4 cm 1.9 0.0 0.0 0.0 0.0 0.0 6.7 1.8 1.7 0.0 8.3 7.1
Induration                        
  Any 16.7 11.8 8.3 7.4 3.9 10.0 48.3 8.8 6.0 10.9 22.9 25.5
  >2.4 cm 3.7 0.0 0.0 0.0 0.0 0.0 3.3 0.9 0.9 2.2 6.3 9.3
Tenderness                        
Any 13.0 11.8 12.5 8.6 10.5 12.0 46.7 25.7 26.5 41.3 58.3 82.8
Interfered with limb movement § 1.9 2.0 4.2 1.2 1.3 0.0 3.3 6.2 8.5 13.0 20.8 39.4
* For 118-9, 2 of 60 subjects were ≥ 24 months of age.
For 118-12, dose 3 was administered at 15 - 18 mos. of age. For 118-16, dose 3 was administered at 12 - 15 mos. of age.
For 118-16 and 118-18, ≥ 2 cm.
§ Tenderness interfering with limb movement.

Table 8 presents the rate of systemic events observed in the efficacy study when Prevnar (pneumococcal 7-valent conjugate) ® was administered concomitantly with DTaP.

TABLE 8: Percentage of Subjects* Reporting Systemic Events Within 2 Days Following Immunization With Prevnar (pneumococcal 7-valent conjugate) ® or Control Vaccine Concurrently With DTaP Vaccine at 2, 4, 6, and 12-15 Months of Age20,21

Reaction Dose 1 Dose 2 Dose 3 Dose 4
Prevnar® Control Prevnar® Control Prevnar® Control Prevnar® Control
N=710 N=711 N=559 N=508 N=461 N=414 N=224 N=230
Fever
   ≥ 38.0°C 15.1 9.4§ 23.9 10.8§ 19.1 11.8§ 21.0 17.0
   > 39.0°C 0.9 0.3 2.5 0.8§ 1.7 0.7 1.3 1.7
Irritability 48.0 48.2 58.7 45.3§ 51.2 44.8 44.2 42.6
Drowsiness 40.7 42.0 25.6 22.8 19.5 21.9 17.0 16.5
Restless Sleep 15.3 15.1 20.2 19.3 25.2 19.0§ 20.2 19.1
Decreased Appetite 17.0 13.5 17.4 13.4 20.7 13.8§ 20.5 23.1
Vomiting 14.6 14.5 16.8 14.4 10.4 11.6 4.9 4.8
Diarrhea 11.9 8.4§ 10.2 9.3 8.3 9.4 11.6 9.2
Urticaria-like Rash 1.4 0.3§ 1.3 1.4 0.4 0.5 0.5 1.7
* Approximately 75% of subjects received prophylactic or therapeutic antipyretics within 48 hours of each dose.
Investigational meningococcal group C conjugate vaccine (MnCC).
Most of these children had received DTP for the primary series. Thus, this is a 4th dose of a pertussis vaccine, but not of DTaP.
§ p < 0.05 when Prevnar (pneumococcal 7-valent conjugate) ® compared to control group using a Chi-Square test.

Table 9 presents results from a second study (Manufacturing Bridging Study) conducted at Northern California and Denver Kaiser sites, in which children were randomized to receive one of three lots of Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197Protein), Prevnar (pneumococcal 7-valent conjugate) ®, with concomitant vaccines including DTaP, or the same concomitant vaccines alone. Information was ascertained by scripted telephone interview, as described above.

TABLE 9: Percentage of Subjects* Reporting Systemic Reactions Within 3 Days Following Immunization With Prevnar (pneumococcal 7-valent conjugate) ®, DTaP, HbOC, Hep B, and IPV vs. Control In Manufacturing Bridging Study25

Reaction Dose 1 Dose 2 Dose 3
Prevnar ® Control Prevnar ® Control Prevnar ® Control
N=498 N=108 N=452 N=99 N=445 N=89
Fever
> 38.0°C 21.9 10.2 33.6 17.2 28.1 23.6
> 39.0°C 0.8 0.9 3.8 0.0 2.2 0.0
Irritability 59.7 60.2 65.3 52.5 54.2 50.6
Drowsiness 50.8 38.9 30.3 31.3 21.2 20.2
Decreased Appetite 19.1 15.7 20.6 11.1 20.4 90
* Approximately 72% of subjects received prophylactic or therapeutic antipyretics within 48 hours of each dose.
Control group received concomitant vaccines only in the same schedule as the Prevnar (pneumococcal 7-valent conjugate) ® group (DTaP, HbOC at dose 1, 2, 3; IPV at doses 1 and 2; Hep B at doses 1 and 3).
p < 0.05 when Prevnar (pneumococcal 7-valent conjugate) ® compared to control group using Fisher's Exact test.

Fever ( ≥ 38.0°C) within 48 hours of a vaccine dose was reported by a greater proportion of subjects who received Prevnar (pneumococcal 7-valent conjugate) ®, compared to control (investigational meningococcal group C conjugate vaccine [MnCC]), after each dose when administered concurrently with DTP-HbOC or DTaP in the efficacy study. In the Manufacturing Bridging Study, fever within 48-72 hours was also reported more commonly after each dose compared to infants in the control group who received only recommended vaccines. When administered concurrently with DTaP in either study, fever rates among Prevnar (pneumococcal 7-valent conjugate) ® recipients ranged from 15% to 34%, and were greatest after the 2nd dose.

Table 10 presents the frequencies of systemic reactions in previously unvaccinated older infants and children.

TABLE 10: Percentage of Subjects Reporting Systemic Reactions Within 3 Days of Immunization With Prevnar (pneumococcal 7-valent conjugate) ® in Infants and Children from 7 Months Through 9 Years of Age31

Age at 1 st Vaccination 7 - 11 Mos. 12 -23 Mos. 24 - 35 Mos. 36 - 59 Mos 5 - 9 Yrs.
Study No. 118 -12 118 -16 118 - 9* 118-18 118 -18 118 -18 118 - 18
Dose Number 1 2 3 1 2 3 1 1 2 1 1 1
Number of Subjects 54 51 24 85 80 50 60 120 117 47 52 100
Reaction
Fever
   ≥ 38.0°C
20.8 21.6 25.0 17.6 18.8 22.0 36.7 11.7 6.8 14.9 11.5 7.0
  >39.0°C 1.9 5.9 0.0 1.6 3.9 2.6 0.0 4.4 0.0 4.2 2.3 1.2
Fussiness 29.6 39.2 16.7 54.1 41.3 38.0 40.0 37.5 36.8 46.8 34.6 29.3
Drowsiness 11.1 17.6 16.7 24.7 16.3 14.0 13.3 18.3 11.1 12.8 17.3 11.0
Decreased Appetite 9.3 15.7 0.0 15.3 15.0 30.0 25.0 20.8 16.2 23.4 11.5 9.0
* For 118-9, 2 of 60 subjects were ≥ 24 months of age.
For 118-12, dose 3 was administered at 15 - 18 mos. of age. For 118-16, dose 3 was administered at 12 - 15 mos. of age.

Of the 17,066 subjects who received at least one dose of Prevnar (pneumococcal 7-valent conjugate) ® in the efficacy trial, there were 24 hospitalizations (for 29 diagnoses) within 3 days of a dose from October 1995 through April 1998. Diagnoses were as follows: bronchiolitis (5); congenital anomaly (4); elective procedure, UTI (3 each); acute gastroenteritis, asthma, pneumonia (2 each); aspiration, breath holding, influenza, inguinal hernia repair, otitis media, febrile seizure, viral syndrome, well child/reassurance (1 each). There were 162 visits to the emergency room (for 182 diagnoses) within 3 days of a dose from October 1995 through April 1998. Diagnoses were as follows: febrile illness (20); acute gastroenteritis (19); trauma, URI (16 each); otitis media (15); well child (13); irritable child, viral syndrome (10 each); rash (8); croup, pneumonia (6 each); poisoning/ingestion (5); asthma, bronchiolitis (4 each); febrile seizure, UTI (3 each); thrush, wheezing, breath holding, choking, conjunctivitis, inguinal hernia repair, pharyngitis (2 each); colic, colitis, congestive heart failure, elective procedure, hives, influenza, ingrown toenail, local swelling, roseola, sepsis (1 each).20,21

In the large-scale efficacy study, urticaria-like rash was reported in 0.4%-1.4% of children within 48 hours following immunization with Prevnar (pneumococcal 7-valent conjugate) ® administered concurrently with other routine childhood vaccines. Urticaria-like rash was reported in 1.3%-6% of children in the period from 3 to 14 days following immunization, and was most often reported following the fourth dose when it was administered concurrently with MMR vaccine. Based on limited data, it appears that children with urticaria-like rash after a dose of Prevnar (pneumococcal 7-valent conjugate) ® may be more likely to report urticaria-like rash following a subsequent dose of Prevnar (pneumococcal 7-valent conjugate) ®.

One case of a hypotonic-hyporesponsive episode (HHE) was reported in the efficacy study following Prevnar (pneumococcal 7-valent conjugate) ® and concurrent DTP vaccines in the study period from October 1995 through April 1998. Two additional cases of HHE were reported in four other studies and these also occurred in children who received Prevnar (pneumococcal 7-valent conjugate) ® concurrently with DTP vaccine.27,30

In the Kaiser efficacy study in which 17,066 children received a total of 55,352 doses of Prevnar (pneumococcal 7-valent conjugate) ® and 17,080 children received a total of 55,387 doses of the control vaccine (investigational meningococcal group C conjugate vaccine [MnCC]), seizures were reported in 8 Prevnar (pneumococcal 7-valent conjugate) ® recipients and 4 control vaccine recipients within 3 days of immunization from October 1995 through April 1998. Of the 8 Prevnar (pneumococcal 7-valent conjugate) ® recipients, 7 received concomitant DTP-containing vaccines and one received DTaP. Of the 4 control vaccine recipients, 3 received concomitant DTP-containing vaccines and one received DTaP.20,21 In the other 4 studies combined, in which 1,102 children were immunized with 3,347 doses of Prevnar (pneumococcal 7-valent conjugate) ® and 408 children were immunized with 1,310 doses of control vaccine (either investigational meningococcal group C conjugate vaccine [MnCC] or concurrent vaccines), there was one seizure event reported within 3 days of immunization.28 This subject received Prevnar (pneumococcal 7-valent conjugate) ® concurrent with DTaP vaccine.

Twelve deaths (5 SIDS and 7 with clear alternative cause) occurred among subjects receiving Prevnar (pneumococcal 7-valent conjugate) ®, of which 11 (4 SIDS and 7 with clear alternative cause) occurred in the Kaiser efficacy study from October 1995 until April 20, 1999. In comparison, 21 deaths (8 SIDS, 12 with clear alternative cause and one SIDS-like death in an older child), occurred in the control vaccine group during the same time period in the efficacy study.20,21,25 The number of SIDS deaths in the efficacy study from October 1995 until April 20, 1999 was similar to or lower than the age and season-adjusted expected rate from the California State data from 1995-1997 and are presented in Table 11.

TABLE 11: Age and Season-Adjusted Comparison of SIDS Rates in the NCKP Efficacy Trial With the Expected Rate from the California State Data for 1995-199720,21

Vaccine < One Week After Immunization ≤ Two Weeks After Immunization ≤ One Month After Immunization ≤ One Year After Immunization
Exp Obs Exp Obs Exp Obs Exp Obs
Prevnar® 1.06 1 2.09 2 4.28 2 8.08 4
Control* 1.06 2 2.09 3 4.28 3 8.08 8
* Investigational meningococcal group C conjugate vaccine (MnCC).
Does not include one additional case of SIDS-like death in a child older than the usual SIDS age (448 days).

In a review of all hospitalizations that occurred between October 1995 and August 1999 in the efficacy study for the specific diagnoses of aplastic anemia, autoimmune disease, autoimmune hemolytic anemia, diabetes mellitus, neutropenia, and thrombocytopenia, the numbers of such cases were equal to or less than the expected numbers based on the 1995 Kaiser Vaccine Safety Data Link (VSD) data set.

Overall, the safety of Prevnar (pneumococcal 7-valent conjugate) ® was evaluated in a total of five clinical studies in the US in which 18,168 infants and children received a total of 58,699 doses of vaccine at 2, 4, 6, and 12-15 months of age. In addition, the safety of Prevnar (pneumococcal 7-valent conjugate) ® was evaluated in 831 Finnish infants using the same schedule, and the overall safety profile was similar to that in US infants. The safety of Prevnar (pneumococcal 7-valent conjugate) ® was also evaluated in 560 children from 4 ancillary studies in the US who started immunization at 7 months to 9 years of age. Tables 12 and 13 summarize systemic reactogenicity data within 2 or 3 days across 4,748 subjects in US studies (3,848 infant doses and 997 toddler doses) for whom these data were collected and according to the pertussis vaccine administered concurrently.

TABLE 12: Overall Percentage of Doses Associated With Systemic Events Within 2 or 3 Days For The US Efficacy Study and All US Ancillary Studies When Prevnar (pneumococcal 7-valent conjugate) ® Administered To Infants As a Primary Series at 2, 4, and 6 Months of Age20,21,25,27,28,29

Systemic Event Prevnar (pneumococcal 7-valent conjugate) ® Concurrently With DTaP and HbOC (3,848 Doses) DTaP and HbOC Control (538 Doses)
Fever
   ≥ 38.0°C 21.1 14.2
   > 39.0°C 1.8 0.4
Irritability 52.5 45.2
Drowsiness 32.9 27.7
Restless Sleep 20.6 22.3
Decreased Appetite 18.1 13.6
Vomiting 13.4 9.8
Diarrhea 9.8 4.4
Urticaria-like Rash 0.6 0.3
Total from which reaction data are available varies between reactions from 3,121-3,848 doses. Data from studies 118-8, 118-12, 118-16.
Total from which reaction data are available varies between reactions from 295-538 doses. Data from studies 118-12 and 118-16.

TABLE 13: Overall Percentage of Doses Associated With Systemic Events Within 2 or 3 Days For The US Efficacy Study and All US Ancillary Studies When Prevnar (pneumococcal 7-valent conjugate) ® Administered To Toddlers as a Fourth Dose At 12 to 15 Months of Age20,21,27

Systemic Event Prevnar (pneumococcal 7-valent conjugate) ® Concurrently With DTaP and HbOC (270 Doses) Prevnar (pneumococcal 7-valent conjugate) ® OnlyNo Concurrent Vaccines (727 Doses)
Fever
   ≥ 38.0°C 19.6 13.4
   > 39.0°C 1.5 1.2
Irritability 45.9 45.8
Drowsiness 17.5 15.9
Restless Sleep 21.2 21.2
Decreased Appetite 21.1 18.3
Vomiting 5.6 6.3
Diarrhea 13.7 12.8
Urticaria-like Rash 0.7 1.2
Total from which reaction data are available varies between reactions from 269-270 doses. Data from studies 118-7 and 118-8.
Total from which reaction data are available varies between reactions from 725-727 doses. Data from studies 118-7 and 118-8.

With vaccines in general, including Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Prevnar (pneumococcal 7-valent conjugate) ®, it is not uncommon for patients to note within 48 to 72 hours at or around the injection site the following minor reactions: edema; pain or tenderness; redness, inflammation or skin discoloration; mass; or local hypersensitivity reaction. Such local reactions are usually self-limited and require no therapy.

As with other aluminum-containing vaccines, a nodule may occasionally be palpable at the injection site for several weeks.40

Postmarketing Experience

Additional adverse reactions identified from postmarketing experience are listed below:

Administration site conditions: injection site dermatitis, injection site urticaria, injection site pruritus

Blood and lymphatic system disorders: lymphadenopathy localized to the region of the injection site

Immune system disorders: hypersensitivity reaction including face edema, dyspnea, bronchospasm; anaphylactic/anaphylactoid reaction including shock

Psychiatric disorders: crying

Skin and subcutaneous tissue disorders: angioneurotic edema, erythema multiforme

There have been spontaneous reports of apnea in temporal association with the administration of Prevnar (pneumococcal 7-valent conjugate) . In most cases Prevnar (pneumococcal 7-valent conjugate) was administered concomitantly with other vaccines including DTP, DTaP, hepatitis B vaccines, IPV, Hib, MMR, and/or varicella vaccine. In addition, in most of the reports existing medical conditions such as history of apnea, infection, prematurity, and/or seizure were present.

Postmarketing Observational Safety Surveillance Study

Safety outcomes were evaluated in an observational study that included 65,927 infants. Primary safety outcomes analyses included an evaluation of pre-defined adverse events occurring in temporal relationship to immunization. Rates of adverse events occurring within various time periods post-vaccination (e.g., 0-2, 0-7, 0-14, 0-30 days) were compared to the rates of those events occurring within a control time window (i.e., 31-60 days). Secondary safety outcomes analyses included comparisons to a historical control population of infants (1995-1996, N=40,223) prior to the introduction of Prevnar (pneumococcal 7-valent conjugate) ®. In addition, the study included extended follow-up of subjects originally enrolled in the NCKP efficacy trial (N=37,866).

The primary safety outcomes analyses did not demonstrate a consistently elevated risk of healthcare utilization for croup, gastroenteritis, allergic reactions, seizures, wheezing diagnoses, or breath-holding across doses, health care settings, or multiple time windows. As in pre-licensure trials, fever was associated with Prevnar (pneumococcal 7-valent conjugate) ® administration. In analyses of secondary safety outcomes, the adjusted relative risk of hospitalization for reactive airways disease was 1.23 (95% CI: 1.11, 1.35). Potential confounders, such as differences in concomitantly administered vaccines, yearly variation in respiratory infections, or secular trends in reactive airways disease incidence, could not be controlled. Extended follow-up of subjects originally enrolled in the NCKP efficacy trial revealed no increased risk of reactive airways disease among Prevnar (pneumococcal 7-valent conjugate) ® recipients. In general, the study results support the previously described safety profile of Prevnar (pneumococcal 7-valent conjugate) ®.41,42

Adverse Event Reporting

Any suspected adverse events following immunization should be reported by the healthcare professional to the US Department of Health and Human Services (DHHS). The National Vaccine Injury Compensation Program requires that the manufacturer and lot number of the vaccine administered be recorded by the healthcare professional in the vaccine recipient's permanent medical record (or in a permanent office log or file), along with the date of administration of the vaccine and the name, address, and title of the person administering the vaccine.

The US DHHS has established the Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine including, but not limited to, the reporting of events required by the National Childhood Vaccine Injury Act of 1986. The FDA VAERS web site is: http://www.fda.gov/cber/vaers/vaers.htm.

The VAERS toll-free number for VAERS forms and information is 800-822-7967.43

Read the entire FDA prescribing information for Prevnar (Pneumococcal 7-valent Conjugate) »

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Prevnar - User Reviews

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