Applies to pneumococcal 13-valent vaccine: intramuscular suspension.
Serious side effects
Along with its needed effects, pneumococcal 13-valent vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking pneumococcal 13-valent vaccine:
More common
- Fever
Rare
- Chest pain
- chills
- coughing
- difficult or labored breathing
- difficulty with swallowing
- fast heartbeat
- noisy breathing
- seizures
- skin itching, rash, or redness
- sneezing
- sore throat
- swelling of the face, throat, or tongue
- tightness in the chest
Incidence not known
- Bladder pain
- blistering, peeling, or loosening of the skin
- bloody or cloudy urine
- bluish lips or skin
- body aches or pain
- choking
- confusion
- decreased urine output
- diarrhea
- difficult, burning, or painful urination
- dilated neck veins
- ear congestion
- extreme fatigue
- fainting
- frequent urge to urinate
- general feeling of discomfort or illness
- headache
- hives or itching
- irregular breathing
- irregular heartbeat
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lightheadedness
- loss of appetite
- loss of voice
- lower back or side pain
- muscle aches and pains
- nasal congestion
- nausea
- not breathing
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid, shallow breathing
- red, irritated eyes
- runny nose
- shivering
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- sweating
- swelling of the face, fingers, feet, or lower legs
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- trouble sleeping
- unusual tiredness or weakness
- vomiting
- weight gain
Other side effects
Some side effects of pneumococcal 13-valent vaccine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Decreased appetite
- decreased sleep
- irritability
- red streaks on the skin
- swelling, tenderness, or pain at the injection site
Rare
- Abdominal or stomach pain
- crying
- weakness
- welts
Incidence not known
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, rash, redness, scarring, soreness, stinging, tingling, ulceration, or warmth at the injection site
- burning, dry, or itching eyes
- eye discharge or excessive tearing
- pain
- stomach cramps
- tenderness
For Healthcare Professionals
Applies to pneumococcal 13-valent vaccine: intramuscular suspension.
General
The most common adverse events were local reactions, irritability, sleep changes, decreased appetite, and fever. Musculoskeletal events were common in adults.[Ref]
Local
Very common (10% or more): Local tenderness (89%), local redness (70%), local swelling (44.5%), induration (32.6%)
Uncommon (0.1% to 1%): Lymphadenopathy localized to the region of the vaccination site
Postmarketing reports: Vaccination site dermatitis, vaccination site urticaria, vaccination site pruritus[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Hypersensitivity reaction (including face edema, dyspnea, and bronchospasm)
Postmarketing reports: Anaphylactic/anaphylactoid reaction including shock[Ref]
Nervous system
Very common (10% or more): Headache (81.4%)
Uncommon (0.1% to 1%): Seizures (including febrile seizures)
Rare (less than 0.1%): Hypotonic-hyporesponsive episode[Ref]
Other
Very common (10% or more): Fever (43%), fatigue
Uncommon (0.1% to 1%): Crying
Rare (less than 0.1%): Sudden infant death syndrome[Ref]
Musculoskeletal
Very common (10% or more): New muscle pain (82%), aggravated muscle pain (55.9%), new joint pain (41.7%), chills (38.1%) aggravated joint pain (28.6%)[Ref]
Metabolic
Very common (10% or more): Decreased appetite (51%)[Ref]
Psychiatric
Very common (10% or more): Irritability (85.6%), increased sleep (71.5%), decreased sleep (45.6%)[Ref]
Gastrointestinal
Very common (10% or more): Vomiting (15%), diarrhea
Uncommon (0.1% to 1%): Gastroenteritis[Ref]
Dermatologic
Common (1% to 10%): Hives (urticaria), rash
Postmarketing reports: Flushing, angioedema, erythema multiforme[Ref]
Respiratory
Uncommon (0.1% to 1%): Bronchiolitis, pneumonia[Ref]
