DTaP "INFANRIX" - INSERT VS. VIS

DTaP "INFANRIX" made by vaccine manufacturer GlaxoSmithKline. On this page you will see the difference between the Adverse Reactions listed on the Vaccine Information Sheet "VIS" (that you receive before vaccinations) and the Adverse Reactions listed on the Manufacturers Insert (that you do not receive)


ADVERSE REACTIONS LISTED ON VIS

Fever / Redness or swelling where the shot was given / Soreness or tenderness where the shot was given / Fussiness / Tiredness / Poor Appetite / Vomiting / Seizure / Non-stop crying, for 3 hours or more / High fever, over 105°F / Serious allergic reaction / Coma / Lowered Consciousness / Permanent Brain Damage


ADVERSE REACTIONS

* Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. There is the possibility that broad use of INFANRIX could reveal adverse reactions not observed in clinical trials. Data on solicited local reactions and general adverse events were collected by parents using standardized diary cards for 4 consecutive days following each vaccine dose (i.e., day of vaccination and the next 3 days)


LOCAL

1. INJECTION-SITE PAIN (pain, redness, swelling)

2. REDNESS

3. SWELLING

4. INCREASE IN MID-THIGH CIRCUMFERENCE

5. INCREASE IN ARM CIRCUMFERENCE

GENERAL

1. FEVER

2. DROWSINESS

3. IRRITABILITY

4. FUSSINESS

5. LOSS OF APPETITE

6. FEVER

7. HYPOTONIC- HYPORESPONSIVE EPISODES (sudden onset of poor muscle tone, reduced consciousness, and pale or bluish skin occurring within 48 hours after vaccination, most commonly pertussis vaccination)

8. PERSISTENT CRYING

9. SEIZURES