Your Health. Your Family. Your Choice.
Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: This is a spontaneous report from a physician via the contactable regulatory authority received under the reference number GB-MHRA-ADR 22297675. A 5 month old female patient of an unspecified ethnicity started to receive PREVENAR 13 intramuscularly on 19Aug2013 at single dose, Men C vaccine (trade name unspecified) intramuscularly on 19Aug2013 at single dose and PEDIACEL intramuscularly on 19Aug2013 at single dose. Medical history included vitiligo and constipation. No congenital abnormalities were found. Healthy term baby with no past medical history of note. No relevant family history. Concomitant medication included macrogol, potassium chloride, sodium bicarbonate, MOVICOL. The patient had immunisations at 2:30pm. The patient was irritable at 7:30pm. at 8:30pm the patient was apnoeic leading to cardiac arrest that recovered at 9:10pm. The patient died due to severe hypoxic injury. No clear cause for collapse was ever found. There was no evidence of sepsis. Negative cultures and polymerase chain reaction reported. In the reporters opinion the events were considered serious due to being medically significant and fatal. Medically significant details: Collapse later that evening and cardiac arrest - cause of cardiac arrest is still unknown despite magnetic resonance imaging/toxicology/septic screen/metabolic screen. The patient did not receive a post mortem examination. Unclear whether the vaccinations played any part whatsoever in the collapse. In the opinion of the regulatory authority the events were considered serious for an unspecified reason. No follow-up attempts possible. No further information expected.
Copyright © 2020 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166