Serious AEFI: Day 1

Student dies 75 minutes after HPV vaccination

Known medical facts

  • At 10:45 AM a 14-year-old girl receives an HPV vaccination along with other girls in her school,
  • At about 11:30 she collapses,
  • By noon she has died at the hospital,
  • There was no evidence of acute allergic reaction or cardiac arrest immediately after the immunization.

Local health department (NHS Coventry)

  • Informed the UK DH immunization director,
  • Informed the national drug regulator (MHRA) of an adverse event through the yellow card system,
  • Issued a brief press statement including facts of death, sympathies to family and friends, and announcing that an urgent and full investigation was being conducted.

Statement also warned that:

"No link can be made between the death and the vaccine until all the facts are known and a post-mortem takes place."

In the UK, health professionals and patients can report suspected drug side effects using the yellow card scheme website, run by the Me­di­ci­nes and Healthcare Products Re­gu­la­to­ry Agency (MHRA).

Once a yellow card is received by the agency, they can start an official inquiry.

National health department (UK DH)

  • Quarantined vaccine batch as a precautionary measure and alerted NHS directors,
  • Confirmed that MHRA had received yellow card and began investigation,
  • Issued press statement with facts of death and information on the vaccination programme,
  • Decided not to suspend vaccination programme during the investigation,
  • Decided not to assign a government spokesperson for interview requests or make any further statements until sufficient information was available.

There was concern that putting someone – for example, a health ministery official or government scientist – up for media interview carried more risks than benefits because they could potentially be forced into making statements that could be difficult to explain and easily misinterpreted.

If asked "can you categorically say the death was not caused by vaccination?" they couldn’t at that point say "not at all." And, in the light of this involving the tragic death of a child, any misstatement risked appearing insensitive.

School misinforms parents

Coventry school sent a letter to parents that said "an unfortunate incident occurred and one of the girls suffered a rare, but extreme reaction to the vaccine."

However, at this point the cause of death was unknown and it was impossible to say whether this tragedy was caused by a reaction to the vaccine.

Even though the school corrected this information on their website later that evening, it caused confusion and concern among the parents and media.

High media interest

  • High interest from media in the story,
  • Local and international evening broadcast news reports girl’s death shortly after receiving HPV vaccination.