Publications

Revised: 9 March 2010

Response to Emma Bailey from the Timaru Herald requesting information on the 31 serious cases reported in association with Gardasil vaccine

Please attribute to Dr Joanne Hart, Manager, Clinical Risk Management, Medsafe

Up to 31 January 2010 the Centre for Adverse Reactions Monitoring (CARM) had received 242 reports of suspected adverse events associated with the Gardasil vaccine. The World Health Organisation (WHO) and the International Conference on Harmonisation (ICH) have published a definition of serious events. Using the criteria outlined below CARM consider that 31 cases were serious.

A serious adverse event or reaction is any untoward medical occurrence that:

In addition CARM considers that cases where the patient attended an Emergency Department or after-hours clinic to be serious.

Reporters are encouraged to report suspected adverse events to vaccines. In other words the reporter does not have to be sure that the vaccine caused the reaction, a mere suspicion will suffice. Therefore the reports received may be true adverse reaction to the vaccine, they may be events related to the process of vaccination rather than to the specific vaccine itself, or they may be coincidental events which have occurred post-vaccination but which would have occurred anyway even if vaccination had not taken place (e.g. they may be due to an underlying medical condition).

The term "severe" is not synonymous with serious, "severe" is used to describe the intensity (severity) of a specific event (as in mild, moderate or severe); the event itself, however, may be of relatively minor medical significance (such as headache).

Since the definition of a serious case is based on the outcome for the patient it is possible to have cases which mention the same type of events but can be defined as serious and non-serious in different cases.

Table 1. An overview of the 31 serious cases

  Number of reports
Death 1
Life-threatening 1
Intervention required 1
Hospitalisation 4
Persisting disability 4
Emergency department attendance 20


Please note that suspected adverse event reporting rates are highly variable and are dependent on many factors. Therefore these data cannot be used to determine the frequency of occurrence of adverse reactions to vaccines or medicines.

There was one report of sudden death, 6 months after the final vaccination. The cause of death is as yet undetermined.

The single life threatening report was of severe hypersensitivity reaction involving tongue swelling.

The intervention report described an injection site abscess that required surgical draining.

The four reports of hospitalization refer to:

  1. Systemic symptoms including diabetes and eye problems, both of which had been diagnosed prior to vaccination.
  2. Convulsions 2 weeks following vaccination
  3. Fainting episodes resulting in overnight observation
  4. Leukaemia reported, but not attributed to vaccination.

The four reports of persisting symptoms all refer to event still present at the time of reporting at least one month after vaccination.

  1. Three reports describe general symptoms of muscle aches, headache and fatigue
  2. One report of hair loss.

The 20 reports of emergency department attendance include:

  1. Nine reports of collapse/syncopal episodes (faints).
  2. Seven reports of allergic-type symptoms such as rash
  3. Two reports of convulsion-like episodes, occurring immediately following immunization and lasting longer that usually observed with a faint.
  4. One report of severe arm pain and swelling
  5. One report of Bell's Palsy (face paralysis) starting within one day of vaccination that may have been due to a recent infection.

A full summary of the 31 cases is given in the following table.

Table 2. Details of Reports Classified as Serious by CARM

Report Reactions Reason Regarded as Serious Patient Outcome at Time of Report
1 Arthropathy
Hypertension
Myalgia
Diabetes mellitus aggravated
Uveitis
Hospitalisation Not yet recovered
2 Convulsions Hospitalisation Recovered
3 Vasovagal reaction
Headache
Hospitalisation Not yet recovered
4 Leukaemia Hospitalisation Not yet recovered
5 Consciousness decreased
Hypotension
Nausea
Pupillary reflex impaired
Mydriasis
Emergency department attendance Recovered
6 Rash maculo-papular Emergency department attendance Recovered
7 Absences Emergency department attendance Recovered
8 Flushing
Nausea
Urticaria
Emergency department attendance Recovered
9 Papular rash Emergency department attendance Recovered
10 Consciousness decreased
Malaise
Gait abnormal
Emergency department attendance Recovered
11 Vasovagal reaction
Muscle contractions involuntary
Tremor
Tachycardia
Emergency department attendance Recovered
12 Consciousness decreased
Apnoea
Hypotension
Mydriasis
Emergency department attendance Recovered
13 Vasovagal reaction
Somnolence
Cyanosis peripheral
Consciousness decreased
Muscle contractions involuntary
Emergency department attendance Recovered
14 Nausea
Bronchospasm
Dyspnoea
Emergency department attendance Recovered
15 Dizziness
Headache
Rash
Angiodema
Emergency department attendance Recovered
16 Angiodema
Pruritis
Injection site erythema
Emergency department attendance Recovered
17 Chest pain Emergency department attendance Recovered
18 Bells palsy
Face oedema
Emergency department attendance Not yet recovered
19 Arm pain
Pain neck/shoulder
Injection site inflammation
Emergency department attendance Unknown
20 Convulsions grand mal Emergency department attendance Recovered
21 Fever
Headache
Dizziness
Chest tightness
Emergency department attendance Recovered
22 Dizziness
Hypoaesthesia
Temperature changed sensation
Respiratory disorder
Emergency department attendance Recovered
23 Syncope Emergency department attendance Recovered
24 Rash pruritic Emergency department attendance Recovered
25 Pallor
Nausea
Tongue swelling non-specific
Life threatening event Recovered
26 Injection site abscess Intervention required to prevent persisting disability Not yet recovered
27 Rigors
Insomnia
Anxiety
Fatigue
Persisting disability Not applicable
28 C-reactive protein positive
Paraesthesia
Headache
Fever
Myalgia
Persisting disability Not applicable
29 Paraesthesia
Lymphadenopathy
Arthralgia
Headache
Muscle weakness
Persisting disability Not applicable
30 Alopecia Persisting disability Not applicable
31 Paraesthesia
Cognitive function abnormal
Muscle weakness
Night sweats
Sudden death
Died Not applicable


ENDS