Revised: 9 March 2010

Publications

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:

• Results in death
• Is life-threatening
• Requires inpatient hospitalization or prolongation of existing hospitalisation
• Results in persistent or significant disability/incapacity
• Requires intervention to prevent permanent disability/ incapacity
• Results in a congenital anomaly

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