2010年4月に、オランダのStokivisさんが、Vaers のデータを調べて、欧州との報告と比較し、Vaers のデータベースに載っているべきなのに載っていない副反応について、Vaers の担当者に質問しています。
この時点で、ドイツでは5件の死亡例が報告されていました。
http://www.verontrustemoeders.nl/Questions%20Regarding%20Gardasil%20and%20Cervarix.pdf
また、２００９年９月にサーバリックス接種直後に亡くなったイギリスの女の子の症例では、検死の結論が翌日に発表されており、肺に腫瘍があり、サーバリックスと死亡との関連が否定されましたが、この関連否定が早急なのではないかという疑問が呈されており、少女は当日も学校に通うほどの健康状態だったことが強調されています。検死の結論がでるのは通常は数カ月後ということです。
また、イギリスではワクチンで起こるアナフィラキシーは、100万接種に1回程度です。
オーストラリアのガーダシルでは、100万接種に2.2回
イギリスのサーバリックスでは、350万接種で、42回報告があり、
サーバリックスではアレルギーについての警告が必要ではないかと提案しています。
Vaersのサーバリックスのデータを解析したところ、アナフィラキシーが起こったケースでは、患者の既往症に他のアレルギー疾患の記載が多くみられたということで、表にしてあります。
その中で、祖母がラテックスアレルギーという症例が以下のエントリーにあります。
VAERS ID:
| |
362373 (history) |
Vaccinated: |
2009-10-05 |
| Age: |
16.0 |
Onset: |
2009-10-05, Days after vaccination: 0 |
| Gender: |
Female |
Submitted: |
2009-10-22, Days after onset: 17 |
| Location: |
Foreign |
Entered: |
2009-10-22 |
| |
| Life Threatening? No |
| Died? No |
| Permanent Disability? No |
| Recovered? No |
| ER or Doctor Visit? No |
| Hospitalized? No |
| Previous Vaccinations: |
| Other Medications: |
| Current Illness: Unknown |
| Preexisting Conditions: Allergy; The subject was reported to be allergic to a plant bulb as a young child. The subject''s grandmother was extremely allergic to latex. |
| Diagnostic Lab Data: UNK |
| CDC Split Type: B0597386A |
|
| Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
| HPV2: HPV (CERVARIX) |
GLAXOSMITHKLINE BIOLOGICALS |
AHPVA055AG |
0 |
UN |
UN |
|
| Administered by: Other Purchased by: Other |
Symptoms: Anaphylactic reaction, Anaphylactic shock, Chest discomfort, Confusional state, Dizziness, Dyspnoea, Fatigue, Lip swelling, Malaise, Migraine, Ocular hyperaemia, Panic reaction, Rash, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad) |
| Write-up: This case was reported by a consumer (patient''s father) and described the occurrence of anaphylactic shock in a 16-year-old female patient who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not yet verified this report. On 05 October 2009 the subject received the 1st dose of CERVARIX (1 injection). On 05 October 2009, within 10 minutes after vaccination with CERVARIX, the subject experienced anaphylactic shock. The subject was treated with adrenaline on site and then taken to hospital where she was administered steroids and antihistamines. The patient was discharged four hours later and advised to continue with steroids and antihistamines at home. On 08 October 2009, approximately 3 days after vaccination with CERVARIX, the subject experienced a "milder form" of an anaphylactic reaction and symptoms included rash, lip swelling, swelling of tongue and light headedness. The patient was treated with antihistamines. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. Verbatim text received: On the 8th October 2009 a father reported that his 16 years old daughter had been administered a first dose of CERVARIX on the 5th October 2009. Within ten minutes of being administered the vaccine, the patient was reported to have experienced an anaphylactic shock and received adrenaline on site. The patient was taken to hospital where she was administered steroids and antihistamines. The patient was discharged four hours later and advised to continue with steroids and antihistamines at home. On the 8th October 2009 the patient was reported have experienced a ''milder form'' of an anaphylactic reaction. The symptoms of this reaction were reported as a rash, swelling of the lips and tongue and light headedness. Following this the patient was taken back to hospital and given antihistamines. The symptoms had all resolved at the time of reporting. The patient was reported to have no other medical condition or known allergies. There was |
|
The subject''s grandmother was extremely allergic to latex.
患者の祖母は、ラテックスに極度のアレルギーを有する。
患者は、1回目のサーバリックスの10分後に、アナフィラキシーショック、その場でアドレナリンで処置、すぐに病院へ行き、そこでステロイドと抗ヒスタミン剤で処置。
3日後、軽度のアナフィラキシー反応を起こす。発疹、口唇腫脹、舌腫脹、意識朦朧。抗ヒスタミン剤で処置。
この症例は、GSKにより医学的に重篤であると評価された。
