IDNUMBER=363699
GB-MHRA-ADR 20510229
Biopsy lymph gland, Immunisation reaction, Lymphadenopathy, Ultrasound scan
Pre-existing illness - ear pain. Concurrent medications. Advised reactive change linked to the vaccination. Medically significant: lymph nodes cervical swollen.
> 5 weeks
IDNUMBER=364041
GB-MHRA-ADR 20511082
Back pain
0 days after vaccination
> 22 days
IDNUMBER=364042
GB-MHRA-ADR 20511059
Folliculitis, Rash follicular
Concurrent medications
> 40 days
IDNUMBER=364512
GB-MHRA-ADR 20510993
Dyskinesia (orofacial)
0 days after vaccinations. Concurrent medications
> 47 days
IDNUMBER=364862
GB-MHRA-ADA 20511133
Fatigue, Full blood count normal, Immunisation reaction, Laboratory test normal, Myalgia, Red blood cell sedimentation rate normal
0-1 day after vaccination
> 46 days
Disabling
IDNUMBER=364863
GB-MHRA-ADR 20511717
Areflexia, Blood immunoglobulin E increased, Demyelinating polyneuropathy, Eosinophil count increased, Eosinophilia, Guillain-Barre syndrome, Muscular weakness, Nerve conduction studies abnormal, Somatoform disorder
0-7 days after vaccination
> 7 months
Disabling
IDNUMBER=365490
GB-MHRA-ADR 20512525
Pruritus, Rash generalised
4 days after vaccination
> 11 days
IDNUMBER=365491
GB-MHRA-ADR 205131B3
Complex regional pain syndrome, Oedema peripheral
0 days after vaccination
> 44 days
Disabling
IDNUMBER=367210
GB-MHRA-ADR 20517889
Asthenia, Dizziness, Headache, Nausea
1 day after vaccination
> 45 days
IDNUMBER=368528
GB-MHRA-ADR-20522503
Headache, Lumbar puncture normal, Neurological examination normal, Nuclear magnetic resonance imaging brain normal, Photophobia
1 day after vaccination. Pre-existing illness - asthma
> 20 days
IDNUMBER=369979
GB-MHRA-ADR 20525521
Chest discomfort, Dyspnoea, Feeling cold, Oedema peripheral
Submitted 13 days after onset. Not recovered. Pre-existing condition: colostomy
> 13 days
Life threatening
IDNUMBER=369982
GB-MHRA-ADR 20526001
Condition aggravated, Convulsion, Syncope
Pre-existing conditions: faint, seizure
0 days after vaccination
IDNUMBER=370667
GB-MHRA-ADR 20528079
Epilepsy
2 days after vaccination. Pre-existing conditions: faint, syncope
Had 1st epileptic fit 2 days after receiving the 2nd dose of CERVARIX. Was admitted overnight for observation. Had 2nd fit the next night.
IDNUMBER=371043
GB-MHRA-ADR 20528862
Asthenia, Fatigue, Vaginal lesion, Viral infection
approx.2 days after vaccination
> 14 days
IDNUMBER=372659
GB-MHRA-ADR 205321122
Encephalitis
Anti-NDMA Encephalitis
0 days after vaccination
> 6 months hospitalised
IDNUMBER=372888
GB-MHRA-ADR 20341756
Convulsion, Intensive care, Status epilepticus
ITU for 3 nights and 5 nights in hospital
2 days after vaccination. Follow-up information: The regulatory authority reported that the status epilepticus was related to CERVARIX
> 8 days
IDNUMBER=374101
GB-MHRA-ADR 20536682
Alopecia
'Child will not go to school due to embarrassment.'
'Allopecia (hair loss) is a common symptom with the HPV vaccines, especially Gardasil': F Birrell
> 23 days
IDNUMBER=374108
GB-MHRA-ADR 20472224
Abscess, Aggression, Agitation, Anxiety, Arthropathy, Autoimmune disorder, Blood product transfusion, Blood test abnormal, Brain injury, Confusional state, Convulsion, Crying, Disorientation, Disturbance in attention, Dysgraphia, Dyspnoea, Electroencephalogram, Emotional disorder, Encephalitis, Epilepsy, Fatigue, Feeling hot, Groin abscess, Hallucination, auditory, Headache, Hyperhidrosis, Hypotension, Insomnia, Logorrhoea, Loss of consciousness, Lumbar puncture, Malaise, Mood disorder due to a general medical condition, Muscle spasms, Nuclear magnetic resonance imaging normal, Panic attack, Partial seizures, Pyrexia, Trichotillomania, Unresponsive to stimuli, Urinary incontinence, Vomiting.
4 days after 3rd vaccination seizures. Also diagnosed with Anti-NMDA Receptor Encephalitis
> Hospitalised for 8 weeks, not fully recovered after a year.
Disabling
IDNUMBER=375300
GB-MHRA-ADR 20517860
Cytomegalovirus test positive, Epstein-Barr virus test positive, Guillain-Barre syndrome
1 day after vaccination
>110 days
Disabling
Life threatening
IDNUMBER=375516
GB-MHRA-ADR 20543385
Asthenia, Balance disorder, Dizziness, Headache, Inner ear disorder, Lethargy
Pre-existing condition: asthma. Other medication: inhaler
0 days after vaccination
Disabling
IDNUMBER=375829
GB-MHRA-ADR 20542398
Convulsion, Obstructive airways disorder
0 days after vaccination
Medically serious
IDNUMBER=376027
GB-MHRA-ADR 20545283
Chest discomfort, Dysphagia, Eye swelling, Mumps antibody test negative, Oropharyngeal pain, Swelling face, Throat tightness
1 day after vaccination. The subject's medical history included an allergy, an allergy to nuts, asthma, a food allergy, a fruit allergy, immunodeficiency, a latex allergy and a penicillin allergy. Concurrent medications.
"The symptoms came on within 24 hours of the vaccination, but escalated and reached a peak 6 days after the injection. The patient was unable to recall any other symptoms as the experience was very hazy in her mind, and so after speaking to her mother, it was revealed that the patient's face was so swollen she could not open her eyes"
21 days
IDNUMBER=376306
GB-MHRA-ADR 20428075
Thirst, Type 1 diabetes mellitus
0-25 days after vaccination
> 403 days
IDNUMBER=376481
GB-MHRA-ADR 20378977
Abdominal pain, Bladder catheterisation, Blood test normal, Intestinal functional disorder, Laboratory test normal, Neurogenic bladder, Ultrasound scan normal, Urinary retention
0-99 days after 2 vaccinations. 2 concurrent medications including penicillin. Patient remained hospitalised after 1 year
>356 days
IDNUMBER=377724
GB-MHR-ADR 20553496
Hallucination, auditory, Psychotic disorder
37 days after 3rd vaccination. Mental health team review put it down to reaction to the vaccine. Patient admitted to psychiatric ward 2-3 months later after the initial psychotic symptoms, due to worsening psychotic symptoms
> 85 days
IDNUMBER=379779
GB-MHRA-ADR 20558902
Back pain, Blood electrolytes normal, Blood urea normal, Full blood count normal, Headache, Liver function test normal, Muscular weakness, Nuclear magnetic resonance imaging normal, Pain in extremity, Red blood cell sedimentation rate normal
10 days after vaccination
> 81 days
IDNUMBER=379897
GB-MHRA-ADR 20559011
Aplastic anaemia, Biopsy bone marrow, Blood product transfusion dependent, Contusion, Laboratory test, Neutropenia, Neutrophil count decreased, Sepsis
7 days after 2nd vaccination. Concurrent medication. 'Patient is severely neutropaenic and at risk of life threatening sepsis. Remains very severe and undergoing tissue typing for bone marrow transplant.'
> 100 days
Life threatening
IDNUMBER=380986
GB-MHRA-ADR 20568756
Post viral fatigue syndrome
0 days after vaccination
> 147 days
Disabling
IDNUMBER=381120
GB-MHRA-ADR 20567470
Induration, Oedema peripheral, Paraesthesia
0 days after vaccination
> 70 days
IDNUMBER=381297
GB-MHRA-ADR 20570293
Malaise, Scar, Urticaria
0 days after vaccination
> 6 weeks
IDNUMBER=384357
GB-MHRA-ADR 20594365
Activities of daily living impaired, Condition aggravated, Headache, Lethargy, Nausea
2 days after vaccination. Pre-existing condition: headache
> 22 days
disabling
IDNUMBER=381971
GB-MHRA-ADR 20573789
Injection site cellulitis
2 days after vaccination. Preexisting Conditions: Elastoplast allergy
> 37 days
IDNUMBER=384024
GB-MHRA-ADR 20594271
Oropharyngeal pain, Rash erythematous
2 days after vaccination
> 196 days
IDNUMBER=384026
GB-MHRA-ADR 20594272
Malaise, Paraesthesia oral, Pruritus, Throat irritation, Urticaria
0 days after vaccination
> 198 days
Disabling
IDNUMBER=384486
GB-MHRA-ADR 20447192
Chest pain, Dizziness, Headache, Malaise, Nausea, Vaccine positive rechallenge
0-1 day after 3rd vaccination
> 394 days
Disabling
IDNUMBER=384487
GB-MHRA-ADR 20595699
Asthma, Condition aggravated, Dyspnoea, Vaccine positive rechallenge, Wheezing
0 days after 2nd vaccination. Concurrent medical conditions included asthma. Concurrent medications
> 20 days
IDNUMBER=384939
GB-MHRA-ADR 20596872
Immediate post-injection reaction, Mass, Pharyngeal oedema, Swelling, Urticaria
0 days after 2nd vaccination
> 136 days
IDNUMBER=385472
GB-MHRA-ADR 20602918
Asthenia, Cerebral palsy, Condition aggravated, Dyskinesia, Hypertonia, Muscular weakness, Pain in extremity
Pre-existing Condition: Movements Involuntary of limbs
2 days after vaccination
> 86 days
Disabling
IDNUMBER=385475
GB-MHRA-ADR 20602904
Dizziness, Feeling hot, Flushing
0 days after vaccination
> 194 days
IDNUMBER=385821
GB-MHRA-ADR 20606872
Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Neurological examination abnormal
0-14 days after vaccination
> 14 days
Life threatening
IDNUMBER=386727
GB-MHRA-ADR 20610962
Groin pain, Headache, Lymphadenopathy, Malaise, Pyrexia
0 days after vaccination. Hospital advised against future HPV vaccinations
5-6 weeks
IDNUMBER=387735
GB-MHRA-ADR 20620265
Activities of daily living impaired, Angioedema, Urticaria chronic
0 days after vaccination. Medically significant: resulting in frequent school absence
> 259 days
IDNUMBER=387744
GB-MHRA-ADR 20620312
Chest discomfort
0 days after vaccination. Concurrent medication
> 22 days
IDNUMBER=389153
GB-MHRA-ADR 20623943
Convulsion
3 days after vaccination
Life threatening
IDNUMBER=390033
GB-MHRA-ADR 20630438
Amenorrhoea, Blood test normal
0-20 days after 1st vaccination
> 30 weeks
IDNUMBER=390131
GB-MHRA-ADR 20630914
Dysarthria, Hypoaesthesia, Lower respiratory tract infection, Paraesthesia, Paraesthesia oral, Sensation of heaviness, Swollen tongue, Vomiting
0 days after vaccination. 'Client had a mild cold on the day of the vaccination'
> 28 days
IDNUMBER=391299
GB-MHRA-ADR 20642159
Cyanosis, Hypokinesia, Pain in extremity
0 days after vaccination. Concurrent medications
> 112 days
IDNUMBER=391515
GB-MHR-ADR 20643356
Abasia, Activities of daily living impaired, Asthenia, Headache, Lethargy, Pain in extremity
1 day after vaccination
> 66 days
Disabling
IDNUMBER=391623
GB-MHRA-ADR 20505173
Anxiety, Depressive symptom, Paranoia
1 day after vaccination. Concurrent medications. Pre-existing conditions
> 278 days
Disabling
IDNUMBER=393617
GB-MHRA-ADR 20661626
Convulsion, Nuclear magnetic resonance imaging normal, Vaccine positive rechallenge
MHRA Verbatim Text: Patient had a seizure one week after receiving the second dose of CERVARIX and a seizure two weeks after the third dose
IDNUMBER=393523
GB-MHRA-ADR 20357549
Ascites, Autopsy, Bronchopneumonia, Cardiac arrest, Cough, Death, Dyspnoea, Endotracheal intubation, Generalised oedema, Hypotension, Inflammation, Lower respiratory tract infection, Mechanical ventilation, Mediastinitis, Necrosis, Oedema, Pleural effusion, Pleurisy, Pyrexia, Respiratory distress, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Skin oedema, Speech disorder, Streptococcal sepsis, Streptococcus test positive, Tachycardia, Tachypnoea, Tracheitis, Upper respiratory tract infection, Upper respiratory tract inflammation
MHRA Verbatim Text: Patient died 3 weeks following 2nd HPV Vaccination. Reported to have died due to Streptococcal A Septicemia. Still awaiting coroners verdict. Follow-up information received on 14 July 2010 from the MHRA: The patient had a cough for one week and then developed fever for three days. Patient was admitted to hospital three weeks after CERVARIX vaccination when the cough got worse and they developed difficulty breathing. On admission the respiratory rate was 60 per minute and they were distressed. They became so distressed they were unable to speak. The patient was transferred to the high dependency unit. On 28 November 2008 the patient then became tachycardic and a chest infection was diagnosed and the patient was taken to the theatre and intubated and ventilated. The patient crashed an hour later and had arrests characterized by very severe hypotension. The patient became asystolic. Despite all efforts the decision that further attempts were futile was made and the patient died on 28 November 2008. The cause of death was streptococcal.
Symptoms from 7 days after 1 vaccination
IDNUMBER=372001
Reported by father
Aphasia, Aphonia, Blood immunoglobulin A, Blood immunoglobulin A normal, Blood immunoglobulin G, Blood immunoglobulin M, Blood immunoglobulin M normal, Eosinophil count decreased, Fatigue, Full blood count normal, Laboratory test normal, Liver function test normal, Mononucleosis heterophile test negative, Oropharyngeal pain, Thyroid function test normal
0 days after vaccination
> 11 months
Disabling
NB: 1 year follow up 22.9.10. Successful use of silica-rich mineral water antidote to aluminium adjuvant in Cervarix
 |
Suspected Adverse Reaction Analysis
CERVARIX Human papillomavirus (HPV) vaccine
29 July 2010
|
MHRA SUMMARY OF UK SAFETY EXPERIENCE
Total number of reports received: 4,445
Total number of suspected reactions: 9,673
Estimated number of doses administered across the UK: > 4 million doses* |
Extract 1: "cases may be true side-effects or they may have been purely coincidental events due to underlying or
undiagnosed illness that would have occurred anyway in the absence of vaccination. Events may also
have been psychogenic in origin."
Extract 2: "the available evidence does not
suggest that the vaccine caused the condition and these may have been coincidental events."
MHRA pdf
MHRA Your Views |
*up to 3 doses per girl
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