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Case Details (Sorted by Age)

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VAERS ID:438725 (history)  Vaccinated:2011-10-04
Age:15.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-17, Days after onset: 13
Location:Foreign  Entered:2011-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Insomnia
Preexisting Conditions: Heat cramps
Diagnostic Lab Data: UNK
CDC Split Type: B0754291A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Gaze palsy, Pallor, Peripheral coldness, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of syncope in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included heat cramps. Concurrent medical conditions included insomnia. On 4 October 2011, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, unknown injection site). On 4 October 2011, less than one day after vaccination with CERVARIX, the subject experienced syncope and vasovagal reaction which resolved on the same day. The physician considered the events were clinically significant (or requiring intervention). In October 2011, less than one week after vaccination, the subject experienced eyeballs raise upward, facial pallor and fingers cold feeling of. The outcome of those events was unspecified. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:438772 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2011-10-17
Location:Foreign  Entered:2011-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0755302A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Histiocytosis haematophagic, Platelet count decreased, Pyrexia
SMQs:, Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of hemophagocytic syndrome in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of CERVARIX (intramuscular, unknown injection site and batch number). Three weeks after vaccination with CERVARIX, the subject experienced fever. She visited the reporting physician and hemophagocytic syndrome and platelets decreased were confirmed. The pharmacist considered the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved.

VAERS ID:438897 (history)  Vaccinated:2011-10-08
Age:15.0  Onset:2011-10-08, Days after vaccination: 0
Gender:Female  Submitted:2011-10-18, Days after onset: 10
Location:Foreign  Entered:2011-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Feeling queasy
Diagnostic Lab Data: Blood pressure, 08Oct2011, 81/60mmHg; Blood pressure, 08Oct2011, 60/40mmHg; Body temperature, 08Oct2011, 35.6deg.C; Heart rate, 08Oct2011, 58bpm; Heart rate, 08Oct2011, 46bpm
CDC Split Type: B0755289A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Body temperature decreased, Bradycardia, Nausea, Pallor, Presyncope, Pulse pressure decreased, Radial pulse decreased
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of vasovagal reaction in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s past medical history included queasy feeling, after 1st inoculation of Japanese encephalitis vaccine. Historic vaccination included influenza virus vaccine (unknown date and manufacturer), unspecified vaccine (unknown date and manufacturer) and Japanese encephalitis vaccine (unknown date, Non-GSK). On 8 October 2011, at 10:25, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, left upper arm). On 8 October 2011, at 10:27, two minutes after vaccination with CERVARIX, the subject experienced vasovagal reaction, queasy, facial pallor, bradycardia and radial pulse decreased. The subject presented with a queasy feeling in the waiting room after receiving CERVARIX in the consultation room. The subject had facial pallor, and bradycardia with which the pulse was feeble. The subject was made to lie down with her legs elevated, and intravenous drip infusion was started. The blood pressure was 60/40 mmHg, and the heart rate was 46 bpm. No oedema, redness or urticaria was observed and vasovagal reflex was suspected. As the subject had a severe queasy feeling, 1 ampoule of PRIMPERAN was administered. The symptoms had gradually recovered. The physician considered the events were clinically significant (or requiring intervention). On 8 October 2011, at 11:20, when the intravenous drip infusion was completed, the blood pressure and heart rate in a sitting position were 81/60 mmHg and 58 bpm, respectively. The symptoms had disappeared and the subject went home, the events were resolved. During the follow-up, the subject''s respiration was stable. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:438903 (history)  Vaccinated:2011-09-24
Age:15.0  Onset:2011-09-24, Days after vaccination: 0
Gender:Female  Submitted:2011-10-18, Days after onset: 24
Location:Foreign  Entered:2011-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0751768A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPAV147AA1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Fall, Syncope, Tooth loss
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of syncope in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Subject''s body temperature before vaccination was 36.2 Deg.C. On 24 September 2011, the subject received 2nd dose of CERVARIX (.5 ml, intramuscular, left upper arm). The subject was taking a rest for approximately 15 minutes after vaccination with CERVARIX. And when she tried to stand up, she experienced syncope. The physician considered the event was clinically significant (or requiring intervention). On 24 September 2011, the event was resolved. The physician considered the event was unrelated to vaccination with CERVARIX. Follow-up information received on 11 October 2011: Because a waiting room was crowded, the subject had to stand and wait for approximately 5 minutes after receiving an examination and the inoculation of CERVARIX. She experienced syncope, which led to fall, and lost 3 front teeth.

VAERS ID:438904 (history)  Vaccinated:2011-08-24
Age:15.0  Onset:2011-08-26, Days after vaccination: 2
Gender:Female  Submitted:2011-10-18, Days after onset: 53
Location:Foreign  Entered:2011-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0744188A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143BA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Gastroenteritis, Headache, Hyperthermia, Pharyngeal erythema
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (broad), Arthritis (broad), Noninfectious diarrhoea (broad)
Write-up: This case was reported by a physician and described the occurrence of acute gastroenteritis in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Subject''s body temperature before the vaccination was 36.6 Deg.C. On 24 August 2011, the subject received 1st dose of CERVARIX (intramuscular, left upper arm). On 26 August 2011 during night, 2 days after vaccination with CERVARIX, the subject experienced headache, arthralgia and hyperthermia. On 27 August 2011, the subject visited the reporting physician''s hospital. Mild redness of the pharynx was observed, and the subject might have experienced cold. An antibiotic and CALONAL were prescribed. At the time of reporting, the outcome of the events was unspecified. The causal relationship of the events to CERVARIX was unassessable. They were related to cold. Follow-up information received on 12 October 2011: On an unspecified date, the subject experienced symptoms of acute gastroenteritis; therefore, the events previously reported were considered to be caused by the acute gastroenteritis. The reporter considered the events as clinically significant (or intervention required). On 28 August 2011, all the events were resolved.

VAERS ID:439184 (history)  Vaccinated:2011-08-22
Age:15.0  Onset:2011-09-01, Days after vaccination: 10
Gender:Female  Submitted:2011-10-19, Days after onset: 48
Location:Foreign  Entered:2011-10-19
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:
Diagnostic Lab Data: Blood count, Sep2011, normal range
CDC Split Type: B0755728A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA118AH IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood count normal, Dizziness, Laboratory test normal, Muscle strain, Syncope, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician via a GSK sales representative and described the occurrence of faint in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). No concomitant medication or relevant medical history was reported. The girl was healthy. On 22 August 2011, the subject received unspecified dose of CERVARIX (intramuscular, unknown injection site). On 1 September 2011, 10 days after vaccination with CERVARIX (approximately one week after vaccination), the subject experienced faint or feeling to faint (5 times) and vertigo. Later on, she experienced muscle strain. This case was assessed as medically serious by GSK. In September 2011, some blood counts, clinical and biochemistry examinations were performed and all were in normal range. After 3 weeks, the events were still ongoing. At the time of reporting, the events were not resolved.

VAERS ID:439187 (history)  Vaccinated:2011-10-07
Age:15.0  Onset:2011-10-07, Days after vaccination: 0
Gender:Female  Submitted:2011-10-19, Days after onset: 12
Location:Foreign  Entered:2011-10-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0755298A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148AB0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Body temperature before vaccination was: 37.3 deg. C. On 7 October 2011, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, left upper arm). On 7 October 2011, several tens of seconds after vaccination with CERVARIX, the subject experienced loss of consciousness and vasovagal reaction. The physician considered the events were clinically significant (or requiring intervention). On 7 October 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:439321 (history)  Vaccinated:2011-10-08
Age:15.0  Onset:2011-10-08, Days after vaccination: 0
Gender:Female  Submitted:2011-10-20, Days after onset: 12
Location:Foreign  Entered:2011-10-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0756081A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Loss of consciousness, Shock
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of shock in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 8 October 2011, the subject received unspecified dose of CERVARIX (intramuscular, left deltoid). On 8 October 2011, less than one day after vaccination with CERVARIX, the subject experienced a state of shock with loss of consciousness and decreased blood pressure. The physician considered the events were clinically significant (or requiring intervention). The subject was treated with drip infusion of SOLITA-T No.3 200 mL. And the subject recovered 1 hour later, and then she left for home. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:439323 (history)  Vaccinated:2011-08-09
Age:15.0  Onset:2011-08-09, Days after vaccination: 0
Gender:Female  Submitted:2011-10-20, Days after onset: 72
Location:Foreign  Entered:2011-10-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 09Aug2011, 36.6deg.C
CDC Split Type: B0756077A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA138AC0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Gait disturbance, Liver disorder, Muscular weakness, Pallor, Presyncope
SMQs:, Rhabdomyolysis/myopathy (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of vasovagal reaction in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 9 August 2011, at 16:30, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, left upper arm). On 9 August 2011, at 16:35, 5 minutes after vaccination with CERVARIX, the subject experienced vasovagal reaction, ill complexion and decreased blood pressure. She experienced mild liver disorder and difficulty in walking due to weakness of limbs. Other symptoms including urticaria were not noted. Body temperature before inoculation was 36.6?C. The subject was hospitalised. At the time of reporting the outcome of the events was unspecified. The physician considered the relationship between the event and vaccination with CERVARIX as unassessable.

VAERS ID:439331 (history)  Vaccinated:2011-09-24
Age:15.0  Onset:2011-09-24, Days after vaccination: 0
Gender:Female  Submitted:2011-10-20, Days after onset: 26
Location:Foreign  Entered:2011-10-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Possible dehydration
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 24Sep2011, 102/60mmHg; Blood pressure, 24Sep2011, 98/56mmHg; Heart rate, 24Sep2011, 9x6bpm; Heart rate, 24Sep2011, 10x6bpm
CDC Split Type: B0751758A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA145AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Fall, Loss of consciousness, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, left deltoid). On 24 September 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced syncope. The physician considered the event was clinically significant (or requiring intervention). On 24 September 2011, the event was resolved. The physician considered the event was related to vaccination with CERVARIX. Follow-up information received on 12 October 2011: The subject''s family history and medical history were unknown. The subject had no past history of loss of consciousness and no obesity was recognized. The subject had no painful/emotional stimulus before the onset of the event. She had no sign or warning regarding the episode and no sweat or warmth feeling before the event. In the morning, the subject had a softball practice game for 3 hours. Then she visited the hospital after eating a slice of toast at home. It was suspected that she originally had dehydration. The physician explained to her that the vaccination would accompany with some pain and this was considered as a triggering event. On 24 September 2011, the subject received vaccination with CERVARIX in the left deltoid muscle while sitting on a chair. When the vaccination site was being pressed with an adhesive tape, she slid from the chair. Because the physician and nurse supported her body, the subject did not have significant injury. She immediately regained her consciousness in that posture and went to bed in the examination room by herself. She had ill complexion for a while, but it resolved soon. Her initial blood pressure (BP) and pulse rate (PR) measured in the bed were 102/60 mmHg and 9 x6 beats/minute, respectively. Her BP and PR before getting out of bed after a conversation for a while were 98/56 mmHg and 10 x6 beats/minute, respectively. The subject was in the sitting position and she collapsed from a chair. The event developed suddenly. After she moved to a bed, facial pallor persisted for a while. The subject lost consciousness completely for a few seconds. Nothing in particular was noted in the subject''s respiratory pattern and movement. It was unknown if the subject did make a movement in association with the fall but she had no tongue biting. She did not receive any medical treatment or medication. No symptom developed after the patient recovered from loss of consciousness. The subject did not remember anything regarding loss of consciousness. She did not undergo any special test. The event did not recur. On 24 September 2011, the loss of consciousness, fall and ill complexion were resolved. At the time of reporting, the outcome of decreased blood pressure was unspecified. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:439912 (history)  Vaccinated:2011-09-29
Age:15.0  Onset:2011-09-29, Days after vaccination: 0
Gender:Female  Submitted:2011-10-25, Days after onset: 26
Location:Foreign  Entered:2011-10-25
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:
Diagnostic Lab Data: Blood pressure, 29Sep2011, 92/60mmHg; Body temperature, 29Sep2011, 36.8deg. C.
CDC Split Type: B0757180A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148CB0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Pallor, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of shock like symptom in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s body temperature before vaccination was 36.8 degrees centigrade. On 29 September 2011, at 17:59, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, right upper arm). On 29 September 2011, at 18:00, immediately after vaccination with CERVARIX, the subject experienced shock like symptom with facial pallor and became unable to maintain the sitting position, and she directly became recumbent. Blood pressure was 92/60 mmHg. The subject received a fluid infusion of DECADRON and the symptoms improved. On 29 September 2011, at 18:48, the subject went home. At 3 hours after the patient went home, the course was determined. The subject had no symptoms in particular. The physician considered the events were clinically significant (or requiring intervention). The physician considered that the causality between shock like symptom and CERVARIX was unassessable. At the time of reporting the shock like symptom was resolved and the other events were improved.

VAERS ID:439913 (history)  Vaccinated:2011-09-30
Age:15.0  Onset:2011-09-30, Days after vaccination: 0
Gender:Female  Submitted:2011-10-25, Days after onset: 25
Location:Foreign  Entered:2011-10-25
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:
Diagnostic Lab Data: Blood pressure, 30Sep2011, 120/80mmHg; Body temperature, 30Sep2011, 36.7deg. C.
CDC Split Type: B0757182A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148AB0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Face injury, Facial bones fracture, Fall, Immediate post-injection reaction, Loss of consciousness, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s body temperature before vaccination was 36.7 degrees Centigrade. On 30 September 2011, at 20:30, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left upper arm). On 30 September 2011, immediately after vaccination with CERVARIX, the subject went into a state of syncope, fell and hit her face on the floor. She was promptly placed in the supine position with legs elevated. Although her face was pale, the pulse was regular with tension. Blood pressure (BP) was 120/80 mmHg. Two to three minutes later, she regained consciousness. The subject had no urticaria, no oedema and no dyspnoea. The subject suffered from a nasal fracture due to the fall and was referred to the plastic surgery department, where no treatment was required. The physician considered the events were clinically significant (or requiring intervention). The physician considered that the causality between syncope and CERVARIX was unassessable. At the time of reporting the outcome of the broken nose was unspecified and all the other events resolved on 30 September 2011.

VAERS ID:439917 (history)  Vaccinated:2011-10-18
Age:15.0  Onset:2011-10-18, Days after vaccination: 0
Gender:Female  Submitted:2011-10-25, Days after onset: 7
Location:Foreign  Entered:2011-10-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Febrile convulsion
Diagnostic Lab Data: UNK
CDC Split Type: B0757211A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148BA2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Epilepsy, Eye movement disorder, Loss of consciousness, Tonic convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician and described the occurrence of afebrile convulsion in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included febrile convulsion. On 18 October 2011, at 16:20, the subject received 3rd dose of CERVARIX (0.5 ml, intramuscular, left upper arm). On 18 October 2011, at 16:21, 1 minute after vaccination with CERVARIX, the subject lost consciousness, experienced ocular deviation to the left and had generalised tonic convulsion for approximately 30 seconds. The subject was referred to another hospital, where she was planned to receive examinations including electroencephalography. The physician considered the events were clinically significant (or requiring intervention). On 18 October 2011, the events were resolved. The physician reported that the relationship between the events and vaccination with CERVARIX was unassessable and considered the events as related to suspected epilepsy.

VAERS ID:440245 (history)  Vaccinated:2011-09-29
Age:15.0  Onset:2011-09-29, Days after vaccination: 0
Gender:Female  Submitted:2011-10-26, Days after onset: 27
Location:Foreign  Entered:2011-10-26
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:
Diagnostic Lab Data: Blood pressure, 29Sep2011, 102/52mmHg; Heart rate, 29Sep2011, 52bpm
CDC Split Type: B0753654A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMAR
Administered by: Other     Purchased by: Other
Symptoms: Altered state of consciousness, Depressed level of consciousness, Feeling abnormal, Pallor, Tremor
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of disturbed consciousness in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). On 1 October 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced facial pallor and feeling poorly. On 1 October 2011, the events were resolved. Additional information received on 20 October 2011: On 20 October 2011, this case was upgraded from non serious to serious case. On 29 September 2011, the subject received unspecified dose of CERVARIX (unspecified deltoid muscle). On 29 October 2011, the subject experienced consciousness disturbed, depressed level of consciousness and tremor. On 29 September 2011, blood pressure was 102/52 mmHg and heart rate was 52 bpm. At time of reporting, the events disturbed consciousness, depressed level of consciousness and tremor were improved. The reporter considered the events were clinically significant (or requiring intervention).

VAERS ID:440336 (history)  Vaccinated:2008-05-01
Age:15.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2011-10-26, Days after onset: 1273
Location:Foreign  Entered:2011-10-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Specific allergy (drug); Chronic rhinitis; House dust mite allergy; Immune tolerance induction
Preexisting Conditions:
Diagnostic Lab Data: Diagnostic laboratory test, 1280, anti-histones antibodies; Diagnostic laboratory test, anti-histones antibodies showed negative; DNA Ab immunoprecipitation, slightly positive; DNA Ab immunoprecipitation, 2; Serum ANA, 4096; Serum ANA, 1280; Serum alanine aminotransferase, 36 iu/l
CDC Split Type: WAES1110USA03270
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase normal, Antinuclear antibody, Arthralgia, Autoantibody negative, DNA antibody positive, Laboratory test normal, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Case received from the Health Authorities on 14-OCT-2011 under the reference number NY20110740. Case medically confirmed. A 15-year-old female patient had received the three doses of GARDASIL (dose, route and batch number not reported) from January 2008 to May 2008. Since September 2007, the patient was undergoing a house dust mites desensitization by house dust mites allergen (STALORAL), which was also reported as suspect. A few days after the third dose, she experienced arthralgia in hands associated with oedema. The symptoms increasingly worsened. In May and June 2008, desensitization was carried on. Initial immunological work-up for polyarthralgia showed antinuclear antibodies 4096, anti-histones antibodies 1280, anti-native DNA antibodies slightly positive. Follow-up immunological work-up (unspecified date) showed antinuclear antibodies 1280, anti-native DNA antibodies at 2 units and no anti-histones antibodies. In April 2011, the patient was seen in a specialized service for a check-up. Laboratory tests showed no inflammatory syndrome, ALAT at 36, and no other anomaly was found. Physical examination showed that the general and joint symptomatology regressed. Nothing was suggestive of an inflammatory rheumatism or an evolution systemic disease. At the time of reporting, the patient had recovered without sequelae. The patient had a medical history of chronic allergic rhinitis since she was 6 years old. She also was allergic to PRIMALAN. The Health Authorities added that the patient experienced a "possible polyarthralgia induced by GARDASIL". Case reported as serious by the Health Authorities with other medically important condition as criteria. The Health Authorities assessed the causal relationship between the reported reaction and vaccination with GARDASIL as possible and for STALORAL as doubtful according to the method of assessment. Other business partner numbers include E2011-06239.

VAERS ID:440870 (history)  Vaccinated:2011-09-29
Age:15.0  Onset:2011-09-29, Days after vaccination: 0
Gender:Female  Submitted:2011-10-31, Days after onset: 32
Location:Foreign  Entered:2011-10-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0753637A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148CB0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a physician and described the occurrence of injection site redness in a 15-year-old female subject who was vaccinated with CERVARIX. On 29 September 2011, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, unknown injection site). On 29 September 2011, less than one day after vaccination with CERVARIX, the subject experienced injected limb mobility decreased. Within the week after vaccination, the subject experienced injection site redness and injection site pain. At the time of reporting, the outcome of injection site redness and injection site pain was unspecified and injected limb mobility decreased was unresolved. The physician considered the events were related to vaccination with CERVARIX. Follow-up information received on 19 October 2011: This case was upgraded to serious. The subject''s body temperature before vaccination was 36.7 deg. C. On 29 September 2011 the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left deltoid). On 29 September 2011, less than one day after vaccination, the subject experienced injection site pain. Around 1 October 2011, the subject experienced injected limb mobility decreased. On 03 October, the pain subsisted. The subject went to see the doctor due the difficulty in raising the left upper limb. On 04 October 2011, the subject visited another hospital for consultation. The physician considered the events were clinically significant (or requiring intervention). The physician considered injected limb mobility decreased was related to vaccination with CERVARIX.

VAERS ID:440872 (history)  Vaccinated:2010-02-26
Age:15.0  Onset:2010-03-01, Days after vaccination: 3
Gender:Female  Submitted:2011-10-31, Days after onset: 608
Location:Foreign  Entered:2011-10-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cholecystectomy; Colitis; Dyslipidemia; Hiatal hernia; Inguinal hernia; Lumbar pain; Malaise; Mitral valve insufficiency; Tobacco smoker; Urinary lithiasis
Preexisting Conditions: Colitis with malaise episode and consultation at emergency service on 02 February 2010, before first vaccination with CERVARIX.
Diagnostic Lab Data: Colonoscopy, Apr2011, normal; Computerized tomogram abdomen, Apr2011, normal; Computerized tomogram abdomen, 22Jun2011, see text; Electroencephalogram, 06Sep2011, see text; Endoscopy, Apr2011, hiatal hernia; Nuclear magnetic resonance ima, 22Jul2011, normal; Pathology test, 10Feb2011, see text; Ultrasound scan, 19Nov2010, see text; Vestibular function test, May2011, normal; 19 November 2010; Heart ultrasound scan: known (since 1-year-old) mild mitral regurgitation which looked like more physiological than pathological according to the cardiologist who refuted to qualify this mitral insufficiency of dystrophy; 10 February 2011, Anatomical pathology test: chronic lithiasic cholecystitis; 22 June 2011, Abdominal CT-scan: no digestive lesion bu
CDC Split Type: B0757276A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Back pain, Cholecystectomy, Cholecystitis chronic, Colonoscopy normal, Computerised tomogram abdomen abnormal, Dyspepsia, Echocardiogram abnormal, Electroencephalogram abnormal, Endoscopy upper gastrointestinal tract abnormal, Fall, Headache, Hemiplegia, Hiatus hernia, Intervertebral disc disorder, Malaise, Mitral valve incompetence, Nervous system disorder, Nuclear magnetic resonance imaging brain normal, Pathology test, Post procedural complication, Urinary incontinence, Vaccine positive rechallenge, Vertigo, Vestibular function test normal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Infectious biliary disorders (narrow), Gallbladder related disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (narrow)
Write-up: This case was reported by the foreign regulatory authority (# MA20112071) and described the occurrence of headache in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Subject''s medical conditions included inguinal hernia surgically treated, tobacco smoker, dyslipidemia, mitral valve insufficiency (known since the patient was 1-year-old), urinary lithiasis, hiatal hernia, lumbar pain (with left sciatalgia type S1 without sensitive or motor deficiency). On 02 February 2010, before first vaccination with CERVARIX, the subject consulted at emergency unit for a colitis with malaise episode. On 26 February 2010, 23 April 2010 and 12 August 2010 the subject received a 1st dose, a 2nd dose and a 3rd dose of CERVARIX (intramuscular, batches and injection sites unknown). Last dose was administered less than 5 months after the second dose (drug dose administration interval too short). In March 2010, between the first and the second vaccination with CERVARIX, the patient complained of headache with vertigo episodes about one time a week. According to the subject''s father, she was hospitalized several times after last vaccination with CERVARIX, between August 2010 and September 2011, for digestive disorder and vertigo. On 19 November 2010, a cardiologist was consulted. Heart ultrasound scan showed a known mild mitral regurgitation which looked like more physiological than pathological according to the cardiologist who refuted to qualify this mitral insufficiency of dystrophy. On 08 February 2011, the subject was hospitalized for a cholecystectomy. Anatomical pathology test dated 10 February 2011 showed a chronic lithiasic cholecystitis. From 04 to 08 April 2011, she was hospitalized for post surgery investigations on digestive disorders. Abdominal and pelvic CT-scan was normal. Endoscopy evidenced hiatal hernia of 35 cm without complication. Total colonoscopy was normal. On discharge her treatment included BETASERC 24 mg 3 times daily and CERAZETTE. In May 2011, an ENT specialist was consulted for an audio vestibular check-up. Vestibular function test were normal. On 22 June 2011, the subject was hospitalized in emergency unit for acute lumbar and abdominal pain. Abdominal CT-scan did not showed digestive lesion but evidenced a very bad lumbar discovertebral condition. On 22 July 2011, cerebral MRI was normal. On 06 September 2011, she consulted at emergency unit for malaise without loss of consciousness with fall, leak of urine and left side paralysis. According to the subject''s father (but not confirmed by the emergency unit). electroencephalogram showed small abnormality on the left. Less than one month after vaccination with CERVARIX, at an unspecified time after vaccination with CERVARIX, the subject experienced headache, vertigo, malaise and abdominal pain. Agency report conclusion noticed that the subject with severe digestive and urinary medical history, vaccinated with CERVARIX in February, April and August 2010, complained of headache and vertigo between each vaccination (positive rechallenge) then followed by multiple recurrences of abdominal pain with malaise since vaccinations. Iatrogenic origin of those events was not medically confirmed. No link with vaccination was reported in all hospitalization records. At the time of reporting the events were unresolved. According to the foreign method of assessment, the agency considered unlikely the causal relationship between vaccination with CERVARIX and the reported events.

VAERS ID:440883 (history)  Vaccinated:2011-05-23
Age:15.0  Onset:2011-05-25, Days after vaccination: 2
Gender:Female  Submitted:2011-10-31, Days after onset: 159
Location:Foreign  Entered:2011-11-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1110USA03637
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Ear, nose and throat examination normal, Gastroenteritis, Laboratory test normal, Myocarditis, Serology test
SMQs:, Cardiomyopathy (broad), Noninfectious diarrhoea (broad)
Write-up: Case received from an allergist on 20-OCT-2011 and medically confirmed. A 15-year-old female patient with no relevant medical history was hospitalized on 28-MAY-2011 due to reversible myocarditis 5 days after receiving the first dose of GARDASIL (batch number not reported). 3 days before hospitalization, she also experienced gastroenteritis. She was given KARDEGIC for a few days. Cardiovascular work-up was performed but results were not reported. Peadiatric work-up, ENT and abdominal investigations and laboratory tests were all unremarkable. Results for infectious serology were not available. The patient recovered on 30-MAY-2011 and was discharged on the same day. Myocarditis and gastroenteritis were considered serious events as they required hospitalization. Other business partner numbers included: E2011-06382. No further information was reported.

VAERS ID:441722 (history)  Vaccinated:2011-10-21
Age:15.0  Onset:2011-10-21, Days after vaccination: 0
Gender:Female  Submitted:2011-11-07, Days after onset: 17
Location:Foreign  Entered:2011-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 21Oct2011, 78/40mmHg; blood pressure, 21Oct2011, 106/66mmHg
CDC Split Type: B0759891A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of vasovagal reaction in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 21 October 2011, at 16:50, the subject received the 1st dose of CERVARIX (intramuscular, left upper arm). On 21 October 2011, at 16:55, 5 minutes after vaccination with CERVARIX, the subject experienced vasovagal reaction and loss of consciousness in the waiting room. She regained consciousness after several seconds. Her respiration was normal and the blood pressure was 78/40 mmHg. She was placed at bed rest and received drip infusion. The physician considered the events were clinically significant (or requiring intervention). On 21 October 2011, several seconds after onset, the events were resolved. On 21 October, at 17:00, the blood pressure was 106/66 mmHg. No abnormalities were found with the general condition nor blood pressure thereafter. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:441757 (history)  Vaccinated:2011-10-25
Age:15.0  Onset:2011-10-25, Days after vaccination: 0
Gender:Female  Submitted:2011-11-07, Days after onset: 13
Location:Foreign  Entered:2011-11-08, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Blood pressure measurement, 25Oct11, 70 mmHg, At 18:30 (Systolic pressure); Blood pressure measurement, 25Oct11, 86 mmHg, At 18:35 (Systolic pressure); Blood pressure measurement, 25Oct11, 94 mmHg, At 18:40 (Systolic pressure); Physical examination, 25Oct11, At 19:07 the consciousness level was II-10. Physical examination, 25Oct11, At 18:45 the consciousness level was II-30. Blood pressure measurement, 25Oct11, 72 mmHg, At 18:40 (Diastolic pressure); Body temp, 25?Oct11, 35.8 degrees C, Before vaccination; Pulse oximetry, 25Oct11, 95%, At 18:30; Pulse oximetry, 25Oct11, 100%, At 18:40; Total heartbeat count, 25Oct11, 78 /min, At 18:30; Total heartbeat count, 25Oct11, 80 /min, At 18:40
CDC Split Type: WAES1110USA04540
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0108AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Blood pressure decreased, Chest pain, Discomfort, Dizziness, Dyskinesia, Eye movement disorder, Fall, Loss of consciousness, Respiratory disorder, Shock, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dyskinesia (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Information has been received from two physicians via agency concerning a 15 year and 1 month old female patient with no history of allergy, underlying diseases, growth problem, vaccination within the past 1 month, other diseases or convulsion who on 25-OCT-2011 (at 18:25) was intramuscularly vaccinated with a dose of GARDASIL, 0.5 mL once a day, injected into left upper arm (batch number: 9QN02R; lot number: 0108AA). No other vaccine was injected at the same time. No information on concomitant medications was provided. The patient''s body temperature before vaccination was 35.8 degrees C. On 25-OCT-2011, at 18:25, GARDASIL was intramuscularly injected into the left upper arm in a sitting position as the initial dose. Approximately 30 seconds later, the patient suddenly experienced dizziness and fell forward. One minute later, she experienced feeling discomfort and weakness, her eyeballs were unstable and a decrease in blood pressure and loss of consciousness occurred. She was laid down on a bed with support, airway was secured and oxygen (with mask) was administered (4 liters/min). Her legs were elevated. She responded when called in loud voice. She complained of pain in chest. She had no strength in hands. There was no obvious convulsion (according to the clinic where the vaccine was injected). At 18:30, blood pressure was 70, Sp02 was 95% and pulse was 78. At 18:35, blood pressure was 86. At 18:40, blood pressure was 94/72, Sp02 was 100% and pulse was 80. At 18:45, an ambulance arrived. The consciousness level was II-30 and there was respiratory discomfort. At 19:07, the patient arrived at the treating physician''s hospital. Her consciousness level was II-10 and she underwent treatment and examinations. Thirty minutes after the onset of the symptoms, her consciousness returned but she began to tremble against her will. Movements involuntary of limbs were observed. At 19:30, she had no respiratory discomfort and her response became clearer. She was admitted to the hospital. On 26-OCT-2011, as of 13:00, movements involuntary of limbs were mainly seen in the right arm but occasionally seen in the right leg and left arm too. The tremor was weakened when the patient was conscious of something else or when she was asleep. The movement subsided with the use of drugs but it continued. At the time of this report, the outcome of syncope and shock was unknown. Comment: (Physician who performed the injection) Regarding syncope, shock and respiratory discomfort, it was judged that there was no possibility of other factors (other diseases, etc.). (Treating physician) Convulsion was negative; this case was being reported as movements involuntary of limbs. The reporting physician felt that movements involuntary of limbs, syncope, shock and respiratory discomfort were definitely related to GARDASIL. The reporting physician considered movements involuntary of limbs to be serious as other important medical event and syncope, shock and respiratory discomfort to be serious due to life-threatening and hospitalization. A lot check has been initiated. Additional information has been requested.

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