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| VAERS ID: | 264284 | Vaccinated: | 2006-09-29 | | Age: | 15.0 | Onset: | 2006-09-29, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2006-10-05, Days after onset: 6 | | Location: | | Entered: | 2006-10-11, Days after submission: 6 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: | | Previous Vaccinations: | | Other Medications: VENTOLIN (ALBUTEROL) | | Preexisting Conditions: Anaphylaxis peanut allergy, allergy to nuts Asthma. | | CDC 'Split Type': WAES0610CAN00009 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Anaphylactic reaction, Anaphylactic shock, Malaise | | Write-up: Information has been received from a consumer concerning her 15 year old daughter with asthma, peanut allergy and allergy to nuts and a history of anaphylaxis (three episodes of anaphylaxis (first at age 8) related to allergy to peanuts/nuts) who on 9/29/06 was vaccinated with first dose of HPV rL1 6 11 16 18 VLP vaccine yeast at approx 16:00. Concomitant therapy included Ventolin (rarely uses it ). The pt stayed in the physicians office for about half an hour with the clinic staff ready for an allergic anaphylactic reaction since she had three episodes of anaphylaxis previously. However she felt fine. On 9/29/06 the pt experienced anaphylactic reaction described as going into shock at approx 20:00 she suddenly felt ill (anaphylactic reaction that could not be traced back to food eaten that day that could have contained nuts). The pt immediately administered on Epi Pen dose. Subsequently the pt was taken to the emergency dept where she received supportive care only as no other medications were needed. Subsequently, the pt recovered from anaphylactic reaction. Upon internal review anaphylactic reaction was considered other important medical event (OMIC). Additional information has been requested. |
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| VAERS ID: | 265930 | Vaccinated: | 2006-09-23 | | Age: | | Onset: | 2006-10-07, Days after vaccination: 14 | | Gender: | Female | Submitted: | 2006-10-31, Days after onset: 24 | | Location: | | Entered: | 2006-11-03, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: | | Previous Vaccinations: | | Other Medications: UNK | | Preexisting Conditions: | | CDC 'Split Type': WAES0610CAN00210 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Encephalitis | | Write-up: Information has been received from a physician concerning a female who on approximately 9/23/06 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). On 10/7/06, the patient experienced acute disseminated encephalomyelitis and was hospitalized in a neurology ward of a children's hospital. Additional information has been requested. |
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| VAERS ID: | 269331 | Vaccinated: | 0000-00-00 | | Age: | | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2006-12-14 | | Location: | | Entered: | 2006-12-19, Days after submission: 5 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: | | Previous Vaccinations: | | Other Medications: UNK | | Preexisting Conditions: | | CDC 'Split Type': WAES0612CAN00035 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 1 | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Epilepsy | | Write-up: Information has been received from a physician concerning a female who was vaccinated with HPV vaccine. Subsequently, 5 days after both dose 1 and dose 2 of HPV vaccine, the patient experienced epileptic seizure. Subsequently, the patient recovered from epileptic seizure. Upon internal review, epileptic seizure was considered to be an other important medical event (OMIC). Additional information has been requested. |
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| VAERS ID: | 269332 | Vaccinated: | 2006-11-29 | | Age: | 16.0 | Onset: | 2006-11-29, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2006-12-14, Days after onset: 15 | | Location: | | Entered: | 2006-12-19, Days after submission: 5 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: | | Previous Vaccinations: | | Other Medications: UNK | | Preexisting Conditions: | | CDC 'Split Type': WAES0612USA00515 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HEP | GLAXOSMITHKLINE BIOLOGICALS | ABVB221B | | | UN | | HPV4 | MERCK & CO. INC. | 0902F | | | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Agitation, Crying, Dyspnoea, Panic reaction, Tongue oedema | | Write-up: Information has been received from a healthcare professional concerning a 16 year old female patient who on 29 Nov 2006 was vaccinated in the left arm with a dose of HPV vaccine, lot 654884/0902F, batch NE24240. Concomitant suspect therapy included hepatitis B vaccine, Engerix B, batch ABVB221BA, given the same day in the opposite arm. Thirty minutes after administration, while being driven home from the clinic, the patient developed a swollen tongue, difficulty breathing, was panicking and crying. She was treated with Piriton and recovered the same day. The events were considered to be other important medical events as the patient had difficulty breathing (OMIC). Additional information has been requested. Other business partner numbers included E20060652. |
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| VAERS ID: | 269851 | Vaccinated: | 2006-10-15 | | Age: | 22.0 | Onset: | 2006-11-10, Days after vaccination: 26 | | Gender: | Female | Submitted: | 2006-12-28, Days after onset: 48 | | Location: | | Entered: | 2006-12-29, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Magnetic resonance imaging 20Nov06 thrombosis of the venous sinuses. | | Previous Vaccinations: | | Other Medications: NONE | | Preexisting Conditions: | | CDC 'Split Type': WAES0612USA03500 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Headache, Venous thrombosis, Visual disturbance | | Write-up: Information has been received from a physician concerning his daughter a 22 year old female who on approximately 15 Oct 2006 (mid October 2006) was vaccainted with first dose of HPV vaccine (lot # not reported) intramuscularly into the upper arm. On approximately 22 Oct 2006 (one week later, end of October 2006) she received a dose of influenza vaccine (manufacturer and lot no unknown). On 10 Nov 2006, the patient developed headache and vision disorder (unspecified). On 20 Nov 2006, a magnetic resonance Imaging (MRI) was performed and thrombosis of the venous sinuses was diagnoses. She was treated with Heparin. To be noted, she was not hospitalized. She recovered within an unspecified time. The reporter considered the event to be serious (other important medical event) (OMIC). Other business partner numbers included E200606931. Additional information is not expected. |
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| VAERS ID: | 270395 | Vaccinated: | 2006-11-29 | | Age: | 16.0 | Onset: | 2006-11-29, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-01-11, Days after onset: 43 | | Location: | | Entered: | 2007-01-11, Days after submission: 0 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: | | Previous Vaccinations: | | Other Medications: | | Preexisting Conditions: | | CDC 'Split Type': B0453076A | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HEP | GLAXOSMITHKLINE BIOLOGICALS | AHBVB221BA | | IM | | | HPV4 | MERCK & CO. INC. | NE24240 | | IM | | |
| Administered by: Other Purchased by: Other | | Symptoms: Dyspnoea, Paraesthesia | | Write-up: This case was reported by a regulatory authority and described the occurrence of breathlessness in a 16 year old female subject who was vaccinated with Hepatitis B vaccine, HPV vaccine for prophylaxis. On 29 November 2006 the subject received unspecified dose of Hepatitis B vaccine (intramuscular) and unspecified dose of Human Papilloma Type 6+11+18 vaccine (intramuscular). On the same day, 30 minutes after vaccination with Hepatitis B vaccine, at an unspecified time after vaccination with HPV vaccine, the subject experienced breathlessness, oral tingling and tongue tingling. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with antihistamine. On 25 November 2006, the events were resolved. |
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| VAERS ID: | 270530 | Vaccinated: | 2006-12-16 | | Age: | 36.0 | Onset: | 2006-12-16, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-01-12, Days after onset: 27 | | Location: | | Entered: | 2007-01-16, Days after submission: 4 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, 2 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: | | Previous Vaccinations: | | Other Medications: HUMAMET, Jul06-cont; REDUCTIL, Jul06-cont | | Preexisting Conditions: Diabetes | | CDC 'Split Type': WAES0701PHL00001 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Erythema, Feeling hot, Hypokinesia, Oedema peripheral, Pain, Skin burning sensation, Skin exfoliation | | Write-up: Information has been received from a physician concerning a 36 year old female with diabetes who on 16-DEC-2006 was vaccinated with GARDASIL. Concomitant therapy included metformin HCL (HUMAMET) and sibutramine hydrochloride (REDUCTIL). Patient was vaccinated in the morning of 16-DEC-2006. Later in the afternoon, the patient experienced swelling, redness and hot feel of both hands and feet. Reportedly, patient could not close fist as it caused pain. On 17-DEC-2006, patient was brought to the emergency room and admitted. Patient was prescribed with descloratadine tablet for 2 weeks and an unspecified ointment. On 19-DEC-2006, patient was discharged. Subsequently, patient experienced peeling of palms and soles. Subsequently, the patient recovered from swelling of both hands and feet. The patient's peeling of palms and soles persisted. The reporting physician and patient felt that swelling of both hands and feet and peeling of palms and soles were related to therapy with GARDASIL vaccine. Additional information has been requested. |
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| VAERS ID: | 272718 | Vaccinated: | 2006-10-29 | | Age: | 17.0 | Onset: | 2006-10-29, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-02-19, Days after onset: 113 | | Location: | | Entered: | 2007-02-20, Days after submission: 1 | |
| Life Threatening Illness? Yes |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: Phobic anxiety | | Diagnostic Lab Data: blood pressure 29Oct06 110/67 mmHg Comment: sitting BP, physical examination 29Oct06 Comment: Pulse rate 55, Glasgow come scale 29Oct06 Comment: 15/15 | | Previous Vaccinations: | | Other Medications: UNK | | Preexisting Conditions: | | CDC 'Split Type': WAES0612AUS00040 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0444F | | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Blood pressure decreased, Bronchospasm, Dizziness, Dyspnoea, Glasgow coma scale, Heart rate decreased, Oxygen supplementation, Pallor, Palpitations, Syncope | | Write-up: Information has been received from a physician concerning a 17 year old female who on 29-OCT-2006 was vaccinated with Gardasil (lot No 654672/0444F, batch no NE01680, Expiry date 23-FEB-2009) on her left deltoid muscle. The patient is needle phobic and had nothing to eat on 29-OCT-2006 until the patient received vaccination on 12:02pm. On 29-OCT-2006 the patient experienced syncope and bronchospasm. Four minutes after injection, the patient had syncope. The symptoms included light headedness, pallor, feeling like fainting and palpitation. The patient had no chest pain but had bronchospasm with dyspnoea. The patient's sitting blood pressure was 110/67 mmHg and pulse rate was 55. Glasgow Coma Score was 15/15. The patient had oxygen mask. The patient was not hospitalized. The physician considered her diagnosis as phobia, syncope vs drug reaction. Subsequently the patient recovered from syncope and bronchospasm. The physician considered syncope and bronchospasm were related to therapy with Gardasil and asked the patient to reconsider about continuing the next dose of Gardasil. Syncope and bronchospasm were considered to be life threatening by the reporting physician. Additional information is not expected. |
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| VAERS ID: | 273098 | Vaccinated: | 0000-00-00 | | Age: | 18.0 | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2007-02-26 | | Location: | | Entered: | 2007-02-27, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: Rheumatism | | Diagnostic Lab Data: Arthrocentesis | | Previous Vaccinations: | | Other Medications: UNK | | Preexisting Conditions: | | CDC 'Split Type': WAES0702USA03743 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Aspiration joint, Condition aggravated, Juvenile arthritis | | Write-up: Information has been received from a hospital physician concerning an 18 year old female with rheumatism who was vaccinated with a first dose of Gardasil. Subsequently the patient experienced juvenile arthritis, which was assumed to be an acute exacerbation of pre existing rheumatism. Beforehand she had been uncomplaining for a long time. She was admitted to the hospital where a joint puncture was carried out. At the time of the report, the symptoms were ongoing. No further information is available. Other business partner numbers included E2007-01082. |
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| VAERS ID: | 273223 | Vaccinated: | 2007-02-17 | | Age: | 19.0 | Onset: | 2007-02-17, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-02-28, Days after onset: 11 | | Location: | | Entered: | 2007-03-01, Days after submission: 1 | |
| Life Threatening Illness? Yes |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: blood pressure 17Feb07 100/70 mmHg Comment: low, blood pressure 17Feb07 100/60 mmHg, total heartbeat count 17Feb07 76/min, total heartbeat count 17Feb07 79/min, temperature measurement 17Feb07 97.6 deg F | | Previous Vaccinations: | | Other Medications: UNK | | Preexisting Conditions: UNK | | CDC 'Split Type': WAES0702POL00004 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 36970 | | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Apnoea, Asthenia, Blood pressure decreased, Body temperature increased, Disorientation, Fall, Head injury, Headache, Heart rate increased, Hypotension, Retrograde amnesia, Syncope | | Write-up: Information has been received from a physician concerning a 19 year old female who on 17-FEB-2007 was placed on therapy with human papillomavirus vaccine, 0.5 ml, 0.5 ml prophylaxis. On 17-FEB-2007 the human papillomavirus was administered intramuscular in deltoid muscle according to manufacturer's recommendation. The reporter felt that the injection was made properly. Immediately after taking human papillomavirus vaccine the patient experienced weakness. At that moment the blood pressure was 100/70, total heartbeat count was 76/min, temperature was 97.6 deg F. Dyspnoe and changes on the skin were not observed. The patient was laid down in horizontal position with her legs elevated for 5 minutes. After 4 minutes the regression of symptoms was observed. Approximately after 20 minutes the patient fell down. The syncope was observed. Head injury and apnoe were observed. Restoring of respiratory patency by deviation of head and removing of collapsed tongue was performed. Regression of apnoe was observed. The patient experienced disorientation and retrograde amnesia. The patient remembered only the weakness before syncope, but she did not remember what happened later. Then the patient regained consciousness. After that the headache was observed in the injured place and later in whole head. At that moment the blood pressure was 100/60. total heartbeat count was 79/min, temperature was 97.6 deg F, Meningeal signs were negative. After 2 hours no abnormalities were observed. Subsequently, the patient recovered from syncope, hypotension, weakness, apnoe, disorientation, retrograde amnesia, head injury and headache. The reporter felt that syncope, hypotension, weakness, apnoe, disorientation, retrograde amnesia, head injury and headache were related to therapy with Gardasil. Syncope and apnoe were considered by the doctor to be immediately life-threatening. Additional information is not expected. |
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| VAERS ID: | 273382 | Vaccinated: | 2007-02-01 | | Age: | 16.0 | Onset: | 2007-02-01, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-03-02, Days after onset: 29 | | Location: | | Entered: | 2007-03-05, Days after submission: 3 | |
| Life Threatening Illness? Yes |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, 0 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: UNK | | Previous Vaccinations: | | Other Medications: UNK | | Preexisting Conditions: UNK | | CDC 'Split Type': WAES0702USA04752 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0859F | | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Anaphylactic reaction, Anxiety, Dyspnoea | | Write-up: Information has been received from a health authority concerning a 16 year old female who on 01-FEB-2007 was vaccinated with the first dose of Gardasil (lot #654740/0859F, batch #NE25270), IM into the left deltoid muscle. It was reported that previous vaccinations were well tolerated. On 01-FEB-2007 at 6:15 pm, the patient experienced anaphylactic reaction with dyspnoea and anxiety reaction and the patient was hospitalized. Subsequently after 75 minutes, the patient recovered from anaphylactic reaction. Anaphylactic reaction was considered to be immediately life-threatening. Case is closed. Other business partner numbers include E2007-01238. Additional information is not expected. |
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| VAERS ID: | 273514 | Vaccinated: | 2007-02-06 | | Age: | 18.0 | Onset: | 2007-02-14, Days after vaccination: 8 | | Gender: | Female | Submitted: | 2007-03-06, Days after onset: 20 | | Location: | | Entered: | 2007-03-07, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: UNK | | Previous Vaccinations: | | Other Medications: NONE | | Preexisting Conditions: NONE | | CDC 'Split Type': WAES0703USA00122 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Abnormal behaviour, Hallucination, auditory, Mental disorder | | Write-up: Information has been received from a health professional concerning an 18 year old female patient with no past medical history who on 06-FEB-2007 was vaccinated with a first dose of Gardasil (dosage not provided). There was no concomitant medication. On 14-FEB-2007 the patient developed bizarre philosophical outlook and claimed to hear the voice of a good entity called "it" which could "redress unbalance in her family." She also described the Gardasil as poison coursing through her body. The patient was seen by the reporter who described her behavior as overtly sexual by throwing herself back in the chair with her legs wide open. The reporter stated it was a major psychiatric breakdown and her parents were unable to cope with her at home. The patient was sectioned to be admitted to the hospital. The patient had not recovered as of 23-FEB-2007. Other business partner numbers included E2007-01291. Additional information has been requested. |
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| VAERS ID: | 273519 | Vaccinated: | 2007-01-27 | | Age: | 38.0 | Onset: | 2007-02-08, Days after vaccination: 12 | | Gender: | Female | Submitted: | 2007-03-06, Days after onset: 26 | | Location: | | Entered: | 2007-03-07, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: Chlamydial infection | | Diagnostic Lab Data: UNK | | Previous Vaccinations: | | Other Medications: UNK | | Preexisting Conditions: | | CDC 'Split Type': WAES0702HUN00008 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Hypoaesthesia | | Write-up: Information ahs been received from a physician concerning a 38 year old female who was vaccinated with Gardasil. On 08-FEB-2007 about two weeks after vaccination, the patient experienced numbness and was hospitalizes. At the time of vaccination patient had chlamidial infection and had taken Botox (botullinum injection used for cosmetic reasons).The action taken with regards to therapy with Gardasil was none. The patient is recovering and the causality reported by treating physician is "possible". No further information is available. |
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| VAERS ID: | 273849 | Vaccinated: | 2007-01-02 | | Age: | 25.0 | Onset: | 2007-01-16, Days after vaccination: 14 | | Gender: | Female | Submitted: | 2007-03-12, Days after onset: 54 | | Location: | | Entered: | 2007-03-13, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, 0 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: UNK | | Previous Vaccinations: | | Other Medications: UNK | | Preexisting Conditions: UNK | | CDC 'Split Type': WAES0703USA00872 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Fatigue, Headache | | Write-up: Information has been received from a physician concerning a 25 year old female who on 02-JAN-2007 was vaccinated with the first dose of Gardasil (lot # not reported), IM in the left arm. Concomitant medication was not reported. On approximately 16-JAN-2007, two to three weeks post vaccination, the patient experienced extreme fatigue. On approximately 06-FEB-2007, five weeks post vaccination, the patient experienced cephalgia. The patient was hospitalized for check-up, but no diagnosis could be established. The patients extreme fatigue and cephalgia persisted. Other business partner numbers included E2007-01394. Additional information is not expected. |
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| VAERS ID: | 274072 | Vaccinated: | 2007-02-23 | | Age: | 28.0 | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2007-03-15 | | Location: | | Entered: | 2007-03-16, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, 3 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: UNK | | Previous Vaccinations: | | Other Medications: acetaminophen Unk - Unk | | Preexisting Conditions: UNK | | CDC 'Split Type': WAES0703USA02259 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Arthralgia, Joint swelling, Urticaria | | Write-up: Information has been received from a dermatologist concerning a female with a sore throat (developed at the time of vaccination) who was vaccinated with primary dose of Gardasil. Concomitant therapy included acetaminophen. Subsequently, four days post vaccination, the patient developed a urticarial rash and joint swelling with arthralgia. The patient was hospitalized for three days, and was treated with erythromycin and CORTISONE. On 07-MAR-2007, the patient contacted the the dermatologist and reported that symptoms had improved notedly. On an unspecified date, the patient had recovered, although, was still receiving CORTISONE therapy. No further information is available. Other business partner number included E2007-01485. |
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| VAERS ID: | 274234 | Vaccinated: | 2007-02-15 | | Age: | 17.0 | Onset: | 2007-02-15, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-03-16, Days after onset: 28 | | Location: | | Entered: | 2007-03-19, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, 0 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: UNK | | Previous Vaccinations: | | Other Medications: NONE | | Preexisting Conditions: UNK | | CDC 'Split Type': WAES0703CAN00131 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0444F | | | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Confusional state, Fall, Head injury, Subarachnoid haemorrhage, Syncope | | Write-up: Information has been received from a physician concerning a 17 year old female who on 15-FEB-2007 was vaccinated with Gardasil (lot # 654672/0444F). There was no concomitant therapy. On 15-FEB-2007, 2-3 minutes after Gardasil injection the patient experienced syncopal episode, fell and hit her head. The patient had a head injury and central lateral subarachnoid bleeding and was hospitalized. The patient's syncopal episode and head injury and central lateral subarachnoid bleeding persisted. It was reported that the patient had a gradual clearing of confusion. Additional information has been requested. |
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| VAERS ID: | 274362 | Vaccinated: | 2007-03-01 | | Age: | 17.0 | Onset: | 2007-03-01, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-03-19, Days after onset: 17 | | Location: | | Entered: | 2007-03-20, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: UNK | | Previous Vaccinations: | | Other Medications: UNK | | Preexisting Conditions: Amenorrhea; Affect lability | | CDC 'Split Type': WAES0703USA02432 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0572F | 0 | IM | LA | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Loss of consciousness, Meningism, Muscle spasms, Syncope | | Write-up: Information has been received from a gynecologist concerning a 17 year old female with a history of emotional lability and probably "stress-related" amenorrhoea who on 01-MAR-2007 was vaccinated with the first dose of Gardasil, IM into the left arm. Concomitant medication was not reported. On 01-MAR-2007, about 2 minutes post vaccination, the patient experienced a convulsion syncope with meningism, muscular spasm and unconsciousness. Subsequently after about 3 minutes, the patient recovered from convulsion syncope. The patient was admitted to the hospital. Other business partner numbers included E2007-01514. Additional information is not expected. |
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| VAERS ID: | 274756 | Vaccinated: | 2007-01-24 | | Age: | 35.0 | Onset: | 2007-01-24, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-03-23, Days after onset: 57 | | Location: | | Entered: | 2007-03-26, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: UNK | | Previous Vaccinations: | | Other Medications: ZIRTEK 12Jan07 - 24Jan07, echinacea (unspecified) 12Jan07 - 24Jan07, fluconazole 12Jan07 - 24Jan07 | | Preexisting Conditions: Abortion missed | | CDC 'Split Type': WAES0703USA03854 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Abortion missed, Drug exposure during pregnancy, Inappropriate schedule of drug administration | | Write-up: Information has been received from a health professional concerning a pregnant 35 year old female with a history of missed miscarriage who on 24-JAN-2007 was vaccinated intramuscularly with a first dose of Gardasil. The site of administration was not reported. concomitant therapy included Echinacea (unspecified), FUNGUSTATIN, ZIRTEK which the patient took as self medication from 12-JAN-2007 to 24-JAN-2007 because she believed she had a possible fungal infection. It was reported that the patient was unaware that she was pregnant at the time of vaccination. The first day after her last menstruation period was 31-DEC-2006 and the patient's expected date of delivery was 07-OCT-2007. The patient realized that she was pregnant on 31-JAN-2007. Approximately 4 days later, the patient experienced a "missed miscarriage." This diagnosis was made by the reporting physician herself. At the time of this report, the outcome was unknown. The reporting physician specified that the miscarriage was not related to therapy with Gardasil. It was also specified that FUNGUSTATIN had not been prescribed by a physician and that it was self-administered by the patient. Upon internal review, miscarriage was considered an other important medical event. Other business partner number included E2007-01696. No further information is available. The case is closed. |
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| VAERS ID: | 274941 | Vaccinated: | 2007-03-13 | | Age: | 15.0 | Onset: | 2007-03-13, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-03-26, Days after onset: 13 | | Location: | | Entered: | 2007-03-27, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: UNK | | Previous Vaccinations: | | Other Medications: UNK | | Preexisting Conditions: UNK | | CDC 'Split Type': WAES0703USA04220 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0572F | | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Agitation, Hypotension, Loss of consciousness, Nausea, Neurological examination, Tonic convulsion | | Write-up: Information has been received from a health professional concerning a 15 year old female who on 13-MAR-2007 was vaccinated IM into the arm with a first dose of Gardasil (lot # 655376/0572F, batch # NE45050). About 5-10 minutes after the vaccination the patient developed symptoms of tonic convulsions and was unconsciousness for about 1-2 minutes. After recovery the patient developed hypotension and felt nauseas for about 20 minutes. The patient recovered completely. It was reported that the patient is tall and slim and was very excited before vaccination. It was also noted that her sister has a history of hydrocephalus and epilepsy. A neurologic check is planned. Other business partner numbers included E2007-01613. |
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| VAERS ID: | 275510 | Vaccinated: | 0000-00-00 | | Age: | 17.0 | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2007-04-02 | | Location: | | Entered: | 2007-04-03, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, 2 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0703USA04719 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Asthenia, Cold sweat, Dyspnoea, Injection site pain, Malaise, Sensation of foreign body | | Write-up: Information has been received from a company representative via a physician's office concerning a 17 year old female who on an unspecified date was vaccinated with the first dose of Gardasil. Concomitant medication was not reported. Subsequently on an unspecified date, immediately following vaccination, the patient complained about injection site pain. The patient left the practice together with her mother. About 15 minutes post vaccination, the patient and her mother returned. At that time, the patient complained about feeling unwell and an intense global feeling in her pharynx. The patient felt like not being able to breath. The patient was treated with corticosteroids. After about 1 hour, the patient recovered from the global feeling in her pharynx but was asthenic and showed cold sweat. The patient was admitted to the hospital. The patient recovered after two days and was discharged from the hospital. Other business partner numbers included E2007-01818. Additional information is not expected. |
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| VAERS ID: | 275511 | Vaccinated: | 2007-03-22 | | Age: | 15.0 | Onset: | 2007-03-22, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-04-02, Days after onset: 11 | | Location: | | Entered: | 2007-04-03, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0703USA05195 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | DTAP | UNKNOWN MANUFACTURER | Z0868 | | IM | | | HPV4 | MERCK & CO. INC. | 0903F | | IM | | | IPV | UNKNOWN MANUFACTURER | Z0868 | | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Asthenia, Cough, Injection site pruritus, Medication error, Pruritus, Visual disturbance, Vomiting, Wrong drug administered | | Write-up: Information has been received from a physician concerning a 15 year old female who on 22-MAR-2007 was vaccinated IM into the right arm with a first dose of Gardasil (lot# 654948/0903F; batch# NE35170). concomitant suspect therapy included given on 22-MAR-2007 included an IM into the left arm booster dose of REPEVAX (batch# Z0868). About 30 minutes later, the patient developed pruritis first at the left than at the right injection site. The patient experienced "subjective" unspecified visual disturbance for a short time. Subsequently, she vomited 5 times and experienced a dry cough and felt weak. the patient's mother brought her back to the practice. She was treated with antihistamines, prednisolone (100 mg) and inhalative salbutamol. Within about 2 hours the patient recovered. It was reported that all previous vaccinations were well tolerated. The reporter felt that pruritis at the injection site, visual disturbance, vomited 5 times, dry cough and weak were considered to be other important medical events. Other business partner numbers include: E200701842. No further information is available. The file is closed. |
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| VAERS ID: | 275701 | Vaccinated: | 2007-03-07 | | Age: | 13.0 | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2007-04-05 | | Location: | | Entered: | 2007-04-06, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0704POL00002 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Peritoneal abscess, Polycystic ovaries | | Write-up: Information has been received from a physician concerning a 13 year old female who on approximately 07-MAR-2007 was vaccinated with GARDASIL. In March 2007, the patient experienced polycystic ovaries and peritoneal abscess (10 centimetres in diameter) and was hospitalized. The patient was treated with antibiotic intravenously. After treatment with antibiotic the diameter of the abscess was about 3 centimetres. Additional information has been requested. |
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| VAERS ID: | 275705 | Vaccinated: | 2007-01-16 | | Age: | 17.0 | Onset: | 2007-02-26, Days after vaccination: 41 | | Gender: | Female | Submitted: | 2007-04-05, Days after onset: 37 | | Location: | | Entered: | 2007-04-06, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, 5 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: cervical smear 02?Mar07- Comment: showed Escherichia coli; HSV type and/or 2 identification PCR 02?Mar07 - Comment: Type I diagnosis made by HCR-PCR; WBC count 02?Mar07 6.4 nl; hematocrit 02?Mar07 39.5%; hemoglobin 02?Mar07 13.6 g/dl; plat | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0703USA05447 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0902F | 0 | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Burning sensation, Escherichia infection, Haematocrit normal, Haemoglobin normal, Herpes simplex, Platelet count, Platelet count normal, Polymerase chain reaction, Rash pustular, Skin fissures, Smear cervix abnormal, Smear vagina, Superinfection, Vaginal inflammation, Vulvovaginal discomfort | | Write-up: Information has been received from a gynaecologist concerning a 17 year old female who on 16-JAN-2007 was vaccinated with the first dose of Gardasil, (lot #654884/0902P, batch #NE24240), IM into the upper arm. Concomitant medication was not reported. On 26-FEB-2007, the patient experienced rhagades, pustules and burning feeling of vulva. On 28-FEB-2007, the patient developed severe inflammation of introitus vaginae. The patient was admitted to hospital on 02-MAR-2007. Severe herpes simplex genitalis and a superinfection with Escherichia coli were diagnosed. the patient was treated with acyclovir and antiinfectives. On an unspecified date, the following laboratory tests were performed leukocytes 6.4 nl, hemoglobulin 13.6 g/dl, hematocrit 39.5%, thrombocytes 251.000 micro/L, IgM positive, IgG positive, vaginal smear showed Escherichia coli and HSV-PCR diagnosed herpes simplex type I. On 07-MAR-2007, the patient was discharged from the hospital. Subsequently on an unspecified date, the patient recovered completely from herpes simplex type I and superinfection. On 19-MAR-2007, the patient received the second dose of Gardasil which was well tolerated (up to the reporting date). File closed. No further information is available. |
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| VAERS ID: | 275780 | Vaccinated: | 2007-01-23 | | Age: | 17.0 | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2007-04-06 | | Location: | | Entered: | 2007-04-09, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: None | | Previous Vaccinations: | | Other Medications: hormonal contraceptives (unspecified) Unk - Unk | | Preexisting Conditions: Contraception | | CDC 'Split Type': WAES0704USA00470 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0902F | | | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Generalised erythema, Injection site discolouration, Pruritus generalised | | Write-up: Information has been received from a gynaecologist concerning a 17 year old female with a history of contraception use who on 23-JAN-2007 was vaccinated with Gardasil (lot # 654884/0902F; batch # NE24240) into the left upper arm (number in the series not reported). Concomitant therapy included hormonal contraceptives (unspecified) for systemic use. On 23-JAN-2007, the same day, the patient experienced generalized pruritus and redness, She was treated with antihistamines and recovered on 24-MAR-2007. On an unspecified date in 2007, the patient developed a "white spot" (diameter approximately 4 cm) in the area of the injection site . At the time of reporting, the white spot was ongoing. This was supposed to be a "persisting damage". The events were ongoing to be serious as Other Important Medical Events. File closed. Other business partner numbers included: E2007-01992. No further information is available. |
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| VAERS ID: | 275994 | Vaccinated: | 0000-00-00 | | Age: | | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2007-04-10 | | Location: | | Entered: | 2007-04-11, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, 0 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: None | | CDC 'Split Type': WAES0704USA01086 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Erythema multiforme | | Write-up: Information has been received from a pediatrician concerning an adolescent female who was vaccinated, intramuscularly, into the upper arm, with a first dose of Gardasil. Approximately 3 week after the vaccination the patient experienced erythema exsudativum multiforme and was hospitalized. She was treated with intravenous corticosteroids. Subsequently, the patient recovered (exact duration not reported). No further information is available. Other business partner numbers included E2007-02193. |
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| VAERS ID: | 276699 | Vaccinated: | 2007-01-22 | | Age: | 15.0 | Onset: | 2007-01-24, Days after vaccination: 2 | | Gender: | Female | Submitted: | 2007-04-17, Days after onset: 82 | | Location: | | Entered: | 2007-04-18, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, 0 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: platelet count 24an07 24 G/l, platelet count 29Jan07 147 G/l | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Upper respiratory tract infection | | CDC 'Split Type': WAES0704HUN00005 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Platelet count decreased, Thrombocytopenia | | Write-up: Information has been received from a physician concerning a 15 year old female with a history of upper respiratory tract infection (1 week prior vaccination) who on 22-Jan-2007 was vaccinated with human papillomavirus vaccine for prophylaxis. On 24-JAN-2007 the patient experienced immuno-throbocytopenia and was hospitalized. Subsequently, the patient recovered from thrombocytopenia due to steroid treatment. The reporter felt that thrombocytopenia was not related to therapy with Gardasil. Additional information has been requested. |
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| VAERS ID: | 277113 | Vaccinated: | 2007-02-12 | | Age: | 16.0 | Onset: | 2007-02-12, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-04-19, Days after onset: 65 | | Location: | | Entered: | 2007-04-20, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, 0 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: None | | CDC 'Split Type': WAES0704USA02616 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Immediate post-injection reaction, Pain in extremity, Paraesthesia, Syncope, Tonic convulsion | | Write-up: Information has been received from a health authority concerning a 16 year old female with reportedly no other relevant medical history, who on 12-FEB-2007w as vaccinated intramuscularly, into the left, upper, arm with Gardasil, (Lot # NE45050). On 12-FEB-2007, immediately post vaccination (P.V.), the patient complained of pain and paraesthesia in the left arm. Ten minutes p.v. the patient experienced syncope with tonic convulsion for one minute. She was hospitalized. No information regarding treatment and duration of hospitalization was given, but the time until complete recovery was reported as "6 hours". The case is closed. Additional information has been requested. |
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| VAERS ID: | 277351 | Vaccinated: | 2007-04-10 | | Age: | 13.0 | Onset: | 2007-04-10, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-04-24, Days after onset: 14 | | Location: | | Entered: | 2007-04-25, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: None | | CDC 'Split Type': WAES0704USA03084 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | NE12410 | 0 | IM | LA | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Erythema, Oedema peripheral, Skin warm | | Write-up: Information has been received from a physician concerning a 13 year old female with no relevant past medical history, and no history of allergies, who on 10-APR-2007 was vaccinated intramuscularly into the left upper arm with the first dose of Gardasil (Batch # NE12410). On 10-Apr-2007, a few hours post vaccination, the patient experienced swelling of the entire left arm including the fingers with redness and warmth. The patient was treated with cortisone and antiallergic agents. At the time of this report, the patient had not recovered. The reporting physician felt that the events were important for other medical events. Additional information has been requested. Other business partner numbers include E2007-02275. |
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| VAERS ID: | 277813 | Vaccinated: | 2007-02-05 | | Age: | 16.0 | Onset: | 2007-02-05, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-05-02, Days after onset: 85 | | Location: | | Entered: | 2007-05-03, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, 3 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: blood pressure 05Feb07 115/60 mmHg, body temp 05Feb07 37.7 deg C, total serum bilirubin 05Feb07 25.8 micromol/L slightly increased | | Previous Vaccinations: | | Other Medications: None | | Preexisting Conditions: None | | CDC 'Split Type': WAES0704CZE00002 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | NE43130 | 0 | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Back pain, Blood bilirubin increased, Blood pressure, Body temperature increased, Cardiac murmur, Chest pain, Cough, Dyspnoea, Hyperhidrosis, Nausea, Vertigo, Viral infection | | Write-up: Information has been received from a physician concerning a 16 year old virgin female who on 05-FEB-2007 was vaccinated (first dose) with Gardasil. There was no concomitant medication, no medical history information. On 05-FEB-2007 the patient experienced vertigo, back pain, chest pain, difficulties in breathing, cough, nausea and sweating and was hospitalized. Subsequently, the patient recovered and was on 08-FEB-2007 discharged from the hospital. The final diagnosis made by hospital physicians was virosis. According to the hospital chart these adverse experiences were not taken as related to vaccination. Based on the re-evaluation of the situation by the physician, administering vaccine, vertigo, back pain, chest pain, difficulties in breathing and cough, nausea and sweating could be possibly related to therapy with Gardasil. Administering physician received the information about patient's hospitalization on 11-APR-2007 when patient was visiting the site in order to obtain second dose of Gardasil vaccine. Vaccination was not performed, physician requested detailed information about hospitalization. - Based on the hospital chart, patient was vaccinated around 3p.m. on 05-FEB-2007. Although patient was informed that she should eliminate any physical activity for 48 hours after vaccination patient went to her temporary job at 6p.m. Patient reported that there was close weather and she experienced vertigo. On 7p.m. patient went to a dancing class and smoked a cigarette, nevertheless she didn't practice because of back pain, vertigo and cough. At 8p.m. patient went together with her friends to a restaurant, smoked cigarettes and experienced nausea, vertigo and sweating. On the way home patient climbed the stairs (4, floor) and experienced difficulty in breathing. Consequently, ambulance was called and patient was admitted to hospital. Cardiological examination excluded cardiac reason of chest pain (accidental murmur present). Total bilirubin was slightly increased (25.8), BP 115/60, temperature 37.7 deg C. Additiona |
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| VAERS ID: | 278381 | Vaccinated: | 2007-04-27 | | Age: | 16.0 | Onset: | 2007-04-27, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-05-10, Days after onset: 13 | | Location: | | Entered: | 2007-05-11, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, 0 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0705USA01162 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0572F | | IM | RA | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Eye rolling, Muscle twitching, Syncope | | Write-up: Information has been received from a health professional concerning a 16 year old female who on 27-APR-2007 was vaccinated, intramuscularly, in the right deltoid muscle, with Gardasil (Lot number 655376/0572F : Batch number NE 45050). On 27-APR-2007 the patient experienced syncope, eyes rolling and twitches of the right arm. The symptoms lasted for less than one hour. She was admitted to the hospital for monitoring. Further course and diagnostic (not specified) was normal. Subsequently, the patient recovered completely. Additional information has been requested. |
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| VAERS ID: | 278577 | Vaccinated: | 0000-00-00 | | Age: | 17.0 | Onset: | 2007-05-07 | | Gender: | Female | Submitted: | 2007-05-14, Days after onset: 7 | | Location: | | Entered: | 2007-05-15, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: None | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0705AUS00041 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0313U | | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Aphasia, Facial paresis, Muscular weakness, Neurological symptom, Neuropathy, Syncope | | Write-up: Information has been received from the foreign Department of Health, via CSL as part of a business agreement (manufacturer's number not yet advised). As part of the regular school-based immunisation program funded by the government, a 17 year old female student was vaccinated with Gardasil (Lot No. 655743/0313U, Batch No. J1022, Expiry date August 2009). Subsequently the patient experienced fainting and was taken to hospital. The patient had neurological symptoms and her reaction was serious enough to warrant consideration to intubation (confirmed as not intubated in follow-up information). The provisional diagnosis appears to be "hysterical reaction". The reporter felt that her reactions were related to therapy with Gardasil (Lot No. 655743/0313U, Batch No. J1022, Expiry date August 2009). Further information was received from a physician. It was stated that the patient was previously well. The patient had no significant medical history and no previous reaction to immunisation. There was no concurrent medication. On 07-MAY-2007, after the first dose of Gardasil (Lot No. 655743/0313U, Batch No. J1022, Expiry date August 2009), the patient developed ascending neuropathy with weakness of limb muscles and facial muscles and aphasia and was hospitalised. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released by the regulatory agency. Additional information has been requested. This is one of several reports received from the same source. |
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| VAERS ID: | 279094 | Vaccinated: | 2007-04-25 | | Age: | 17.0 | Onset: | 2007-04-28, Days after vaccination: 3 | | Gender: | Female | Submitted: | 2007-05-18, Days after onset: 20 | | Location: | | Entered: | 2007-05-21, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: serum ANA 04May07 Normal; serum C-reactive protein slightly elevated 04May07; serum creatinine 04May07 2.0 mg/dL; serum creatinine 05May07 2.5 mg/dL; serum creatinine 06May07 2.8 mg/dL; serum creatinine 10May07 1.4 mg/dL | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0705USA02669 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Antinuclear antibody negative, Blood creatinine increased, C-reactive protein increased, Flank pain, Renal failure acute, Ultrasound kidney abnormal | | Write-up: Information has been received from a physician concerning a 17 year old female patient who on 25-APR-2007 was vaccinated IM in to left upper arm with a first dose of Gardasil. On approximately 28-APR-2007 (3-4 days) post vaccination the patient experienced pain flank. On 04-MAY-2007 she was admitted to the hospital and was diagnosed with Acute renal failure. Her creatinine was 2.0 mg/dL, serum C-reactive protein test (CRP) was slightly increased. Sonographic analysis showed big swollen kidneys. She was treated by Intravenous (IV) fluids therapy. No specified medication was given. The patient improved step by step since 07-MAY-2007. Additional information is not expected. |
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| VAERS ID: | 279189 | Vaccinated: | 2007-03-22 | | Age: | | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2007-05-14 | | Location: | | Entered: | 2007-05-17, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? Yes |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0704USA01691 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | UN | UN | |
| Administered by: Other Purchased by: Other | | Symptoms: Injection site pain, Mobility decreased, Pain in extremity | | Write-up: Information has been received from a physician concerning a female who on 22-MAR-2007 was vaccinated with Gardasil. It was reported that the patient had injection site pain after receiving the vaccination. On 10-APR-2007, the patient called the physician's office and reported that she was still having pain in the arm and shoulder which was aggravated when raising the arm. The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient recovered. This is one of two reports received from the same source. Attempts are being made to obtain identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Upon follow-up it was reported by the physician that the patient received Gardasil, (Lot # "0011V") on 22-MAR-2007. The physician stated that after 4 weeks, the patient's injection site pain was gone. Additional information has been requested. |
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| VAERS ID: | 279247 | Vaccinated: | 2007-04-09 | | Age: | | Onset: | 2007-04-09, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-05-21, Days after onset: 42 | | Location: | | Entered: | 2007-05-22, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: Pregnancy NOS (LMP = 01Mar07) | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: | | CDC 'Split Type': WAES0705SGP00004 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Abortion, Drug exposure during pregnancy | | Write-up: Information has been received from a physician concerning a female who on 09-APR-2007 was vaccinated with the first dose of Gardasil. Subsequently the patient was found to be 9 weeks pregnant when she came back for her second booster dose. The patient's last menstrual period was 01-MAR-2007. The patient did not experience any other adverse effect. Subsequently, on 02-MAR-2007, the patient had an abortion. Upon internal review, this report was considered an other important medical event. No further information is available. |
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| VAERS ID: | 279455 | Vaccinated: | 2007-05-07 | | Age: | 13.0 | Onset: | 2007-05-07, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-05-23, Days after onset: 16 | | Location: | | Entered: | 2007-05-24, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, 0 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: vital signs 07May07 normal | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0705AUS00079 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0313U | | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Asthenia, Conversion disorder, Hypoaesthesia, Lethargy, Muscular weakness, Physical examination, Syncope | | Write-up: Information has been received from the Department of Health as part of a business agreement (manufacturer's number: GARD 2007 05 16 004). As part of the regular school-based immunisation program funded by the government, several female students was vaccinated with Gardasil vaccine (Lot No. 655743/0313U, Batch No. J1022, Expiry date August 2009). Subsequently the patients experienced fainting (the patient reported as below does not have a record of fainting according to follow-up information) and were taken to hospital. It was stated that most of the cases were not serious. The reporter felt that the reactions were related to therapy with Gardasil (Lot No. 655743/0313U, Batch No. J1022, Expiry date August 2009). Follow-up information was received. At the time of reporting on 08-MAY-2007, it was stated that all girl have recovered, although some were possibly admitted to hospital overnight. None were intubated. The provisional diagnosis appeared to be "hysterical reaction." Follow-up information was received from a physician. The patient was a 13 year old female school girl with no past medical history and no known allergy. After vaccination with Gardasil (Lot No. 655743/0313U, Batch No. J1022, Expiry date August 2009) on 07-MAY-2007, she experienced general weakness. On neurological examination at "approximately 5 - 10 mins" post vaccination, the patient showed right leg numbness (approximately L2 - L5) and right leg weakness (1/5 power whole leg). She was transferred to emergency department. Treatment was reported as "observation". No sequelae were reported. At the time of reporting (date not reported), the patient had not yet recovered (also reported as recovered in follow-up information on 08-MAY-2007). Follow-up information was received via a Surveillance of Adverse Events Following Vaccination in the Community. On 07-MAY-2007, within minutes of vaccination with Gardasil (Lot No. 655743/0313U, Batch No. J1022, Expiry date August 2009), the patient reported right leg weakness of 1/5 power, no sensation to pain |
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| VAERS ID: | 279894 | Vaccinated: | 0000-00-00 | | Age: | | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2007-05-25 | | Location: | | Entered: | 2007-05-29, Days after submission: 4 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0705USA04226 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | UN | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Thrombocytopenia | | Write-up: Information has been received from a pharmacist concerning a female patient who was vaccinated with a dose of Gardasil. About 10-14 days post vaccination the patient developed thrombocytopenia and was admitted to the hospital. The outcome was unknown. Other Business Partners include: E2007-03121. Additional information has been requested. |
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| VAERS ID: | 279895 | Vaccinated: | 2007-04-27 | | Age: | 18.0 | Onset: | 2007-05-06, Days after vaccination: 9 | | Gender: | Female | Submitted: | 2007-05-25, Days after onset: 19 | | Location: | | Entered: | 2007-05-29, Days after submission: 4 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0705AUS00150 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Convulsion, Epilepsy, Malaise, Spinal fracture | | Write-up: Information has been received from media monitors summarising the radio talk-back program. A mother of 18 year old female student contacted the radio talk-back program and informed that on 27-APR-2007 her daughter was vaccinated with Gardasil as part of the regular school-based immunisation program funded by the government. On 06-MAY-2007 the school girl got sick. "The hospital" found that she had had a seizure and fractured two vertebrae and the school girl was diagnosed with juvenile epilepsy. "The hospital" did not believe that "the two events" were connected to Gardasil, but the mother was convinced they are. The interviewee of the program, said that epilepsy could be caused by an number of things. Upon internal review, a seizure is determined to be an other important medical event. Additional information is not expected. |
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| VAERS ID: | 279896 | Vaccinated: | 2007-05-01 | | Age: | 18.0 | Onset: | 2007-05-01, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-05-25, Days after onset: 24 | | Location: | | Entered: | 2007-05-29, Days after submission: 4 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: Asthma | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: | | CDC 'Split Type': WAES0705CAN00155 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Asthma, Blood pressure decreased, Condition aggravated, Convulsion, Deafness unilateral, Loss of consciousness | | Write-up: Information has been received from a pharmacist concerning an 18 year old female with asthma who in May 2007, was vaccinated with Gardasil (lot number not available). In May 2007, the patient has a reaction of seizure. It was also reported that the patient passed out, that her blood pressure dropped and that had hearing loss in one ear ("for a short while"). Subsequently, the patient recovered from hearing loss in one ear. It was also reported that the patient's asthma was not as well controlled since the injection of Gardasil. The pharmacist reported that the patient's mother did not want her daughter to have the other doses of Gardasil. Upon internal review, seizure and hearing loss in one ear were considered as other important medical event. Additional information has been requested. |
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| VAERS ID: | 279973 | Vaccinated: | 2007-05-09 | | Age: | 16.0 | Onset: | 2007-05-09, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-05-29, Days after onset: 20 | | Location: | | Entered: | 2007-05-30, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: blood pressure measurement 09?May07 ok, temperature measurement 09?May07 ok, Glasgow coma scale 09?May07 ok, | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0705AUS00158 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | UN | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Blood pressure normal, Body temperature, Confusional state, Disorientation, Dizziness, Glasgow coma scale normal, Headache, Nervous system disorder, Psychomotor hyperactivity | | Write-up: Information has been received from a physician via an other company representative as part of a business agreement concerning a 16 year old female who on approximately 09-MAY-2007 at 11:00 am was vaccinated with Gardasil. On approximately 09-MAY-2007 at 3:00 pm on the day the patient was vaccinated she was taken to her physician. The patient experienced dizziness, hyperactive (also described as overactive/running/shouting), disoriented (also described as confused behaviour), neurological type reaction and headache. The patient's blood pressure, temperature and Glasgow coma scale were found to be okay. Subsequently, the patient recovered from feeling dizzy, hyperactive, disoriented, neurological type reaction and headache. The reporting physician considered dizzy, hyperactive, disoriented and neurological type reaction to be other important medical events. Additional information has been requested. |
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| VAERS ID: | 280070 | Vaccinated: | 2007-05-01 | | Age: | | Onset: | 2007-05-01, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-05-30, Days after onset: 29 | | Location: | | Entered: | 2007-05-31, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0705AUS00147 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Convulsion, Syncope | | Write-up: Information has been received from media monitors summarising the radio talk-back program. A mother of a 17 year old school girl contacted the radio talk-back program and informed that earlier in May 2007 female students of her daughter's school were vaccinated with Gardasil as part of the regular school-based immunisation program funded by the government. She informed that a female student of her daughter's year level had very adverse reactions, including a seizure and fainting. Upon internal review, a seizure is determined to be an other important medical event. Additional information is not expected. This is one of several reports from the same source. |
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| VAERS ID: | 280077 | Vaccinated: | 2007-05-01 | | Age: | | Onset: | 2007-05-01, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-05-30, Days after onset: 29 | | Location: | | Entered: | 2007-05-31, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0705AUS00155 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Convulsion, Syncope | | Write-up: Information has been received from media monitors summarising the radio talk-back program. A mother of a 17 year old school girl contacted the radio talk-back program abd informed that earlier in May 2007 female students of her daughter's school were vaccinated with Gardasil as part of the regular school-based immunisation program funded by the government. She informed that a female student of her daughter's year level had very adverse reactions, including a seizure and fainting. Upon internal review, a seizure is determined to be an other important medical event. Additional information is not expected. This is one of several reports from the same source. |
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| VAERS ID: | 280160 | Vaccinated: | 0000-00-00 | | Age: | | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2007-05-31 | | Location: | | Entered: | 2007-06-01, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0705AUS00175 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Epilepsy | | Write-up: Information has been received from a physician via an other company representative as part of a business agreement (manufacturer control # GARD 2007 05 24 001) concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced epileptic fits after vaccination with Gardasil which needed 2 nurse to control the patient. The physician has referred the patient to specialist before the second dose of Gardasil. Upon internal medical review epileptic fits after vaccination with Gardasil were considered to be an other important medical events. Additional information has been requested. |
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| VAERS ID: | 280161 | Vaccinated: | 0000-00-00 | | Age: | | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2007-05-31 | | Location: | | Entered: | 2007-06-01, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Epileptic seizure | | CDC 'Split Type': WAES0705USA05125 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Condition aggravated, Epilepsy | | Write-up: Information has been received from a gynecologist, concerning an adolescent female with a history of 2 epileptic seizures in childhood, who was vaccinated, IM in the deltoid (date not specified), with the first dose of Gardasil (Batch #NE43160). Immediately following the vaccination, the patient experienced an epileptic seizure; she recovered within a short time. The reporter started that an electroencephalogram (EEG) would be performed. The reporter considered the epileptic seizure to be an other important medical event. No further information is available. Other business partner numbers include #200703213. |
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| VAERS ID: | 280230 | Vaccinated: | 2007-05-22 | | Age: | 16.0 | Onset: | 2007-05-22, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-06-01, Days after onset: 10 | | Location: | | Entered: | 2007-06-04, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0705AUS00191 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Brachial plexopathy, Hypokinesia, Injected limb mobility decreased, Injection site anaesthesia, Mobility decreased, Muscular weakness, Neck pain, Paraesthesia, Paralysis, Pharyngeal hypoaesthesia | | Write-up: Information has been received from a physician at an infectious diseases unit, who was notified of the following adverse event by a consultant neurologist who was the treating physician. This information was reported to us via a agency, as part of a business agreement (manufacturer's case number: GARD 2007 05 28 003). The patient is a 16 year old female who on 22-MAY-2007 was vaccinated with Gardasil as prophylaxis. On 22-MAY-2007, following vaccination with Gardasil, the patient experienced numbness at injection site which increased over the next five days. She was also unable to move her left leg but this resolved on 27-MAY-2007, five days post-vaccination. On 27-MAY-2007 the patient developed paralysis of injected limb and was unable to move her left arm. She had some left neck pain and paraesthesia and some throat numbness. She also experienced weakness in her left arm. The patient was hospitalised and at the time of reporting on 28-MAY-2007 was awaiting investigation. The consultant neurologist (treating physician) made a clinical diagnosis of "probable post-vaccine brachial plexopathy" but at the time of reporting a magnetic resonance imaging (MRI) and nerve conduction studies had not been performed. The patient's numbness at injection site; inability to move left arm; weakness in left arm; left neck pain and paraesthesia, and throat numbness persisted. The reporter felt that paralysis of injected limb; inability to move left arm and left leg; numbness at injection site; weakness in left arm; left neck pain and paresthesia, and throat numbness were related to therapy with Gardasil. Additional information has been requested. |
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| VAERS ID: | 280231 | Vaccinated: | 2007-04-26 | | Age: | 16.0 | Onset: | 2007-04-26, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-06-01, Days after onset: 36 | | Location: | | Entered: | 2007-06-04, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: body temp 26Apr07 38.4 celcius | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: None | | CDC 'Split Type': WAES0705USA05126 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0902F | | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Body temperature increased, Pyrexia, Thrombocytopenia | | Write-up: Information has been received from a Gynecologist concerning a 16 year old female with no relevant history who on 26-APR-2007 was vaccinated with her first dose of Gardasil (batch# NE24240, lot# 654884/09024F), into the deltoid muscle, intramuscularly. On 26-APR-2007, in the evening the patient experienced fever up to 38.4 Celcius and recovered within one day. Subsequently the patient developed relapsing fever episodes. The patient was referred to a hematologist. Thrombocytopenia was diagnosed on 22-MAY-2007. The Gynecologist considered the fever and thrombocytopenia as other important medical events. Other business partner numbers include E2007-03254 (0). No further information is available. |
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| VAERS ID: | 280393 | Vaccinated: | 2007-05-22 | | Age: | 19.0 | Onset: | 2007-05-22, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-06-04, Days after onset: 13 | | Location: | | Entered: | 2007-06-05, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, 1 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: electrocardiogram 22May07 normal | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Computerised tomogram normal; Electroencephalogram; Traffic accident | | CDC 'Split Type': WAES0705USA05770 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 1024F | 0 | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Convulsion, Electrocardiogram normal, Epilepsy, Flushing, Loss of consciousness, Salivary hypersecretion, Syncope | | Write-up: Information has been received from a gynecologist concerning a 19 year old female with a history of traffic accident (September 2006) and normal cranial CT and EEG at that time, who on 22-MAY-2007 was vaccinated IM into the deltoid with a first dose of Gardasil (lot # 655671/1024F; batch # NE51780). On 22-MAY-2007, 2.5 hours after vaccination, (in a department store, on a very hot and sticky day) she developed a questionable seizure for a short time. The patient's mother reported that the patient was at the end of a large moving staircase and she suddenly fainted and "crooked" her whole body. Saliva was seen at the corners of her mouth and red flushes in the area of the decollete. She was unconscious for about 3 minutes and subsequently recovered. An ambulance was called and she was taken to the hospital. She was admitted to the hospital for monitoring and was discharged the same day. The ECG was normal. An EEG and cranial MRI are scheduled for 29-MAY-2007. The reporter considered epileptic seizure and flushing to be other important medical events. Other business partner numbers include E2007-03307. Additional information has been requested. |
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| VAERS ID: | 280674 | Vaccinated: | 2007-05-07 | | Age: | 13.0 | Onset: | 2007-05-07, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-06-05, Days after onset: 29 | | Location: | | Entered: | 2007-06-06, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0705AUS00082 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0313U | | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Body temperature increased, Conversion disorder, Dizziness, Headache, Hemiplegia, Nausea, Tremor, Wheelchair user | | Write-up: Information has been received from a nurse as part of a business agreement (manufacturer's case number: GARD 2007 05 11 002). On 07-MAY-2007, as part of the regular school-based immunisation program funded by the government, a female student was vaccinated with Gardasil (Lot No. 655743/0313U, Batch No. J1022, Expiry date August 2009). The patient was observed for 15 minutes after vaccination and return to the classroom. On 07-MAY-2007, on return to the classroom, the student experienced headache, nausea and feeling faint. Subsequently the patient was "fine". The nurse, who gave the patient the vaccine, considered that the events were due to "mass hysteria". In follow-up, the reporting nurse stated that during the 15 minute observation period after the vaccination on 07-MAY-2007, the patient was symptom-free. The patient was not transported to hospital and was sent home complaining of headache, nausea and feeling faint. This is one of several reports received from the same source. Further information was received from media monitors summarising a radio talk-back program, a television evening news and a paper on 22-MAY-2007. The principal of the student's school stated that "the girl's reactions were not related to the vaccination itself and it is not uncommon for girls of this age group to react to vaccinations in ways that are not necessarily physical in origin". The hospital, where the other five female students of the school (other than this patient) were taken after fainting, released a statement indicating that they do not believe Gardasil was responsible. Follow-up information was received from the principal of the patient's school. On 07-MAY-2007 approximately 590 girls were vaccinated with Gardasil by two nurses over a morning beginning at 9:30 am and finishing around 1:00 pm. There was no interruption to the vaccinations after some girls' adverse events, which occurred through out the morning. Some girls experienced adverse events immediately after vaccination, whilst others only after that had returned t |
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| VAERS ID: | 280841 | Vaccinated: | 2007-05-10 | | Age: | 16.0 | Onset: | 2007-05-12, Days after vaccination: 2 | | Gender: | Female | Submitted: | 2007-06-06, Days after onset: 25 | | Location: | | Entered: | 2007-06-07, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: none | | CDC 'Split Type': WAES0706USA00445 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 1341F | 0 | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Leukocytoclastic vasculitis | | Write-up: Information has been received from a health authority concerning a 16 year old female with no medical history, who on 10-MAY-2007 was vaccinated IM with a first dose of Gardasil (lot# 1341F, batch# NF12410). On 12-MAY-2007, the patient experienced allergic vasculitis and was admitted to the hospital. At the time of this report, the patient had not recovered. Other business partner numbers include: E200703502 and PEI2007004696. No further information is available. |
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| VAERS ID: | 281021 | Vaccinated: | 2007-01-29 | | Age: | 14.0 | Onset: | 2007-05-16, Days after vaccination: 107 | | Gender: | Female | Submitted: | 2007-06-07, Days after onset: 22 | | Location: | | Entered: | 2007-06-08, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: complete blood cell count 25May07 "no info yet" | | Previous Vaccinations: | | Other Medications: albuterol Unk - Unk, hepatitis a virus inactivated (+ 29Jan07, hepatitis a virus vaccine inactivated (+ 16May07, vitamins (unspecified) Unk - Unk | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0706CAN00027 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Chills, Dizziness, Fatigue, Full blood count, Headache, Hypoaesthesia, Influenza like illness, Malaise, Mass, Migraine, Migraine with aura, Nausea, Pallor, Paraesthesia, Paralysis, Pyrexia, Rash, Syncope, Tinnitus, Tremor, Vomiting | | Write-up: Information has been received from a pharmacist and his wife concerning a 14 year old female, very athletic, who on 29-JAN-2007 (first dose) and 16-MAY-2007 (second dose) was vaccinated with Gardasil. Concomitant therapy included Twinrix, vitamins (unspecified) and albuterol. Subsequently, after the first dose of Gardasil, the patient experienced migraine. There was no reaction at the site of injection of Gardasil. On 16-MAY-2007, the patient received the second dose of Gardasil. On 16-MAY-2007 the patient experienced migraine aura, tingling, numbness, dizziness, then fainted, was pale, shaking, some paralysis and ringing in ears (it was reported that some paralysis and ringing in ears "lasted a long time") and headache. It was also reported that that whole evening, the patient also experienced chills and was wiped out, slept. On 17-MAY-2007 and 18-MAY-2007 the patient was tired. On 19-MAY-2007 the patient experienced slight rash on legs, which has been disappearing and coming back, "not a big issue". Therapy with Benadryl and witch hazel (+) Penaten was initiated for rash. On 20-MAY-2007 the patient experienced, above the left clavicle, 3 painful lumps; 2 pea size, 1 bean size. From 21-MAY-2007 to 25-MAY-2007, the lumps grew. On 25-MAY-2007, the patient experienced fever and chills, flu-like reaction. On 25-MAY-2007 the patient went to see a physician. There was no swollen spleen or other swollen glands. It was reported that the physician did not think it "was viral". A complete blood cell count was done but "no info yet". From 25-MAY-2007 to the time of report on 31-MAY-2007, the patient came from school exhausted, experienced a lot of malaise, general headaches, nausea, a bit of vomiting and was still experiencing tingling but there was no diarrhea and the lumps were still swollen but less. Upon internal review, some paralysis was considered as an other important medical event. Tingling and numbness were determined to be important medical events based on agency requirements. No further is available. |
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| VAERS ID: | 281649 | Vaccinated: | 2007-03-01 | | Age: | 23.0 | Onset: | 2007-05-01, Days after vaccination: 61 | | Gender: | Female | Submitted: | 2007-06-13, Days after onset: 43 | | Location: | | Entered: | 2007-06-14, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: cervical smear ??May07 Cervical intra-epithelial neoplasia II (CIN II), cervix biopsy ??May07 cervical intra-epithelial neoplasia II, cervix conization 01May07 cervical intra-epithelial neoplasia III | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0706TWN00004 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Biopsy, Biopsy cervix, Cervical dysplasia, Smear cervix abnormal | | Write-up: Information has been received from a physician concerning a 23 year old female who in March and April 2007, was vaccinated with the first and second doses of Gardasil. In May 2007, the patient was done a cervical screening by a smear test and cervical biopsy and found an abnormal result showed cervical intra-epithelial neoplasia II (CIN II). In May 2007, she was then hospitalized for cone biopsy for the abnormal cell changes and found cervical intra-epithelial neoplasia III (CIN III). The patient was discharged after the test was finished. Additional information has been requested. |
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| VAERS ID: | 281896 | Vaccinated: | 0000-00-00 | | Age: | | Onset: | 0000-00-00 | | Gender: | | Submitted: | 2007-06-14 | | Location: | | Entered: | 2007-06-15, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0706AUS00022 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Convulsion | | Write-up: Information has been received from an acquaintance of a patient who was vaccinated with Gardasil. Subsequently the patient experienced convulsions. An ambulance was called. Upon internal review, the convulsion was felt to be an other important medical event. Additional information is expected. |
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| VAERS ID: | 281899 | Vaccinated: | 2007-06-05 | | Age: | 20.0 | Onset: | 2007-06-05, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-06-14, Days after onset: 9 | | Location: | | Entered: | 2007-06-15, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: blood pressure measurement 05Jun07 110/70 mmHg, vital sign 05Jun07 80 bpm, heart rate-80bpm | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0706PHL00004 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0513F | | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Blood pressure normal, Discomfort, Heart rate normal, Immediate post-injection reaction, Loss of consciousness | | Write-up: Information has been received from a physician concerning a 20 year old female who on 05-JUN-2007 was vaccinated with Gardasil, LOT No. 655101/0513F/BATCH NO. NY48390. Patient has no concurrent conditions, no allergy to egg, and no concomitant therapies. Patient came in to request for vaccination with Gardasil after learning about it from newspaper. Physician explained the benefits and possible adverse experiences to the patient. Patient mentioned that she had several vaccinations during childhood. Patient also claimed that she can tolerate pain well. Before vaccination, patient's blood pressure measurement was 110/70 while HR was 80bpm. Patient was vaccinated on the left arm. Within 30 seconds post-vaccination, patient was noted to be curling down and was about to fall from her seat. She was caught by the physician and her parent before completely falling down. She was brought to patient's bed. A few seconds after, patient regained consciousness. All she could remember was that there was discomfort on her left arm and felt as though the vaccine was flowing through her left arm. Patient was monitored for vital signs which was found to be stable. She was admitted for further monitoring. On 06-Jun-2007, patient was discharged. No further complaints noted. Loss of consciousness was considered by reporter as other important medical event. The reporter felt that loss of consciousness was related to therapy with Gardasil. No further information is available. |
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| VAERS ID: | 282132 | Vaccinated: | 2007-05-26 | | Age: | 12.0 | Onset: | 2007-05-26, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-06-15, Days after onset: 20 | | Location: | | Entered: | 2007-06-18, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0706PHL00001 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Dizziness, Fall, Laceration, Loss of consciousness | | Write-up: Information has been received from a physician concerning a 12 year old female who on 26-MAY-2007 was vaccinated with Gardasil, there were no reported concomitant medications nor concurrent conditions. On the morning of 26-MAY-2007, before going to physician's clinic for vaccination, patient only had one slice of bread and a glass of milk. While waiting for her turn, patient had a can of juice approximately 200mL. At around 11:30AM, patient was vaccinated with Gardasil. Approximately 5-10 minutes after vaccination, patient complained of dizziness and subsequently lost consciousness and collapsed. Patient also suffered a laceration on her lip when she hit the floor. A few minutes after, patient regained consciousness. There were no further complain of dizziness. The reporter felt that loss of consciousness and dizziness were related to therapy with Gardasil. Laceration of the lips is not related to Gardasil. No further information is available. |
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| VAERS ID: | 282133 | Vaccinated: | 2007-06-07 | | Age: | 12.0 | Onset: | 2007-06-07, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-06-15, Days after onset: 8 | | Location: | | Entered: | 2007-06-18, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0706AUS00039 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Hypoaesthesia, Oedema peripheral, Peripheral coldness, Sensation of heaviness | | Write-up: Information has been received from a physician via as part of a business agreement (manufacturer control # GARD 2007 06 07 002) concerning a 12 year old female who on 07-JUN-2007 was vaccinated with Gardasil at school. On 07-JUN-2007, 2 hours after vaccination with Gardasil, the patient experienced heavyness in arm, swelling across the hand, cold hands and numbness in fingers and was taken to the medical centre. The patient's heavyness in arm, swelling across the hand, cold hands and numbness in fingers persisted. The patient was referred to neurologist immediately. Heavyness in arm, swelling across the hand, cold hands and numbness in fingers were considered to be an other important medical event by the reporting physician. Additional information has been requested. |
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| VAERS ID: | 282134 | Vaccinated: | 0000-00-00 | | Age: | | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2007-06-15 | | Location: | | Entered: | 2007-06-18, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0706USA01521 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Depression, Facial palsy | | Write-up: Information has been received from a physician concerning an adult female who was vaccinated with Gardasil on an unspecified date. One week after vaccination, the patient experienced facial paralysis and due to this depression. The patient was admitted to the hospital on an unspecified date. The patient's outcome was not reported. |
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| VAERS ID: | 282218 | Vaccinated: | 2007-02-16 | | Age: | 13.0 | Onset: | 2007-02-20, Days after vaccination: 4 | | Gender: | Female | Submitted: | 2007-06-18, Days after onset: 117 | | Location: | | Entered: | 2007-06-19, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0706USA02450 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0859F | 1 | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Abdominal pain, Angioedema, Dyspnoea, Nausea | | Write-up: Information has been received from a gynaecologist concerning a 13 year old female patient who on 16-FEB-2007 was vaccinated into the left upper arm with a second dose of Gardasil, lot #654740/0859F, batch #NE25270. Four days post-vaccination the patient developed Quincke's edema, dyspnea, abdominal cramps and nausea. Her symptoms were relapsing since then. On an unspecified date she was admitted to the hospital. Routine laboratory findings (not specified) were normal. The patient's first dose of Gardasil had been well tolerated. Additional information has been requested. Other business partner numbers included E2007-03733. |
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| VAERS ID: | 282372 | Vaccinated: | 2007-06-01 | | Age: | 17.0 | Onset: | 2007-06-01, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-06-19, Days after onset: 18 | | Location: | | Entered: | 2007-06-20, Days after submission: 1 | |
| Life Threatening Illness? No |
Died? Yes
Date died: 0000-00-00 |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Dental operation | | CDC 'Split Type': WAES0706USA02451 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Autopsy, Loss of consciousness, Resuscitation, Sudden death | | Write-up: Information has been received from a gynecologist who was informed of the case from another gynecologist concerning a 17 year old female who in June 2007 (week 23), was vaccinated with a first dose of Gardasil (lot number, injection site and route not reported). During the evening of the same day, the patient was found unconscious (lifeless) by the mother. Resuscitation was performed by the emergency physician but was unsuccessful. The patient subsequently died. The cause of death was sudden death. It was noted that the patient had a dental surgery the day before she was vaccinated. An autopsy was done. The results were not known. Other business partner numbers include E2007-03769. Additional information has been requested. |
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| VAERS ID: | 282582 | Vaccinated: | 2007-03-16 | | Age: | 17.0 | Onset: | 2007-04-12, Days after vaccination: 27 | | Gender: | Female | Submitted: | 0000-00-00 | | Location: | | Entered: | 2007-06-21 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, 0 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: diagnostic laboratory test 12?Apr07 inflammatory alternations, diagnostic laboratory test 05?June07 inflammatory alternations | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0706USA02684 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Bacterial infection, Inflammation, Laboratory test abnormal, Nausea, Pyrexia, Similar reaction on previous exposure to drug, Staphylococcal sepsis | | Write-up: Information has been received from a general practitioner concerning a 17 week old female who on 16-MAR-2007 received her first dose of Gardasil, intramuscularly into the upper arm. On 12-APR-2007, she experienced staphylococcal sepsis with fever and nausea. She was admitted to the hospital and treated on the intensive care unit. She recovered within an unspecified time. On 01-JUN-2007, the patient received her second dose of the Gardasil, intramuscularly into the upper arm. On 05-JUN-2007, she developed a similar clinical picture (bacterial infection with fever and nausea). She received outpatient treatment with antibiotics. She recovered within an unspecified time. Lab findings in both cases showed inflammatory alternations (not specified). No further information is available. Other business partner numbers included E2007-03785. |
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| VAERS ID: | 282583 | Vaccinated: | 2001-01-23 | | Age: | 23.0 | Onset: | 2007-02-13, Days after vaccination: 2212 | | Gender: | Female | Submitted: | 2007-06-20, Days after onset: 126 | | Location: | | Entered: | 2007-06-21, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: beta-human chorionic gonadotropin (unsp) 13Feb07 Negative | | Previous Vaccinations: | | Other Medications: None | | Preexisting Conditions: None | | CDC 'Split Type': WAES0706PER00006 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test negative | | Write-up: Information has been received from a physician concerning a 23 year old female on 23-JAN-2001 was vaccinated with Gardasil. There was no concomitant medication. On 13-FEB-2007 the patient experienced spontaneous abortion. The reporter felt that spontaneous abortion was an other medical event and was not related to therapy with Gardasil. No further information is available. |
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| VAERS ID: | 282647 | Vaccinated: | 2007-03-20 | | Age: | 21.0 | Onset: | 2007-03-20, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-06-21, Days after onset: 93 | | Location: | | Entered: | 2007-06-22, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: injection site inflammation~HPV (Gardasil)~0~21~Patient | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0706USA02449 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Dyspnoea, Injection site inflammation, Total lung capacity decreased | | Write-up: Information has been received from a gynecologist's assistant concerning a 21 year old female who on 20-MAR-2007 was vaccinated intramuscularly with a first dose of Gardasil. The patient subsequently experienced mild injection site inflammation post vaccination with the first dose. The patient recovered from injection site inflammation within an unspecified time. On 30-MAY-2007, the patient was vaccinated intramuscularly in the upper arm with a second dose of Gardasil (batch NE35170, lot 654948/0903F). A half an hour later, already at home, the patient experienced severe dyspnea. She presented at the family physician who administered corticosteroids IV. Lung capacity was measured and was reduced to 2 liters. Shortly after administration of corticosteroids, she recovered (exact duration not reported). Booster dose will not be administered. The patient's dyspnea and total lung capacity low were considered other important medical events. Other business partner numbers included E2007-03784 and E2007-03792. Additional information is not expected. Case is closed. |
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| VAERS ID: | 282914 | Vaccinated: | 2007-01-30 | | Age: | 24.0 | Onset: | 2007-05-07, Days after vaccination: 97 | | Gender: | Female | Submitted: | 2007-06-26, Days after onset: 50 | | Location: | | Entered: | 2007-06-27, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, 0 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: NONE | | Previous Vaccinations: | | Other Medications: None | | Preexisting Conditions: None | | CDC 'Split Type': WAES0706PER00010 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Abortion spontaneous | | Write-up: Information has been received from a physician concerning a 24 year old female who on 30-JAN-2007 was vaccinated with Gardasil. There was no concomitant medication. On 07-MAY-2007 the patient experienced spontaneous abortion and was hospitalized. Subsequently, the patient recovered from spontaneous abortion. No further information is available. |
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| VAERS ID: | 282949 | Vaccinated: | 2007-04-13 | | Age: | 13.0 | Onset: | 2007-04-13, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-06-27, Days after onset: 75 | | Location: | | Entered: | 2007-06-28, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0706USA04634 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Convulsion, Syncope | | Write-up: Information has been received from a physician (a gynecologist), concerning a 13 year old female patient, who on 13-APR-2007 was vaccinated IM in the upper arm, with the first dose, of Gardasil (Lot # not provided). On 13-APR-2007, immediately following vaccination, she had an episode of convulsive syncope; she was helped to lay down with her legs raised, and recovered within a short time. On 15-JUN-2007, the reporting confirmed that the patient was vaccinated with the second dose of Gardasil (Lot #655671/1024F; Batch NE51790), and the vaccination was well tolerated. This file is closed. Upon internal review, convulsive syncope was considered to be serious as an other significant medical event. Other business partner numbers include: E2007-03766. |
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| VAERS ID: | 283518 | Vaccinated: | 0000-00-00 | | Age: | | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2007-06-29 | | Location: | | Entered: | 2007-07-02, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0706PHL00010 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Anaphylactic shock | | Write-up: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced anaphylactic shock. Outcome, causality and other patient demographics were unknown. Anaphylactic shock was considered as an other important medical event. No further information is available at the time of report. Contact details of physician was not available. Additional information has been requested. |
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| VAERS ID: | 283519 | Vaccinated: | 0000-00-00 | | Age: | | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2007-06-29 | | Location: | | Entered: | 2007-07-02, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0706PHL00011 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Anaphylactic shock | | Write-up: Information has been received from a physician concerning 2 female patients who were vaccinated with Gardasil. Subsequently the patients experienced anaphylactic shock. Outcome, causality and other patient demographics were unknown. Anaphylactic shock was considered an other important medical event. No further information is available at the time of report. Contact details of reporting physician was not available. Additional information has been requested. |
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| VAERS ID: | 283825 | Vaccinated: | 2007-05-25 | | Age: | 13.0 | Onset: | 2007-05-26, Days after vaccination: 1 | | Gender: | Female | Submitted: | 2007-07-03, Days after onset: 38 | | Location: | | Entered: | 2007-07-05, Days after submission: 2 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: diagnostic laboratory test Pfieffer's disease negative, Lyme disease assay negative | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0706USA05283 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Borrelia burgdorferi serology negative, Fatigue, Hypersomnia, Laboratory test abnormal, Mononucleosis heterophile test negative, Somnolence | | Write-up: Information has been received from a health professional concerning a 13 year old female who on 25-MAY-2007 was vaccinated with a first dose of Gardasil. On 26-MAY-2007 the patient experienced severe fatigue that was still ongoing one month after vaccination. It was also reported that the girl slept a lot and sometimes fell asleep during the day. The girl used to have a lively character. It was also reported that according to the GP it was not likely that the vaccination caused the fatigue however it could not be ruled out. Other underlying causes were under investigation and test for Lyme's disease and Pfiffer's disease were negative. At the time of this report, the patient had not recovered. Fatigue and slept a lot were considered to be other important medical events. Other business partner numbers include: E200704170. No further information is available. |
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| VAERS ID: | 283827 | Vaccinated: | 2007-06-13 | | Age: | 16.0 | Onset: | 2007-06-14, Days after vaccination: 1 | | Gender: | Female | Submitted: | 2007-07-03, Days after onset: 19 | | Location: | | Entered: | 2007-07-05, Days after submission: 2 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: clinical serology test 18?Jun07 negative | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0706USA05134 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | IM | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Borrelia burgdorferi serology negative, Facial palsy, Serology negative | | Write-up: Information has been received from a physician (general practitioner), concerning a 16 year old female patient, who on 13-JUN-2007 was vaccinated IM in the left deltoid, with the first dose of Gardasil (Batch NF13760). On 14-JUN-2007, one day following vaccination, the patient developed facial paralysis. On 18-JUN-2007, she was hospitalized for evaluation and diagnostics; serology testing including borrelia, was negative. At the time of this report the patient had not recovered, but it was noted that on 22-JUN-2007, she had only "discrete symptoms." No further information is available. Other business partner number included: E2007-04121. |
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| VAERS ID: | 284101 | Vaccinated: | 0000-00-00 | | Age: | 19.0 | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2007-07-06 | | Location: | | Entered: | 2007-07-09, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, 0 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0707USA00445 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 2 | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Epistaxis, Pyrexia | | Write-up: Information has been received from a 19 year old female consumer, who on an unspecified date was vaccinated with the third dose of Gardasil (Lot and Bach # not provided). Subsequently, the patient developed a nosebleed and a fever (value not specified). The consumer visited the ER, as the nose bleed did not resolve; it was indicated that she was hospitalized (dated and duration not provided). Subsequently, the patient recovered from the nosebleed and fever (treatment and duration not reported). Additional information has been requested. Other business partner numbers include: E2007-04260. |
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| VAERS ID: | 284184 | Vaccinated: | 2007-06-07 | | Age: | 18.0 | Onset: | 2007-06-07, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-09, Days after onset: 32 | | Location: | | Entered: | 2007-07-10, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0707AUS00055 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0138U | | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Anaphylactic reaction, Feeling abnormal, Nausea, Pallor, Rash macular, Throat tightness, Urticaria | | Write-up: Information has been received from the Department of health and Therapeutic Good Administration as part of a business agreement with follow-up information on request by the Company received via a Line Listing from the department of Health. As part of the regular school-based immunisation program funded by the government, on 07-JUN-2007 an 18 year old female was vaccinated with her second dose of Gardasil (Lot No. 655742/0138U, Batch No. J0800, Expiry date 07-AUG-2009). On 07-JUN-2007 there was no immediate reaction but minutes post vaccine she felt funny, nauseated, blotches were noted on her neck, developed urticarial rash, tightness in throat and her colour was poor. It was stated that 0.5 ml adrenaline was given to the patient and she was sent to an emergency department with no further treatment and the patient was discharged. This patient's event was considered as anaphylaxis by the health department. Subsequently, the patient recovered from anaphylaxis. The reporter considered that anaphylaxis was probably related to with Gardasil. The original reporting source was not provided. Additional information is not expected. |
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| VAERS ID: | 284185 | Vaccinated: | 2007-06-21 | | Age: | 16.0 | Onset: | 2007-06-21, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-09, Days after onset: 18 | | Location: | | Entered: | 2007-07-10, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0707AUS00056 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0138U | | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Anaphylactic reaction, Anxiety, Dizziness, Rash macular, Throat tightness, Urticaria | | Write-up: Information has been received from the Department of Health as part of a business agreement with follow-up information on request by the Company received via a Line Listing from the Department of Health. As part of the regular school-based immunisation program funded by the government, on 21-JUN-2007 a 16 year old female was vaccinated with her second dose of Gardasil (Lot No. 655742/0138U, Batch No. J0800, Expiry date 07-AUG-2009). On 21-JUN-2007, 10 minutes post vaccine, the patient returned to the clinic with throat tightness, slight dizziness, urticarial blotchy rash across her face and upper chest and anxiety was noted. It was stated that 0.5 ml adrenaline was given to the patient and she was sent to an emergency department. Subsequently, the patient recovered from anaphylaxis. The reporter considered that anaphylaxis was probably related to therapy with Gardasil. The original reporting source was not provided. Additional information is not expected. |
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| VAERS ID: | 284186 | Vaccinated: | 2007-06-07 | | Age: | 17.0 | Onset: | 2007-06-07, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-09, Days after onset: 32 | | Location: | | Entered: | 2007-07-10, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: electroencephalography 07Jun07 | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0707AUS00057 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0138U | | | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Agitation, Anaphylactic reaction, Dyspnoea, Electroencephalogram, Fall, Flushing, Nausea, Tachycardia, Unresponsive to stimuli | | Write-up: Information has been received from the Department of Health, as part of a business agreement, with follow-up information received on request by the Company via a Line Listing from the Department of Health. As part of the regular school-based immunisation program funded by the government, on 07-JUN-2007 a 17 year old female was vaccinated with Gardasil (Lot No. 655742/0138U, Batch No. J0800, expiry date 07-AUG-2009). Five minutes after being vaccinated with Gardasil, the patient collapsed. Her face was flushed, spreading to her hairline, she was tachycardic and not responding. The patient became agitated, nauseated and experienced mild shortness of breath. Subsequently, 0.5 ml of adrenaline was administered, with little effect, so the dose was repeated. The patient was transferred to the emergency department of hospital and discharged PM, post EEG. The patient recovered from anaphylaxis. The reporter considered that anaphylaxis was probably related to therapy with Gardasil. The original reporting source was not provided. Additional information is not expected. |
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| VAERS ID: | 284187 | Vaccinated: | 2007-05-02 | | Age: | 16.0 | Onset: | 2007-05-02, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-09, Days after onset: 68 | | Location: | | Entered: | 2007-07-10, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Immediate post-injection reaction | | CDC 'Split Type': WAES0707AUS00058 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0138U | | | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Anaphylactic reaction, Dyspnoea, Immediate post-injection reaction, Nausea, Paraesthesia, Rash macular, Rash pruritic | | Write-up: Information has been received from the Department of Health, as part of a business agreement, with follow-up information received on request by the Company via a Line Listing from the Department of Health. As part of the regular school-based immunisation program funded by the government, on 02-MAY-2007, a 16 year old female with a history of adrenaline received following a tetanus vaccination, was vaccinated with Gardasil as prophylaxis (Lot No. 655742/0138U), Batch No. J0798, Expiry date 07-AUG-2009). Immediately post-vaccination, the patient felt nauseous, developed a blotchy, itchy rash on her face and experienced laboured breathing. Adrenaline was administered and the patient improved. She was transferred to the emergency department of hospital. Subsequently, one day post-vaccination, the patient was itchy all over her body and she experienced pins and needles in her hands. The patient recovered from anaphylaxis. The reporter considered that anaphylaxis was probably related to therapy with Gardasil. The original reporting source was not provided. Additional information is not expected. |
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| VAERS ID: | 284188 | Vaccinated: | 2007-06-19 | | Age: | 15.0 | Onset: | 2007-06-19, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-09, Days after onset: 20 | | Location: | | Entered: | 2007-07-10, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0707AUS00059 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0138U | | | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Emotional distress, Nausea, Syncope vasovagal | | Write-up: Information has been received from the Department of Health, as part of a business agreement, with follow-up information received on request by the Company via a Line Listing from the Department of Health. As part of the regular school-based immunisation program funded by the government, on 19-JUN-2007 a 15 year old female was vaccinated with her second dose of Gardasil (Lot No. 655742/0138U, Batch No. J0800, expiry date 07-AUG-2009) as prophylaxis. Five minutes post-vaccination, the patient felt faint and dizzy. She was coherent and talking. The patient commenced to grab her neck and was gasping, distressed and nauseous. The symptoms settled momentarily and then the difficulty breathing returned. Adrenaline 0.5 was administered and the patient was transferred to the emergency department of hospital. The patient recovered. In the emergency department summary, "vasovagal" was reported rather than allergy. The patient was also seen by her general physician. The reporter considered that anaphylaxis was possibly related to therapy with Gardasil. The original reporting source was not provided. Additional information is not expected. |
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| VAERS ID: | 284189 | Vaccinated: | 2007-06-26 | | Age: | 13.0 | Onset: | 2007-06-26, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-09, Days after onset: 13 | | Location: | | Entered: | 2007-07-10, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: blood pressure measurement 26Jun07 decreased, electroencephalography 28Jun07 'alterations' not specified; dysrhythmia, total heartbeat count 27Jun07 96/min, total heartbeat count 28Jun07 avg. 90/min | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: None | | CDC 'Split Type': WAES0707USA00640 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | IM | LA | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Arrhythmia, Blood pressure decreased, Breath holding, Electroencephalogram, Electroencephalogram abnormal, Grand mal convulsion, Heart rate increased, Nausea, Syncope, Syncope vasovagal, Unresponsive to stimuli, Vomiting | | Write-up: Information has been received from a physician concerning a 13 year old female who on 26-JUN-2007 was vaccinated with a first dose of Gardasil ("batch # NE47410") IM into the left deltoid muscle. On 26-JUN-2007, immediately post vaccination, the patient experienced a vasovagal convulsive syncope for a "short time". She was unresponsive to verbal stimuli and her breath was held for a short time. Her blood pressure was decreased. She recovered. The episode was not considered as serious by the reporter. On 26 and 29-JUN-2007, additional information was received from the girl's father who is a physician, too. Since about 1 PM on 26-JUN-2007, the girl additionally complained about nausea and vomited. She recovered on 27-JUN-2007 in the evening. Additionally her pulse was increased (96/min). On 28-JUN-2007, an electroencephalogram (EEG) was carried out and showed "alterations" (not specified). At that time, her pulse rate was still increased (average 90/min). A cardiologic check up including ECG is scheduled for 02-JUL-2007. On 04-JUL-2007, the reporter was contacted by phone. The case was upgrade to serious (other important medical events). The EEG showed "dysrhythmia" which might be a sign a "condition after convulsion". Tonic-clonic convulsion was assumed. The results of the cardiologic check-up were pending. Other business numbers included: E2007-04114. No further information is available. |
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| VAERS ID: | 284190 | Vaccinated: | 2007-05-02 | | Age: | | Onset: | 2007-05-02, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-09, Days after onset: 68 | | Location: | | Entered: | 2007-07-10, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: diagnostic laboratory test ??May07, magnetic resonance imaging ??May07, urinalysis ??May07 | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0707AUS00035 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Abnormal behaviour, Confusional state, Drug toxicity, Immunisation reaction, Insomnia, Laboratory test, Nuclear magnetic resonance imaging, Pruritus, Psychotic disorder, Speech disorder, Urine analysis | | Write-up: Information has been received from a parent via a blog web site concerning his daughter who on 02-MAY-2007 was vaccinated with GARDASIL as part of the regular school-based immunisation program funded by the government. In the evening of the vaccination on 02-MAY-2007, the female student started to mumble erratically and started to make very disjointed comments and she found it difficult to sleep. She also complained of itchiness in her back in the morning on 03-MAY-2007. The father stated that she became lost and confused, a very pale comparison to the daughter he was used to seeing. It was stated that she used to be a modest, humble quiet, organised, kind and intelligent. The patient consulted a psychologist the next day to try to see what was wrong. The psychologist was concerned with the responses that she made to his questions. The parents became extremely worried about her, undertaking urine and blood tests as well as an MRI scan to the brain. Soon after, the school contacted the parents saying that they didn't want her to return unless she was psychiatrically evaluated and that she would want her to return unless she was psychiatrically evaluated and that she would not harm herself or others. The patient's conditions has steadily worsened and she recently had a more severe psychosis. For the first time "last night", on 11-JUN-2007, she did not sleep at all. She has been on RISPERDAL which she started taking about 3 days ago, on approximately 08-JUN-2007, however her condition has been worsening. The reporter stated that the treating physician believed that this was a classic example of a "major reaction of toxicity caused by a vaccine". The reporter felt that severe psychosis were related to therapy with GARDASIL. Upon internal medical review, severe psychosis was considered to be an Other Important Medical Event. Additional information is not expected. |
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| VAERS ID: | 284191 | Vaccinated: | 0000-00-00 | | Age: | | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2007-07-09 | | Location: | | Entered: | 2007-07-10, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0707AUS00034 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Convulsion | | Write-up: Information has been received from the Department of Health as part of a business agreement, concerning a female school student, aged between 13 and 17 years of age, who was vaccinated with Gardasil as part of the regular school-based immunisation program funded by the government. The patient was vaccinated with one of the following batches - J0798, J0799, J0800 or J1021. Subsequently the patient experienced a seizure. Upon internal medical review, seizure is considered to be an Other Important Medical Event. Additional information is not expected. |
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| VAERS ID: | 284192 | Vaccinated: | 2007-05-24 | | Age: | 17.0 | Onset: | 2007-05-24, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-09, Days after onset: 46 | | Location: | | Entered: | 2007-07-10, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, 0 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0707AUS00033 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0138U | | | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Anaphylactic reaction, Cyanosis, Dyspnoea, Erythema, Livedo reticularis, Nausea, Pharyngeal oedema, Swollen tongue | | Write-up: Information has been received from the Department of Health as part of a business agreement with follow-up information on request by the Company received via a Public Case Detail form. As part of the regular school-based immunisation program funded by the government, on 24-MAY-2007 a 17 year old female was vaccinated with Gardasil (Lot No. 655742/0138U, Batch No. J0799, Expiry date 07-AUG-2009). On 24-MAY-2007 the patient experienced anaphylactic reaction, dyspnoea, cyanosis, nausea, pharyngeal oedema and swollen tongue and was hospitalized. It was stated that the patient developed red, mottled face to waist. The patient was nauseated and cyanosed, and experienced difficulty in breathing. The patient's throat and tongue restricted. However, no stridor cough was developed. The patient was given adrenaline 0.5 ml with no improvement. Further adrenaline 0.5 ml was given 5 minutes later and the patient's symptoms improved. On 24-MAY-2007 the patient recovered from anaphylactic reaction, dyspnoea, cyanosis, nausea, pharyngeal oedema and swollen tongue. The agency considered that anaphylactic reaction, dyspnoea, cyanosis, nausea, pharyngeal oedema and swollen tongue were probably related to therapy with Gardasil. The original reporting source was not provided. Additional information is not expected. |
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| VAERS ID: | 284193 | Vaccinated: | 2007-05-15 | | Age: | 16.0 | Onset: | 2007-05-16, Days after vaccination: 1 | | Gender: | Female | Submitted: | 2007-07-09, Days after onset: 54 | | Location: | | Entered: | 2007-07-10, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, 0 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: Physical examination 16May07 pulse 68; colour-good | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0707AUS00032 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0313U | | | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Anaphylactic reaction, Anxiety, Dyspnoea, Haematemesis, Heart rate normal, Stridor, Vomiting | | Write-up: Information has been received from the Department of Health as part of a business agreement with follow-up information on request by the Company received via a Public Case Detail form. As part of the regular school-based immunisation program funded by the government, on 15-MAY-2007 a 16 year old female was vaccinated with Gardasil (Lot No. 655743/0313U, Batch No. J1021, Expiry date 08-AUG-2009). On 16-MAY-2007 the patient experienced anaphylactic reaction, anxiety, dyspnoea, stridor and vomiting was hospitalised. It was stated that the patient experienced severe vomiting with mucous and blood within 10 minutes of injection. The patient had a feeling of impending doom and experienced difficulty of breathing, respiratory stridor. The patient's pulse was 68 and the colour of the patient was good. This patient's event was considered as anaphylaxis by the agency. The patient was given intramuscular injection of adrenaline. On 16-MAY-2007 the patient recovered from anaphylactic reaction, anxiety, dyspnoea, stridor and vomiting. The agency considered that anaphylactic reaction, anxiety, dyspnoea, stridor and vomiting were probably related to therapy with Gardasil. The original reporting source was not provided. Additional information is not expected. |
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| VAERS ID: | 284194 | Vaccinated: | 0000-00-00 | | Age: | | Onset: | 0000-00-00 | | Gender: | Female | Submitted: | 2007-07-09 | | Location: | | Entered: | 2007-07-10, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0707AUS00025 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Convulsion | | Write-up: Information has been received from the Department of Health as part of a business agreement, concerning a female school student, aged between 13 and 17 years of age, who was vaccinated with Gardasil as part of the regular school-based immunisation program funded by the government. The patient was vaccinated with one of the following batches - J0798, J0799, J0800 or J1021. Subsequently the patient experienced a seizure. Upon internal medical review, seizure is considered to be an Other Important Medical Event. Additional information is not expected. |
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| VAERS ID: | 284652 | Vaccinated: | 2007-05-15 | | Age: | 17.0 | Onset: | 2007-05-15, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-13, Days after onset: 59 | | Location: | | Entered: | 2007-07-13, Days after submission: 0 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: Unknown | | Diagnostic Lab Data: UNK | | Previous Vaccinations: | | Other Medications: | | Preexisting Conditions: | | CDC 'Split Type': D0053905A | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | NE51790 | | UN | LA | | TDAP | GLAXOSMITHKLINE BIOLOGICALS | AC37B024CB | | UN | RA | |
| Administered by: Other Purchased by: Other | | Symptoms: Erythema multiforme, Injection site swelling, Rash papular, Urticaria | | Write-up: This case was reported by a regulatory authority and described the occurrence of erythema exsudativum multiforme in a 17-year-old female subject who was vaccinated with Boostrix for prophylaxis. The subject received no concomitant medication. Concomitant vaccination included Gardasil (Non-GSK) (Sanofi Pasteur MSD). On 15 May 2007 the subject received the first dose of Boostrix (0.5 ml, unknown, left deltoid) and an unknown dose of Gardasil (0.5 ml, unknown, right deltoid), contralaterally. Approximately one week post vaccination with Boostrix, on an unknown date in May 2007, the subject experienced erythema exsudativum multiforme with generalized urticarial and papular rash. Additionally, the subject experienced very severe injection site swelling at the site of vaccination with Boostrix. The injection site of vaccination with Gardasil was uneventful. This case was assessed as medically serious by GSK criteria. The subject was not hospitalized for these events. The subject was treated with systemic corticosteroid (Corticoid). The events were resolved after some days on an unknown date in 2007. The reporter considered that the causal relationship of the systemic events to vaccination with Boostrix was evident due to the concurrent severe local injection site and due to the morphological similarity. No further information will be available. |
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| VAERS ID: | 284708 | Vaccinated: | 2007-06-01 | | Age: | 21.0 | Onset: | 2007-06-01, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-13, Days after onset: 42 | | Location: | | Entered: | 2007-07-16, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Dizziness | | CDC 'Split Type': WAES0707USA01348 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Convulsion, Dizziness, Hypotension, Pulse pressure decreased, Syncope | | Write-up: Information has been received from a health professional concerning a 21 year old female patient with a history of feeling dizzy following blood tests, who in June 2007, was vaccinated with a first dose of Gardasil. Ten minutes post vaccination, the patient fainted, experienced a weak pulse, low blood pressure and experienced a short fit. It was reported that there was no associated lip or tongue swelling. The patient received treatment with oxygen. Subsequently, the patient recovered. The reporter considered a short fit, low blood pressure, fainted and weak pulse, to be other important medical events. Other business partners numbers included: E200704423. No further information is available. |
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| VAERS ID: | 284709 | Vaccinated: | 2007-06-18 | | Age: | 15.0 | Onset: | 2007-06-20, Days after vaccination: 2 | | Gender: | Female | Submitted: | 2007-07-13, Days after onset: 23 | | Location: | | Entered: | 2007-07-16, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: electroencephalography normal results, magnetic resonance imaging normal results, laboratory test increased serum lipids in liquor/blood test, cerebrospinal fluid total protein test moderately increased | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: None | | CDC 'Split Type': WAES0707USA01352 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Accommodation disorder, CSF protein increased, Cerebellar syndrome, Diplopia, Electroencephalogram normal, Intention tremor, Laboratory test, Lipids increased, Nausea, Nuclear magnetic resonance imaging normal | | Write-up: Information has been received from a pediatrician concerning a 15 year old female patient with no medical history who on 18-JUN-2007, was vaccinated with a first dose of Gardasil. On 20-JUN-2007, the patient experienced dysdiadochokinesis, intention tremor, accommodation disorder with diplopia and nausea. Laboratory diagnostic studies included EEG and MRI which showed normal results. In the Cerebral Spinal Fluid, protein was moderately increased (no exact results reported). Blood tests were also taken, the results are not known. At the time of this report, the patient had not yet recovered. The reporter considered dysdiadochokinesis, nausea, accommodation disorder and intention tremor to be other important medical events. Other business partners numbers include: E200704378. No further information is expected. |
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| VAERS ID: | 284855 | Vaccinated: | 2007-04-05 | | Age: | 15.0 | Onset: | 2007-06-24, Days after vaccination: 80 | | Gender: | Female | Submitted: | 2007-07-16, Days after onset: 22 | | Location: | | Entered: | 2007-07-17, Days after submission: 1 | |
| Life Threatening Illness? Yes |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: magnetic resonance imaging alterations; spinal tap no typical viruses causing viral encephalitis were found | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: None | | CDC 'Split Type': WAES0707USA00892 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Encephalitis viral, Leukoencephalomyelitis, Lumbar puncture, Nuclear magnetic resonance imaging abnormal | | Write-up: Information has been received from a gynecologist concerning a 15 year old female with no medical history reported who on 05-APR-2007 was vaccinated with first dose of Gardasil. On 30-MAY-2007, the patient was vaccinated with second dose of Gardasil (lot # 1340F; batch # NF14740). On 24-JUN-2007, the patient was hospitalized due to suspicious virus-encephalitis. A magnetic resonance imaging was performed which showed alterations. The results of the lumbar puncture were not reported in detail but no typical viruses causing a viral encephalitis were found. The diagnosis reported from the physician at the hospital was acute disseminated encephalomyelitis. The treatment in the hospital was cortisone, antibiotics, and Zovirax (ACYCLOVIR). At the time of the report, the patient was still in the hospital but recovering. The acute disseminated encephalomyelitis was considered to be immediately life-threatening. Other business partner numbers included: E2007-04352. No further information is available. |
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| VAERS ID: | 284857 | Vaccinated: | 2007-06-08 | | Age: | 17.0 | Onset: | 2007-06-08, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-16, Days after onset: 38 | | Location: | | Entered: | 2007-07-17, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Vascular collapse; Epileptiform movement | | CDC 'Split Type': WAES0707USA01355 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0572F | 0 | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Circulatory collapse, Condition aggravated, Epilepsy, Immediate post-injection reaction | | Write-up: Information has been received from a gynecologist, concerning a 17 year old female patient with a history of vascular collapse and epileptiform movement, who on 08-JUN-2007, was vaccinated IM in the arm, with the first dose of Gardasil (Lot #655376/0572F; Batch NE45050). On 08-JUN-2007, immediately following the vaccination, the patient experienced vascular collapse followed by epileptiform movement. The event lasted for 5 minutes, and the patient then recovered. An examination was performed by a neurologist, and no pathologies were found. Additional exams were scheduled. The reporter considered vascular collapse and epiltiform movement to be serious, as other important medical events. Other business partner numbers include: E2007-04376. |
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| VAERS ID: | 285147 | Vaccinated: | 2007-05-15 | | Age: | 15.0 | Onset: | 2007-05-15, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-18, Days after onset: 64 | | Location: | | Entered: | 2007-07-19, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: diagnostic laboratory test ??May07 NAD | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0707AUS00043 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0138U | | | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Grand mal convulsion, Laboratory test normal, Syncope, Syncope vasovagal | | Write-up: Information has been received from the Department of Health as part of a business agreement, concerning a female school student, aged between 13 and 17 years of age, who was vaccinated with Gardasil as part of the regular school-based immunisation program funded by the government. The patient was vaccinated with one of the following batches - J0798, J0799, J0800 or J1021. Subsequently the patient experienced syncope. Follow-up information was received from the Department of Health via a line listing. The patient was a 15 year old female student who on 15-May-2007 was vaccinated with Gardasil (Lot No. 655742/0138U, Batch No. J0799, Expiry date 07-AUG-2009). Immediately after the vaccination the patient fainted. Tonic Clonic seizure was noted during vasovagal episode. The patient recovered with no injury (also the outcome reported as ongoing in the line listing). The patient was followed up with blood tests which results were nothing abnormal detected. A CT scan is to be performed later in June 2007. The reporter considered that syncope was possibly related to therapy with Gardasil. The original reporting source was not provided. Information/Follow-up information received on 04-JUL-2007 contained the following adverse experiences" tonic clonic seizure (15-MAY-2007). Upon internal medical review, clonic tonic seizure is considered to be Other Important Medical Event. Additional information is not expected. |
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| VAERS ID: | 285148 | Vaccinated: | 2007-07-04 | | Age: | 16.0 | Onset: | 2007-07-04, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-18, Days after onset: 14 | | Location: | | Entered: | 2007-07-19, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, 2 days | | Extended hospital stay? No |
| Current Illness: Grand Mal convulsion; Epilepsy | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: LAMICTAL Unk - Unk | | Preexisting Conditions: | | CDC 'Split Type': WAES0707USA01866 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Convulsion, Grand mal convulsion | | Write-up: Information has been received from a pediatrician, concerning a 16 year old female patient with genuine grand mal epilepsy, who on 04-JUL-2007 was vaccinated IM in the arm, with the first dose of Gardasil (Lot # not provided). Concomitant therapy included lamotrigine (LAMICTAL). On 04-JUL-2007, in the evening following the vaccination, and while working on the computer, she had a grand mal seizure. She was immediately taken to the hospital and was admitted; she recovered, and was discharged the following day; 05-JUL-2007. The reporter noted that for many years the patient had experienced no seizures, but in the last two years, she had been having seizures up to 3 times a year. The last seizure also happened while she was working with the computer, however she had had shown a response to photogenic triggers during examination. The file is closed. Other business partner numbers include: E2007-04428. |
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| VAERS ID: | 285149 | Vaccinated: | 2007-07-09 | | Age: | 13.0 | Onset: | 2007-07-09, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-18, Days after onset: 9 | | Location: | | Entered: | 2007-07-19, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, 1 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: None | | CDC 'Split Type': WAES0707USA01868 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0903F | | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Contusion, Dizziness, Fall, Head injury, Somnolence | | Write-up: Information has been received from a physician concerning a 13 year old female with no medical history, who on 09-JUL-2007 was vaccinated IM into the deltoid muscle with first dose of Gardasil (lot# 654948/0903F; batch# NE 38100). About five to ten minutes after vaccination, the patient felt dizzy, and fell down and bruised her head. Afterwards she was very sleepy. The reporter considered the event to be syncope. The patient was hospitalized because of the head injury, although pulse and blood pressure were normal. The patient was kept in the hospital for at least until the next day. At the time of this report, the patient's outcome was unknown. Other business partner numbers include: E200704448. No further information is available. |
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| VAERS ID: | 285150 | Vaccinated: | 2007-06-26 | | Age: | 15.0 | Onset: | 2007-06-26, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-18, Days after onset: 22 | | Location: | | Entered: | 2007-07-19, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0707USA02314 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | NF23310 | | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Face injury, Facial bones fracture, Fall, Mouth injury, Surgery, Syncope | | Write-up: Information has been received from a physician concerning a 15 year old female who on 26-JUN-2007 was vaccinated intramuscularly in the left upper arm with the first dose of Gardasil. Subsequently, 30 seconds post vaccination the patient experienced syncope. She fell down, broke her nose and injured her lips. The physician reported that she recovered from the syncope within 2 to 3 minutes. The duration and outcome of the other events was not reported. The reporting physician felt that since the nose fracture needed surgical intervention it was a serious other medical event. Additional information has been requested. |
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| VAERS ID: | 285915 | Vaccinated: | 2007-07-02 | | Age: | 13.0 | Onset: | 2007-07-02, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-24, Days after onset: 22 | | Location: | | Entered: | 2007-07-25, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, 4 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Immunisation | | CDC 'Split Type': WAES0707USA02629 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 1 | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: No reaction on previous exposure to drug, Pyrexia, Ulcer, Vulvitis | | Write-up: Information has been received from a gynecologist concerning a 13 year old female who on 02-JUL-2007 was vaccinated IM into the upper arm with a second dose of GARDASIL. On 02-JUL-2007 in the evening, the patient developed a fever up to 39 C. On 04-JUL-2007 the gynecologist diagnosed severe painful ulcerative vulvitis and the patient was hospitalized. The patient was treated with analgesic (unspecified) and sitz bath. A Herpes simplex infection was ruled out. The patient improved and was discharged on 08-JUL-2007. On 09-JUL-2007 the patient was seen by her gynecologist. At this time the patient showed one ulcer of 1 cm diameter. It was reported that the first vaccination with GARDASIL was well tolerated. Additional information is not expected. Other business partner numbers included E2007-04570. |
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| VAERS ID: | 285916 | Vaccinated: | 2007-05-31 | | Age: | 16.0 | Onset: | 2007-05-31, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-24, Days after onset: 54 | | Location: | | Entered: | 2007-07-25, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: serum creatine kinase 19Jun07 1036; serum creatine kinase 260 | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Amyotrophy | | CDC 'Split Type': WAES0707USA03077 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | IM | LA | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Blood creatine phosphokinase increased, Myositis, Pain in extremity | | Write-up: Information has been received from a physician concerning a 16 year old female with a history of right shoulder amyotrophy of unknown etiology who on 31-MAY-2007 was vaccinated IM in the left deltoid with a first dose of GARDASIL. On 15-JUN-2007 the mother of the patient called the reporter and told her that her daughter experienced pain of the left arm down to the elbow especially while stretching the arm since the vaccination. On 19-JUN-2007 a blood sample was taken, serum creatine kinase test reported 1036. Myositis was diagnosed. The patient was treated with ibuprofen and resting. On an unknown date another blood sample was taken and the serum creatine kinase test reported 260. At the time of the report, the patient had improved. The reporting physician considered myositis to be another important medical event. Additional information is not expected. Other business partner numbers include E2007-04641. |
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| VAERS ID: | 286186 | Vaccinated: | 2007-07-06 | | Age: | 25.0 | Onset: | 2007-07-06, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-27, Days after onset: 21 | | Location: | | Entered: | 2007-07-30, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Electrocardiogram 06Jul07 Comment: Bradycardia | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES707POL00019 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | 0 | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Bradycardia, Convulsion, Electrocardiogram abnormal, Loss of consciousness | | Write-up: Information has been received from a physician concerning a 25 year old female who on 06-JUL-2007 was vaccinated with Gardasil. On 06-JUL-2007 after administration of whole dose of Gardasil the patient experienced loss of consciousness, bradycardia and convulsion. Lost of consciousness and convulsion lasted several seconds. Bradycardia lasted about half an hour. Electrocardiogram performed on 06-JUL-2007 showed bradycardia. The reporter marked life threatening as unknown for lost of consciousness. Therapy with human papillomavirus vaccine was discontinued (the reporter decided not to administer in the future the second and the third dose of Gardasil). The patient recovered from loss of consciousness, bradycardia and convulsion. The reporter felt that loss of consciousness, bradycardia and convulsion were related to therapy with Gardasil. Upon internal review, convulsion was considered to be an other important medical event. Additional information is not expected. |
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| VAERS ID: | 286269 | Vaccinated: | 2007-05-17 | | Age: | 17.0 | Onset: | 2007-05-17, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-30, Days after onset: 74 | | Location: | | Entered: | 2007-07-31, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? Yes, 0 days | | Extended hospital stay? No |
| Current Illness: Allergic reaction to antibiotics; Arthritis; Asthma; Gastrooesophageal reflux; Delayed gastric emptying | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: | | CDC 'Split Type': WAES0707AUS00221 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0138U | | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Flushing, Headache, Paraesthesia | | Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form and a Case Line Listing concerning a 17 year old female with severe allergies to antibiotics, arthritis, asthma, gastric reflux and delayed emptying who on 17-MAY-2007 was vaccinated with Gardasil (Lot # 655742/0138U, Batch # J0800, Expiry Date 07-AUG-2009). On 17-MAY-2007 after vaccination with Gardasil the patient experienced tingling in fingers and toes, flushing and headache and was hospitalised and was treated with adrenaline. On 17-MAY-2007, the patient recovered from tingling in fingers and toes, flushing and headache. The agency considered that tingling in fingers and toes, flushing and headache were possibly related to therapy with Gardasil. The original reporting source was not provided. Additional information is not expected. |
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| VAERS ID: | 286270 | Vaccinated: | 2007-07-05 | | Age: | 24.0 | Onset: | 2007-07-05, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-30, Days after onset: 25 | | Location: | | Entered: | 2007-07-31, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? Yes |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0707AUS00223 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0313U | | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Pruritus, Rash maculo-papular | | Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form and a Case Line Listing concerning a 24 year old female who on 05-JUL-2007 was vaccinated with Gardasil (Lot No. 655743/0313U, Batch No. J1022, Expiry date, 08-AUG-2009). On 05-JUL-2007 after vaccination with Gardasil the patient developed pruritus over trunk and arms and rash maculo-papular over trunk and arms. On 11-JUL-2007, the patient recovered from pruritus over trunk and arms and rash maculo-papular over trunk and arms. The agency considered that pruritus over trunk and arms and rash maculo-papular over trunk and arms were related to therapy with Gardasil. The original reporting source was not provided. Pruritus over trunk and arms and rash maculo-papular over trunk and arms were considered to be disabling by the agency. Additional information is not expected. |
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| VAERS ID: | 286271 | Vaccinated: | 2007-05-23 | | Age: | | Onset: | 2007-05-23, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-30, Days after onset: 68 | | Location: | | Entered: | 2007-07-31, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0707AUS00224 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0138U | | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Deafness, Dizziness, Nausea, Vision blurred | | Write-up: Information was obtained on request by the Company from the agency via a Case Line Listing and a Public Case Detail form. The patient was a female who on 23-MAY-2007 was vaccinated with Gardasil (Lot No. 655742/0138U, Batch No. J0799, Expiry date, 07-AUG-2009). On 23-MAY-2007 the patient experienced nausea, dizziness, blurred vision and loss of hearing post vaccination. The agency considered that nausea, dizziness, deafness and blurred vision were possibly related to therapy with Gardasil. The original reporting source was not provided. Upon internal review, deafness was considered to be an other important medical event. Additional information is not expected. |
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| VAERS ID: | 286272 | Vaccinated: | 2007-05-08 | | Age: | 17.0 | Onset: | 2007-05-08, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-30, Days after onset: 83 | | Location: | | Entered: | 2007-07-31, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? Yes |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: amoxicillin 04May07 - 10May07 | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0707AUS00226 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0138U | | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Fatigue, Feeling hot and cold, Headache, Nausea, Unresponsive to stimuli | | Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form and a Case Line Listing concerning a 17 year old female who on 08-MAY-2007 was vaccinated with Gardasil (Lot # 655742/0138U, Batch # J0798, Expiry Date 07-AUG-2009). Concomitant therapy included amoxicillin (AMOXIL). On 08-MAY-2007 one minute post vaccination, the patient felt drained, felt hot and cold and experienced headache, nausea and was unresponsive to stimuli. At the time of reporting to the agency on 11-MAY-2007, the patient's felt drained, feeling hot and cold, headache, nausea and unresponsive to stimuli persisted. The agency considered that felt drained, feeling hot and cold, headache, nausea and unresponsive to stimuli were possibly related to therapy with Gardasil. The original reporting source was not provided. Felt drained 1 minute post vaccination, feeling hot and cold, headache, nausea and unresponsive to stimuli were considered to be disabling by the agency. Additional information is not expected. |
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| VAERS ID: | 286413 | Vaccinated: | 2007-07-24 | | Age: | 23.0 | Onset: | 2007-07-25, Days after vaccination: 1 | | Gender: | Female | Submitted: | 2007-07-31, Days after onset: 6 | | Location: | | Entered: | 2007-08-01, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? Yes |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0707AUS00222 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Erythema, Hypersensitivity, Oedema peripheral | | Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail form and a Case Line Listing concerning a 23 year old female who on 24-JUL-2007 was vaccinated with Gardasil. On 25-JUL-2007 the patient experienced erythema - fingers to wrist and swollen red and sensitive hands from the tips of fingers to wrist, bilaterally. At the time of reporting to the agency on 25-JUL2007 the outcome of erythema - fingers to wrist and swollen red and sensitive hands from the tips of fingers to wrist, bilaterally were unknown. The agency considered that erythema - fingers to wrist and swollen red and sensitive hands from the tips of fingers to wrist, bilaterally were possibly related to therapy with Gardasil. The original reporting source was not provided. Erythema - fingers to wrist and swollen red and sensitive hands from the tips of fingers to wrist, bilaterally were3 considered to be disabling by the agency. Additional information is not expected. |
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| VAERS ID: | 286414 | Vaccinated: | 2007-05-15 | | Age: | 15.0 | Onset: | 2007-05-17, Days after vaccination: 2 | | Gender: | Female | Submitted: | 2007-07-31, Days after onset: 75 | | Location: | | Entered: | 2007-08-01, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? Yes |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: sertraline HCl Unk - Unk | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0707AUS00225 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | UN | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Bedridden, Muscle spasms, Neck pain | | Write-up: Information was obtained on request by the Company from the agency via a Case Line Listing and a Public Case Detail form. The patient was a 15 year old female who on 15-MAY-2007 was vaccinated with Gardasil. Concomitant therapy included sertraline HCl. On 17-MAY2007 the patient experienced painful muscle spasm in neck which was diagnosed as "acute wry neck" by a physician. The patient was bedridden for 2 days. On 23-MAY-2007, it was reported to the agency that the patient still had a sore neck but no where near as severe as before. The agency considered that painful muscle spasm in possibly were related to therapy with Gardasil. Painful muscle spasm in neck was considered to be disabling by the agency. Additional information is not expected. |
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| VAERS ID: | 286415 | Vaccinated: | 2007-05-01 | | Age: | 14.0 | Onset: | 2007-05-01, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2007-07-31, Days after onset: 91 | | Location: | | Entered: | 2007-08-01, Days after submission: 1 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: | |
