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This is VAERS ID 289488

History of Changes from the VAERS Wayback Machine

First Appeared on 12/31/2007

VAERS ID: 289488
VAERS Form:
Age:16.0
Sex:Female
Location:Michigan
Vaccinated:2007-04-10
Onset:2007-04-18
Submitted:2007-08-14
Entered:2007-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 2 UN / IM

Administered by: Other      Purchased by: Unknown
Symptoms: Cardiolipin antibody negative, Blood homocysteine normal, Deep vein thrombosis, Factor V Leiden mutation, Antiphospholipid antibodies negative

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: ultrasound, venography CT venogram factor II activity test within normal limits, plasma protein C test within normal limits, blood factor V Leiden within normal limits, serum Angiostrongylus within normal limits, serum homocysteine within n
CDC 'Split Type':

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, th"e patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medic


Changed on 12/8/2009

VAERS ID: 289488 Before After
VAERS Form:
Age:16.0
Sex:Female
Location:Michigan
Vaccinated:2007-04-10
Onset:2007-04-18
Submitted:2007-08-14
Entered:2007-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 2 UN / IM

Administered by: Other      Purchased by: Unknown Other
Symptoms: Cardiolipin antibody negative, Computerised tomogram abnormal, Hyperaemia, Oedema peripheral, Paraesthesia, Protein total normal, Ultrasound Doppler, Ultrasound Doppler abnormal, Venogram abnormal, Blood homocysteine normal, Protein C, Deep vein thrombosis, Anticoagulant therapy, Thrombin-antithrombin III complex normal, Factor V Leiden mutation, Antiphospholipid antibodies negative

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None Heme/onc consult 8/14/07 reports pt has never been on oral contraceptives or hormone tx.
Allergies:
Diagnostic Lab Data: ultrasound, venography CT venogram factor II activity test within normal limits, plasma protein C test within normal limits, blood factor V Leiden within normal limits, serum Angiostrongylus within normal limits, serum homocysteine within n
CDC 'Split Type': (blank) WAES0707USA03234

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, th"e the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medic medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with enoxaparin sodium (LOVENOX) and is currently being treated with warfarin sodium (COUMADIN). Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX: Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2'' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on Coumadin. ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on Coumadin.


Changed on 3/2/2010

VAERS ID: 289488 Before After
VAERS Form:
Age:16.0
Sex:Female
Location:Michigan
Vaccinated:2007-04-10
Onset:2007-04-18
Submitted:2007-08-14
Entered:2007-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 2 UN LA / IM

Administered by: Other Private      Purchased by: Other Private
Symptoms: Cardiolipin antibody negative, Computerised tomogram abnormal, Hyperaemia, Oedema peripheral, Paraesthesia, Protein total normal, Ultrasound Doppler, Ultrasound Doppler abnormal, Venogram abnormal, Blood homocysteine normal, Protein C, Deep vein thrombosis, Anticoagulant therapy, Thrombin-antithrombin III complex normal, Factor V Leiden mutation, Antiphospholipid antibodies negative

Life Threatening? No Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None Heme/onc consult 8/14/07 reports pt has never been on oral contraceptives or hormone tx.
Allergies:
Diagnostic Lab Data: ultrasound, venography Ultrasound; venography, CT venogram factor venogram; Factor II activity test within normal limits, plasma limits; Plasma protein C test within normal limits, blood limits; Blood factor V Leiden within normal limits, serum limits: Serum Angiostrongylus within normal limits, serum limits; Serum homocysteine within n
CDC 'Split Type': WAES0707USA03234

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with enoxaparin sodium (LOVENOX) LOVENOX and is currently being treated with warfarin sodium (COUMADIN). COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX: Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2'' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on Coumadin. COUMADIN. ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on Coumadin. COUMADIN. This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian ve


Changed on 4/7/2010

VAERS ID: 289488 Before After
VAERS Form:
Age:16.0
Sex:Female
Location:Michigan
Vaccinated:2007-04-10
Onset:2007-04-18
Submitted:2007-08-14
Entered:2007-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 2 LA / IM

Administered by: Private      Purchased by: Private
Symptoms: Cardiolipin antibody negative, Coagulation factor decreased, Coagulation factor V level normal, Hyperaemia, Oedema peripheral, Paraesthesia, Protein total normal, Prothrombin level normal, Skin discolouration, Ultrasound Doppler, Venogram, Subclavian vein thrombosis, Blood homocysteine normal, Protein C, Blood test normal, Antithrombin III, Deep vein thrombosis, Antiphospholipid antibodies negative, Immunology test normal

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None Heme/onc consult 8/14/07 reports pt has never been on oral contraceptives or hormone tx.
Allergies:
Diagnostic Lab Data: Ultrasound; venography, CT venogram; Factor II activity test within normal limits; Plasma protein C test within normal limits; Blood factor V Leiden within normal limits: Serum Angiostrongylus within normal limits; Serum homocysteine within
CDC 'Split Type': WAES0707USA03234

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX: Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2'' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN. ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN. This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian ve


Changed on 7/31/2010

VAERS ID: 289488 Before After
VAERS Form:
Age:16.0
Sex:Female
Location:Michigan
Vaccinated:2007-04-10
Onset:2007-04-18
Submitted:2007-08-14
Entered:2007-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 2 LA / IM

Administered by: Private      Purchased by: Private
Symptoms: Cardiolipin antibody negative, Coagulation factor decreased, Coagulation factor V level normal, Hyperaemia, Oedema peripheral, Paraesthesia, Protein total normal, Prothrombin level normal, Skin discolouration, Ultrasound Doppler, Venogram, Subclavian vein thrombosis, Blood homocysteine normal, Protein C, Blood test normal, Antithrombin III, Deep vein thrombosis, Antiphospholipid antibodies negative, Immunology test normal

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None Heme/onc consult 8/14/07 reports pt has never been on oral contraceptives or hormone tx.
Allergies:
Diagnostic Lab Data: Ultrasound; venography, CT venogram; Factor II activity test within normal limits; Plasma protein C test within normal limits; Blood factor V Leiden within normal limits: Serum Angiostrongylus within normal limits; Serum homocysteine within
CDC 'Split Type': WAES0707USA03234

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX: Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2'' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN. ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN. This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian ve


Changed on 1/4/2011

VAERS ID: 289488 Before After
VAERS Form:
Age:16.0
Sex:Female
Location:Michigan
Vaccinated:2007-04-10
Onset:2007-04-18
Submitted:2007-08-14
Entered:2007-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 2 LA / IM

Administered by: Private      Purchased by: Private
Symptoms: Cardiolipin antibody negative, Coagulation factor decreased, Coagulation factor V level normal, Protein total normal, Prothrombin level normal, Skin discolouration, Ultrasound Doppler, Venogram, Subclavian vein thrombosis, Blood homocysteine normal, Protein C, Blood test normal, Antithrombin III, Deep vein thrombosis, Antiphospholipid antibodies negative, Immunology test normal

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None Heme/onc consult 8/14/07 reports pt has never been on oral contraceptives or hormone tx.
Allergies:
Diagnostic Lab Data: Ultrasound; venography, CT venogram; Factor II activity test within normal limits; Plasma protein C test within normal limits; Blood factor V Leiden within normal limits: Serum Angiostrongylus within normal limits; Serum homocysteine within normal limits; Antithrombin III test within normal limits; Lupus anticoagulant within normal limits. 6/24/08 Received only US of LUE report which revealed probable thrombosis within left internal jugular vein & proximal subclavian vein. Labs and Diagnostics: Venous Doppler US of ULE 4/18/2007 (+) for thrombosis in left internal jugular vein and proximal subclavian vein. Repeat 7/02/2008 WNL except inability to visualize cephalic vein. CT scan of LUE and thorax (+) for minimal non-occlusive thrombus in
CDC 'Split Type': WAES0707USA03234

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX: Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2'' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN. ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN. This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian ve vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.


Changed on 4/13/2011

VAERS ID: 289488 Before After
VAERS Form:
Age:16.0
Sex:Female
Location:Michigan
Vaccinated:2007-04-10
Onset:2007-04-18
Submitted:2007-08-14
Entered:2007-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 2 LA / IM

Administered by: Private      Purchased by: Private
Symptoms: Cardiolipin antibody negative, Coagulation factor decreased, Coagulation factor V level normal, Hyperaemia, Oedema peripheral, Paraesthesia, Protein total normal, Prothrombin level normal, Skin discolouration, Ultrasound Doppler, Venogram, Subclavian vein thrombosis, Blood homocysteine normal, Protein C, Blood test normal, Antithrombin III, Deep vein thrombosis, Antiphospholipid antibodies negative, Immunology test normal

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None Heme/onc consult 8/14/07 reports pt has never been on oral contraceptives or hormone tx.
Allergies:
Diagnostic Lab Data: Ultrasound; venography, CT venogram; Factor II activity test within normal limits; Plasma protein C test within normal limits; Blood factor V Leiden within normal limits: Serum Angiostrongylus within normal limits; Serum homocysteine within normal limits; Antithrombin III test within normal limits; Lupus anticoagulant within normal limits. 6/24/08 Received only US of LUE report which revealed probable thrombosis within left internal jugular vein & proximal subclavian vein. Labs and Diagnostics: Venous Doppler US of ULE 4/18/2007 (+) for thrombosis in left internal jugular vein and proximal subclavian vein. Repeat 7/02/2008 WNL except inability to visualize cephalic vein. CT scan of LUE and thorax (+) for minimal non-occlusive thrombus in
CDC 'Split Type': WAES0707USA03234

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX: Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2'' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN. ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN. This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.


Changed on 5/13/2011

VAERS ID: 289488 Before After
VAERS Form:
Age:16.0
Sex:Female
Location:Michigan
Vaccinated:2007-04-10
Onset:2007-04-18
Submitted:2007-08-14
Entered:2007-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 2 LA / IM

Administered by: Private      Purchased by: Private
Symptoms: Cardiolipin antibody negative, Coagulation factor decreased, Coagulation factor V level normal, Hyperaemia, Oedema peripheral, Paraesthesia, Protein total normal, Prothrombin level normal, Skin discolouration, Ultrasound Doppler, Venogram, Subclavian vein thrombosis, Blood homocysteine normal, Protein C, Blood test normal, Antithrombin III, Deep vein thrombosis, Antiphospholipid antibodies negative, Immunology test normal

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None Heme/onc consult 8/14/07 reports pt has never been on oral contraceptives or hormone tx.
Allergies:
Diagnostic Lab Data: Ultrasound; venography, CT venogram; Factor II activity test within normal limits; Plasma protein C test within normal limits; Blood factor V Leiden within normal limits: Serum Angiostrongylus within normal limits; Serum homocysteine within normal limits; Antithrombin III test within normal limits; Lupus anticoagulant within normal limits. 6/24/08 Received only US of LUE report which revealed probable thrombosis within left internal jugular vein & proximal subclavian vein. Labs and Diagnostics: Venous Doppler US of ULE 4/18/2007 (+) for thrombosis in left internal jugular vein and proximal subclavian vein. Repeat 7/02/2008 WNL except inability to visualize cephalic vein. CT scan of LUE and thorax (+) for minimal non-occlusive thrombus in
CDC 'Split Type': WAES0707USA03234

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX: Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2'' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN. ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN. This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.


Changed on 6/11/2011

VAERS ID: 289488 Before After
VAERS Form:
Age:16.0
Sex:Female
Location:Michigan
Vaccinated:2007-04-10
Onset:2007-04-18
Submitted:2007-08-14
Entered:2007-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 2 LA / IM

Administered by: Private      Purchased by: Private
Symptoms: Cardiolipin antibody negative, Coagulation factor decreased, Coagulation factor V level normal, Hyperaemia, Oedema peripheral, Paraesthesia, Protein total normal, Prothrombin level normal, Skin discolouration, Ultrasound Doppler, Venogram, Subclavian vein thrombosis, Blood homocysteine normal, Protein C, Blood test normal, Antithrombin III, Deep vein thrombosis, Antiphospholipid antibodies negative, Immunology test normal

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None Heme/onc consult 8/14/07 reports pt has never been on oral contraceptives or hormone tx.
Allergies:
Diagnostic Lab Data: Ultrasound; venography, CT venogram; Factor II activity test within normal limits; Plasma protein C test within normal limits; Blood factor V Leiden within normal limits: Serum Angiostrongylus within normal limits; Serum homocysteine within normal limits; Antithrombin III test within normal limits; Lupus anticoagulant within normal limits. 6/24/08 Received only US of LUE report which revealed probable thrombosis within left internal jugular vein & proximal subclavian vein. Labs and Diagnostics: Venous Doppler US of ULE 4/18/2007 (+) for thrombosis in left internal jugular vein and proximal subclavian vein. Repeat 7/02/2008 WNL except inability to visualize cephalic vein. CT scan of LUE and thorax (+) for minimal non-occlusive thrombus in
CDC 'Split Type': WAES0707USA03234

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX: Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2'' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN. ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN. This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.


Changed on 6/14/2014

VAERS ID: 289488 Before After
VAERS Form:
Age:16.0
Sex:Female
Location:Michigan
Vaccinated:2007-04-10
Onset:2007-04-18
Submitted:2007-08-14
Entered:2007-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 2 LA / IM

Administered by: Private      Purchased by: Private
Symptoms: Cardiolipin antibody negative, Coagulation factor decreased, Coagulation factor V level normal, Hyperaemia, Oedema peripheral, Paraesthesia, Protein total normal, Prothrombin level normal, Skin discolouration, Ultrasound Doppler, Venogram, Subclavian vein thrombosis, Blood homocysteine normal, Protein C, Blood test normal, Antithrombin III, Deep vein thrombosis, Antiphospholipid antibodies negative, Immunology test normal

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None Heme/onc consult 8/14/07 reports pt has never been on oral contraceptives or hormone tx.
Allergies:
Diagnostic Lab Data: Ultrasound; venography, CT venogram; Factor II activity test within normal limits; Plasma protein C test within normal limits; Blood factor V Leiden within normal limits: Serum Angiostrongylus within normal limits; Serum homocysteine within normal limits; Antithrombin III test within normal limits; Lupus anticoagulant within normal limits. 6/24/08 Received only US of LUE report which revealed probable thrombosis within left internal jugular vein & proximal subclavian vein. Labs and Diagnostics: Venous Doppler US of ULE 4/18/2007 (+) for thrombosis in left internal jugular vein and proximal subclavian vein. Repeat 7/02/2008 WNL except inability to visualize cephalic vein. CT scan of LUE and thorax (+) for minimal non-occlusive thrombus in
CDC 'Split Type': WAES0707USA03234

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX: Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2'' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN. ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN. This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.


Changed on 5/14/2017

VAERS ID: 289488 Before After
VAERS Form:
Age:16.0
Sex:Female
Location:Michigan
Vaccinated:2007-04-10
Onset:2007-04-18
Submitted:2007-08-14
Entered:2007-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 2 LA / IM

Administered by: Private      Purchased by: Private
Symptoms: Cardiolipin antibody negative, Coagulation factor decreased, Coagulation factor V level normal, Hyperaemia, Oedema peripheral, Paraesthesia, Protein total normal, Prothrombin level normal, Skin discolouration, Ultrasound Doppler, Venogram, Subclavian vein thrombosis, Blood homocysteine normal, Protein C, Blood test normal, Antithrombin III, Deep vein thrombosis, Antiphospholipid antibodies negative, Immunology test normal

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None Heme/onc consult 8/14/07 reports pt has never been on oral contraceptives or hormone tx.
Allergies:
Diagnostic Lab Data: Ultrasound; venography, CT venogram; Factor II activity test within normal limits; Plasma protein C test within normal limits; Blood factor V Leiden within normal limits: Serum Angiostrongylus within normal limits; Serum homocysteine within normal limits; Antithrombin III test within normal limits; Lupus anticoagulant within normal limits. 6/24/08 Received only US of LUE report which revealed probable thrombosis within left internal jugular vein & proximal subclavian vein. Labs and Diagnostics: Venous Doppler US of ULE 4/18/2007 (+) for thrombosis in left internal jugular vein and proximal subclavian vein. Repeat 7/02/2008 WNL except inability to visualize cephalic vein. CT scan of LUE and thorax (+) for minimal non-occlusive thrombus in
CDC 'Split Type': WAES0707USA03234

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX: Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2'' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN. ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN. This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.


Changed on 9/14/2017

VAERS ID: 289488 Before After
VAERS Form:(blank) 1
Age:16.0
Sex:Female
Location:Michigan
Vaccinated:2007-04-10
Onset:2007-04-18
Submitted:2007-08-14
Entered:2007-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 2 3 LA / IM

Administered by: Private      Purchased by: Private
Symptoms: Cardiolipin antibody negative, Coagulation factor decreased, Coagulation factor V level normal, Protein total normal, Prothrombin level normal, Skin discolouration, Ultrasound Doppler, Venogram, Subclavian vein thrombosis, Blood homocysteine normal, Protein C, Blood test normal, Antithrombin III, Deep vein thrombosis, Antiphospholipid antibodies negative, Immunology test normal

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None Heme/onc consult 8/14/07 reports pt has never been on oral contraceptives or hormone tx.
Allergies:
Diagnostic Lab Data: Ultrasound; venography, CT venogram; Factor II activity test within normal limits; Plasma protein C test within normal limits; Blood factor V Leiden within normal limits: Serum Angiostrongylus within normal limits; Serum homocysteine within normal limits; Antithrombin III test within normal limits; Lupus anticoagulant within normal limits. 6/24/08 Received only US of LUE report which revealed probable thrombosis within left internal jugular vein & proximal subclavian vein. Labs and Diagnostics: Venous Doppler US of ULE 4/18/2007 (+) for thrombosis in left internal jugular vein and proximal subclavian vein. Repeat 7/02/2008 WNL except inability to visualize cephalic vein. CT scan of LUE and thorax (+) for minimal non-occlusive thrombus in the mid left subclavian vein region, less extensive than in April. Repeat CT 11/15/07 with no residual thrombus seen. MTHFR C677T heterozygous (+). PT and INR repeatedly high 4/19/07-2/11/08. Ultrasound, 04/18/07, positive DVT Left I.J. and proximal subclavian veinvenography
CDC 'Split Type': WAES0707USA03234

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX: Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2'' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN. ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN. This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.


Changed on 2/14/2018

VAERS ID: 289488 Before After
VAERS Form:1
Age:16.0
Sex:Female
Location:Michigan
Vaccinated:2007-04-10
Onset:2007-04-18
Submitted:2007-08-14
Entered:2007-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 3 LA / IM

Administered by: Private      Purchased by: Private
Symptoms: Cardiolipin antibody negative, Coagulation factor decreased, Coagulation factor V level normal, Protein total normal, Prothrombin level normal, Skin discolouration, Ultrasound Doppler, Venogram, Subclavian vein thrombosis, Blood homocysteine normal, Protein C, Blood test normal, Antithrombin III, Deep vein thrombosis, Antiphospholipid antibodies negative, Immunology test normal

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None Heme/onc consult 8/14/07 reports pt has never been on oral contraceptives or hormone tx.
Allergies:
Diagnostic Lab Data: Ultrasound; venography, CT venogram; Factor II activity test within normal limits; Plasma protein C test within normal limits; Blood factor V Leiden within normal limits: Serum Angiostrongylus within normal limits; Serum homocysteine within normal limits; Antithrombin III test within normal limits; Lupus anticoagulant within normal limits. 6/24/08 Received only US of LUE report which revealed probable thrombosis within left internal jugular vein & proximal subclavian vein. Labs and Diagnostics: Venous Doppler US of ULE 4/18/2007 (+) for thrombosis in left internal jugular vein and proximal subclavian vein. Repeat 7/02/2008 WNL except inability to visualize cephalic vein. CT scan of LUE and thorax (+) for minimal non-occlusive thrombus in the mid left subclavian vein region, less extensive than in April. Repeat CT 11/15/07 with no residual thrombus seen. MTHFR C677T heterozygous (+). PT and INR repeatedly high 4/19/07-2/11/08. Ultrasound, 04/18/07, positive DVT Left I.J. and proximal subclavian veinvenography
CDC 'Split Type': WAES0707USA03234

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX: Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2'' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN. ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN. This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.


Changed on 6/14/2018

VAERS ID: 289488 Before After
VAERS Form:1
Age:16.0
Sex:Female
Location:Michigan
Vaccinated:2007-04-10
Onset:2007-04-18
Submitted:2007-08-14
Entered:2007-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 3 LA / IM

Administered by: Private      Purchased by: Private
Symptoms: Cardiolipin antibody negative, Coagulation factor decreased, Coagulation factor V level normal, Protein total normal, Prothrombin level normal, Skin discolouration, Ultrasound Doppler, Venogram, Subclavian vein thrombosis, Blood homocysteine normal, Protein C, Blood test normal, Antithrombin III, Deep vein thrombosis, Antiphospholipid antibodies negative, Immunology test normal

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None Heme/onc consult 8/14/07 reports pt has never been on oral contraceptives or hormone tx.
Allergies:
Diagnostic Lab Data: Ultrasound; venography, CT venogram; Factor II activity test within normal limits; Plasma protein C test within normal limits; Blood factor V Leiden within normal limits: Serum Angiostrongylus within normal limits; Serum homocysteine within normal limits; Antithrombin III test within normal limits; Lupus anticoagulant within normal limits. 6/24/08 Received only US of LUE report which revealed probable thrombosis within left internal jugular vein & proximal subclavian vein. Labs and Diagnostics: Venous Doppler US of ULE 4/18/2007 (+) for thrombosis in left internal jugular vein and proximal subclavian vein. Repeat 7/02/2008 WNL except inability to visualize cephalic vein. CT scan of LUE and thorax (+) for minimal non-occlusive thrombus in the mid left subclavian vein region, less extensive than in April. Repeat CT 11/15/07 with no residual thrombus seen. MTHFR C677T heterozygous (+). PT and INR repeatedly high 4/19/07-2/11/08. Ultrasound, 04/18/07, positive DVT Left I.J. and proximal subclavian veinvenography
CDC 'Split Type': WAES0707USA03234

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX: Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2'' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN. ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN. This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.


Changed on 8/14/2018

VAERS ID: 289488 Before After
VAERS Form:1
Age:16.0
Sex:Female
Location:Michigan
Vaccinated:2007-04-10
Onset:2007-04-18
Submitted:2007-08-14
Entered:2007-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 3 LA / IM

Administered by: Private      Purchased by: Private
Symptoms: Cardiolipin antibody negative, Coagulation factor decreased, Coagulation factor V level normal, Protein total normal, Prothrombin level normal, Skin discolouration, Ultrasound Doppler, Venogram, Subclavian vein thrombosis, Blood homocysteine normal, Protein C, Blood test normal, Antithrombin III, Deep vein thrombosis, Antiphospholipid antibodies negative, Immunology test normal

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None Heme/onc consult 8/14/07 reports pt has never been on oral contraceptives or hormone tx.
Allergies:
Diagnostic Lab Data: Ultrasound; venography, CT venogram; Factor II activity test within normal limits; Plasma protein C test within normal limits; Blood factor V Leiden within normal limits: Serum Angiostrongylus within normal limits; Serum homocysteine within normal limits; Antithrombin III test within normal limits; Lupus anticoagulant within normal limits. 6/24/08 Received only US of LUE report which revealed probable thrombosis within left internal jugular vein & proximal subclavian vein. Labs and Diagnostics: Venous Doppler US of ULE 4/18/2007 (+) for thrombosis in left internal jugular vein and proximal subclavian vein. Repeat 7/02/2008 WNL except inability to visualize cephalic vein. CT scan of LUE and thorax (+) for minimal non-occlusive thrombus in the mid left subclavian vein region, less extensive than in April. Repeat CT 11/15/07 with no residual thrombus seen. MTHFR C677T heterozygous (+). PT and INR repeatedly high 4/19/07-2/11/08. Ultrasound, 04/18/07, positive DVT Left I.J. and proximal subclavian veinvenography
CDC 'Split Type': WAES0707USA03234

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX: Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2'' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN. ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN. This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.


Changed on 9/14/2018

VAERS ID: 289488 Before After
VAERS Form:1
Age:16.0
Sex:Female
Location:Michigan
Vaccinated:2007-04-10
Onset:2007-04-18
Submitted:2007-08-14
Entered:2007-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 3 LA / IM

Administered by: Private      Purchased by: Private
Symptoms: Cardiolipin antibody negative, Coagulation factor decreased, Coagulation factor V level normal, Protein total normal, Prothrombin level normal, Skin discolouration, Ultrasound Doppler, Venogram, Subclavian vein thrombosis, Blood homocysteine normal, Protein C, Blood test normal, Antithrombin III, Deep vein thrombosis, Antiphospholipid antibodies negative, Immunology test normal

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None Heme/onc consult 8/14/07 reports pt has never been on oral contraceptives or hormone tx.
Allergies:
Diagnostic Lab Data: Ultrasound; venography, CT venogram; Factor II activity test within normal limits; Plasma protein C test within normal limits; Blood factor V Leiden within normal limits: Serum Angiostrongylus within normal limits; Serum homocysteine within normal limits; Antithrombin III test within normal limits; Lupus anticoagulant within normal limits. 6/24/08 Received only US of LUE report which revealed probable thrombosis within left internal jugular vein & proximal subclavian vein. Labs and Diagnostics: Venous Doppler US of ULE 4/18/2007 (+) for thrombosis in left internal jugular vein and proximal subclavian vein. Repeat 7/02/2008 WNL except inability to visualize cephalic vein. CT scan of LUE and thorax (+) for minimal non-occlusive thrombus in the mid left subclavian vein region, less extensive than in April. Repeat CT 11/15/07 with no residual thrombus seen. MTHFR C677T heterozygous (+). PT and INR repeatedly high 4/19/07-2/11/08. Ultrasound, 04/18/07, positive DVT Left I.J. and proximal subclavian veinvenography
CDC 'Split Type': WAES0707USA03234

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX: Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2'' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN. ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN. This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.


Changed on 10/14/2018

VAERS ID: 289488 Before After
VAERS Form:1
Age:16.0
Sex:Female
Location:Michigan
Vaccinated:2007-04-10
Onset:2007-04-18
Submitted:2007-08-14
Entered:2007-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 3 LA / IM

Administered by: Private      Purchased by: Private
Symptoms: Cardiolipin antibody negative, Coagulation factor decreased, Coagulation factor V level normal, Protein total normal, Prothrombin level normal, Skin discolouration, Ultrasound Doppler, Venogram, Subclavian vein thrombosis, Blood homocysteine normal, Protein C, Blood test normal, Antithrombin III, Deep vein thrombosis, Antiphospholipid antibodies negative, Immunology test normal

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None Heme/onc consult 8/14/07 reports pt has never been on oral contraceptives or hormone tx.
Allergies:
Diagnostic Lab Data: Ultrasound; venography, CT venogram; Factor II activity test within normal limits; Plasma protein C test within normal limits; Blood factor V Leiden within normal limits: Serum Angiostrongylus within normal limits; Serum homocysteine within normal limits; Antithrombin III test within normal limits; Lupus anticoagulant within normal limits. 6/24/08 Received only US of LUE report which revealed probable thrombosis within left internal jugular vein & proximal subclavian vein. Labs and Diagnostics: Venous Doppler US of ULE 4/18/2007 (+) for thrombosis in left internal jugular vein and proximal subclavian vein. Repeat 7/02/2008 WNL except inability to visualize cephalic vein. CT scan of LUE and thorax (+) for minimal non-occlusive thrombus in the mid left subclavian vein region, less extensive than in April. Repeat CT 11/15/07 with no residual thrombus seen. MTHFR C677T heterozygous (+). PT and INR repeatedly high 4/19/07-2/11/08. Ultrasound, 04/18/07, positive DVT Left I.J. and proximal subclavian veinvenography
CDC 'Split Type': WAES0707USA03234

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX: Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2'' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN. ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN. This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.

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