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Found 6894 cases where Vaccine is HPV4 and Serious

Case Details

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VAERS ID: 287889 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-03-09
Onset:2007-04-09
   Days after vaccination:31
Submitted: 2007-08-10
   Days after onset:123
Entered: 2007-08-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Uterine dilation and curettage
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amoxicillin, carbamazepine, diuretic (unspecified), ORTHO TRI-CYCLEN, ibuprofen, levothyroxine sodium, spironolactone, venlafaxine hydrochloride
Current Illness: Pregnancy NOS (LMP = 3/4/2007); Bipolar disorder; Depression; Oedema hands; Foot oedema; Hypertension; Sore throat; Hypothyroidism; Viral infection
Preexisting Conditions: Early onset of delivery
Allergies:
Diagnostic Lab Data: beta-human chorionic 04/09/07 posit
CDC Split Type: WAES0708USA00308

Write-up: Information has been received from an investigator from GLAXOSMITHKLINE (GSK) BIOLOGICS (manufacturer control # B0465767A) regarding a 24 year old female with bipolar disorder, depression, oedema hands and feet, hypertension, sore throat, hypothyroidism and viral infection with a history of 1 pre-term pregnancy and with a normal birth who entered a GSK clinical sponsored trial. On 09-MAR-2007 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Ortho Tri-Cyclen, venlafaxine HCl, spironolactone, levothyroxine Na, carbamazepine, ibuprofen, diuretic (unspecified) and amoxicillin. On 09-APR-2007, a pregnancy test was positive. Her LMP was on 04-MAR-2007 and Ortho Tri-Cyclen, was used for contraception until 16-MAR-2007. On 01-MAY-2007 the patient experienced spontaneous abortion at 8.2 weeks of pregnancy. She was hospitalized for 2 days and the event was considered clinically significant. She was treated with dilation and curettage and the event resolved on 01-MAY-2007. It was noted that her partner had no abnormal medical or family history. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy. The patient was withdrawn from the study due to the spontaneous abortion and subsequent study administration discontinued. No further information is available.


VAERS ID: 288024 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-02-15
Onset:2007-05-09
   Days after vaccination:83
Submitted: 2007-08-13
   Days after onset:96
Entered: 2007-08-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Muscular weakness, Myelitis transverse, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown 10/3/08-PMH: asthma, URI 3-4 weeks prior to admit, tonsillitis, smoker. Family hx DM.
Allergies:
Diagnostic Lab Data: Unknown 8/29/08-information received-MRI of brain suggested MS. MRI was consistent with TM at cervical level, and was found to have elevated lipase and amylase. 10/3/08-records recived-LABS: WBC 14.1(H), neutros 92%(H), lymphs 5(L). ESR 15. Chemistry WNL. Lipase 130(H), amylase 125(H). Brain CT & MRI abnormal. Cervical & thoracic MRI abnormal. CSF: WBC 18(H), 97% lymphs(H), 3% monos(L), glucose 62(N), protein 45(N), IgG 1.29(H). ANA & RF (-). EEG WNL. Blood c/s neg.
CDC Split Type: WAES0708USA00964

Write-up: ved-Information has been received from a physician concerning a female who on 15-FEB-2007 was vaccinated IM with a 0.5 ml dose of Gardasil (lot # 653736/0868F). On 09-MAY-2007 the patient developed weakness and paresthesia of the upper and lower extremities. The patient was hospitalized from 09-MAY-2007 to 14-MAY-2007. The diagnosis was determined to be transverse myelitis. Details of the hospitalization and treatment were not available. The physician reported that the patient had required additional hospitalization but the details were not available. At the time of the report, the patient''s transverse myelitis persisted. Additional information has been requested. 8/29/08-from CDC-19 y/o female who received the vaccine on 2/15/07, chart indicates she refused second dose because of symptoms after first dose (although not clear), on 5/17/07 she was admitted for leg weakness/numbness. The working diagnosis was TM although occasional back spasms had them consider seizure disorder as well. She experienced her nadir of no sensation to chest level and inability to walk. At one point ONM was also considered though unclear. After which she also developed seizure disorder. Final dx (thusfar): TM and MS*. She seemed to have improved in general. 10/3/08 Reviewed hospital medical records of 5/9-5/14/2007. FINAL DX: transverse myelitis w/left sided weakness (neuro suggested Devic''s disease/neuromyelitis optica); back arching spasms; questionable seizure disorder Records reveal patient experienced left side weakness & paresthesias x 1 day. Neuro consult done & exam abnormal. Tx w/high dose steroids x 5 days w/o improvement. Transferred to higher level of care. 10/15/08-records received for DOS 5/14-5/17/08-DC DX:transverse myelitis. One week of progressive left-sided weakness and numbness. Left sided weakness.


VAERS ID: 288164 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Virgin Islands  
Vaccinated:2007-08-14
Onset:2007-08-15
   Days after vaccination:1
Submitted: 2007-08-15
   Days after onset:0
Entered: 2007-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0245U / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2157BA / 1 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B016BA / 6 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Abdominal pain, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none. PMH: none. LMP 3 weeks ago. NKDA.
Allergies:
Diagnostic Lab Data: Labs and Diagnsotics: Abdominal US showed a large (7-8cm) solid, heterogenic mass in the pelvis and mid-abdomen. CT abdomen (+) possible ovarian or mesentaric mass. (+) ascities. CBC with WBCs of 15.5 on admission. H&H dropped to 6.4 and 19.1 post-op requiring 2 units PRBCs. LFT''s: AST 66, ALT 26. ALP 157. Amylase 23. LDH 2078. BUN 34. glucose 160. UA (+) for protein of 100. Unsure of exact test. Mother told me sonogram and CT scan
CDC Split Type:

Write-up: mother called morning after vaccines. child c/o abdominal pain, nausea and vomiting. no fever. no diarrhea. no other symptoms. 09/04/2007 MR received for DOS 8/16-20/2007. Pt presented with 2 day hx of abdominal pain, nausea, vomiting. Upon PE a large protuberant mass was noted in her abdomen. (+) tenderness. Pt taken to OR for Exploratory Lap with L salpingo-oophorectomy for a hemorrhagic ovarian mass and necrosed Fallopian tube. Post-op course complicated by severe anemia. Transfused with 2 units PRBCs. Discharge DX: Left ovarian mass. Follow-up: This is follow up to form completed 8/15/07. Pnone call to mother today who state she took child to pediatrician for continued abdominal pain and vomiting. Received shot for symptoms. No relief. Went to ER and was admitted to hospital for "abdominal mass" according to mother from sonogram/CT scan.


VAERS ID: 288173 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2007-07-06
Onset:2007-07-11
   Days after vaccination:5
Submitted: 2007-08-15
   Days after onset:35
Entered: 2007-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. UNKNOWN / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Angioedema, Arthralgia, Blood bicarbonate, Blood chloride normal, Blood creatinine normal, Blood culture negative, Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein increased, Full blood count, Haematocrit normal, Liver function test normal, Pain, Platelet count normal, Red blood cell sedimentation rate normal, Serum sickness, Urine analysis normal, Urticaria, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: 1. recently completed course of keflex for parotitis (Mumps IgM titers were negative, amitriptyline 25 mg QHS (IBS symptoms), seasonale (OCP)
Current Illness: had already recovered from episode of parotitis
Preexisting Conditions: history of idiopathic chronic urticaria 8/16/07- PMH: 1st episode of urticaria at 18months of age and several subsequent episodes but less frequent. Mild hives 2003. Chronic sinus infections. Frequent pharyngitis and has had up to 4 rounds of antibiotics per year. Parotitis times 2 this summer with negative mumps, IgM titers and poisitve IgG titers. Usually her episodes of angioedema and urticaria are triggered by infection. 8/22/07-records received-PMH: Past history of this condition with her most recent reaction in 5/2003. The episodes usually occur after acute illness.Two episodes of parotitis in past six weeks. Irritable bowel syndrome
Allergies:
Diagnostic Lab Data: Labs from the above hospitalization included CBC (WBC 12.8, hct 39.7, plt 281), BMP (Na 138, K 3.9, Cl 108, HCO3 26, BUN 8, Cr 0.7), LFT''s(essentially normal), ESR 16, and CRP 7.9, and UA (normal). Blood cultures normal x 2. 8/16/07-records received-Labs essentially normal. ESR 16 and CRP 7.9, normal. 8/22/07-records received- WBC 12.8. Electrolytes were appropriate. Total protein low at 6.4. sed rate elevated at 16, CRP elevated at 7.9
CDC Split Type:

Write-up: developed serum sickness with arthralgias, urticaria, and angioedema of eyes and lips, high CRP during hospitalization (CRP = 7.9). Received Gardasil on 7/6/07, 5 days before her symptoms began. Hospitalization lasted 5 days for refractory pain from arthralgias. Did not have fever. Urticaria were refractory and lasted for several days after her hospitalization. Of potential confouding interest, she had also recently received keflex (finished a few days prior to when her symptoms began) 8/16/07-records received for DOS-8/9/07-clinic visit after hospitalization for uticaria, angioedema and pain secondary to arthralgias. 7/11/07-began having mild arthralgias in hands and feet followed by urticarial rash head to toe and angioedema of her eyes and lips. Sensation of throat swelling. Two days later after steroid treatment admitted to hospital with worsening arthralgias for pain control. Impression chronic idiopathic urticaria with angioedema. 8/22/07records received for DOS 7/13/07-7/17/07-DC DX: Allergic reaction. Episode 3 days ago of urticaria, extreme arthralgias accompanied by angioedema of face lip and tongue. Generalized itching was severe and generalized rash.


VAERS ID: 288215 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Virginia  
Vaccinated:2007-07-13
Onset:2007-07-13
   Days after vaccination:0
Submitted: 2007-08-10
   Days after onset:28
Entered: 2007-08-16
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1426F / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2277AA / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C268AA / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood test normal, Computerised tomogram normal, Fall, Head injury, Loss of consciousness, Tonic clonic movements
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Head CT scan normal, Blood test normal. Labs and Diagnostics: Head CT with no focal mass effect. Drug screen (-). CBC WNL. UA with 6-10 WBCs and (+) leukocyte esterase. UC (+) for mixed skin flora.
CDC Split Type:

Write-up: Patient fell to floor and hit her head, developed LOC and tonic-clonic movements of arms for about 30 secs and recovered with full orientation for a few minutes then fell again and had a second similar episode. She was taken to the hospital ER when she had a 3rd episode hours later. Recovered without any further problems. 8/28/2007 MR received for ER visit following fainting episode with questionable seizure activity. When pt fell at health dept pt hit head, but pain has resolved. Pt passed out x1 in the ED BR. Clinical Impression Syncope, Vasovagal. Heart Murmurs NOS.


VAERS ID: 288453 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2007-06-26
Onset:2007-07-09
   Days after vaccination:13
Submitted: 2007-08-17
   Days after onset:39
Entered: 2007-08-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 2 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Blindness unilateral, Multiple sclerosis
SMQs:, Glaucoma (broad), Optic nerve disorders (broad), Demyelination (narrow), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 18 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown Family HX: diabetes, both parents & others.
Allergies:
Diagnostic Lab Data: Unknown, LABS from pcp: CT of brain revealed multiple large lesions. Biopsy of right parietal lesion revealed demyelination w/o tumor. Brain MRI s/p tx revealed improvement. Full spine MRI was WNL. LABS from hospital: blood glucose elevated. MRI of neck & spine was WNL. MRI of head revealed multiple lesions one of which encroached the left optic nerve. EKG WNL. Brain biopsy.
CDC Split Type: WAES0708USA02045

Write-up: Information has been received from a physician concerning a 16 year old female who on 24-APR-2007 was vaccinated with the first dose of Gardasil (lot # 654510/0962F). On 24-APR-2007, the patient was vaccinated with the second dose of Gardasil (lot # 654702/0011U). The patient sought medical attention and was hospitalized on 09-JUL-2007 after experiencing blindness in her left eye. The patient was diagnosed with multiple sclerosis while hospitalized. The physician noted the blindness had been experienced for approximately 6-8 weeks prior to the hospitalization. At the time of reporting, the outcome was unspecified. Upon internal review, multiple sclerosis was considered to be an Other Important Medical Event. Additional information has been requested. 8/23/07 Received vax record from PCP but unable to read. Contacted PCP office & verbally gave 4/24 0962F & 6/26 00110. VAERS database updated w/same. Received medical records from PCP which included neuro consult which indicates patient experienced progressive visual loss in association w/demyelinating lesions c/w ADEM & was hospitalized 7/9-7/27/2007. Left eye vision disturbance began approx 6-8 weeks prior to admit then 2 days prior to admit had HA & increasing vision loss of both eyes. Consult to oncology & optho. Tx w/high-dose steroids, IVIG x5, plasmapheresis x5. Very little clinical improvement, remained completely blind in left eye & significantly impaired in right eye. FINAL DX: disseminated demyelination w/tumefactive lesion of right parietal region./ss 8/28/07 Received vax info w/readable lot #''s. Patient received 1st dose on 4/24/07 & 2nd dose on 6/26/06. VAERS database updated w/same. 9/4/07 Received hospital medical records which reveal patient experienced vision loss & HA. Admitted 7/9-7/27/07. Ophtho, heme/onc, neurosurgery consults done. Had routine optometry exam on 7/5 w/only mild increased in prescription. On 7/6 had awakened w/blurred vision of right eye & headache over left posterior head. On 7/7, burry vision worsened, progressed to left eye & HA worsened & localized bifrontally. Went to outlying ER. CT scan there revealed brain lesions & transferred to higher level of care. Exam revealed left pupil unreactive to light. Tx w/steroids, IVIG, plasmapheresis FINAL DX: Demyelinating cortical process.


VAERS ID: 288458 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-08-06
Onset:2007-08-06
   Days after vaccination:0
Submitted: 2007-08-17
   Days after onset:11
Entered: 2007-08-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0929U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Blood thyroid stimulating hormone normal, Diarrhoea, Full blood count normal, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OVCON
Current Illness:
Preexisting Conditions: Cholecystectomy
Allergies:
Diagnostic Lab Data: complete blood cell 08/07/07 normal; serum TSH 08/07/07 normal
CDC Split Type: WAES0708USA01429

Write-up: Information has been received from a registered nurse concerning a 19 year old female patient with a history of cholecystectomy (FEBRUARY 2005) and no allergies who on 06-AUG-2007, was vaccinated IM with a first 0.5ml dose of Gardasil (Lot # 658282/0929U). Concomitant therapy included ethinyl estradiol/norethidrone (OVCON). About 2 hours after receiving the vaccine, the patient experienced severe abdominal pain, nausea, vomiting and diarrhea. The patient stated that the area that hurts was about 2 inches from her belly button. The patient was prescribed atropine sulfate (+) diphenoxylate hydrochloride (LOMOTRIL) and promethazine hydrochloride (PHENERGAN). It was reported that the next day the patient called the office and her stomach pain had gotten worse. On a scale of 1 to 10 the patient felt her pain was a six. Laboratory diagnostic studies given on 07-AUG-2007 included a CBC and a thyroid study. Both were reported as normal. The patient no longer has diarrhea but was still experiencing nausea and vomiting. The outcome of severe abdominal pain was unknown. No product quality complaint was involved. Severe abdominal pain, nausea, vomiting and diarrhea were considered to be disabling. Additional information has been requested.


VAERS ID: 288761 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Virginia  
Vaccinated:2007-05-29
Onset:2007-05-29
   Days after vaccination:0
Submitted: 2007-08-22
   Days after onset:85
Entered: 2007-08-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Drug administered at inappropriate site, Incorrect dose administered, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol; antimicrobial (unspecified); YASMIN; phentermine hydrochloride 37.5 mL
Current Illness: Obesity; Hypersensitivity; Asthma
Preexisting Conditions: Headache
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0708USA01863

Write-up: Information has been received from a physician concerning a 24 year old female with obesity, hypersensitivity and asthma and a history of headaches who on 29-MAY-2007 was vaccinated in the left arm with a 65 ml confirmed dose of Gardasil. Concomitant therapy included albuterol, phentermine HCL, antimicrobial (unspecified) and Yasmin. On 29-MAY-2007 the needle accidentally hit a "vursar sac" in the patient''s left arm. Subsequently, the patient developed arm pain. The patient was going to physical therapy and is seeing an orthopedic doctor. At the time of the report the patient had not recovered. The reporting physician considered arm pain to be disabling. Additional information has been requested.


VAERS ID: 289290 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-08-14
Entered: 2007-08-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Appendicitis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707USA02026

Write-up: Information has been received from a physician''s assistant (PA), via a company representative, regarding a 17 year old female patient, who "months ago" was vaccinated with the first dose of Gardasil (Lot # not provided). The day following the vaccination, she developed appendicitis and was hospitalized (dates and duration not reported). At the time of this report, the patient was recovering from the event. Additional information has been requested.


VAERS ID: 289488 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Michigan  
Vaccinated:2007-04-10
Onset:2007-04-18
   Days after vaccination:8
Submitted: 2007-08-14
   Days after onset:118
Entered: 2007-08-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 3 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Antiphospholipid antibodies negative, Antithrombin III, Blood homocysteine normal, Blood test normal, Cardiolipin antibody negative, Coagulation factor V level normal, Coagulation factor decreased, Deep vein thrombosis, Immunology test normal, Protein C, Protein total normal, Prothrombin level normal, Skin discolouration, Subclavian vein thrombosis, Ultrasound Doppler, Venogram
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage laboratory terms (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? 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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