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Case Details (Sorted by Age)

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VAERS ID:487550 (history)  Vaccinated:2012-10-09
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-03-21
Location:Texas  Entered:2013-03-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Strabismus; Allergy: PCN, cephalosporins
Diagnostic Lab Data: Orthostatic BP - 73/50; Low vit D
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ2108 IN 
Administered by: Private     Purchased by: Private
Symptoms: Hypersomnia, Hypotension, Lethargy, Vitamin D decreased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad)
Write-up: Progressive lethargy - now sleeps approximately 14-16 hrs/day, worsens with greater activity. Also, hypotension.

VAERS ID:487741 (history)  Vaccinated:2009-03-04
Age:13.0  Onset:2009-07-27, Days after vaccination: 145
Gender:Female  Submitted:2013-03-25, Days after onset: 1337
Location:Ohio  Entered:2013-03-25
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The following information was obtained through follow-up and/or provided by the government. Family hx DM Type II.
Diagnostic Lab Data: The following information was obtained through follow-up and/or provided by the government. 5/7/2013 lab/diagnostic records received for DOS 7/20-22/2009. Blood: RBC 5.41 M/mcL (N), Hct 51% (H), Hgb 17.3 g/dL (H), glucose 495 mg/dL (H), Hgb A1c 13% (H), BUN 21 mg/dL (H). UA: hazy, spec grav 1.032 (H), ketone 40 (H), WBC 30-49 (H), RBC 50+ (H), glucose $g1000 (H), leukocyte esterase (+). Blood gases abnormal. Thyriod panel WNL.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS1297X0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0072Z0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2568AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURUF457CA0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Abdominal pain, Asthenia, Blood gases abnormal, Blood glucose increased, Blood urea increased, Dizziness, Dry mouth, Fatigue, Glucose urine present, Glycosylated haemoglobin increased, Haematocrit increased, Haemoglobin increased, Mucosal dryness, Nausea, Pancreatic disorder, Pollakiuria, Polydipsia, Polyuria, Red blood cell count normal, Red blood cells urine positive, Specific gravity urine increased, Temperature intolerance, Thirst, Thyroid function test normal, Type 1 diabetes mellitus, Urine abnormality, Urine ketone body present, Urine leukocyte esterase positive, Vomiting, Weight decreased, White blood cells urine positive
SMQs:, Acute renal failure (broad), Acute pancreatitis (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad)
Write-up: Patient was showing signs of weakness, vomiting, extremely thirsty, using bathroom a lot, after taking her to doctor her blood sugar was well over 600 therfore causing her to be sent straight to hospital where she wad diagnosed with pancreatic failure and is now insulin dependant. The following information was obtained through follow-up and/or provided by the government. 5/7/2013 hospital records received for DOS 7/20-22/2009. D/c Dx: new onset DM type I. Pt presented w/ 2 wk hx polyuria, polydipsia, fatigue, dizziness/lightheadedness on standing, cold intolerance; 2 day hx dry mouth; 1 day hx vomiting, nausea, abdominal pain; weight loss. PCP noted elevated glucose & (+) urine ketones, sent pt to ER. PE: dry mucous membranes, abnormal labs. Admitted. Tx''t: IVF, insulin initiation, diabetes education. Pt d/c''d home in good condition w/ Rx, care & f/u instructions.

VAERS ID:487757 (history)  Vaccinated:2013-03-20
Age:13.0  Onset:2013-03-21, Days after vaccination: 1
Gender:Female  Submitted:2013-03-25, Days after onset: 4
Location:Nebraska  Entered:2013-03-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1SYRAR
Administered by: Private     Purchased by: Other
Symptoms: Abdominal pain upper, Anxiety, Confusional state, Dizziness, Dyspnoea, Eye swelling, Fear, Feeling abnormal, Headache, Injection site pain, Mental impairment, Nausea, Pain, Pain in extremity, Somnolence
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Very confused, out of it, brain wasn''t working, couldn''t think, pain of injection site, eyes swollen, very bad headache, very dizzy, nausea 7 AM - trouble breathing, very difficult to breathe, very dizzy, very confused, brain fuzzy/not working right, shortness of breath, leg aching, bad stomach ache, body hurt. That lasted all day and into the next day. Very, very worried and scared patient!! Doctor on call said to take Zyrtec and 2 Benadryl and see if that helped. Patient was very sleepy but still had symptoms... got a bit better, then worse with confusion. Very confused at times. Still on 3-25 - still confused and brain not clear.

VAERS ID:488080 (history)  Vaccinated:2013-03-25
Age:13.0  Onset:2013-03-25, Days after vaccination: 0
Gender:Female  Submitted:2013-03-28, Days after onset: 3
Location:Nevada  Entered:2013-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0139771UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0172431UNLA
Administered by: Private     Purchased by: Public
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Skin rash on arms, back, abdomen and itching.

VAERS ID:488060 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-03-29
Location:Illinois  Entered:2013-03-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1303USA013573
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Nervous system disorder, Psychogenic seizure, Wheelchair user
SMQs:
Write-up: This spontaneous report was received from a physician via company representative refers to a 13 year old female patient. On an unknown date, the patient was vaccinated with a second dose of GARDASIL, (lot number, expiry date and route was not reported). On an unknown date, the patient developed pseudo-seizures (disability), other central nervous system issues (disability) and headache (disability) 2 weeks after receiving the second dose of GARDASIL. Due to these adverse events the patient had to use a wheel chair. The outcome of the reported events were not recovered. The patient sought medical attention (patient saw the physician). Additional information has been requested.

VAERS ID:488177 (history)  Vaccinated:2009-08-17
Age:13.0  Onset:2009-09-17, Days after vaccination: 31
Gender:Female  Submitted:2013-04-01, Days after onset: 1292
Location:Minnesota  Entered:2013-04-01
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Desmopressin
Current Illness: No
Preexisting Conditions: No! Perfectly healthy. The following information was obtained through follow-up and/or provided by the government. PMH: tonsillectomy, adenoidectomy. Allergy: PCN.
Diagnostic Lab Data: Patient was diagnosed with Myasthenia Gravis The following information was obtained through follow-up and/or provided by the government. 4/1/2013 lab/diagnostic records received for DOS 6/30-10/25/2010. Swallow study: weakened pharyngeal contraction, overflow aspiration particularly w/ thin liquids. MRI brain: inflammatory ethmoid sinus disease, otherwise WNL. Echo, lung bx WNL. CXR: opacity of RML & RLL, pneumothorax s/p chest tube removal. CT chest: pulmonary nodules. AChR binding Ab 74.7 nmol/L (H), AChR modulating Ab 95 nmol/L (H). Striated muscle Ab, allergen testing, mono, strep (-). 4/9/2013 lab/diagnostic records received for DOS 8/13-17/2011. Blood/urine cx (-). Central line cx (+) - most likely contaminant. Echo WNL. 4/9/2
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0216Y2IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Abdominal tenderness, Adjustment disorder, Antiacetylcholine receptor antibody positive, Anxiety, Aspiration, Asthenia, Atelectasis, Barium swallow abnormal, Biopsy lung, Biopsy lung normal, Blood culture negative, Bone density decreased, Candida test negative, Catheter culture positive, Central venous catheterisation, Chest X-ray abnormal, Chest pain, Chest tube insertion, Choking, Computerised tomogram thorax abnormal, Cough, Culture urine negative, Diarrhoea, Diplopia, Dysarthria, Dysphagia, Dysphonia, Dyspnoea, Echocardiogram normal, Enuresis, Erythema, Eye pain, Eye pruritus, Eyelid ptosis, Facial paresis, Fall, Fatigue, Headache, Herpes simplex serology negative, Hypoaesthesia oral, Hypotension, Immunoglobulin therapy, Migraine, Mononucleosis heterophile test negative, Muscle spasms, Myasthenia gravis, Nasal congestion, Nausea, Nuclear magnetic resonance imaging brain normal, Pain, Pain in extremity, Pain in jaw, Parasite cervical specimen test negative, Plasmapheresis, Pneumonia aspiration, Pneumothorax, Pulmonary mass, Retching, Sensation of foreign body, Sensation of heaviness, Sinusitis, Skin test negative, Speech disorder, Streptococcus test negative, Temperature intolerance, Thymectomy, Ultrasound scan normal, Visual impairment, Vomiting, Weight decreased
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Osteoporosis/osteopenia (narrow), Periorbital and eyelid disorders (narrow), Osteonecrosis (broad), Ocular motility disorders (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow)
Write-up: Began having swallowing issues, talking issues, weakness, breathing problems, droopy eyelid. The symptoms started out with her feeling tired and weak not long after the shot. By April and may she started having difficulties with swallowing and she started to fall down. I began calling doctors in may and struggled to get appointments with specialists. A pediatric neurologist didn''t diagnose anything. It was a neurologist who ordered more testing. He sent her to the facility on July 14, 2010. Patient was diagnosed with Myasthenia Gravis at the age of 14. The following information was obtained through follow-up and/or provided by the government. 4/1/2013 neuro consultant records received for DOS 6/30-7/14/2010. Impression: dysphagia w/ dysarthria w/o clear cause. Pt c/o 2 wk hx difficulty swallowing, mouth/tongue numbness, voice changes. Symptoms worse in evenings. Sinus infection tx''d w/ ABX 2 wks prior to symptom onset. Foods feel stuck in throat, liquids feel like they will come out nose. Pt also c/o leg weakness & pain, falling, charley horses. PE unremarkable. Sent for MRI, blood work, speech eval, EMG of legs. Condition worsened, pt aspirating on liquids (even thickened), barely able to speak, coughing & choking on saliva, increased fatigue & legs giving out, eyelids heavy. Sent for hospital admission. 4/1/2013 pedi neuro consultant records received for DOS 8/27/2010. Impression: generalized Myasthenia Gravis, stable. Pt w/ hx as above, c/o double vision, weakness (especially on rt), neck weakness, difficulty swallowing. PE: thin, weak voice, vague abdominal tenderness, some ptosis, weak facial movements, neck weakness. Pt also c/o chest pain s/p surgery - resolving. Tx''t: steroids, Mestinon adjustment. Given care & f/u instructions. 4/9/2013 PCP records received for DOS 9/17/2009-1/10/2013. Assessments: 1) headaches; 2) Myasthenia gravis. Pt followed w/ c/o nausea, vomiting, diarrhea, dry heaves, weight loss, abdominal pain, body aches, fatigue, jaw pain, nasal congestion, itchy eyes, eye pain, vision changes, chest pain, SOB, muscular weakness, migraines, heat/cold intolerance, anxiety. Symptoms treated. Aspiration pneumonia several times. Chest tubes multiple times for pneumothorax. 4/9/2013 hospital records received for DOS 7/14-19/2010, 7/31-8/10/2010. D/c Dx''s: 1) Myasthenia gravis; 2) atelectasis; 3) incidental bilateral noncalcified nodules on CT; 4) recent weight loss & at risk for malnutrition; 5) nocturnal enuresis; 6) adjustment disorder w/ anxiety. Pt hospitalized for IVIG Tx''t. C/o worsening weakness. PE: fatigability OU, ptosis w/ sustained upgaze, proximal muscle weakness, facial weakness. Tx''t: central line. Plasmapheresis not tolerated. Mestinon dose adjusted. Lung nodules noted. Abdominal pain when pt anxious. Pt d/c''d home w/ Rx''s, care, & f/u instructions. 4/9/2013 hospital records received for DOS 8/19-24/2010. D/c Dx: Myasthenia gravis. Pt unresponsive to conventional medical therapy. Tx''t: thoracoscopic thymectomy w/ lt upper lobe wedge bx, chest tube, ABX. Developed pneumothorax. Condition improved, pt d/c''d home w/ care & f/u instructions. 4/9/2013 hospital records received for DOS 6/3-12/2011, 7/18-31/2011. D/c Dx: Myasthenia exacerbation. Pt admitted multiple times for MG exacerbations. Tx''t: central line, plasmapheresis, Rituximab infusions. HOTN, pain, & fatigue during plasmapheresis. Headaches s/p plasmapheresis. D/c''d home w/ care & f/u instructions. 4/9/2013 hospital records received for DOS 8/13-17/2011, 8/27-29/2012. D/c Dx: Myasthenia exacerbation. Pt c/o pain & redness to central line site, increased weakness & difficulty chewing/swallowing, difficulty speaking, frequent coughing/gagging while eating, difficulty smiling. Symptoms typically improve over course of day. CXR concerning for lt side infiltrate. Tx''t: ABX, Rituximab. Returned c/o acute onset MG symptoms. MG well controlled w/ home Rxs, IVIG every other wk, Rituximab 4x/yr. Tx''t: ABX, IVIG. D/c''d home in stable condition w/ care & f/u instructions.

VAERS ID:488204 (history)  Vaccinated:2013-03-19
Age:13.0  Onset:2013-03-19, Days after vaccination: 0
Gender:Female  Submitted:2013-04-01, Days after onset: 13
Location:Michigan  Entered:2013-04-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1303USA011135
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Crying, Dizziness, Feeling abnormal, Headache, Immediate post-injection reaction, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a consumer refers to her daughter, a 13 year old female. The medical history, drug reaction and allergies were reported as none. On 19-MAR-2013, the patient received "her first and last'' standard dose of GARDASIL, via intramuscular. On 19-MAR-2013, immediately after vaccination the patient developed headache. This reaction was followed by nausea, vomiting, lightheadedness, severe stomach ache, until she was in tears. The patient also developed fever. The reporter explained that the patient developed these symptoms after being hit in the arm where she had received the vaccine. The patient told that the impact on her arm was the "strangest feeling that she''d ever felt". Therapy with GARDASIL was discontinued. No laboratory test was performed. No treatment was given for the adverse event. The patient sought unspecified medical attention. The outcome of limb discomfort, headache, stomach ache, lightheadedness, nausea, vomiting, limb injury and crying were unknown. Additional information has been requested.

VAERS ID:488405 (history)  Vaccinated:2012-10-29
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-04-03
Location:Florida  Entered:2013-04-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1304USA000623
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0101AE1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report was received from a registered nurse concerning a 13 year old female patient. Weight of the patient was reported as 104 (units unspecified). As reported as 64 inches. On 29-OCT-2012, at 14:57:25, the patient was vaccinated with dose 2 of improperly stored (that was exposed to 31 Fahrenheit for up to 68 hours) GARDASIL (lot number and expiry date reported as 672721/0101AE and 10-OCT-2014 respectively), intramuscularly in the left arm at a private doctor office or hospital with the private funds. No concomitant medications were reported. No adverse effects were reported. A signed informed consent form was obtained in which the parent of the patient had signed. This is one of two reports from the same source. Additional information is not expected.

VAERS ID:488563 (history)  Vaccinated:2012-08-01
Age:13.0  Onset:0000-00-00
Gender:Male  Submitted:2013-04-05
Location:Unknown  Entered:2013-04-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1304USA002262
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report was received from a mother refers to her 13 year old son (who is also the patient). On an unknown date in JUN-2012, the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported). On an unknown date in AUG-2012, the patient was vaccinated with secod dose of GARDASIL, (lot number, expiry date and route was not reported). The patient was yet to receive the third dose of the vaccine and it was well beyond the time frame for dosing listed in the Pl and no side effects was reported. This is one of the two reports received from the same reporter. Additional information is not expected.

VAERS ID:488582 (history)  Vaccinated:2013-04-01
Age:13.0  Onset:2013-04-03, Days after vaccination: 2
Gender:Female  Submitted:2013-04-04, Days after onset: 1
Location:Massachusetts  Entered:2013-04-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0200021IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives on upper torso and neck on 4-3-13. BENADRYL given, good effect noted by mother.

VAERS ID:488772 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Male  Submitted:0000-00-00
Location:Ohio  Entered:2013-04-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H020022SYRLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site haemorrhage, No adverse event
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: While injecting, I noted bright red blood in hole - I removed the needle syringe, pushed the sm amt blood out, used a new needle and re-injected at a different (L) deltoid site. There were no apparent adverse effects.

VAERS ID:488802 (history)  Vaccinated:2013-04-08
Age:13.0  Onset:2013-04-08, Days after vaccination: 0
Gender:Female  Submitted:2013-04-09, Days after onset: 1
Location:Kansas  Entered:2013-04-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4285AA0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4347AA0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0167581UNRA
Administered by: Public     Purchased by: Public
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Rec''d vaccinations at approx 9-10 a.m. Started breaking out in hives over chest area and back and legs at 500 p.m. Went to ER and rec''d BENADRYL I.V.

VAERS ID:488932 (history)  Vaccinated:2013-04-10
Age:13.0  Onset:2013-04-10, Days after vaccination: 0
Gender:Male  Submitted:2013-04-10, Days after onset: 0
Location:California  Entered:2013-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0155552IMLA
Administered by: Public     Purchased by: Military
Symptoms: Presyncope
SMQs:, Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient was given PPD and HPV Immunization and had vasovagal reaction 10 mins later. Patient got up on his own and was sent to ED for further evaluation.

VAERS ID:489038 (history)  Vaccinated:2011-06-17
Age:13.0  Onset:2011-06-17, Days after vaccination: 0
Gender:Female  Submitted:2013-04-11, Days after onset: 664
Location:California  Entered:2013-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1304USA002538
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0477AA0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This spontaneous report as received from a certified medical assistant refers to a 13 year old female patient with no medical history or drug reactions/allergies reported. On 17-JUN-2011 the patient was vaccinated with the first dose of GARDASIL (lot # 668819/0477AA, exp 29-JUN-2013), intramuscularly. After receiving the first dose of GARDASIL, on 17-JUN-2011, the patient fainted and developed a seizure. Oxygen was given to the patient. No lab diagnostics studies were performed. Patient''s outcome was reported as recovered on 17-JUN-2011. The patient sought medical attention, the physician saw the patient. Upon internal review, seizure was considered as other medically important event. This is 2 of 4 cases reported. Additional information has been requested.

VAERS ID:489276 (history)  Vaccinated:2009-05-13
Age:13.0  Onset:2013-04-08, Days after vaccination: 1426
Gender:Female  Submitted:2013-04-12, Days after onset: 4
Location:Massachusetts  Entered:2013-04-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CONCERTA 36 mg; YAZ 0.02 mg tablets
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Unk
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 1SCUN
Administered by: Private     Purchased by: Other
Symptoms: Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Pt at present time on exchange program. Fever occurred 2 weeks before eruption of rash.

VAERS ID:489422 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-04-16
Location:Unknown  Entered:2013-04-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1304USA006502
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.    
Administered by: Other     Purchased by: Other
Symptoms: Varicella
SMQs:
Write-up: This spontaneous report as received from a health care worker and follow up information received from a licensed practitioner nurse refers to a 13 year old female patient. On an unknown date the patient was vaccinated with a dose of (Merck) VARIVAX (lot#, dose and route was not reported). On an unknown date following vaccination of (Merck) VARIVAX the patient developed around 30 chicken pocks. And the patient was not pregnant. It was not known if the patient sought medical attention. The outcome of event was reported as not recovered/not resolved. Additional information is not expected.

VAERS ID:489460 (history)  Vaccinated:2013-04-09
Age:13.0  Onset:2013-04-10, Days after vaccination: 1
Gender:Female  Submitted:2013-04-16, Days after onset: 6
Location:Nevada  Entered:2013-04-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0139771UNLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Headache, Hot flush, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Headaches, nausea, dizziness, and hot flashes in her body.

VAERS ID:489791 (history)  Vaccinated:2013-04-01
Age:13.0  Onset:2013-04-06, Days after vaccination: 5
Gender:Female  Submitted:2013-04-22, Days after onset: 16
Location:California  Entered:2013-04-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Permethrin
Current Illness: ??Scabies
Preexisting Conditions: No
Diagnostic Lab Data: 4/13/13: samples of right wrist, left hip, suprapubic area vaccinia positive by DFA. 4/15/13: samples (right wrist and left hip) PCR positive for Non-Variola Orthopox
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A IDUN
Administered by: Military     Purchased by: Military
Symptoms: Immunology test abnormal, Infection transmission via personal contact, Polymerase chain reaction, Rash papular, Viral test positive
SMQs:, Hypersensitivity (broad)
Write-up: Contact transmission. 21yo female who had intimate contact with a person, primary vaccinee on 4/1/13 (vaccination date 3/18/13). According to the pt there was no dressing on the "scabbed lesion". According to the patient the lesion was covered with a band-aid. On 4/2/13 the pt applied the other person''s Permethrin cream to her body for self diagnosed scabies (the primary vaccinee was treated for scabies on March 19, 2013). On 4/6/13 the pt noted a papular lesion one her right wrist; on 4/7/13 she noted a lesion on her left hip and on 4/9/13 she noted a lesions in her right groin and several (about 10 lesions) in her suprapubic area. On 4/9/13 she went to the ER and the physician notified the CDC of the possibility of a contact transmission. On 4/11/13 the pt noted 4 lesions on her gluteal cleft. The pt was treated with VIG at ER on 4/14/13. Lesions from the right wrist, left hip and suprapubic area were positive for vaccinia by DFA and PCR.

VAERS ID:489788 (history)  Vaccinated:2013-01-08
Age:13.0  Onset:2013-01-09, Days after vaccination: 1
Gender:Female  Submitted:2013-04-23, Days after onset: 103
Location:South Dakota  Entered:2013-04-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Novalog, Lantus
Current Illness: No
Preexisting Conditions: Good health but Type 1 Diabetes.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC. 1IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0SYRRA
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  SYR 
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal discomfort
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Injection site started out with a bean size red mark and grew to a grapefruit size swelling mark with pain and joint discomfort.

VAERS ID:489853 (history)  Vaccinated:2013-04-12
Age:13.0  Onset:2013-04-12, Days after vaccination: 0
Gender:Female  Submitted:2013-04-23, Days after onset: 11
Location:Unknown  Entered:2013-04-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1304USA008068
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect dose administered
SMQs:
Write-up: This spontaneous report as received from a nurse refers to a 13 year old female patient. On 12-APR-2013 the patient should have received the second dose GARDASIL (dosing information and route were not provided). However the patient was inadvertently administered two doses of GARDASIL on the same day (12-APR-2013). The outcome of patient was inadvertently administered two doses of GARDASIL on the same day is unknown. Additional information has been assistant.

VAERS ID:489962 (history)  Vaccinated:2013-02-25
Age:13.0  Onset:2013-03-05, Days after vaccination: 8
Gender:Female  Submitted:2013-04-24, Days after onset: 49
Location:California  Entered:2013-04-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acetaminophen
Current Illness: Tonsillar concretions
Preexisting Conditions:
Diagnostic Lab Data: All labwork including CBC, ESR and rheumatological testing was negative.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0190881IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Abdominal pain, Arthralgia, Asthenia, Fatigue, Full blood count normal, Joint swelling, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Swelling
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: 1 month of symptoms starting 10 days after her 2nd HPV vaccine Gardisal (1st HPV on 2/24/12, 2nd 2/25/13) multiple joint pain, intermittent migratory joint pain and abdominal pain, weakness and fatigue lasting about a month. 10 days after vaccine ago woke up in the night with bilateral knee pain with mild swelling; over the next few days had bilateral ankle and wrist pain. The joint pain seemed to migrate to different areas, moving around every 5-10 minutes, no more than 1 hour in one particular joint. The swelling was present over the wrist / ankles / knees, resolved in around 2 weeks. The pain seems to persist however until 1 month. Cold water tends to help the pains. Upon waking the morning she has no pain or no stiffness. She has been waking up in the middle of the night with pain, but less so this week than last week. Chest, back, abdominal pain present 5 days after the joint pains. Each pain was brief in duration. Chest pain is resolved. Abdominal pain is bilateral periumbilical, but improved. No diarrhea / vomiting / blood in stool.

VAERS ID:490068 (history)  Vaccinated:2013-04-15
Age:13.0  Onset:2013-04-15, Days after vaccination: 0
Gender:Male  Submitted:2013-04-25, Days after onset: 10
Location:Georga  Entered:2013-04-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Claritin
Current Illness: None
Preexisting Conditions: Latex, shellfish, Penicillin
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0216080IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Asthenia, Balance disorder, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Dizziness, nausea, weak, wobbly.

VAERS ID:490088 (history)  Vaccinated:2012-01-01
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-04-25
Location:New Jersey  Entered:2013-04-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1304USA009612
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incomplete course of vaccination
SMQs:
Write-up: This spontaneous report was received form a consumer concerning her 13 year old daughter. Approximately on an unknown date in October 2011 (reported as October or November 2011), the patient was vaccinated with the first dose of 0.5 milliliter (ml) (reported as standard dose) of GARDASIL (lot number and expiry date unspecified), intramuscularly. Approximately on an unknown date in January 2012, the patient was vaccinated with the second dose of 0.5 ml (reported as standard dose) of GARDASIL (lot number and expiry date unspecified), intramuscularly. The patient did not receive her third dose of GARDASIL. No concomitant medications were reported. This is one of the two reports from the same source. Additional information has been requested.

VAERS ID:490118 (history)  Vaccinated:2012-09-19
Age:13.0  Onset:2012-09-20, Days after vaccination: 1
Gender:Female  Submitted:2013-04-26, Days after onset: 218
Location:Unknown  Entered:2013-04-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1304USA015152
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Diarrhoea
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This spontaneous report as received from a medical assistant via a field representative refers to a 13 year old female patient with no drug reactions or allergies, the medical assistant''s daughter. On 19-SEP-2012, 14-NOV-2012 and 21-MAR-2013, the patient was vaccinated with the three doses of GARDASIL because patient''s mother wanted her to have it, respectively. It was reported that the patient experienced stomach cramps and diarrhea within 24 hours of receiving each GARDASIL dose. The patient did not seek medical attention. No treatment was given for the events. No lab diagnostics studies were performed. The representative reported that the adverse events experienced lasted 24 hours. The outcome of diarrhea and stomach cramps was reported as recovered. Additional information has been requested.

VAERS ID:490254 (history)  Vaccinated:2013-04-26
Age:13.0  Onset:2013-04-26, Days after vaccination: 0
Gender:Female  Submitted:2013-04-26, Days after onset: 0
Location:Pennsylvania  Entered:2013-04-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data: BP down 85/54, 90/55, blood glucose 103 in office, Hgb 11.5 in office.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0101AE0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3974AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood glucose normal, Blood pressure decreased, Dizziness, Haemoglobin normal, Pallor, Unresponsive to stimuli, Visual impairment
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: After pt received Tdap and GARDASIL today, pt became lightheaded (about 5 min after vaccines were given). Pt was helped to the floor by RN and pt''s mother. Pt was pale, pt c/o vision closing in on her LOC?. Pt''s eyes remained open however did not respond to questions for less than 1 min, pt began to feel better was observed in office after 5-10 min pt walked out with mother.

VAERS ID:490216 (history)  Vaccinated:2013-04-02
Age:13.0  Onset:2013-04-03, Days after vaccination: 1
Gender:Male  Submitted:2013-04-19, Days after onset: 16
Location:Colorado  Entered:2013-04-29, Days after submission: 10
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen during prior week
Current Illness: Mild cough; Runny nose one week The following information was obtained through follow-up and/or provided by the government. 2-3 wks of URI symptoms (cough, congestion, fatigue). Self medicated w/ OTC cold medicine.
Preexisting Conditions: Constipation; Microcytosis The following information was obtained through follow-up and/or provided by the government. PMH: peri-oral dermatitis.
Diagnostic Lab Data: Also had evidence of mycoplasma infection/ibuprofen use The following information was obtained through follow-up and/or provided by the government. 5/15 & 17/2013 lab/diagnostic records received for DOS 4/5-13/2013. HSV PCR (-). Blood: WBC 14.7 K/mm3 (H), segs 71% (H), bands 6% (H), lymphs 6% (L), monos 16% (H), RBC 5.7 M/mm3 (H), Hct 46.1% (H), Na 134 mEq/L (L), ESR 15 mm/hr (H), CRP 2.3 mg/dL (H).
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0146450IMLA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain, Band neutrophil percentage increased, Blood sodium decreased, Breath odour, C-reactive protein increased, Chapped lips, Conjunctival hyperaemia, Decreased appetite, Dysphagia, Dysuria, Eye discharge, Gastrointestinal tube insertion, Haematocrit increased, Herpes simplex serology negative, Leukoplakia oral, Lip swelling, Lymphadenopathy, Lymphocyte percentage decreased, Monocyte percentage increased, Mycoplasma infection, Nausea, Neutrophil percentage increased, Ocular hyperaemia, Oral mucosal exfoliation, Oral pain, Oropharyngeal pain, Red blood cell count increased, Red blood cell sedimentation rate increased, Stevens-Johnson syndrome, Swelling face, Thrombophlebitis, Upper respiratory tract infection, Urethral disorder, Vision blurred, Vitreous floaters, Vomiting, Weight decreased, White blood cell count increased
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Haematopoietic leukopenia (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal premalignant disorders (narrow), Oropharyngeal neoplasms (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (narrow), Conjunctival disorders (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow)
Write-up: Stevens Johnson syndrome; onset one day after HPV vaccine dose #1. The following information was obtained through follow-up and/or provided by the government. 5/15 & 17/2013 hospital records received for DOS 4/5-13/2013. D/c Dx''s: 1) Stevens Johnson Syndrome; 2) URI. Pt c/o nausea, abdominal pain, emesis starting the day after vaccination. Progressed to lip swelling, white spots in mouth, sore throat, difficulty swallowing, lt facial swelling, swollen lymph nodes, blurred vision, floaters in field of vision, eyes red w/ crusty yellow discharge, burning w/ urination, unable to open mouth, decreased appetite, weight loss. PE: facial & lip edema, conjunctival injection, yellow discharge OU, lips swollen & cracked, white plaque tongue, halitosis, submandibular & anterior cervical adenopathy, periurethral erythema, unable to fully open mouth due to pain, superficial thrombophlebitis LUE. Admitted. Tx''t: antiviral, IVF, ABX, eye gtts, oral care, NG tube w/ continuous feeds. Condition improved, pt able to take PO intake. Question if NSAIDS contributed to SJS. Pt d/c''d home in good condition w/ Rx, care & f/u instructions. Referral to allergist.

VAERS ID:490228 (history)  Vaccinated:2013-01-11
Age:13.0  Onset:2013-01-18, Days after vaccination: 7
Gender:Female  Submitted:2013-04-11, Days after onset: 82
Location:New Mexico  Entered:2013-04-29, Days after submission: 18
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Eczema
Diagnostic Lab Data: (-) Varicella; (-) bronchitis; (-) zoster; abnormal creatinine 3.0 (+); (+) Stevens Johnson Syndrome; (+) Mycoplasma
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4482AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Abdominal pain upper, Blood creatinine increased, Chest X-ray normal, Dysphagia, Eye discharge, Eye pain, Intensive care, Mycoplasma test positive, Oral disorder, Skin lesion, Stevens-Johnson syndrome, Swelling, Varicella virus test negative
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad)
Write-up: 1/18/2013: stomach ache, eye pain, lesions on left arm, lesions in mouth. 1/20/13: eye drainage, swelling. 01/21/13 taken to ER given Rx Acyclovir, Z-pak; 01/22/13 condition worsened unable to swallow, taken to Hospital ER. Admitted to PICU. Hospitalized for 15 days (11 ICU; 4 ward). PICC line, IV TPN. Dx: Stevens Johnson Syndrome.

VAERS ID:490377 (history)  Vaccinated:2013-04-29
Age:13.0  Onset:2013-04-29, Days after vaccination: 0
Gender:Female  Submitted:2013-04-30, Days after onset: 1
Location:Vermont  Entered:2013-04-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4034AA IMRA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Pallor, Posture abnormal
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient became pale after receiving shot. She stood up and pitched forward and was caught by her dad and lower to the floor. She was responsive. Her pulse was strong and steady. After 10 minutes we helped her to the chair where she sat for another 5 minutes then said she was feeling woozy again so we laid her on the floor for another 20 minutes. After sitting for about 5 min she was ready to leave. I cautioned dad to hold on to her as they exited. He refused a call to 911.

VAERS ID:490614 (history)  Vaccinated:2013-04-25
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-05-01
Location:Unknown  Entered:2013-05-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1304USA016288
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.H019104 IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0200021UNRA
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: This spontaneous report as received from a medical assistant refers to a currently 13 year old female patient with no pertinent history, or drug reactions or allergies reported. On an unknown date when the patient was 9 years old, was vaccinated with GARDASIL (lot number and expiration date not specified) (dose, route and anatomical location not specified). No other suspect therapies or concomitant medications were reported. The medical assistant reported that the patient returned on 25-APR-2013 (reported as "today") to receive her second dose of GARDASIL. The patient is now 13 years old. Additional information has been requested.

VAERS ID:490752 (history)  Vaccinated:2013-04-26
Age:13.0  Onset:2013-04-28, Days after vaccination: 2
Gender:Male  Submitted:2013-04-29, Days after onset: 1
Location:New York  Entered:2013-05-03, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX120241IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site swelling, Injection site warmth, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Large local reaction at injection site warm and swollen shoulder to elbow.

VAERS ID:490819 (history)  Vaccinated:2013-05-03
Age:13.0  Onset:2013-05-03, Days after vaccination: 0
Gender:Male  Submitted:2013-05-03, Days after onset: 0
Location:North Carolina  Entered:2013-05-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: WCC but had cold and not feeling well
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.H0191040IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4418AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0184600SCLA
Administered by: Private     Purchased by: Private
Symptoms: Pallor, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: 5 minutes after vaccines pt standing and became pale and fainted. Vomited x 2. Patient laid down elevated feet drank 8 oz carbonated soda. Waited 20 minutes Dr checked pulse which was normal.

VAERS ID:490934 (history)  Vaccinated:2013-05-02
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-05-06
Location:Illinois  Entered:2013-05-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0155550IMLA
Administered by: Unknown     Purchased by: Public
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Patient came to clinic 2 days after administration of vaccine with complaint of redness, swelling warm sensation and tender. Patient was prescribed KEFLEX to take 1 capsule (500 mg) by mouth every 8 hours for 7 days.

VAERS ID:491003 (history)  Vaccinated:2013-02-14
Age:13.0  Onset:2013-02-14, Days after vaccination: 0
Gender:Male  Submitted:2013-05-06, Days after onset: 80
Location:Michigan  Entered:2013-05-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA001550
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0209100IMUN
Administered by: Other     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: This spontaneous report was received from a physician via a company representative concerning a 13 year old male patient who on 14-FEB-2013 was vaccinated with the first dose of GARDASIL lot # H020910 expiration date 18-JUN-2015. No other co-suspect or concomitant medications were reported. The physician reported that on 14-FEB-2013, the patient broke out in hives after receiving his first dose of GARDASIL. The patient was given BENDARYL as treatment for the event. On an unknown date, the patient had recovered from the event and the physician stated that he would not be completing the series of GARDASIL. Additional information is not expected.

VAERS ID:491230 (history)  Vaccinated:2013-04-30
Age:13.0  Onset:2013-04-30, Days after vaccination: 0
Gender:Male  Submitted:2013-05-08, Days after onset: 8
Location:Unknown  Entered:2013-05-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA002232
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H016057 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site reaction, Injection site swelling, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report as received from a medical assistant refers to a 13 year old male patient. On 30-APR-2013 the patient was vaccinated with VARIVAX (Merck) (lot # h016057, expiration date 30-APR-2013), 0.5 ml, via intramuscular (anatomical location unknown). On 30-APR-2013, the patient developed numbness, tingling, redness and swelling with no induration at the injection site. The patient sought medical attention (office visit) and no treatment was given at this time. The outcome of numbness, swelling, redness and tingling was reported as not recovered/not resolved. Additional information has been assistant.

VAERS ID:491231 (history)  Vaccinated:2013-04-12
Age:13.0  Onset:2013-04-19, Days after vaccination: 7
Gender:Male  Submitted:2013-05-08, Days after onset: 19
Location:Wisconsin  Entered:2013-05-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA002906
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Lymphadenopathy
SMQs:
Write-up: Information has been received from a consumer to report an adverse event on behalf of her 13 year old male son. No drug reactions/allergies were reported. No pertinent medical history was reported. On 12-APR-2013 the patient was vaccinated with a dose of GARDASIL (route of administration, lot and dose # not reported). No concomitant medications were reported. About one week after receiving GARDASIL (19-APR-2013), the patient suffered from right supraclavicular lymphadenopathy. Patient did seek medical attention from the physician and was treated for this adverse event. He was recovering. Additional information is not expected.

VAERS ID:491379 (history)  Vaccinated:2013-05-06
Age:13.0  Onset:2013-05-09, Days after vaccination: 3
Gender:Female  Submitted:2013-05-10, Days after onset: 1
Location:Tennessee  Entered:2013-05-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: High Fever~DTaP (no brand name)~1~0.25~Patient|High Fever~DTaP (no brand name)~2~0.50~Patient|High Fever~DTaP (no brand name)~3~
Other Medications:
Current Illness: None
Preexisting Conditions: Allergy to pertussis
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB542AA IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H016238 IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4273AA IMLA
TD: TETANUS DIPHTHERIA (TENIVAC)SANOFI PASTEUR43696CA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H016738 SCRA
Administered by: Public     Purchased by: Public
Symptoms: Blister, Swelling face
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Child awoke with swollen face and vesicles on hands. Mother treated with Benadryl.

VAERS ID:491613 (history)  Vaccinated:2013-05-13
Age:13.0  Onset:2013-05-13, Days after vaccination: 0
Gender:Male  Submitted:2013-05-14, Days after onset: 1
Location:Florida  Entered:2013-05-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0420AE0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Patient mother called pcp last night to inform that he developed a high fever 105F less than 1 hr. after LD shot.

VAERS ID:491756 (history)  Vaccinated:2013-05-06
Age:13.0  Onset:2013-05-07, Days after vaccination: 1
Gender:Male  Submitted:2013-05-16, Days after onset: 9
Location:Unknown  Entered:2013-05-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA005458
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Tic
SMQs:, Dyskinesia (broad), Dystonia (broad)
Write-up: A spontaneous report was received from a company representative who learned of this information from a physician regarding a male consumer who on 07MAY2013 reportedly suffered symptoms of TIC disorder after the administration of GARDASIL injection on 06MAY2013. Legal issue involved AE sent to legal. The patient''s current status was reported as recovering. No further AE information was provided.

VAERS ID:491904 (history)  Vaccinated:2013-05-14
Age:13.0  Onset:2013-05-16, Days after vaccination: 2
Gender:Male  Submitted:2013-05-17, Days after onset: 1
Location:Oregon  Entered:2013-05-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ritilan
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: My require antibiotics for cellulitis that maybe developing.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB690BA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0218610IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0187911SCRA
Administered by: Unknown     Purchased by: Public
Symptoms: Erythema, Injection site pruritus, Skin warm, Somnolence
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (broad)
Write-up: 7mm Raised, red, very warm to the touch, injection site that itches, increased sleepiness.

VAERS ID:492012 (history)  Vaccinated:2013-05-14
Age:13.0  Onset:2013-05-15, Days after vaccination: 1
Gender:Male  Submitted:2013-05-17, Days after onset: 2
Location:Pennsylvania  Entered:2013-05-20, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Pt is on PEN VK; ROCEPHIN
Current Illness: Pharyngitis; Spherocytosis The following information was obtained through follow-up and/or provided by the government. C/o headache, sore throat, abdominal pain since 5/11.
Preexisting Conditions: NKDA; Hereditary spherocytosis; Laparoscopic splenectomy and cholecystectomy The following information was obtained through follow-up and/or provided by the government. PMH: hereditary spherocytosis, cholecystectomy, splenectomy. Non compliant w/ daily PCN.
Diagnostic Lab Data: 40K WBC (had fever and sore throat prior strep (-)) The following information was obtained through follow-up and/or provided by the government. 6/19/2013 lab/diagnostic records received for DOS 5/14-20/2013. Rapid strep, mono, flu A/B, blood cx (-). UA: ketones 10 (H). CXR WNL. Blood: WBC 41 K/uL (H) w/ lt shift, segs 49% (L), bands 9% (H), lymphs 17% (L), monos 14% (H) Plt 496 K/uL (H), ESR 11 mm/hr (H), CRP 23.73 mg/dL (H). US LUE: extensive subq edema & hyperemia c/w cellulitis w/o evidence of abscess.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1561AA2IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4097AA1IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0157494IMLA
Administered by: Private     Purchased by: Public
Symptoms: Abdominal pain, Band neutrophil percentage increased, Blood culture, Blood culture negative, C-reactive protein increased, Chest X-ray normal, Chills, Headache, Hypophagia, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Injection site erythema, Injection site induration, Leukocytosis, Local reaction, Lymphocyte percentage decreased, Malaise, Monocyte percentage increased, Mononucleosis heterophile test negative, Neutrophil percentage decreased, Platelet count increased, Pyrexia, Red blood cell sedimentation rate increased, Shift to the left, Streptococcus test, Streptococcus test negative, Tachycardia, Ultrasound scan abnormal, Urine ketone body present, Vaccination complication, Vaccination site pain, Vaccination site swelling, Viral infection, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Fever/erythema and induration (L) deltoid. Blood culture sent/WBC 40K/ROCEPHIN. The following information was obtained through follow-up and/or provided by the government. 6/19/2013 hematology/oncology records received for DOS 5/20/2013. Assessment: 1) significant localized reaction to vaccination in left upper arm which is improving; 2) leukocytosis improving. Pt seen in f/u to hospitalization for fever, erythema & swelling LUE s/p vaccinations. Some swelling noted to RUE vaccination site. Pt c/o intermittent abdominal pain lasting up to 5 min. PE: LUE 8x5 erythematous/firm/mildy tender area. Significant improvement from hospitalization. Given care & f/u instructions. 6/19 & 8/13/2013 hospital records received for DOS 5/16-17/2013. D/c Dx''s: 1) vaccine reaction; 2) viral illness. Pt c/o fevers, chills, arm pain/swelling/redness, malaise, decreased oral intake, headache. Seen in ER 5/15, given ABX, sent home. Condition worsened, returned to ER. PE: fever (39.7 C), swelling/tenderness LUE, tachycardia. Tx''t: ABX, antipyretic. Swelling decreased. Pt d/c''d home w/ Rx, care, & f/u instructions.

VAERS ID:492085 (history)  Vaccinated:2013-05-07
Age:13.0  Onset:2013-05-08, Days after vaccination: 1
Gender:Male  Submitted:0000-00-00
Location:Minnesota  Entered:2013-05-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0216082IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Injection site swelling, redness, pruritus, tingling and heat on day 2. Rx Ibuprofen and ice.

VAERS ID:492290 (history)  Vaccinated:2013-05-07
Age:13.0  Onset:2013-05-09, Days after vaccination: 2
Gender:Male  Submitted:2013-05-22, Days after onset: 13
Location:Missouri  Entered:2013-05-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zrytec weekly environmental allergy injections
Current Illness:
Preexisting Conditions: Food and environmental allergies
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4181AA0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Erythema, Injection site swelling
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: 5-9-13 mild swelling left deltoid in AM becoming excessive after school. Redness extending from shoulder to elbow. Afebrile. To Dr evening of 5-9-13 low-dose steroid given.

VAERS ID:492313 (history)  Vaccinated:2013-05-20
Age:13.0  Onset:2013-05-20, Days after vaccination: 0
Gender:Female  Submitted:2013-05-22, Days after onset: 2
Location:Massachusetts  Entered:2013-05-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol inhaler prn only
Current Illness: None
Preexisting Conditions: Hx asthma
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0155551IMLA
Administered by: Private     Purchased by: Private
Symptoms: Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt received GARDASIL (L) arm IM on 5/20/13 at 10am that evening pt developed itchy red rash on (R) wrist which spread to (R) inner elbow and then to back and belly and finally to (L) arm near inj site. No difficulty breathing. Parent called MD. BENADRYL given at 10 pm 5/20 and 330 am 5/22. Rash gone by 7 am 5/21/13.

VAERS ID:492347 (history)  Vaccinated:2013-05-13
Age:13.0  Onset:2013-05-13, Days after vaccination: 0
Gender:Female  Submitted:2013-05-22, Days after onset: 9
Location:Illinois  Entered:2013-05-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin; Lotrisone cream
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0459AE0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B081AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient received Tdap vaccination to left deltoid then patient received HPV vaccination to right deltoid after vaccination given pt had syncopal episode.

VAERS ID:492350 (history)  Vaccinated:2012-06-01
Age:13.0  Onset:2012-06-01, Days after vaccination: 0
Gender:Female  Submitted:2013-05-23, Days after onset: 356
Location:Unknown  Entered:2013-05-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Hypersensitivity; Contraception
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA011987
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1696AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Arthralgia, Blood test, Dyspnoea, Eye swelling, Nausea, Rash, Ultrasound scan, Vomiting, X-ray
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: This spontaneous report as received from a mother concerning her 13 year old daughter. In June 2012, the patient was vaccinated with GARDASIL dose 1, intramuscular. On October 2012, the patient was vaccinated with GARDASIL dose 2, intramuscular. Concomitant therapy included birth control and allergy medication. In June 2012, "soon after receiving her first dose of GARDASIL", the patient experienced various symptoms including nausea and vomiting, stomach cramping with severe stomach pain which was "constant and debilitating", joint pain, intermittent swelling around eyes, intermittent rashes and shortness of breath. The mother stated that her daughter was "significantly incapacitated due to the constant pain". The patient was unrelieved of these symptoms at this time and there was no diagnosis or resolution to her symptoms post-testing, including "multiple" hospitalizations. Ultrasound, x-ray and blood work were performed with no result provided. The hospital''s name and lengths of stay were undisclosed. The events were considered to be other important medical events. Stomach cramping with severe stomach pain which was "constant and debilitating" and joint pain were considered disabling. Additional information has been requested.

VAERS ID:492398 (history)  Vaccinated:2013-05-20
Age:13.0  Onset:2013-05-20, Days after vaccination: 0
Gender:Female  Submitted:2013-05-23, Days after onset: 3
Location:Unknown  Entered:2013-05-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA012705
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0306AA1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a healthcare worker and a licensed practical nurse refers to a 13 year old female patient. On 15-JUN-2012 the patient was vaccinated with first dose of GARDASIL (strength, formulation, lot#, dose/frequency, route and duration were unspecified). On 20-MAY-2013 the patient was vaccinated with second dose of expired GARDASIL (injection, lot # 668554/0306AA, exp date 10-MAY-2013, 0.5 ml, intramuscular in the left arm). No adverse effects reported. Patient had sought unspecified medical attention. The outcome was unknown. Additional information has been requested.

VAERS ID:492464 (history)  Vaccinated:2013-05-13
Age:13.0  Onset:2013-05-13, Days after vaccination: 0
Gender:Male  Submitted:2013-05-23, Days after onset: 10
Location:Texas  Entered:2013-05-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 128/109 not provided
CDC 'Split Type': WAES1305USA010424
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0213460IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Feeling abnormal, Lethargy, Loss of consciousness
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), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This spontaneous report as received from a physician refers to a 13 year old male patient. On 13-MAY-2013 the patient was vaccinated with the first dose of GARDASIL lot # H021346, exp. 01-OCT-2015, intramuscular. The physician administered the GARDASIL shot to the male patient, then had the male patient wait 10 minutes prior to leaving the office area to go complete blood work in another area of the facility. Upon completing the routine blood work, which was scheduled during this doctor''s appointment, this male patient experienced lightheadedness and feeling of being dizzy. The laboratory staff then escorted the male patient back to the office area where the office nurse was informed of the patient''s condition. The office nurse had the male patient lie down in the room and vital signs were taken, of which blood pressure reading of 128/109 was obtained. The office nurse continued to monitor the patient''s condition which was not improving much. The patient was very lethargic and had to be shaken 3 times to be aroused along with having to have his father assist him to the bathroom "because of being out of it." After a period of 1 hour, the physician felt as though the patient was stable enough to be sent home. The physician followed up on 15-MAY-2013 with the patient who was still experiencing lightheadedness and being dizzy, "I just don''t feel like myself." The patient was not recovered from the event at reporting time. Therapy with GARDASIL was reported as continued. Additional information has been requested.

VAERS ID:492450 (history)  Vaccinated:2013-05-17
Age:13.0  Onset:2013-05-17, Days after vaccination: 0
Gender:Male  Submitted:2013-05-24, Days after onset: 7
Location:Unknown  Entered:2013-05-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA011940
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a healthcare worker refers to 13 years old male patient. In 2011 the patient was vaccinated with first dose of GARDASIL (dose, route, injection site, lot# and indication not provided). On 17-MAY-2013 (reported as now) the patient was vaccinated with the second dose of GARDASIL (dose, route, injection site, lot# and indication not provided). The reporter stated that the patient was late for his second dose of GARDASIL. No adverse effects reported. The outcome of events was unknown. Additional information is not expected.

VAERS ID:492485 (history)  Vaccinated:2013-05-22
Age:13.0  Onset:2013-05-23, Days after vaccination: 1
Gender:Male  Submitted:2013-05-23, Days after onset: 0
Location:California  Entered:2013-05-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INH
Current Illness: None
Preexisting Conditions: Latent TB
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0126431IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4421AA0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Localized, indurated, erythema, swelling, 6 x 6 cm in size on (R) lateral upper arm.

VAERS ID:492524 (history)  Vaccinated:2012-10-17
Age:13.0  Onset:0000-00-00
Gender:Male  Submitted:2013-05-24
Location:Florida  Entered:2013-05-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA011682
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  IMRA
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.  IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMRA
Administered by: Private     Purchased by: Public
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and Liquid PEDVAXHIB (Lot number, expiry date, route and dose were not reported). Medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated other 104 children received GARDASIL and other 18 children received Liquid PEDVAXHIB vaccine. Follow up information has been received from the medical assistant regarding a 13 years old, male patient with no pertinent medical history reported. On 17-OCT-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Other suspect therapies included Liquid PEDVAXHIB (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). Concomitant medications included Hepatitis A vaccine (manufacturer unknown) (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.

VAERS ID:492525 (history)  Vaccinated:2012-11-15
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-05-24
Location:Florida  Entered:2013-05-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA011683
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMLA
Administered by: Private     Purchased by: Public
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a medical assistant refers a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding a 13 years old, female patient with no pertinent medical history reported. On 15-NOV-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Concomitant medications included Hepatitis A vaccine (manufacturer unknown) (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.

VAERS ID:492544 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-05-27
Location:Alabama  Entered:2013-05-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA013473
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Dyskinesia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This spontaneous report as received, via field employee, from a physician refers to a 13 year old female patient. In approximately May 2012, reported as one year ago, the patient was vaccinated with GARDASIL (dose, lot number and expiration date were not reported) dose 1, intramuscular. In approximately May 2012, reported as one year ago, after receiving the first dose of GARDASIL, the patient experienced involuntary hand movements once a day, for an unspecified period of time. On an unspecified date, in approximately 2013, reported as recently at an unspecified timeframe, the patient received a second dose of GARDASIL, (dose, lot number and expiration date were not reported). On an unknown date, in approximately 2013, (72 hours after vaccination with second dose of GARDASIL) the patient experienced seizure. The patient sought medical attention with a neurologist visit (unspecified Health Care Professional (HCP)) and received unspecified treatment. The outcome of involuntary hand movements once a day and seizure was reported as recovering/resolving. Upon internal review the event seizure was considered as medically significant. Additional information has been requested.

VAERS ID:492637 (history)  Vaccinated:2013-05-28
Age:13.0  Onset:2013-05-28, Days after vaccination: 0
Gender:Female  Submitted:2013-05-28, Days after onset: 0
Location:Oregon  Entered:2013-05-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Blood Pressure: 120/80
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH666AA0SCRA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal discomfort, Dizziness postural, Loss of consciousness, Nausea, Rash
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Pt received the yellow fever vaccine at around 1:30PM. Approximately 10 minutes later, she stated she was feeling nauseous and dizzy while standing. She then lost consciousness and was laid back on the floor, feet raised in a chair. She regained consciousness within 15-20 seconds. Her blood pressure was 120/80. There was a slight rash on her arms and stomach that went away after several minutes and she denied itching. After 20 minutes of having received vaccine, pt stated stomach was feeling better and color returned.

VAERS ID:492903 (history)  Vaccinated:2013-02-18
Age:13.0  Onset:0000-00-00
Gender:Male  Submitted:2013-05-28
Location:Florida  Entered:2013-05-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA011696
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMRA
Administered by: Private     Purchased by: Public
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 13 year old, male patient with no pertinent medical history reported. On 18-FEB-2013 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On an unknown date the patient received the another dose of GARDASIL (lot number and expiration date not reported) (route and dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.

VAERS ID:492909 (history)  Vaccinated:2013-03-15
Age:13.0  Onset:0000-00-00
Gender:Male  Submitted:2013-05-28
Location:Florida  Entered:2013-05-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA011698
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMLA
Administered by: Private     Purchased by: Public
Symptoms: Incorrect dose administered, No adverse event
SMQs:
Write-up: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and LIQUID PEDVAXHIB (Lot number, expiry date, route and dose were not reported). Certified Medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated other 104 children received GARDASIL and other 18 children received LIQUID PEDVAXHIB. Follow up information has been received from the medical assistant regarding a 13 years old, male patient with no pertinent medical history reported. On 07-DEC-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Other suspect therapies included LIQUID PEDVAXHIB (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). On 15-MAR-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports received from the same source. Additional information is not expected.

VAERS ID:492966 (history)  Vaccinated:2013-03-04
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-05-28
Location:Florida  Entered:2013-05-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA011693
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMRA
Administered by: Private     Purchased by: Public
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding a 13 year old, female patient with no pertinent medical history reported. On 31-JAN-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 04-MAR-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.

VAERS ID:492846 (history)  Vaccinated:2013-02-26
Age:13.0  Onset:0000-00-00
Gender:Male  Submitted:2013-05-29
Location:Florida  Entered:2013-05-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA011708
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 13 years old, male patient with no pertinent medical history reported. On 26-FEB-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Concomitant medications included Hep A vaccine (manufacturer unknown) on an unknown date (intramuscular in the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.

VAERS ID:492945 (history)  Vaccinated:2013-04-02
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-05-30
Location:Florida  Entered:2013-05-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA011723
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMLA
Administered by: Private     Purchased by: Public
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 13 years old, female patient with no pertinent medical history reported. On 31-JAN-2013 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 02-APR-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). This is one of the several reports from the same source. Additional information is not expected.

VAERS ID:492950 (history)  Vaccinated:2012-11-02
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-05-30
Location:Florida  Entered:2013-05-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA011724
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMRA
Administered by: Private     Purchased by: Public
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 13 years old, female patient with no pertinent medical history reported. On 28-AUG-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 02-NOV-2012 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.

VAERS ID:493084 (history)  Vaccinated:2013-01-08
Age:13.0  Onset:0000-00-00
Gender:Male  Submitted:2013-05-30
Location:Florida  Entered:2013-05-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA011716
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Private     Purchased by: Public
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and LIQUID PEDVAXHIB (Lot number, expiry date, route and dose were not reported). Certified Medical assistant reported that both vaccines were exposed to temperature of 26 F for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated other 104 children received GARDASIL and other 18 children received LIQUID PEDVAXHIB. Follow up information has been received from the certified medical assistant regarding a 13 years old, male patient with no pertinent medical history reported. On 24-OCT-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (dose and route not reported). Other suspect therapies included LIQUID PEDVAXHIB (lot number and expiration date not reported) (dose and route not reported). Concomitant medications included Hepatitis A vaccine (manufacturer unknown) administered on 24-OCT-2012 (dose and route not reported). On 08-JAN-2013 the patient received another dose of GARDASIL (lot number and expiration date not reported) (dose and route not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.

VAERS ID:492976 (history)  Vaccinated:2013-04-08
Age:13.0  Onset:2013-04-15, Days after vaccination: 7
Gender:Female  Submitted:2013-05-31, Days after onset: 46
Location:Utah  Entered:2013-05-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Slight Eczema
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0126430IMRA
Administered by: Unknown     Purchased by: Public
Symptoms: Rash, Skin papilloma
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: One week after vaccine patient developed bumps on / near vaginal area. They were determined to be warts. Patient is not sexually active.

VAERS ID:493153 (history)  Vaccinated:2013-05-28
Age:13.0  Onset:2013-05-28, Days after vaccination: 0
Gender:Female  Submitted:2013-05-31, Days after onset: 3
Location:California  Entered:2013-05-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD; Clindamycin soln for acne
Current Illness: None
Preexisting Conditions: None except acne, obesity
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB703AA0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Child fainted for approximately < 10 seconds several minutes after receiving vaccine (she also received TB PPD skin test).

VAERS ID:493530 (history)  Vaccinated:2013-05-09
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-06-03
Location:Missouri  Entered:2013-06-06, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0162380IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX110760IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B07BBA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Incorrect drug dosage form administered
SMQs:
Write-up: Client only administered liquid component of the MENVEO. Powder was not mixed in. LPN called Novartis to see if client needs to be reimmunized. They stated if she would be traveling outside the country or around a foreigner, to reimmunize. Called client''s guardian and have left several messages. Will continue to try to contact client''s guardian.

VAERS ID:493560 (history)  Vaccinated:2013-06-06
Age:13.0  Onset:2013-06-06, Days after vaccination: 0
Gender:Female  Submitted:2013-06-06, Days after onset: 0
Location:Arizona  Entered:2013-06-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None known
Preexisting Conditions: Elevated blood pressure, history of syncope, TMJ, scoliosis, hearing loss, decreased visual acuity. Allergies: Blue Cheese and Augmentin
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.H012669 IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0176980IMRA
Administered by: Public     Purchased by: Public
Symptoms: Chest pain, Headache
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Patient reported chest pain and headache. She was evaluated through walk in clinic and saw a MD. Symptoms resolved without treatment.

VAERS ID:493572 (history)  Vaccinated:2013-05-20
Age:13.0  Onset:2013-05-20, Days after vaccination: 0
Gender:Female  Submitted:2013-06-01, Days after onset: 12
Location:New York  Entered:2013-06-06, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: Scheduled for a EEG on June 11, 2013
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Private     Purchased by: Other
Symptoms: Convulsion, Cyanosis, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad)
Write-up: She had a seizure then turned blue and stopped breathing. Taken by ambulance to emergency rm. Follow up with pediatrician and neurologist.

VAERS ID:493766 (history)  Vaccinated:2013-06-10
Age:13.0  Onset:2013-06-10, Days after vaccination: 0
Gender:Female  Submitted:2013-06-10, Days after onset: 0
Location:Florida  Entered:2013-06-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Flonase
Current Illness: No here on well care The following information was obtained through follow-up and/or provided by the government. 7/15/13: Sinusitis. 7/18/13: Cough.
Preexisting Conditions: Latex The following information was obtained through follow-up and/or provided by the government. 7/15/13 PMH: Recent sinusitis treatment. Allergy. 7/18/13 PMH: Allergy to latex. 8/15/13: Similar in episodes in the past consisting of abdominal discomfort, queasiness, nausea, paleness, feeling faint, vision faint, falling, lack of response, spasms of hands and wrists - associated with stressful, painful, or anxiety-producing situations. Urinary tract infections, smaller left kidney.
Diagnostic Lab Data: The following information was obtained through follow-up and/or provided by the government. 7/15/13 Labs and Diagnostics: CBC - HCT 35.9% (L) Lymph 41.5% (H) CT Head - Abnormal for sinusitis. 8/15/13 Labs and Diagnostics: EEG - WNL. ECG - WNL. Echocardiogram - Normal Study. MRI Brain - Small lipoma associated with posterior aspect of corpus callosum; recent cerebral infraction, intracranial hemorrhage, intracranial mass effect or abnormal contrast enhancement; severe extensive chronic sinusitis, mild chronic left mastoiditis.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0535AE IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H021608 IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4418AA IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Altered state of consciousness, Brain neoplasm benign, Capillary nail refill test abnormal, Chronic sinusitis, Convulsion, Fatigue, Gait disturbance, Gaze palsy, Haematocrit decreased, Hyperhidrosis, Joint contracture, Lymphocyte percentage increased, Malaise, Mastoiditis, Musculoskeletal stiffness, Nausea, Nervous system disorder, Nuclear magnetic resonance imaging brain abnormal, Opisthotonus, Orthostatic intolerance, Pallor, Photopsia, Posture abnormal, Posturing, Presyncope, Syncope, Unresponsive to stimuli, Urinary incontinence, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dystonia (narrow), Parkinson-like events (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad)
Write-up: While checking out she said she did not feel well, and went pale. Receptionist had her sit in chair. She then arched her back, hands turned inwards clenched and urinated herself, head down and eyes rolled. Lasted about 2 -3 minutes and doctor came out and she had repeated action, pale, clenched first and completely out of it for 1 minute and came to. Patient does not remember the event at all. Doctor carried to exam room and observed for about 10 minutes and then wheelchaired to ER in same building. The following information was obtained through follow-up and/or provided by the government. 7/15/13 ER records received. Service dates 6/10/13. Diagnosis: New Onset Seizure. Patient presents with generalized seizure witnessed at doctor''s office. Incontinence, brief posturing. Second episode with upper arms clenched but remained awake. Feels very tired. Zofran injection, admitted. 7/16/13 Cardiology Consultant medical records received. Service dates 7/3/13. Diagnosis: Symptoms vasovagal, orthostatic. Patient presents after 2 recent syncopal episodes associated with seizure activity. Described as feeling weak and field of vision closing in, pale and diaphoretic, "out" for a few seconds then feeling fine. Normal cardiac exam and ECG. Treatment consists of reassurance, mainenance of adequate hydration, healthy eating habits, and avoiding sudden changes in position. 7/18/13 Consultant/PCP medical records received. Service date 6/10/13. Diagnosis: Seizure, syncope. Patient presents for well-child visit. After vaccine administration diaphoretic and wobbly followed by back arching, urinary incontinence, lack of response lasting 2 minutes. Second similar event lasting 30 seconds w/o incontinence. Transferred to ER. Exam benign except for tachycardia, cool and clammy. Alert and responsive. Sluggish capillary refill. Inpatient observation for 24 hours. 8/5/13 Hospital Records received. Service dates 6/10/13 to 6/11/13. Additional Information Abstracted. Diagnosis: Syncope as Result of Vasovagal Event. Shortly after receiving vaccinations patient "felt everything go black and saw flashes of light" and "very pale and collapsed". Eyes rolled up, became very stiff, tonic posturing. Initial ED workup negative. Complaining of nausea. Pale and fainted after CAT scan. IV Potassium Chloride/Dextrose/Sodium Chloride. Anxious. Small lipoma associated with posterior aspect of corpus callosum; recent cerebral infraction, intracranial hemorrhage, intracranial mass effect or abnormal contrast enhancement; severe extensive chronic sinusitis, mild chronic left mastoiditis.

VAERS ID:493982 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:2013-03-27
Gender:Female  Submitted:2013-06-12, Days after onset: 77
Location:New Jersey  Entered:2013-06-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1306USA005156
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0216081UNUN
Administered by: Private     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report was received from a physician refers to 4 patients of unknown age and gender. On 01-APR-2013 the patients were vaccinated with GARDASIL (lot number H021608, expiration date 13-AUG-2015, route not reported). The physician noted that GARDASIL was shipped on 27-MAR-2013 and did not arrive at the office until 01-APR-2013 and the GARDASIL was in the shipper the entire time. The physician''s office could not determine the exact temperature the GARDASIL was exposed to while in the shipment from 27-MAr-2013 to 01-ARP-2013. No patient contact details available. No further information was available. Follow up information was received. The receptionist stated that she spoke with the nurse and she was not aware of the situation and she also stated that the physician would call back. Follow up document included information about 13 year old female patient who on 01-APR-2013 (at 10:31 AM) was vaccinated in left arm with GARDASIL (lot number H021608, expiration date 13-AUG-2015, route and dose not reported). There was none adverse event. This is one of several reports from the same source. Additional information is not expected.

VAERS ID:494195 (history)  Vaccinated:2013-06-13
Age:13.0  Onset:2013-06-13, Days after vaccination: 0
Gender:Female  Submitted:2013-06-13, Days after onset: 0
Location:Maine  Entered:2013-06-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0129680IMRA
Administered by: Private     Purchased by: Other
Symptoms: Immediate post-injection reaction, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Pt passed out immediately receiving the vaccine (#3/3) v/s were obtained, pt passed out for approx. 30 sec., she was administered 2L of 02 via nasal cannula and monitored. After she was able, she sat up for 20 min, ate crackers, drank 2 juice boxes. Pt left w/mother - walked out on her own. Total amt. of time approx 30 min.

VAERS ID:494228 (history)  Vaccinated:2013-06-13
Age:13.0  Onset:2013-06-13, Days after vaccination: 0
Gender:Female  Submitted:2013-06-14, Days after onset: 1
Location:Michigan  Entered:2013-06-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic Acid 1 mg; Cyproheptadine 4 mg
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0206920IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Laceration, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt had syncopal episode at time of vaccination, falling off exam table and lacerating her chin. Pt treated for laceration.

VAERS ID:494350 (history)  Vaccinated:2013-06-11
Age:13.0  Onset:2013-06-11, Days after vaccination: 0
Gender:Male  Submitted:2013-06-13, Days after onset: 2
Location:Arizona  Entered:2013-06-17, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0218610IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Anxiety, Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: 6/13/13 Patient here for follow-up. Two days ago, he received HPV vaccine. He tells me when he was sitting in the waiting room he had a mild headache. He felt anxious. He tells me he gets nervous easily. At about 5:00 p.m., he developed nausea. Then about 7:00 p.m., after going out to dinner, he vomited and his headache increased. He was brought to the ER. ER note is on chart. Today, he tells me he is back to normal.

VAERS ID:494442 (history)  Vaccinated:2013-06-17
Age:13.0  Onset:2013-06-17, Days after vaccination: 0
Gender:Female  Submitted:2013-06-17, Days after onset: 0
Location:Minnesota  Entered:2013-06-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: ADHD
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA174BJ UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM12027 UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Severe headache, dizziness, nausea onset 2 hours after shot baby aspirin administered at home around 6:00 pm.

VAERS ID:494466 (history)  Vaccinated:2013-06-18
Age:13.0  Onset:2013-06-18, Days after vaccination: 0
Gender:Female  Submitted:2013-06-18, Days after onset: 0
Location:South Carolina  Entered:2013-06-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Pt did not eat lunch, and in fact only had a glass of milk and a couple of cookies early in the morning.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0155551IMLA
Administered by: Unknown     Purchased by: Public
Symptoms: Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt was walking to car in garage facility, and she suddenly felt light headed and fainted.

VAERS ID:494599 (history)  Vaccinated:2012-03-06
Age:13.0  Onset:2012-03-08, Days after vaccination: 2
Gender:Male  Submitted:2013-06-19, Days after onset: 467
Location:Maine  Entered:2013-06-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Allegra D, Flonase
Current Illness: Congested
Preexisting Conditions: Seasonal allergies
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNAR
Administered by: Private     Purchased by: Private
Symptoms: Nausea, Respiratory tract congestion, Vertigo
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)
Write-up: Vertigo, room spinning, nausea. Has suffered off and on ever since, with symptoms lasting over two months at a time.

VAERS ID:494839 (history)  Vaccinated:2013-06-21
Age:13.0  Onset:2013-06-21, Days after vaccination: 0
Gender:Female  Submitted:2013-06-21, Days after onset: 0
Location:California  Entered:2013-06-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arrived for sports physical and vaccine with no illnesses. Immediately after the vaccine, she experienced loss of sight, and fainting. Loss of sight approximately one to two minutes prior to or while fainting.
Preexisting Conditions: None
Diagnostic Lab Data: Side effect? Not sure about the loss of sight.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Private
Symptoms: Blindness, Immediate post-injection reaction, Syncope, Vision blurred, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Vaccine administered at approximately 10:45 AM At 10:50 AM patient said her sight was blurry and fading out and eventually said she could not see. This was within a two minute span. During that two minute span she began fainting (dropping to the point that she had to be carry walked to lay down) Dr. listened to her heart, took her pulse and the nurse took her blood pressure. She was communicating the entire time. She rested for about 5 to ten minutes before we left the doctor''s office.

VAERS ID:495099 (history)  Vaccinated:2013-06-20
Age:13.0  Onset:2013-06-20, Days after vaccination: 0
Gender:Unknown  Submitted:2013-06-25, Days after onset: 5
Location:Unknown  Entered:2013-06-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1306USA010454
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect dose administered, No adverse event
SMQs:
Write-up: This spontaneous report was received from a pharmacist refers to a 13 year old patient. On 20-JUN-2013, the patient was vaccinated with an adult dose (first dose) of VAQTA, (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse effects were reported. Additional information is not expected.

VAERS ID:495119 (history)  Vaccinated:2013-06-25
Age:13.0  Onset:2013-06-25, Days after vaccination: 0
Gender:Male  Submitted:2013-06-25, Days after onset: 0
Location:Texas  Entered:2013-06-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma; Eczema and contact dermatitis
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4594AB1UNLA
Administered by: Private     Purchased by: Private
Symptoms: Chest pain, Heart rate increased, Lip discolouration, Nausea, Pallor, Tinnitus, Vision blurred
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Per mom, 10 mins after vaccine child complained of chest pain, elevated heart rate, nausea, hands shaky, child looked pale to face and lips were white. Ringing to ears and not able to hear with blurr vision. Child was very anxious and nervous before vaccine child was fasting.

VAERS ID:495237 (history)  Vaccinated:2013-06-26
Age:13.0  Onset:2013-06-26, Days after vaccination: 0
Gender:Male  Submitted:2013-06-26, Days after onset: 0
Location:Idaho  Entered:2013-06-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Clonidine, Abilify, Risperdal
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Blindness, Dizziness, Muscle contracture, Posturing
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Psychosis and psychotic disorders (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Vestibular disorders (broad)
Write-up: Heart felt funny, light headed, 15 second tonic posturing where sustained contraction of muscles in the legs and arms occurred, loss of vision, unable to sit up.

VAERS ID:495451 (history)  Vaccinated:2011-07-28
Age:13.0  Onset:2013-01-01, Days after vaccination: 523
Gender:Female  Submitted:2013-06-28, Days after onset: 177
Location:Georga  Entered:2013-06-28
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None known
Preexisting Conditions: No
Diagnostic Lab Data: The following information was obtained through follow-up and/or provided by the government. 9/19/2013 lab/diagnostic records received for DOS 6/1-8/27/2012. Blood: WBC 9.57 K/uL (N), neutros 45.9-87.5% (L-H), lymphs 45-10.1% (H-L), Ca 8.7 mg/dL (L), lipase 172 U/L (H). EBV, urine cx (+). ANA, rapid strep, urine pregnancy test, CSF, CSF cx (-). Duodenum/gastric/esophagus bx''s, NCS, MRI brain, UA WNL. CT head: small frontal hypodense lesion w/o edema. X-ray abdomen: moderate stool in colon, small punctate calcification lt lower pelvis.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1271Z1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal X-ray, Abdominal pain, Abdominal pain upper, Antinuclear antibody negative, Autoimmune disorder, Back pain, Biopsy intestine normal, Biopsy oesophagus normal, Biopsy stomach normal, Blindness, Blood calcium decreased, CSF culture negative, CSF test normal, Central nervous system inflammation, Chest discomfort, Computerised tomogram head abnormal, Culture urine positive, Dyspnoea, Endoscopy, Epstein-Barr virus test positive, Headache, Hypoaesthesia, Lipase increased, Lymphocyte percentage decreased, Lymphocyte percentage increased, Migraine, Nausea, Nerve conduction studies normal, Neuralgia, Neutrophil percentage decreased, Neutrophil percentage increased, Nuclear magnetic resonance imaging brain normal, Phonophobia, Photophobia, Pregnancy test negative, Status migrainosus, Streptococcus test, Streptococcus test negative, Throat irritation, Urine analysis normal, Vision blurred, Vomiting, White blood cell count normal, X-ray abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Haematopoietic leukopenia (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad)
Write-up: Head pain, constant nausea, cycle vomiting, nerve pain, neurological inflammation, autoimmune started. The following information was obtained through follow-up and/or provided by the government. 9/20/2013 hospital records received for DOS 6/1-5/2012. D/c Dx: headache. Seen in outside ER previous day, Tx''d for migraine, released home w/ some improvement. Presented c/o persistent headache, nausea, transient vision loss, blurred vision 1 day prior, RUE numbness, photophobia. Headache localized retro-orbital area. PE unremarkable. Admitted for evaluation. Tx''t: Raskin protocol ineffective, MgSO4 provided brief improvement, PT, TENS unit, stretching exercises. Additional c/o abdominal pain, SOB, chest/throat discomfort. Pt d/c''d home in stable condition w/ care & f/u instructions. 9/20/2013 neuro consultant records received for DOS 8/17/2012. D/c Dx: status migrainosus. Pt c/o headache on side of head & behind eyes for 81 days, w/ nausea, vomiting, photophobia, phonophobia. PE unremarkable. Multiple medications unsuccessful @ providing relief. Given Rx, care & f/u instructions. 9/20/2013 surgical records received for DOS 8/27/2012. Postop Dx: 1) vomiting; 2) epigastric pain; 3) headaches; 4) back pain. Pt presented for upper endoscopy w/ bx''s for abdominal pain & vomiting. Undergoing Tx''t for migraines as noted above. Pt tolerated procedure well.

VAERS ID:495472 (history)  Vaccinated:2013-06-13
Age:13.0  Onset:2013-06-13, Days after vaccination: 0
Gender:Male  Submitted:2013-06-28, Days after onset: 15
Location:Florida  Entered:2013-06-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Fish oil supplement
Current Illness: None The following information was obtained through follow-up and/or provided by the government. 7/2/13: Erythematous papular rash on arms of 1 year duration.
Preexisting Conditions: None The following information was obtained through follow-up and/or provided by the government. 7/2/13 PMH: Circumcision.
Diagnostic Lab Data: WBC 3.8, HGB 13.7, Plt 94. EBV, CMV, Hepatitis A, B, C, Parvovirus B19 all negative. CT showed intraparenchymal splenic hematoma 12cm x 10.5 cm. The following information was obtained through follow-up and/or provided by the government. 7/2/13 Labs and Diagnostics: CBC - WBC 4.3 K/UL (L) RBC 3.77 M/UL (L) HGB 11.9 G/DL (L) HCT 33.6% (L) MCH 31.6 PG (H) Platelets 114 K/UL (L) Gran 36.7% (L) Lymph 49.0% (H) Gran# 1.6 K/UL (L), WBC Morphology abnormal. CHEM - Alk Phos 71 U/L (L) Total Protein 5.7 G/DL (L) Albumin 3.4 G/DL (L) Glucose 105 MG/DL (H) AST 62 IU/L (H) ALT 53 IU/L (H) Total Bilirubin 4.2 MG/DL (H). Molecular Analysis - Abnormal, Heterozygous Methylenetetrahydrofolate Reductase C677T gene (+). Abdominal Ultrasound - Abnormal. CT Abdo
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0420AC2IMRA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal distension, Abdominal mass, Abdominal pain, Alanine aminotransferase increased, Anaemia, Aspartate aminotransferase increased, Blood albumin decreased, Blood alkaline phosphatase decreased, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood glucose increased, C-reactive protein increased, Chromaturia, Computerised tomogram abnormal, Cough, Cytomegalovirus test negative, Epstein-Barr virus antibody positive, Epstein-Barr virus test negative, Gene mutation identification test positive, Granulocyte count decreased, Granulocyte percentage, Haematocrit decreased, Haemoglobin decreased, Haemoglobin normal, Hepatitis A virus test, Hepatitis B test negative, Hepatitis C test negative, Hepatitis viral test negative, Intensive care, Keratosis pilaris, Leukopenia, Lymphocyte percentage increased, Nausea, Neutropenia, Parvovirus B19 test negative, Platelet count decreased, Protein total decreased, Protein urine present, Pyrexia, Red blood cell count decreased, Splenic haematoma, Splenomegaly, Spontaneous haematoma, Thrombocytopenia, Ultrasound scan abnormal, Urine ketone body present, Vomiting, White blood cell count decreased, White blood cell morphology abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Biliary system related investigations, signs and symptoms (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad)
Write-up: Patient''s father called through the answering service to report that patient had vomited several times and had fever of 104 on the evening of him receiving his 3rd Gardasil vaccine. The following day patient was examined and found to have splenomegaly and on US and CT he was noted to have a large hematoma that appears to be spontaneous as there is no history of trauma. He was transferred from ER to another hospital''s ICU where surgery and hematology were consulted. He was admitted 6-14-13 and discharged 6-19-13. No additional treatment was needed. The following information was obtained through follow-up and/or provided by the government. 7/2/13 Hospital records and discharge summary received. Service dates 6/14/13 to 6/19/13. Diagnosis: Splenomegaly. Splenic hemorrhage, hematoma of spleen, emesis, fever. Patient presented as a transfer from another facility. Had developed nausea, emesis, fever. Distended non-tender mass in LUQ which continued to enlarge. PICU. Leukopenia, neutropenia, anemia, thrombocytopenia. IV fluids. Discharged. Minimize activity at home, no contact sports, heavy lifting, avoid trauma to area. 7/2/13 ER Records received. Service date 6/14/13. Additional Information Abstracted. Patient presents with abdominal pain, vomiting, fever. Rash. Abdomen distended and firm. Transferred to a higher level facility. 7/11/13 PCP/Consultation records received. Service dates 6/13/13 to 6/20/13. Diagnosis: Spleen Enlargement, Thrombocytopenia. Keratosis Pilaris. Patient presents with rash, vomiting, cough, abdomen is distended. Stop fish oil supplement. Spleen palpable.

VAERS ID:495614 (history)  Vaccinated:2010-08-03
Age:13.0  Onset:2011-04-01, Days after vaccination: 241
Gender:Female  Submitted:2013-06-27, Days after onset: 818
Location:Ohio  Entered:2013-07-01, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None - Perfectly healthy before HPV
Diagnostic Lab Data: X-rays; C-scan; Upper GI; Stomach scope; ER visits (3); blood work; Barium swallow; Physical therapy; Week in the hospital; Acne on back; White spots around moles
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0331Z0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Acne, Arthralgia, Back pain, Barium swallow, Blood test, Cardiovascular disorder, Chest pain, Computerised tomogram, Decreased appetite, Depression, Endoscopy upper gastrointestinal tract, Fatigue, Hair colour changes, Melanocytic naevus, Memory impairment, Musculoskeletal chest pain, Pain in extremity, Panic attack, Raynaud's phenomenon, Skin ulcer, Stomach scan, Weight decreased, X-ray, X-ray with contrast upper gastrointestinal tract
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Arthritis (broad)
Write-up: Memory problems, joint pain, rib and chest pain, ulcers on fingers, bad circulation, Raynaud''s, back and leg pain, extreme tiredness, loss of appetite, weight loss, strands of grey hair, panic attack, depression - more symptoms continued to pop-up - nothing has been cured.

VAERS ID:496025 (history)  Vaccinated:2013-06-24
Age:13.0  Onset:2013-06-24, Days after vaccination: 0
Gender:Female  Submitted:2013-07-04, Days after onset: 10
Location:Unknown  Entered:2013-07-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1306USA013216
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0218611UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a medical assistant refers to a 13 year old female patient. On 03-AUG-2011, the patient was vaccinated with a first dose of GARDASIL (lot number was reported as 0306AA, expiry date: 10-MAY-2013, dose and route were not reported) and on 24-JUN-2013, the patient was vaccinated with a second dose of GARDASIL (lot # H021861, expiry date: 09-OCT-2015, dose and route were not reported). No adverse effect reported. Additional information has been requested.

VAERS ID:496043 (history)  Vaccinated:2013-06-28
Age:13.0  Onset:2013-06-28, Days after vaccination: 0
Gender:Unknown  Submitted:2013-07-04, Days after onset: 6
Location:Unknown  Entered:2013-07-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1307USA000277
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.H020134 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: This spontaneous report as received from a registered nurse refers to a 13 year old patient who on 28-JUN-2013, was inadvertently vaccinated with a dose of PROQUAD (lot # H020134, Exp. Date: 07-MAY-2014) subcutaneous (dose not reported). The patient had an unknown vaccination history and it was unspecified if this was the first dose of varicella vaccine that the patient ever received. No adverse effects were reported. Additional information has been requested.

VAERS ID:495906 (history)  Vaccinated:2013-07-01
Age:13.0  Onset:2013-07-01, Days after vaccination: 0
Gender:Male  Submitted:2013-07-03, Days after onset: 2
Location:California  Entered:2013-07-05, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CONCERTA
Current Illness: None
Preexisting Conditions: Penicillin
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0041972UNLA
Administered by: Private     Purchased by: Private
Symptoms: Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Headache, fever 102

VAERS ID:496110 (history)  Vaccinated:2013-06-28
Age:13.0  Onset:2013-07-01, Days after vaccination: 3
Gender:Male  Submitted:2013-07-05, Days after onset: 4
Location:Virginia  Entered:2013-07-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MANTOUX SKIN TEST
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 07/01/2013 Tuberculin test positive
CDC 'Split Type': WAES1307USA001759
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Tuberculin test positive
SMQs:
Write-up: This spontaneous report was received from a physician regarding a 13 year old male patient with no pertinent medical history or drug reactions or allergies. On 28-JUN-2013 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (dose and route not reported) for immunization. Other suspect therapies included MANTOUX SKIN TEST administered intradermally on 28-JUN-2013. There was no concomitant medications. The physician reported that the mother of the patient believed that the concurrent administration of GARDASIL and MANTOUX SKIN TEST that were both administered during an office visit, may have caused her son to have a positive PPD test on 01-JUL-2013. The physician prescribed the patient Isoniazid and ordered a chest x-ray to be obtained as soon as possible to determine if the PPD result wsa a false positive or not. Outcome for the PPD test positive was unknown at the time of the report. Additional information has been requested.

VAERS ID:496341 (history)  Vaccinated:2013-06-27
Age:13.0  Onset:2013-06-27, Days after vaccination: 0
Gender:Female  Submitted:2013-06-28, Days after onset: 1
Location:Georga  Entered:2013-07-09, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB646AA0IMRA
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERSKBACS2B092FA0IMLA
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURERMSDH0147271SCRA
Administered by: Public     Purchased by: Public
Symptoms: Anxiety, Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Faintness 10 minutes after administration. No treatment. Patient very anxious about vaccines.

VAERS ID:496462 (history)  Vaccinated:2007-08-06
Age:13.0  Onset:2008-08-01, Days after vaccination: 361
Gender:Female  Submitted:2013-06-13, Days after onset: 1777
Location:Ohio  Entered:2013-07-11, Days after submission: 28
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None - perfectly healthy before HPV
Diagnostic Lab Data: Raynauds; Auto immune; Blood work
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0802U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal discomfort, Acne, Arthralgia, Autoimmune disorder, Blood test, Dizziness, Fatigue, Feeling abnormal, Headache, Immunology test, Joint swelling, Memory impairment, Nail growth abnormal, Nausea, Oedema peripheral, Onychoclasis, Poor peripheral circulation
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: Bad acne, very tired, bad headaches, joint pain, auto-immune symptoms - bad circulation in hands and feet. Toe nails stopped growing and fell off. Swollen joints, hands, and feet, memory problems, zoning out, nausea, dizziness, upset stomach.

VAERS ID:496505 (history)  Vaccinated:2012-02-28
Age:13.0  Onset:2012-03-03, Days after vaccination: 4
Gender:Female  Submitted:2013-07-11, Days after onset: 494
Location:Unknown  Entered:2013-07-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: development of Behcets~HPV (Gardasil)~2~13.08~Patient
Other Medications:
Current Illness: None per Mom
Preexisting Conditions:
Diagnostic Lab Data: Patient now followed for development of Behcets, relationship of disease state to vaccine administration is unknown.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Behcet's syndrome
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vasculitis (narrow)
Write-up: Per mom, adminstration of the first dose of vaccine may have unmasked or otherwise been associated with the development of Behcets Syndrome. Upon receipt of second dose, symptoms returned more strongly and a questionable, causal association was made between the development of Behcets and the Gardasil vaccine. Mom is against further vaccination with gardasil for patient.

VAERS ID:496631 (history)  Vaccinated:2013-07-10
Age:13.0  Onset:2013-07-10, Days after vaccination: 0
Gender:Female  Submitted:2013-07-12, Days after onset: 2
Location:New Hampshire  Entered:2013-07-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Asthma; AUGMENTIN allergy
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0216081IMLA
Administered by: Private     Purchased by: Public
Symptoms: Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Approx. 5 mins after vaccination in (L) arm, pt felt (R) hand weakness that lasted 1 hr, then resolved. Also experienced 5 mins of (L) hand weakness during episode. Now resolved with no lingering effects.

VAERS ID:496667 (history)  Vaccinated:2004-04-01
Age:13.0  Onset:2004-04-01, Days after vaccination: 0
Gender:Female  Submitted:2013-07-14, Days after onset: 3390
Location:Unknown  Entered:2013-07-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: severe allergic reaction~Hep A (no brand name)~UN~14.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNAR
Administered by: Public     Purchased by: Private
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Pharyngeal oedema, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Throat swelling, trouble breathing, hives, rapid heartbeat & dizziness. About 10 minutes after having received vaccination.

VAERS ID:496818 (history)  Vaccinated:2013-07-02
Age:13.0  Onset:2013-07-02, Days after vaccination: 0
Gender:Male  Submitted:2013-07-15, Days after onset: 13
Location:Unknown  Entered:2013-07-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1307USA006145
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a nurse refers to a 13 year old male patient. Nurse reported two patients (brothers) received first dose of VAQTA 25/0.5 intramuscular on 06-FEB-2013 and the second dose of VAQTA 25/0.5 (lot# unknown) intramuscular five months after the first dose on 02-JUL-2013. No co-suspected medicine reported. No concomitant medication reported. No adverse effect reported. The outcome was unknown. Action taken not provided. This is one of several reports from the same source. Additional information has been requested.

VAERS ID:496894 (history)  Vaccinated:2013-07-11
Age:13.0  Onset:2013-07-11, Days after vaccination: 0
Gender:Male  Submitted:2013-07-16, Days after onset: 5
Location:New Jersey  Entered:2013-07-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0145611IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site cellulitis
SMQs:
Write-up: Cellulitis surrounding injection site within 24 hours of receiving vaccine.

VAERS ID:496897 (history)  Vaccinated:2013-07-15
Age:13.0  Onset:2013-07-16, Days after vaccination: 1
Gender:Male  Submitted:2013-07-16, Days after onset: 0
Location:Illinois  Entered:2013-07-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Takes Singulair daily & Advair twice daily for asthma. Please note that client received 3 doses of MMR as first dose was given 12 days prior to first birthday and would not be valid, second dose given at age 4. The dose given 7/15/13 Varic
Current Illness:
Preexisting Conditions: Hx of Asthma
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS5J5HT1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.HO155551IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.H0158253SCRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4412BA1IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4106BA1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J0001532SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site vesicles
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Clients reports noting 1 inch line of small fluid filled blisters on Rt arm where MMR was given yesterday, also note Lt arm had 1 inch C shaped reddened area where Varicella was placed. No other symptoms.

VAERS ID:496955 (history)  Vaccinated:2013-06-28
Age:13.0  Onset:2013-06-28, Days after vaccination: 0
Gender:Female  Submitted:2013-07-16, Days after onset: 18
Location:California  Entered:2013-07-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD
Current Illness: Unknown
Preexisting Conditions: Fasting
Diagnostic Lab Data:
CDC 'Split Type': WAES1307USA000691
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0176981UNUN
Administered by: Other     Purchased by: Other
Symptoms: Fall, Scratch, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This spontaneous report as received from a Licensed Vocational Nurse (LVN) refers to a 13 year old female patient with no known drug reactions/allergies. On an unknown date the patient was vaccinated with GARDASIL lot # H017698 dose 2 (site and dose not specified). The patient had not eaten before being administered the vaccine. Concomitant therapies included diphtheria toxoid (+) pertussis whole cell vaccine (+) tetanus toxoid (manufacturer unknown), influenza virus vaccine (manufacturer unknown) and tuberculin purified protein derivative (PPD). On 28-JUN-2013 the patient fainted after receiving GARDASIL. After falling, the patient developed a little scratch on her face or head area. The patient was given oxygen, elevated her legs and provided a sugar popcicle. No lab diagnostic tests were performed. The event occurred during an office visit. The outcome of the events was unknown. The causal relationship was not reported. Additional information has been requested.

VAERS ID:497235 (history)  Vaccinated:2013-07-18
Age:13.0  Onset:2013-07-18, Days after vaccination: 0
Gender:Female  Submitted:2013-07-19, Days after onset: 1
Location:Texas  Entered:2013-07-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4260AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B093AA0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Incorrect dose administered, No adverse event
SMQs:
Write-up: 2 SISTERS WERE IN FOR THEIR WELL CHILD EXAMS AND VACCINES. THEY BOTH REQUIRED THE TDAP AND MCV VACCINES. WERE SEEN IN THE SAME EXAM ROOM TOGETHER. A MEDICAL ASSISTANT DREW UP THE 2 TDAPS AND MCV INJECTIONS AND BROUGHT THEM ALL TO THE ROOM AT THE SAME TIME. SHE THEN GROUPED THEM SEPERATELY ON THE COUNTER AS VACCINE TYPE INSTEAD OF PT. I CAME IN THE ROOM TO ASSIST. WE WERE GOING TO GIVE THE VACCINES SIMULTANEOUSLY TO MINIMIZE DISCOMFORT TO THE PT. THE MEDICAL ASSISTANT TOOK A VACCINE AND I THEN TOOK THE REMAINING VACCINE FROM THE GROUP WHICH WAS MARKED "RIGHT" IN MARKER ON THE NEEDLE COVER. WE PROCEEDED TO GIVE THE VACCINE, ME TO THE RIGHT DELYOID AND HER TO THE LEFT AND I IMMEDIATELY SAW THAT WE EACH HAD GIVEN THE TDAP B/C OF THE PRE DRAWN SYRINGE. I IMMEDIATELY REPORTED TO THE PROVIDER. PT WAS EXAMINED. I ADMINISTERED THE MCV IN THE RIGHT DELTOID AND PT WAS RELEASED WITH NO ADVERSE SYMPTOMS.

VAERS ID:497361 (history)  Vaccinated:2013-07-19
Age:13.0  Onset:2013-07-19, Days after vaccination: 0
Gender:Male  Submitted:2013-07-21, Days after onset: 2
Location:Pennsylvania  Entered:2013-07-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0047700IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Pt lost consciousness 30 seconds after immunization. Lasted 5 seconds. No treatment needed. Pt''s mother stated pt passes out when blood drawn.

VAERS ID:497458 (history)  Vaccinated:2013-07-22
Age:13.0  Onset:0000-00-00
Gender:Male  Submitted:2013-07-22
Location:Colorado  Entered:2013-07-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0496AE2SCLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM110420UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0167151SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: Pt requested meningococcal and Varicella vaccines. Provider gave MMR. There were no adverse reactions from this. No treatment nec.

VAERS ID:497477 (history)  Vaccinated:2013-07-22
Age:13.0  Onset:2013-07-22, Days after vaccination: 0
Gender:Female  Submitted:2013-07-23, Days after onset: 1
Location:Texas  Entered:2013-07-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: CBC, CMP
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS5J5HT0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0216080IMLA
Administered by: Private     Purchased by: Public
Symptoms: Dyskinesia, Full blood count, Immediate post-injection reaction, Injection site pain, Metabolic function test, Pallor, Presyncope, Sensation of heaviness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: IMMEDIATELY FELT PAIN AT INJECTION SITE, LEFT DELTOID. THEN FELT HEAVINESS IN LEFT ARM SECONDS AFTER. WITHIN ONE MINUTE (LESS THAN A MINUTE) PATIENT WAS NEAR SYNCOPE, STARTED TO FALL OVER, PALE WHITE TO THE FACE, EYES CLOSED, HAD A COUPLE JERKY MOVEMENTS, LAID PATIENT DOWN, LENGTH OF TIME WAS 10-15 SECONDS. PATIENT OPENED EYES AND ASKED WHAT HAPPENED. PATIENT WAS UNAWARE OF WHAT HAPPENED. DOCTOR INFORMED AND PATIENT EXAMINED AGAIN. BLOOD SUGAR 80, BLOOD PRESSURE 110/64 LEFT ARM LAYING DOWN WITH HEAD ELEVATED 45 DEGREES. BLOOD PRESSURE STANDING 118/70. LATE BREAKFAST AT 10:00 AM, NO LUNCH. GAVE DR. PEPPER TO DRINK, WAITED 30 MINUTES OR MORE BEFORE LEAVING. COLOR CAME BACK IN FACE WITHIN A FEW MINUTES. LABS ORDERED CBC, CMP. RESULTS PENDING.

VAERS ID:497484 (history)  Vaccinated:2013-07-16
Age:13.0  Onset:2013-07-18, Days after vaccination: 2
Gender:Female  Submitted:2013-07-23, Days after onset: 5
Location:Missouri  Entered:2013-07-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0636AE0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4646AA IMRA
Administered by: Public     Purchased by: Private
Symptoms: Asthenia, Erythema, Fatigue, Feeling hot, Urticaria, Vaccination site vesicles
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: Large baseball sized welt, redness, heat, pt had weakness and fatigue. Skin over vaccine area had area of fluid filled vesicles.

VAERS ID:497496 (history)  Vaccinated:2012-04-16
Age:13.0  Onset:2012-04-17, Days after vaccination: 1
Gender:Female  Submitted:2013-07-23, Days after onset: 462
Location:Illinois  Entered:2013-07-23
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Respiridone 0.5 mg, Sertraline 75 mg
Current Illness: Potentially had dizziness and vomiting
Preexisting Conditions: Bipolar disorder, developmental delays
Diagnostic Lab Data: CSF studies were normal; NMDA testing was normal; MRI of brain was normal; multiple EEGs were normal; unremarkable serum chemistries; child did have positive ribonucleoprotein antibody
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1495AA1IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Abasia, Amnesia, Anti-NMDA antibody negative, Antinuclear antibody positive, CSF test normal, Dizziness, Dystonia, Electroencephalogram normal, Headache, Laboratory test normal, Nuclear magnetic resonance imaging brain normal, Psychogenic seizure, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Child had vomiting, dizziness, that proceeded to headaches, over ensuing weeks, child developed amnesia, dystonia, and lost ability to walk; child had multiple pseudoseizures.

VAERS ID:497566 (history)  Vaccinated:2013-07-18
Age:13.0  Onset:2013-07-18, Days after vaccination: 0
Gender:Female  Submitted:2013-07-24, Days after onset: 6
Location:Kansas  Entered:2013-07-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': KS2013002
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB692BA1IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS74AP31IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J0016471SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Incoherent, Moaning, Pallor, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Skin pallor. Patient starts to moan after immunizations administered. Patient is incoherent for short period of time. Legs and arms start to shake uncontrollably for 12 seconds.

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