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Case Details (Sorted by Age)

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VAERS ID:342129 (history)  Vaccinated:2008-12-10
Age:13.0  Onset:2008-12-10, Days after vaccination: 0
Gender:Female  Submitted:2009-03-13, Days after onset: 92
Location:Minnesota  Entered:2009-03-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0903USA00013
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0570X2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Flushing, Headache, Rosacea
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: Information has been received from a nurse concerning a 13 year old female patient who on 10-DEC-2008 was vaccinated with her third dose of GARDASIL. The patient since 10-DEC-2008 had rosacea on the face that was worse in the evening. On 10-DEC-2008 later evening the patient had a bad headache, flushed face and achy joints. The patient had visited physician''s office for medical attention. Follow-up information has been received from the nurse that the patient was vaccinated with her first dose of GARDASIL (lot # 659962/1740U) on 30-MAY-2008. The patient was vaccinated with her second dose of GARDASIL (lot # 659964/1978U) on 05-AUG-2008. The patient was vaccinated with her third dose of GARDASIL (lot # 660616/0570X) on 10-DEC-2008. The nurse stated that no labs were performed. A physician may ask if there was any correlation of rosacesa and GARDASIL. Additional information has been requested.

VAERS ID:342404 (history)  Vaccinated:2008-07-29
Age:13.0  Onset:2009-01-01, Days after vaccination: 156
Gender:Female  Submitted:2009-03-13, Days after onset: 70
Location:Michigan  Entered:2009-03-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PROVENTIL; FLONASE. 5/29/09 Neurological consult records recieved DOS 1/29/09 to 2/19/09. Inderal
Current Illness:
Preexisting Conditions: Unknown. 5/27/09 medical records PMH: tension vascular HA, stomach pain. T&A. Allergy: PCN, erythromycin, amoxicillin, hydrocodone-acetaminophen. Family hx: breast cancer. 5/29/09 Neurological consult records recieved DOS 1/29/09 to 2/19/09. Learning disability with speech delay. 6/1/09 Neuro records of 3/9/09 PMH: (+) strep titer w/o tonsils tx w/antibiotics but self d
Diagnostic Lab Data: Unknown. 5/27/09 medical records LABS: BUN/creat ratio 24(H). X-ray of right wrist WNL. 5/29/09 Neurological consult records recieved DOS 1/29/09 to 2/19/09. LABS and DIAGNOSTICS: CBC-WNL. ASO titer - $g200 (H). MRI WNL. EEG WNL.
CDC Split Type: WAES0902USA02704
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0843X0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal discomfort, Abdominal pain upper, Electroencephalogram normal, Full blood count normal, Headache, Muscle tightness, Myofascial pain syndrome, Neuralgia, Nuclear magnetic resonance imaging brain normal, Pain in extremity, Retching, Streptococcus identification test, Tremor, X-ray limb normal
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning a 13 year old female who in July 2008, was vaccinated with the first dose of GARDASIL. Concomitant therapy included FLONASE and PROVENTIL. After getting the first dose (onset date reported as January 2009), the patient experienced pain in hands, stomach ache and headache. Magnetic resonance imaging (MRI) was performed but the result was unknown. At the time of reporting, the patient''s pain in hands and stomach ache and headache persisted. The patient will not be taking the second and the third dose of GARDASIL. Additional information has been requested. 5/27/09 Received vaccine & PCP medical records of 1/22-2/17/2009. Records reveal patient experienced tremor of both hands x 2 wks when seen on 1/22. Neuro exam WNL. Tx w/meds. RTC 2/17 w/right wrist pain, tx w/splint & ice. No further records available. 5/29/09 Neurological consult records recieved DOS 1/29/09 to 2/19/09. FINAL DIAGNOSIS: None Provided. Post vaccination intermittent shaking of hands. Headaches. ''Dry heaves'' stomach pains. 6/1/09 Received Neuro consult records of 3/9/09. FINAL DX: accentuated physiologic tremor; cervical myofascial pain w/intermittent occipital neuralgia; muscle tension-contraction cephalgia w/vascular overlap. Tx w/meds & referred back to PCP.

VAERS ID:342427 (history)  Vaccinated:2008-10-09
Age:13.0  Onset:2009-01-17, Days after vaccination: 100
Gender:Female  Submitted:2009-03-13, Days after onset: 54
Location:Wisconsin  Entered:2009-03-16, 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: Drug hypersensitivity
Preexisting Conditions: HPV #3 2/11/2009, lot # 1311X
Diagnostic Lab Data: None
CDC Split Type: WAES0902USA02175
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0575X1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Migraine
SMQs:
Write-up: Information has been received from a consumer concerning her 13 year old daughter with drug allergies to codeine and IMITREX and no other pertinent medical history who on approximately 12-AUG-2008 ("6 months ago") was vaccinated with the first dose of GARDASIL. Then the patient received the second dose of GARDASIL and when she had her menstrual cycle. After that on 17-JAN-2009 ("26 days ago") the patient experienced a migraine. On 11-FEB-2009 the patient received the third dose of GARDASIL. There was no concomitant medication. The patient also happened to start her cycle again and experienced another migraine. The patient started her menstrual cycle when she was eight year old and she had never had migraines before. No lab diagnostics studies were performed. The patient''s migraine persisted. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:342613 (history)  Vaccinated:2007-10-15
Age:13.0  Onset:2007-10-15, Days after vaccination: 0
Gender:Female  Submitted:2009-03-13, Days after onset: 515
Location:Washington  Entered:2009-03-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sulfonamide allergy
Preexisting Conditions: Acne 7/23/09 Medical records received DOS 6/20/08 to 6/26/09. Allergy to Sulfa, Dust mite extract, Cefazolin, house dust. PMH: Acne. Fx of humerus. H/A. Allergy to Sulfa, Dust mite extract, Cefazolin, house dust.
Diagnostic Lab Data: Unknown. 7/7/09 PCP MR received. Labs and Diagnostics: Culture of papular lesion (-). X-ray R foot, B ankles, wrist(-). ESR 10. ANA 1:40. Lyme (-). RF (-). Bone scan with increased activity of the sternoclavicular joints, considered WNL for age. 7/23/09 Medical records received DOS 6/20/08 to 6/26/09. LABS and DIAGNOSTICS: MRI Brain - Expected postsurgical changes. X-rays ankles/wrists - negative exam. CBC - WNL. Sed Rate - WNL. ANA (-) Rheumatoid Factor (-). Nuclear Medicine Whole Body Bone Scan - normal. Thyroid function tests indicate euthyroid. Lyme Disease Antibody - Negative. Labs and Diagnostics: Head CT abnormal. MRI brain abnormal-possible leptomeningeal cyst.
CDC Split Type: WAES0902USA01500
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB181AA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0802U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2385BA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Antinuclear antibody negative, Arthralgia, Arthropod bite, Autoimmune disorder, Blister, Blood pressure systolic increased, Bone scan normal, Borrelia burgdorferi serology, Borrelia burgdorferi serology negative, Computerised tomogram abnormal, Condition aggravated, Culture negative, Erythema, Excoriation, Fatigue, Full blood count normal, Gait disturbance, Headache, Hypothyroidism, Insomnia, Joint stiffness, Ligament laxity, Mass, Meningeal disorder, Migraine, Nuclear magnetic resonance imaging brain abnormal, Pain in extremity, Rash erythematous, Rash papular, Rash pruritic, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Scar, Surgery, Tendonitis, Thyroid function test abnormal, X-ray limb normal
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Accidents and injuries (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypothyroidism (narrow), Hyperthyroidism (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (narrow)
Write-up: Information has been received from a consumer concerning her 14 year old daughter with sulfa allergy and with no previous medical history reported who on 15-OCT-2007 was vaccinated with the first dose of GARDASIL (Lot number 658490/0802U) and on 16-JUN-2008 with the second dose of GARDASIL (Lot number 659180/1758U). Concomitant therapy included LEVOTHYROXINE Na. Four months ago, approximately in September 2008, the patient experienced joint pain in her ankles and wrists after receiving GARDASIL. The reporter also noted that the patient had experienced hypothyroidism after she received GARDASIL. The patient''s joint pain in her ankles and wrists and hypothyroidism persisted. Bone scan and blood work were performed to test for lymes disease (results were not provided). The patient sought medical attention with the physician. The consumer wanted to know if there have been any reports of these symptoms associated with the specific lot numbers that her daughter had received. A lot check has been initiated. Additional information has been requested. A standard lot check investigation was performed. All in-process qualit checks for the lot number in question were satisfactory. The lot met the requirments and was released. Additional information has been requested. 8/3/09 Records received from PCP for dates 10/2007 to 6/2008. In for WCC 10/15/07 with assessment: Healthy. Acne. 3 vax given. Pt returned 11/29/07 with c/o worsening H/As, most recent x 4 days, not resolving. Now more frequent. Painful mass on head. Assess: H/A- some migrainous characteristics. Lump/mass on head. Sent for head CT which was abnormal. Visual exam 12/7/07 doubt ocular origin of H/A. Referred to neurology. Thyroid studies noted to be abnormal. Now with c/o fatigue. Missing multiple days of school. 7/7/09 PCP MR received. OV for HPV vax on 6/16/08 (1758U). OV 8/14/08 for itchy, painful rash. Erythematous papular lesions with excoriation of center noted. Culture (-). OV 12/4/08 with c/o 1-2 month hx of bilateral wrist pain and stiffness and more acute heel pain. Having difficulty walking. PE (+) for diffuse tenderness over dorsal wrists and with dorsiflexion, ball of foot. Sent for labs. Assess: Joint pain. Return 1/5/09, 4/22/09 with same c/o. Ortho consult 4/20/09. Dx: Tendonitis. Joint Pain. 7/23/09 Medical records received DOS 6/20/08 to 6/26/09. Assessment: Autoimmune Hypothyroidism. Patient continues to be on thyroid replacement, has chronic migraine headaches, and had a recent repair of a left meningeal cyst. Surgical scar left fronto-parietal junction. Insect bites on both legs that are blistering. Joint stiffness and achiness involving ankles, wrists, fingers. Right heel pain. Redness over wrists. Bilateral ankle pain. Ligamentous laxity. Trouble sleeping. Elevated systolic blood pressure.

VAERS ID:342032 (history)  Vaccinated:2009-02-17
Age:13.0  Onset:2009-02-17, Days after vaccination: 0
Gender:Female  Submitted:2009-03-18, Days after onset: 28
Location:Missouri  Entered:2009-03-18
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: not physician diagnosed allergy to dial soap
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1311X0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2842AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2773AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Approximately one hr. after receiving vaccinations c/o itching to left cheek then progressing to right cheek, chin and ankles. Red raised "pimple-like" rash. Progressively subsided after approx. five days.

VAERS ID:342033 (history)  Vaccinated:2009-02-17
Age:13.0  Onset:2009-02-17, Days after vaccination: 0
Gender:Female  Submitted:2009-03-18, Days after onset: 28
Location:Missouri  Entered:2009-03-18
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.1311X0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2842AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2773AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Pruritus, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Approximately three hours following vaccination c/o itching on neck, cheeks and chest areas. Also reports accompanied by red,raised rash. Symptoms progressively improved and subsided after approximately five days.

VAERS ID:342035 (history)  Vaccinated:2008-05-27
Age:13.0  Onset:2008-06-01, Days after vaccination: 5
Gender:Female  Submitted:2009-03-18, Days after onset: 290
Location:Louisiana  Entered:2009-03-18
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none 4/2/09-menarche began at age 11 and everyother month very heavy and cramping.
Diagnostic Lab Data: Premature menopause 4/2/09-records received-Pelvic ultrasound WNL. DHEA 154 normal.Estradiol 23, LH 32.3 and FSH 96.5. Chromosome analysis normal.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U2UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Amenorrhoea, Blood follicle stimulating hormone, Blood luteinising hormone, Chromosome analysis normal, Oestradiol, Premature menopause, Ultrasound pelvis, Ultrasound scan normal, Weight increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Fertility disorders (narrow)
Write-up: She has not had a period after receiving her third vaccine. It''s been ten months since she had a period.4/2/09-records received for DOS 3/17/09-office visit 25 pound weight gain since 8/08-last period 8 months ago.

VAERS ID:342045 (history)  Vaccinated:2007-10-18
Age:13.0  Onset:2007-10-18, Days after vaccination: 0
Gender:Female  Submitted:2009-03-18, Days after onset: 517
Location:Tennessee  Entered:2009-03-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: The doctors office is showing two other shots Td Adult lot#C2775AA its hard to read the form given on 10/17/08; also meningococcal lot#U2426AA also given on 10/18/07; its very hard to read the lot numbers on the form. None; at the time of v
Current Illness: All of the side effects started at the time of the vaccination and the skin indentions started shortly after the first shot; no illnesses at the time vaccination; she developed symptoms; fatigue and fever right after receiving the shot; the other symptoms as well shortly after
Preexisting Conditions: None; my daughter was very healthy and athletic; so healthy she wouldn''t drink but maybe two soft drinks a year; she is allergic to the fruit formula given before having a CAT scan; we discovered that whe she was hospitalized for severe abdominal going to her side; no pre-existing conditions; purpose of the doc. visit complete physical in order to play volleyball for school; she was very healthy at the time; none of these symptoms; physical was a clean bill of health; after vaccinated she started experiencing all these symptoms; submitted form to your system a couple of days ago but I did not have all the lot numbers and info for the vaccines; this is the second and correct lot number submission
Diagnostic Lab Data: Several biopsies; performed by two dermatologist (specialist); regular dermatologist; plus regular doctor visits; and ultrasound and CAT scan of abdomen 3/23/09-records received-biopsy obtained. two skin graphs and blood work; specialist stated her fibers in her skin are breaking down
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500487P IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC.1265U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2426AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2775AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain, Asthma, Biopsy skin, Computerised tomogram, Lethargy, Myalgia, Ovarian cyst ruptured, Pyrexia, Scar, Skin disorder, Ultrasound abdomen, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: Fever, severe abdominal pain; muscle aches, lethargic, has asthma now, also developed skin indentions (tissue break down up underneath the skin) indentions are circular in size, starting around the injection site and has spread throughout entire body; specialist have never seen anything like it; referred for further testing; indentions are not going away but permanently scarring my child, also experiencing vertigo. 3/23/09-records received for DOS 11/10/08-presented with C/O lesions to trunk and extremities- 3/30/09-records received-ED visit 11/2/08-C/O abdominal pain, DX: ruptured ovarian cyst. Follow-up: (hospitalization, moody, headaches, sweating, vomiting, has developed a rash (skin indentions); attended a wide dermatologist meeting; commented it looks almost like a "pox"; they''ve never seen; also referred me; visual looks like an indentation someone might receive from a polio shot; please help; she has over seventy now and spreading.

VAERS ID:343156 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2009-03-06
Location:Unknown  Entered:2009-03-18, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA02502
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Information has been received from a nurse practitioner concerning a female who at the age of 13 (approximately 1996) was vaccinated with a first dose of RECOMBIVAX HB (manufacturer unknown) and developed a fever of 104 degrees F. No additional information was available. Additional information has been requested.

VAERS ID:343208 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2009-03-06
Location:Delaware  Entered:2009-03-18, 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: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0808USA03092
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hypersensitivity
SMQs:, Angioedema (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a medical assistant concerning a 20 year old female who was vaccinated with RECOMBIVAX HB. Concomitant therapy included MENINGOCOCCAL vaccine (unspecified). Subsequently the patient experienced an unspecified allergic reaction when she received her first dose of RECOMBIVAX HB. The patient received the vaccine by her primary care physician when she was in the 7th grade. The patient was no longer under the care of the same physician therefore there was no additional AE information available. Subsequently, the patient recovered from unspecified allergic reaction. Follow-up information was received from the physician''s office. The healthcare professional stated that the "patient did not have the GARDASIL vaccine due to an apparent allergy to aluminum, had reaction after receiving RECOMBIVAX HB and MENINGOCOCCAL vaccine series was done. Additional information is not expected.

VAERS ID:343394 (history)  Vaccinated:2008-02-02
Age:13.0  Onset:2008-02-02, Days after vaccination: 0
Gender:Female  Submitted:2009-03-04, Days after onset: 396
Location:Illinois  Entered:2009-03-18, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: MRSA Infection. History: MRSA infection of the skin. No known drug allergies. No adverse events following previous vaccinations.
Diagnostic Lab Data: Blood pressure, 02Feb2008, low; CBC, 11Feb2008, normal; CT scan, 11Feb2008, normal; Chest x-ray, 11Feb2008, normal; Creatine phosphokinase, 11Feb2008, normal; Electrocardiogram, 11Feb2008, normal; Erythrocyte sedimentation rate, 11Feb2008,
CDC Split Type: A0709448A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB211AA0UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.0384U0UNUN
Administered by: Private     Purchased by: Private
Symptoms: Blood creatine phosphokinase normal, Chest X-ray normal, Computerised tomogram normal, Electrocardiogram normal, Full blood count normal, Heart rate increased, Hypotension, Influenza serology negative, Metabolic function test normal, Mononucleosis heterophile test negative, Presyncope, Red blood cell sedimentation rate normal
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of near fainting in a 13-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), GARDASIL. The subject''s medical history included MRSA infection of the skin. On 2 February 2008 at 09:30 the subject received 2nd dose of HAVRIX (.5 ml, left arm) and the 1st dose of GARDASIL. On 2 February 2008, 12 hours after vaccination with GARDASIL and HAVRIX, the subject experienced near fainting, low blood pressure and rapid heartbeat. The subject was seen in the emergency room. At the time of reporting the outcome of the events were unspecified. On 28 February 2008 follow-up was received via the healthcare professional. She reported that on 02 February 2008, the subject experienced near fainting, low blood pressure and rapid heartbeat. The events resolved on 08 February 2008. On 11 February 2008, diagnostic test for influenza, CBC, ESR and CPK were normal. A CT scan of the head, chest x-ray and EKG were also normal. She considered that the events were not serious and she considered that the events were possibly related to the use of HAVRIX. She also stated that she was unsure which product were suspect.

VAERS ID:343441 (history)  Vaccinated:2008-08-02
Age:13.0  Onset:0000-00-00
Gender:Male  Submitted:2009-03-04
Location:New York  Entered:2009-03-18, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No concurrent medications
Current Illness: Unknown
Preexisting Conditions: The subject has no relevant medical history and no history of adverse events following previous vaccinations.
Diagnostic Lab Data: The subject''s blood pressure remained within 90/50 (his normal is 110/55). After 20 minutes he felt better and was sent home. His blood pressure went back up to 96/53.
CDC Split Type: A0742501A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB291AA1UNLA
Administered by: Private     Purchased by: Private
Symptoms: Blood pressure decreased, Fatigue, Hyperhidrosis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of sweating in a 13-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). There were no concurrent medications. On the morning of 2 February 2008 the subject received 1st dose of HAVRIX at 0.5 ml in the left arm. An unspecified amount of time following vaccination with HAVRIX, the subject experienced sweating and feeling very tired. This resolved after 20 minutes. Then on the morning of 02 August 2008 (the subject was now 14 years old) the subject received a 2nd dose of HAVRIX at 0.5 ml in the left arm. Immediately afterwards, he experienced tiredness and sweating which lasted 10 minutes. His blood pressure remained within 90/50 (his normal is 110/55). After 20 minutes he felt better and was sent home. His blood pressure went back up to 96/53 (improved). Follow-up information was received on 04 September 2008 via a physician, which conflicted with the initial report. The physician reported that all of the events resolved after 20 minutes, but listed the date of onset as 08 May 2008, which differs from the previously reported vaccination dates. The physician indicated that the events were resolved and were possibly related to vaccination with HAVRIX. In addition, the physician stated that no action was taken other than rest for the subject.

VAERS ID:342285 (history)  Vaccinated:2009-01-23
Age:13.0  Onset:2009-01-23, Days after vaccination: 0
Gender:Male  Submitted:2009-03-09, Days after onset: 44
Location:Florida  Entered:2009-03-20, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec
Current Illness: None
Preexisting Conditions: Environmental allergies & foods also
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2728AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Oedema peripheral, Pain in extremity, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Extensive local swelling including entire arm and proximal forearm with localized pain and urticaria.

VAERS ID:342334 (history)  Vaccinated:2009-02-26
Age:13.0  Onset:2009-02-26, Days after vaccination: 0
Gender:Male  Submitted:2009-03-20, Days after onset: 21
Location:Maryland  Entered:2009-03-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: allergy to azithromycin - vomiting PMH: hives approx 6 mo earlier, cause unknown; dyspnea at rest; eczema. Allergy: lobster.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2640AA0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3068AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Anaphylactic reaction, Auricular swelling, Chest discomfort, Depressed level of consciousness, Dizziness, Dyspnoea, Lip swelling, Nausea, Oropharyngeal pain, Pallor, Rash, Speech disorder, Swelling face, Swollen tongue, Syncope, Urticaria
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Oropharyngeal allergic conditions (narrow), 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: 3-4 hours after vaccines (and after dinner + dessert), developed hives, lip/tongue swelling, throat and chest discomfort and dyspnea; then syncope. Resolved after EPINEPHRINE, SOLUMEDROL, BENADRYL. 4/6/09 Received hospital medical records of 2/26-2/27/2009. FINAL DX: anaphylaxis Records reveal patient experienced facial swelling, bilateral pinna edema, rash, nausea, pallor, difficulty speaking, shortness of breath, chest discomfort & lightheadedness approx 2.5 hr s/p vaccinations. Had eaten ice cream w/peanut butter. Had syncopal episode & became obtunded while in ER. Eats nuts/PB regularly. Tx w/epi, IV steroids. Rash resolved, swelling decreased. Admitted overnight for observation. No rebound & d/c to home w/epipen. Already had allergist appt for coming mo.

VAERS ID:342565 (history)  Vaccinated:2009-03-17
Age:13.0  Onset:2009-03-18, Days after vaccination: 1
Gender:Female  Submitted:2009-03-19, Days after onset: 1
Location:Pennsylvania  Entered:2009-03-24, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~DTaP + Hib (no brand name)~4~1~Patient
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB257AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0575X0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2668AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0785X1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness, swelling (half dollar sized) at injection site of VARIVAX vaccine 24 hours prior.

VAERS ID:342569 (history)  Vaccinated:2009-01-27
Age:13.0  Onset:2009-02-17, Days after vaccination: 21
Gender:Female  Submitted:2009-03-17, Days after onset: 27
Location:North Carolina  Entered:2009-03-24, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: LABS: Urine c/s of 2/17 no growth. UA 2/24 WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB257AA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0575X2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain lower, Culture urine negative, Dysuria, Eye infection, Malaise, Micturition urgency, Pallor, Pollakiuria, Rash erythematous, Urinary tract infection, Urine analysis abnormal
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular infections (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: GARDASIL dose #3 1/27/09 2/17/09 - Dysuria with Lower Abdominal Pain UA - Large Blood, small leuks, Prot $g 300 mg/DL cx-neg symptoms lasted 1 week - Repeat urine x 2 - normal. 4/3/09 Received vac records & PCP medical records for 2/17-2/26/2009. FINAL DX: UTI, dysuria Records reveal on 2/17/09 patient experienced pain w/urination, grequency & urgency x 1 day. Had just completed menses. Tx w/oral antibiotics. RTC 2/26 & had felt unwell since 1/27. Had eye infection 2/4, possible UTI 2/11 & now UTI w/abdominal pain & dysuria. Exam revealed erythematous blanching rash thought to be drug vs vaccine reaction. Antibiotic d/c. No further records available.

VAERS ID:342596 (history)  Vaccinated:2008-04-08
Age:13.0  Onset:2008-04-08, Days after vaccination: 0
Gender:Female  Submitted:2009-03-24, Days after onset: 350
Location:Arizona  Entered:2009-03-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Calcium (unspecified); Iron (unspecified); Vitamins (unspecified)
Current Illness: Pregnancy NOS (LMP = 12/28/2007)
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0809USA04651
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTOX: DIPHTHERIA TOXOIDS (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.    
Administered by: Other     Purchased by: Other
Symptoms: Caesarean section, Drug exposure during pregnancy, Large for dates baby
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow)
Write-up: Information has been received from a consumer, who was the guardian of the patient, for the Pregnancy Registry for GARDASIL, concerning a 14 year old female with no pertinent medical history or drug reactions or allergies who on 08-APR-2008 was vaccinated with a 0.5 ml dose of GARDASIL. On the same day, the patient was also vaccinated with VARIVAX (Merck), tetanus toxoid vaccine, diphtheria toxoid vaccine, meningococcal conj vaccine (unspecified), hepatitis A virus vaccine (unspecified) (manufacturer unknown) and "ACHD". Concomitant therapy included calcium (unspecified), iron (unspecified) and prenatal vitamins. It was reported that the patient would be delivering next week. There were no lab tests performed. It was reported that the patient had no ill effects from this. The patient sought unspecified medical attention via the physician. Follow-up information was received from a staff member in the physician''s office via phone call. It was reported that the patient delivered a healthy and normal baby boy on 05-OCT-2008 via C-section. The C-section was performed because the baby was "like 12 lbs". The reporter did not have any additional information to provide. Upon internal review, the baby was "like 12 lbs" that required C-section was considered to be other important medical event. Additional information is not expected.

VAERS ID:342655 (history)  Vaccinated:2008-12-04
Age:13.0  Onset:2008-12-07, Days after vaccination: 3
Gender:Female  Submitted:2009-03-25, Days after onset: 107
Location:Ohio  Entered:2009-03-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: None
Preexisting Conditions: No pre-existing diagnosed issues 3/26/09-records received-PMH: sprained thumb and mononucleosis 4/20/09-records received-PMH:Depression PVCs.
Diagnostic Lab Data: MRI (1/20/09)- pineal cyst - neurosurgeon validated this was not impacting any vessels which would cause headache. CATSCAN: normal / Sleep study: no sleep apnea. 46 awakenings. Blood tests: normal / Allergy tests (2/2/09) : no allergies / Cardiology: PVC''s on average 22% of time. Cardiologist validated this was not cause of headaches / Lumbar Puncture (2/23/09): normal 3/26/09-records received-CT brain negative. 4/20/09-records received-Pineal cyst noted on MRI. PVCs seen on EKG during sleep study. CSF opening pressure normal. CSF counts normal. MRIs negative. Negative sleep study.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2795AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Allergy test negative, Asthenia, Blood test normal, CSF pressure normal, Computerised tomogram normal, Electrocardiogram abnormal, Fatigue, Headache, Hypophagia, Insomnia, Lumbar puncture normal, Malaise, Nausea, Nuclear magnetic resonance imaging abnormal, Scan brain, Sleep disorder, Sleep study abnormal, Ventricular extrasystoles, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)
Write-up: Approximately 4:00PM 12/7/08 Symptom: Headache This came on suddenly. Pain level was a 5. Described as aching pain on back (upper) head. Was seen in ER on 12/9/08 after pain had continued for 48+ hours with no abatement (increased to level 7 pain) and getting < 4hrs of sleep per night. ER treated with Toradol, Midrin and Phenegrin. Pain level reduced to 4 and discharged from ER. Pain continued and increased to Level 7. Again treated at ER with no long term benefits. This has continued since 12/7. Pain is continual 24 x7. 3 ER visits and 4 day hospital admittance on 2/23/09 for high dose steroids IV. This did not aleviate pain. Insomnia that has occurred since 12/7 has been treated with Ambien since 2/26/09 3/26/09-records received for ED visit 12/9/08-C/O gradual onset of headache began 3 days ago. Bilateral sharp pain 7 out of 10. Nausea. Assessment:Headache. 4/20/09-records received-for DOS 2/23-2/26/09-Presented with headaches since 12/7/08 constant and localized to occipital region throbbing in character. HA is made worse by activity and unable to attend school for past 2 months. As HA worsens C/O feeling nauseous and has had decreased PO intake with 15 pound weight loss. Insomnia. Malaise, weakness, fatigue. Abdominal pain.

VAERS ID:342667 (history)  Vaccinated:2009-03-16
Age:13.0  Onset:2009-03-18, Days after vaccination: 2
Gender:Male  Submitted:2009-03-25, Days after onset: 7
Location:California  Entered:2009-03-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2820AA0SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3030AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1777X1IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Mass, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Had 2 swollen lump area. One lump to left deltoid 8.5x5.5mm. One lump to left arm sub-q 5 x 5mm. Lumps occurred one day after injection.

VAERS ID:342785 (history)  Vaccinated:2009-03-23
Age:13.0  Onset:2009-03-23, Days after vaccination: 0
Gender:Male  Submitted:2009-03-26, Days after onset: 3
Location:Arizona  Entered:2009-03-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: None
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2816AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2768BA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Back pain, Loss of consciousness, Mydriasis, Pallor, Pyrexia, Respiratory rate increased, Syncope, Tremor, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Patient received his Tdap vaccine first. It took us 10 minutes after administration of the Tdap to determine he also needed MCV. This was administered. Within one minute, he had an episode of syncope which started with paleness and pupil dilation. He lost consciousness for 5-10 seconds and then regained it. He began breathing quickly when he regained consciousness. His pulse was slow and steady throughout the episode. After about 30 seconds he verbalized the need to vomit and then did so. He was able to talk and drink juice. He stayed seated for about 20 minutes. When he left the office he said he was feeling a little weak, but was other wise fine. He walked to the car without help. He had no symptoms of allergic reaction and did not fall in the office. I spoke with mom the following day. She stated he was still feeling a little weak, but went to school that day. He was in the nurse''s office after about an hour complaining of weakness, feeling shaky and back pain. She gave him food since he had not had breakfast and finished the day at school. When he went home he had a slight fever. No temp was taken. Mom gave his Ibuprofen and if any other symptoms emerged I told her to call and inform me.

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