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Case Details (Sorted by Age)

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VAERS ID: 279250 (history)  
Age: 23.0  
Gender: Female  
Location: Washington  
Vaccinated:2007-04-19
Onset:2007-04-20
   Days after vaccination:1
Submitted: 2007-05-21
   Days after onset:31
Entered: 2007-05-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 0 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Asthma, Condition aggravated, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VENTOLINE (ALBUTEROL SULFATE, LORATIDINE D, SINGULAIR
Current Illness: Asthma; Hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0705USA02873

Write-up: Information has been received from a health professional concerning a 23 year old black/white female receptionist with asthma (diagnosed at the age of 5 year old) and outdoor allergies who on 19-APR-2007 at 01:15 (AM or PM not reported) was vaccinated IM in left arm deltoid with a first dose of Gardasil lot #655849/0263U. Concomitant therapy included montelukast sodium (MSD) loratadine (+) pseudoephedrine sulfate (LORATIDINE D) and albuterol sulfate (VENTOLINE (albuterol sulfate)). On 20-APR-2007, Friday night at 11:00 PM patient woke up with short of breath. Her rescue inhaler did not help so she used her nebulizer. On 21-APR-2007 she used her nebulizer again around 6:30 AM and through out that day 4 to 6x. On 22-APR-2007, Sunday she did 6 nebulizer treatment within one-two hours before being admitted at the hospital. In the hospital she had additional nebulizer treatment (10+) times and steroid injections. Patient stated that this was her worst asthma attack since being diagnosed. Patient recovered. Additional information is not expected.


VAERS ID: 279584 (history)  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-05-07
Onset:2007-05-09
   Days after vaccination:2
Submitted: 2007-05-24
   Days after onset:15
Entered: 2007-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV111 / 0 LA / SC
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS UNKNOWN / 0 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Erythema, Induration, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none known
Current Illness: none known
Preexisting Conditions: depression and insomnia
Diagnostic Lab Data: none
CDC Split Type:

Write-up: 8X6 inch area of warmth, erythema and enduration 48 hours post Anthrax immunization


VAERS ID: 279616 (history)  
Age: 23.0  
Gender: Male  
Location: Delaware  
Vaccinated:2007-05-18
Onset:2007-05-18
   Days after vaccination:0
Submitted: 2007-05-21
   Days after onset:3
Entered: 2007-05-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB287BA / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

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: Non-Alcoholic Fatty Liver Disease
Diagnostic Lab Data:
CDC Split Type:

Write-up: About 15 min after injection ,pt c/o dizziness and blurry vision. He was escorted back to exam room to lay on exam table and given water (which he requested). He denied HA, abdominal pain, nausea, SOB, chest pain, or palpitations. At about 2:00 he indicated that his sxs had resolved and he was released to care of his brother at 2:34 PM.


VAERS ID: 280766 (history)  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2006-04-14
Onset:2006-04-24
   Days after vaccination:10
Submitted: 2007-05-16
   Days after onset:387
Entered: 2007-05-24
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1110R / 0 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Drug ineffective, Herpes zoster, Varicella
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: VZV stain no results provided
CDC Split Type: WAES0606USA00387

Write-up: Information has been received from a registered nurse concerning a 23 year old female, with no medical history and no allergies, who on 14-APR-2006 was vaccinated (route unknown) with a first dose in the left arm of Varivax (Lot # 650235/1110R). There was no concomitant medication. There was no illness at the time of vaccination and no adverse events following prior vaccination. On 24-APR-2006 the patient developed a scattered maculopapular rash, bilateral, on her upper arms, trunk, back, shoulders, and scalp with pruritus. There was no oozing, drainage, fever, or diarrhea. The patient was seen by a company physician and diagnosed with varicella. She was treated with an over the counter antihistamine (unspecified). Subsequently, the patient fully recovered on an unspecified date. The lab diagnostic studies performed indicated that the patient had a titer prior to vaccination. No product quality complaint was involved. Additional information is not expected.


VAERS ID: 279981 (history)  
Age: 23.0  
Gender: Female  
Location: Nebraska  
Vaccinated:2007-05-16
Onset:2007-05-16
   Days after vaccination:0
Submitted: 2007-05-22
   Days after onset:6
Entered: 2007-05-30
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0216F / 2 LA / SC

Administered by: Public       Purchased by: Private
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

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: Diabetes Type I
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Severe dizziness within 15 minutes of immunization. S/S increased a few hours after injection. She did not pass out.


VAERS ID: 280049 (history)  
Age: 23.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2007-05-08
Onset:2007-05-15
   Days after vaccination:7
Submitted: 2007-05-30
   Days after onset:15
Entered: 2007-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0388U / - LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)

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: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received vaccine on 5-8-2007 in L Deltoid. The site hurt initially but the discomfort was gone the next day. The site began hurting again 1 week later and called office and was instructed to use warm compresses and Tylenol or Advil and to call back if no better.The patient denied any redness at the site and denied fever. She states her arm did feel better but became very sore on May 27th. Hurts more at night than during the day. States she can not lift her arm above her head and getting dressed is difficult. States she feels fine otherwise, denies redness, swelling at site or fever.


VAERS ID: 280102 (history)  
Age: 23.0  
Gender: Male  
Location: Ohio  
Vaccinated:2007-05-16
Onset:2007-05-17
   Days after vaccination:1
Submitted: 2007-05-23
   Days after onset:6
Entered: 2007-05-31
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB403AA / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Codeine
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Had 1st Hep B vaccine on Wednesday (5/16) at 1:00pm. Noticed hives on forehead, cheeks, behind ears and back of neck at 11:0am (5/17). Took Benadryl and Chlorpheneramine but did not notice improvement. Hives left Monday night roughly (5/21). Had little on Tuesday (5/22).


VAERS ID: 280253 (history)  
Age: 23.0  
Gender: Female  
Location: Mississippi  
Vaccinated:2007-05-21
Onset:2007-05-22
   Days after vaccination:1
Submitted: 2007-05-29
   Days after onset:7
Entered: 2007-06-04
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U1621AA / 0 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth, Rash generalised
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: CUT @ RT LOWER LEG
Preexisting Conditions: NONE IDENTIFIED
Diagnostic Lab Data: None
CDC Split Type: MS0718

Write-up: Left deltoid swelling, bruising, warm at site, rash over all of body. Small bumps began day after Td given 5/21/07. Patient seen by Dr, PMD seen 5/22/07. Given antibiotics requested Td due to cut to right lower leg.


VAERS ID: 283417 (history)  
Age: 23.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:1990-03-01
Onset:2006-06-12
   Days after vaccination:5947
Submitted: 2007-05-30
   Days after onset:352
Entered: 2007-06-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antibody test positive, Blood immunoglobulin G, Measles antibody positive, No adverse reaction, Rubella antibody positive
SMQs:, Vasculitis (broad), Hypersensitivity (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: hydrochlorothiazide mg
Current Illness:
Preexisting Conditions: Anti-HBs antibody negative
Diagnostic Lab Data: serum measles IgG 06/12/06 2.28 - positive; serum mumps IgG antibody 06/12/06 <_91 - ; serum rubella IgG 06/12/06 101.3 - positive
CDC Split Type: WAES0607USA00974

Write-up: Information has been received from a pharmacist and registered nurse concerning a 23 year old male with no known drug allergies and a history of low titer to Hepatitis B, who on 05-FEB-1985 was vaccinated with his first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The patient received the second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 01-MAR-1990. Concomitant therapy included hydrochlorothiazide (start date unspecified). The nurse reported that the patient had a partial failure to M-M-R vaccine involving a mumps titer. A mumps titer performed 12-JUN-2006 was less than 0.91. Results for component products were positive on this date, Rubella titer 101.3 and Measles titer 2.28. Unspecified medical attention was sought. At the time of this report, the patient outcome was unknown. A product quality complaint was not involved. Subsequently, the patient experienced an event with hepatitis B virus vaccine rHBsAg (yeast) vaccine (WAES# 0607USA00971).


VAERS ID: 283484 (history)  
Age: 23.0  
Gender: Male  
Location: Texas  
Vaccinated:2006-10-19
Onset:2006-10-31
   Days after vaccination:12
Submitted: 2007-05-30
   Days after onset:210
Entered: 2007-06-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0216F / - UN / SC

Administered by: Private       Purchased by: Private
Symptoms: Body temperature increased, Eosinophil count decreased, Erythema, Lymphadenopathy, Myalgia, Pyrexia, Rash, Rash maculo-papular, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: eosinophil count 10/31/06 13 - slightly decreased; body temp 10/31/06 $g100 - low fever; WBC count 10/31/06 3.3 - slightly decreased
CDC Split Type: WAES0611USA01077

Write-up: Information has been received from a nurse practitioner concerning a 23 year old white male with no medical history or allergies who on 19-OCT-2006 at 14:30 was vaccinated in the right arm with a SC 0.5 mL dose of MMR (lot # 653338/0216F). Vaccination history was not available. There patient was illness at the time of vaccination. Vaccination history not available. On 31-OCT-2006 the patient reported developing a low fever($g100), muscle aches, and a red rash on his shoulders. It was also reported that the morning of 31-OCT-2006 the patient developed lymphadenopathy, post-cervical and post-auricular. He also developed a generalized maculo-papular rash over his face with a few patches on his chest and upper back. Unspecified medical attention was sought. A CBC was performed that indicated slightly low levels of white blood cells(3.3) and eosinophils(13). All other values were normal. The patient recovered. The patient did not experience any adverse events following prior vaccinations. There was no product quality complaint involved. Additional information is not expected.


VAERS ID: 283498 (history)  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2006-12-06
Onset:2006-12-06
   Days after vaccination:0
Submitted: 2008-03-12
   Days after onset:461
Entered: 2007-06-04
   Days after submission:282
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0805F / - - / SC

Administered by: Other       Purchased by: Other
Symptoms: Accidental exposure, Eye irritation, Laboratory test normal
SMQs:, Corneal disorders (broad), Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: MIRENA, naproxen
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: laboratory test, 12/06/06, labs sent out; diagnostic laboratory;
CDC Split Type: WAES0612USA00966

Write-up: Information has been received from a registered nurse concerning a 23 year old female, with no medical history, who on 06-DEC-2006 got a small amount of MMR II (Lot# 654821/0805F) splashed into her right eye. Concomitant therapy included Naproxen and MIRENA. Initially, on 06-DEC-2006, the patient experienced burning. A medical assistant irrigated the affected eye and the eye was no longer burning. It was noted that the patient was doing fine and she went to see a health care professional. No product quality complaint was involved. No other information was provided. Additional information has been requested. Follow-up received 06/18/2008. Medical attention was sought and general labs were performed. No medical problems were reported. No further information is expected. This is in follow-up to report (s) previously submitted on 5/30/2007. It has been determined that WAES #0612USA00966 is a duplicate of WAES #0612USA01077. Therefore, WAES #0612USA00966 is being deleted from our files and the reports consolidated into WAES #0612USA01077. Additional information has been requested.


VAERS ID: 281181 (history)  
Age: 23.0  
Gender: Male  
Location: Wisconsin  
Vaccinated:2007-05-27
Onset:2007-06-05
   Days after vaccination:9
Submitted: 2007-06-11
   Days after onset:6
Entered: 2007-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 0 LA / ID
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z06632 / 0 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Body temperature increased, Headache, Mental status changes, Nausea, Pharyngolaryngeal pain, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: Unknown
Preexisting Conditions: Penicillin. PMH:PCN allergy.
Diagnostic Lab Data: Unknown, full work up was done, records are unavailable at this time. Labs and Diagnostics: CBC and Chem unremarkable. UA (-). Blood cultures (-). Rapid strep (-). ECG with non-specific T wave abnormality.
CDC Split Type:

Write-up: Seen at the Medical Clinic on 6/5/07 with c/o HA, vomiting, sore throat and mental status change. Elevated temp of 102.6. Sent to ER for full work up and was admitted due to continue Febrile status. IV fluids given. D/C''d to home on 6/7/07 and followed up with the Medical Clinic on 6/8/07 with c/o vertigo and nausea. Patient reported at that time that he had a spike in his temperature the previous night. Patient had received smallpox vaccination on 5/27/07. Given quarters x 48 hours, ordered Ibuprofen and Meclizine prn and Azithromycin was started. 06/14/2007 Additional records received from reporter for 3 OV of June 5,8,& 11 2007. Initial visit of 6/5/07 for c/o fever, vomiting, dizziness, feeling of passing out, h/a and sore throat as well as pain at smallpox injection site. Appeared lethargic and and had difficulty answering questions upon PE. Disoriented. Not well hydrated. Tenderness noted on lateral aspect of neck. Coordination and cerrebellum abnormalities noted. Assessment: Mental Status Change. Refered to ER. 2nd visit 6/8/07 in F/U of ER visit with DX of Febrile Viral Illness vs Smallpox Reaction. Still c/o fever, vertigo, and nausea. Still appearing lethargic but now oriented x3. A/P Infectious Disease-Viral. F/u 6/11/2007 reports no better with cont H/A, nausea, vomiting, fevers, and pain. A/P Headache Syndromes with ? etiology-new onset migraines vs viral./pc 06/18/2007 MR received for admission 6/5-7/2007 for fever, chills, vertigo and vomiting. Pt had headache and sore throat x 3 days. (+) fatigue, lethargy and malaise. PE (+) for temp of 104.1''F (40.1''C). Pulse 105. Otherwise WNL. Remained weak during admission, and C/o mild SOB with ambulation. Throat pain remained. Discharge DX: Fevers and lethargy, viral syndrome vs. reaction to small pox vaccine. 02/01/2010 Combined with headaches one month post vaccination and reported palpitatiosn and SOB at noc x 3.5 mm that started 19 June 07 fast reset to our TMC 21 hre 07.


VAERS ID: 281434 (history)  
Age: 23.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2007-05-08
Onset:2007-05-08
   Days after vaccination:0
Submitted: 2007-06-12
   Days after onset:35
Entered: 2007-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0389U / 2 LA / IM

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), Hypoglycaemia (broad)

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:

Write-up: Became very faint after getting immunization (Gardasil) put in supine position w/legs elevated.


VAERS ID: 282572 (history)  
Age: 23.0  
Gender: Male  
Location: Iowa  
Vaccinated:2007-03-21
Onset:2007-03-22
   Days after vaccination:1
Submitted: 2007-05-17
   Days after onset:56
Entered: 2007-06-18
   Days after submission:32
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0904F / 0 RA / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1278F / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2632AA / 0 LA / IM
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UE998AA / 0 LA / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Body temperature increased, Chills, Full blood count normal, Laboratory test normal, Pain, Pain in extremity
SMQs:, Neuroleptic malignant syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: He did not have any medical history, was not on any medications and did not have any illness at the time of the vaccinations.
Diagnostic Lab Data: CMP and CBC Unremarkable
CDC Split Type: 200701314

Write-up: Initial report received from a health care professional in the USA on 18 April 2007. A 23 year old, male patient complained of a temperature of 100F overnight, chills, aching arm and generalized achiness, after he received Adacel (lot number not known, route and site of administration not known) and YF-Vax (lot number UE998AC, route and site administration not known) on 21 March 2007. He also received Hepatitis A vaccine and Hepatitis B vaccine (lot number (s) not known, tradename (s), route (s) and site (s) of administration not known) on the same day. He did not have ant medical history, was not on any medications and did not have any illness at the time of the vaccinations. He was not treated with medications. His symptoms resolved within 24 hours and he recovered. Follow-up information received on 14 May 2007 from a health care professional provided the following batch numbers: Adacel (C2632AA) given intramuscularly in the left deltoid, YF-Vax (UE998AC) given subcutaneously in the left arm, Hepatitis A (1278F) given intramuscularly in the right upper deltoid, and Hepatitis B (0904F) given intramuscularly in the right lower deltoid. A complete metabolic panel and complete blood count were noted to be unremarkable, and no treatment was given. No given information is expected. This case has the same reporter as case 2007-01315.


VAERS ID: 283789 (history)  
Age: 23.0  
Gender: Female  
Location: Maryland  
Vaccinated:2007-04-20
Onset:2007-04-20
   Days after vaccination:0
Submitted: 2007-06-14
   Days after onset:55
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0388U / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Abdominal pain lower, Back pain, Dizziness, Headache, Nausea, Pyrexia, Vertigo
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0705USA01657

Write-up: Information has been received from a registered nurse concerning a 23 year old female who on 20-APR-2007 was vaccinated with the second dose of Gardasil, lot# 657622/0388U. There was no concomitant medication. On 20-APR-2007 within a few minutes after the vaccination the patient felt light headed and dizzy and had to lie down. She was monitored at the physician''s office for 25 minutes and hydrated with water, and she recovered and felt she was able to drive home. While the patient was driving home, she developed a severe headache, vertigo and lower abdominal pain. She felt she had to pull off the road and fell asleep. When she awoke, she felt well enough to drive home but the symptoms had not fully recovered. That same day, approximately 6 hours later, the patient developed abdominal cramps, back pain, was nauseous and felt like she had a low grade fever. The patient took IBUPROFEN and OTC TYLENOL which was effective and she slept. The next day, on 22-APR-2007 the patient had a very mild case of nausea, but no back pain and no abdominal pain. The nurse stated that the patient called the office sometime the week of 30-APR-2007 on an unrelated issue and then mentioned the adverse event she experienced when she arrived home. It was reported that within 24 hours all the symptoms had resolved and the patient had recovered. The nurse indicated that she previously reported a similar adverse event for another patient (reference WAES# 0612USA02247). Additional information has been requested.


VAERS ID: 283795 (history)  
Age: 23.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2007-02-05
Onset:2007-02-19
   Days after vaccination:14
Submitted: 2007-06-14
   Days after onset:114
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Corrective lens user, Vision blurred, Visual acuity tests abnormal
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPO-PROVERA 0
Current Illness:
Preexisting Conditions: ASTHMA
Diagnostic Lab Data: visual acuity test, 02/19?/07, negative 600; visual acuity test, 05?/??/07, negative 700
CDC Split Type: WAES0705USA01751

Write-up: Information has been received from a health professional concerning a 24 year old female who on 05-FEB-2007 was vaccinated with Gardasil. Concomitant therapy included DEPO-PROVERA. On approximately 19-FEB-2007 the patient experienced blurry vision. The patient''s vision "was negative 600 and is now negative 700." The nurse practitioner reported that Gardasil would not be reintroduced. Additional information has been requested. This is in follow-up to reports previously submitted on 06/14/2007. Initial and follow-u information has been received from a health professional concerning a 24 year old female with a history of and no illness at the time of vaccination who on 05-FEB-2007 was vaccinated at 16:20 in the right arm with a first dose of GARDASIL (lot # 655619/1427F). Concomitant vaccinations included a fifth dose of DEPO-PROVERA (Lot # 06P601) in the left arm. On approximately 19-FEB-2007 the patient experienced blurry vision in the left eye even with contacts and glasses. The patient saw an eye doctor and her vision for the past two years was negative 600 and is now negative 700. The nurse practioner reported that GARDASIL would not be reintroduced. At the time of this report, the patient had not recovered. Additional information is not expected.


VAERS ID: 283803 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-02-22
Onset:0000-00-00
Submitted: 2007-06-14
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0705USA01987

Write-up: Information has been received from a medical assistant and a 23 year old medical secretary concerning herself who on 18-SEP-2006 was vaccinated intramuscularly with the first 0.5 mL dose of Gardasil (lot #"069F"). On 28-SEP-2006, the patient was vaccinated intramuscularly with the second 0.5 mL dose of Gardasil (lot #653937/0637F). On 22-FEB-2007 the patient was vaccinated with the third dose of Gardasil (lot #653937/0637F). The patient reported that she "experienced a 20 minute period of parasthesia (numbness and tingling) in the arm after the first and second dose of the vaccine were administered." Patient stated she "did not have the same experience after receiving the third dose." The patient sought unspecified. The patient recovered. There was no product quality complaint. Additional information has been requested.


VAERS ID: 283967 (history)  
Age: 23.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-02-08
Onset:2007-02-08
   Days after vaccination:0
Submitted: 2007-06-14
   Days after onset:125
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 0 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Haemoglobin normal, Nausea, Urine analysis normal, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: IMURAN, 100 mg; COLAZAL; SEASONALE
Current Illness: Menstruation irregular; Attention deficit/hyperactivity disorder
Preexisting Conditions: Unknown; Crohn''s disease; Infectious mononucleosis
Diagnostic Lab Data: Unknown; blood pressure, 02/09/07, 88/52, At the time of admission in ER; pulse oximetry, 02/09/07, 100%, on RA(At the time of discharge from ER); blood pressure, 02/09/07, 88/55, At the time of discharge from ER; temperature measurement, 02/09/07, 102.4 Deg F, oral(At the time of admission to ER); WBC count, 02/09/07, 10.4; vital sign, 02/09/07, 135, Heart rate (At the admission time to ER); vital sign, 02/09/07, 108, Heart rate (At the time of discharge from ER); respiratory rate, 02/09/07, 19, Discharge time from ER; urinalysis, 02/09/07, Negat; hemoglobin, 02/09/07, 12.3; respiratory rate, 02/09/07, 20, At the time of admission to ER
CDC Split Type: WAES0705USA02912

Write-up: This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a nurse and from the emergency room medical record concerning a 23 year old female hair stylist with irregular menstruation, attention deficit/hyperactivity disorder and a history of anaemia, Crohn''s disease and infectious mononucleosis who on 08-FEB-2007, at 14:15 PM was vaccinated IM in to right deltoid with a first dose of Gardasil lot #654702/0011U. She received the second dose of Gardasil on an unspecified date. Concomitant therapy included azathioprine (IMURAN (azathioprine)), ethinyl estradiol (+) levonorgestrel (SEASONALE) and balsalazide disodium (COLAZAL). On 08-FEB-2007 later that day patient experienced nausea and vomiting. She was seen in the emergency room (ER) that night. She was treated with an unnamed antinausea medication and intravenous fluids. She was sent home later. She had no adverse symptoms after the second injection. The patient recovered. The reporter felt that getting unnamed antinausea medication and intravenous fluids was to prevent patient from being serious and considered this as a serious other medical event. Additional information has been requested. In the follow up it was indicated that on 08-FEB-2007 patient began experiencing nausea and vomiting approximately 1/2 hour after receiving her first dose of GARDASIL was unable to hold down any food, fluids through the afternoon or evening. She went to the emergency room (ER) for evaluation and Intravenous (IV) fluids. ER record indicated she wen to the ER complained pain in her back, legs and abdomen. She had nausea, vomiting, fever and she was pale and weak. The pain characteristic was cramping, sharp and constant. She also had bodyache and myalgia, she was treated in the ER with TYLENOL gram by mouth, ANTIVERT 12.5 milligram intravenous (IV), TORADOL 30 milligram IV, ROCEPHIN 2 gram IV and 2 litters of normal saline solution (NSS) IV. Initially patient went to the ER her temperature measurement was 102.4 F, pulse was 135, respiration was 20 and blood pressure was 88/52. Patient''s blood pressure measurement was 88/55, heart rate was 108 and respiration was 19 at the time of discharge from the ER. Pulse Oximetry was 100% on room air (RA). On 09-FEB-2007 the patient recovered. On an unspecified day she received the second dose of GARDASIL and had no adverse symptoms. The reporter no longer considered the events to be other important medical events. Additional information is not expected.


VAERS ID: 283977 (history)  
Age: 23.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-05-08
Onset:2007-05-13
   Days after vaccination:5
Submitted: 2007-06-14
   Days after onset:32
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0388U / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood pressure normal, Chills, Dysuria, Genital discharge, Hot flush, Hyperhidrosis, Occult blood, Ovarian enlargement, Pruritus, Pyrexia, Swelling, Urinary incontinence, Urinary tract infection, Urine leukocyte esterase, Urine odour abnormal, Uterine enlargement, Vulvovaginitis
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: JANUVIA; vitamins (unspecified)
Current Illness: Sexually active
Preexisting Conditions: Unknown
Diagnostic Lab Data: blood pressure, 05/08/07, 110/7, Many; urinalysis, 05/15/07, Cloudy; urinalysis, 05/15/07, +Keytones Occult Blood Leukocytes Esterase; urine leukocytes esterase, 05/15/07, 2+; temperature measurement, 05/13/07, 104.2; urine MBC count, 05/15/07, $g or, < or, 5; urine squamos, 05/15/07, 20-40, < or 5; urine bacteria screen, 05/15/07, Many
CDC Split Type: WAES0705USA02998

Write-up: Information has been received from a 23 year old sexually active female who on 08-MAY-2007 was vaccinated intramuscularly in the left deltoid with a first dose of Gardasil (657622/0388U). Concomitant therapy included sitagliptin phosphate (MSD). On 14-MAY-2007 the patient experienced fever, chills, excessive swelling, swollen uterus and swollen ovaries, hot flashes, perspiration, excessive swelling, yellow discharge, odor, irritation, and itching. She took an unspecified pill for itching that was for yeast infections and it helped. As of 15-MAY-2007 the patient started with not being able to hold urine for long periods of time and burning. A complete urinalysis was performed revealing cloudy urine with the presence of ketones, occult blood, protein, leukocytes esterase, white blood cells, squamos epithelial cells, and bacteria all consistent with vulvovaginitis and a Urinary Tract Infection. Atthe time of the report the patient had not recovered. Additional information has been requested.


VAERS ID: 284175 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-05-09
Onset:2007-05-09
   Days after vaccination:0
Submitted: 2007-06-14
   Days after onset:36
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SEASONALE
Current Illness: Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: magnetic resonance 05/??/07 - focal fluid collected along the facial plane of deltoid and infraspinatus muscle
CDC Split Type: WAES0705USA04016

Write-up: Information has been received from a physician concerning a female with drug hypersensitivity to codeine who on 09-MAY-2007 was vaccinated with Gardasil. Concomitant therapy included Seasonale. In May 2007, the patient experienced left shoulder pain. An MRI showed that there was a focal fluid collected along the facial plane at the deltoid and infraspinatus muscle. The patient was treated with Advil and Aleve. The patient had begun to get some relief on 22-MAY-2007 but the pain had not resolved. No further details were provided. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning a 23 year old female with drug hypersensitivity to codeine who on 09-MAY-2007 was vaccinated with a second dose of GARDASIL in the left deltoid. Concomitant therapy included SEASONALE. No illness at the time of the vaccination was specified. On 09-MAY-2007, the patient experienced left shoulder/deltoid pain. On 18-MAY-2007, an MRI showed that there was a focal fluid collected along the facial plane at the deltoid and infraspinatus muscle. The physician reported "that the MRI was reviewed with a radiologist and fluid collection appears to be edema, not blood, not infection/abscess". The patient was treated with ADVIL with no help and ALEVE with little help. The patient had begun to get some relief on 22-MAY-2007 but the pain had not resolved. The patient was to start physical therapy (date unspecified). The physician reported that the event may be related to the patient''s recent GARDASIL. No further details were provided. Additional information has been requested.


VAERS ID: 284515 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-03-29
Onset:2007-03-29
   Days after vaccination:0
Submitted: 2007-06-14
   Days after onset:77
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: VALTREX
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0705USA05457

Write-up: Information has been received from a 23 year old female with no drug reactions/allergies and no medical history who on 29-MAR-2007 was vaccinated with her first dose of Gardasil, 0.5 ml, intramuscularly. There was no concomitant medication. On 29-MAR-2007 the patient fainted after receiving the first dose of the Gardasil. The patient sought unspecified medical attention. On 29-MAR-2007, the patient recovered from fainting. Additional information is not expected. Information has been received from a registered nurse concerning a 23 year old female with no pertinent medical history who on 28-MAR-2007 was vaccinated with her first dose of GARDASIL, 0.5 ml, intramuscular administration. Concomitant therapy included VALTREX. Subsequently, the patient fainted after receiving her initial dose of GARDASIL and recovered that same day. The nurse reported that the GARDASIL was improperly stored at room temperature for three weeks prior to use (approximately 07-MAR-2007). Approximately two months later (28-MAY-2007) the patient received her second dose of GARDASIL. It was reported that the patient''s second dose had been stored at room temperature for five days prior to use (approximately 23-MAY-2007). Product Quality Control (PQC) was not involved. Additional information has been requested.


VAERS ID: 284517 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-06-14
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0089U / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pruritus, Injection site rash
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lactobacillus acidophilus; hormonal contraceptives
Current Illness: Sulfonamide allergy
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0705USA05504

Write-up: Information has been received from a health professional concerning a female who was vaccinated with a dose of Gardasil. Subsequently the patient experienced rash at injection site and itching at injection site. The patient''s rash at injection site and itching at injection site persisted. The patient sought unspecified medical attention. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a health professional concerning an approximately 23 year old female with a sulfa allergy and no other medical history who was vaccinated with a dose of GARDASIL (lot # 655324/0089U). Concomitant therapy included unspecified birth control pills and acidophilus. Subsequently the patient experienced rash at injection site and itching at injection site. The patient''s rash at injection site and itching at injection site subsided with no treatment required. The patient told the nurse she will not complete the series at the office. No additional information was available. Additional information is not expected.


VAERS ID: 284527 (history)  
Age: 23.0  
Gender: Female  
Location: Missouri  
Vaccinated:2007-05-29
Onset:2007-05-29
   Days after vaccination:0
Submitted: 2007-06-14
   Days after onset:16
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:
CDC Split Type: WAES0705USA05701

Write-up: Information has been received from a physician concerning a 24 year old female who in 2007 was vaccinated with the first dose of 0.5 ml Gardasil intramuscularly. There were no adverse events. The second Gardasil 0.5 ml dose was given intramuscularly on 29-MAY-2007. On 30-MAY-2007 the patient experienced significant rash and hives. The patient''s significant rash and hives persisted. No lab testing was performed. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a physician and a health care professional concerning a 23 year old female who in 2007 was vaccinated intramuscularly with the first 0.5 ml dose of the GARDASIL. There were no adverse events. The second GARDASIL (Lot # 657622/0388U) 0.5 ml dose was given intramuscularly on 29-MAY-2007. On 29-MAY-2007, the patient experienced injection site warmth, redness, and hives around the site. The outcome of the patient''s injection site redness, warmth and hives was unknown. Additional information is not expected.


VAERS ID: 284544 (history)  
Age: 23.0  
Gender: Female  
Location: Missouri  
Vaccinated:2007-05-01
Onset:0000-00-00
Submitted: 2007-06-14
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site reaction, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Unknown
CDC Split Type: WAES0706USA00002

Write-up: Information has been received from a registered nurse concerning a 23 year old female who in approximately May 2007, was vaccinated with Gardasil. Subsequently the patient experienced a red welt at injection site. Additional information has been requested.


VAERS ID: 282625 (history)  
Age: 23.0  
Gender: Female  
Location: Arizona  
Vaccinated:2007-06-13
Onset:2007-06-14
   Days after vaccination:1
Submitted: 2007-06-15
   Days after onset:1
Entered: 2007-06-21
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Other       Purchased by: Unknown
Symptoms: Chest pain, Paraesthesia, Paraesthesia oral
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Td Adsorbed (no brand name)~2~0.00~In Patient
Other Medications: UNK
Current Illness: Right hand splint
Preexisting Conditions: Codeine tachycardia
Diagnostic Lab Data:
CDC Split Type:

Write-up: 6-15-07 pt came to urgent care and reported having side effect from TD injection given at ER hospital. 6/13/07 to report tingling to forehead, lips aching in chest.


VAERS ID: 282878 (history)  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-06-21
Onset:2007-06-21
   Days after vaccination:0
Submitted: 2007-06-23
   Days after onset:2
Entered: 2007-06-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV108 / 4 RA / SC

Administered by: Military       Purchased by: Military
Symptoms: Hypoaesthesia, Injection site swelling
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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:

Write-up: Swelling of injection site with numbness in fingers of right hand. (Right arm injection) Duration of 3 days until medical help was asked for. LR-6 from literature


VAERS ID: 282932 (history)  
Age: 23.0  
Gender: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-06-27
Entered: 2007-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z1102 / 0 LA / IM

Administered by: Private       Purchased by: Public
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), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received vaccine, felt faint, smelling salts used. Patient then had seizure for 10-15 seconds. EMT / 911 called. Patient went to hospital for follow-up. Spoke with Patient the next day. No adverse affects with full recovery.


VAERS ID: 283087 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2007-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / 0 LA / SC

Administered by: Military       Purchased by: Military
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)

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:

Write-up: Redness at injection site approximately 3.5 inches in diameter 2 days after receiving vaccine.


VAERS ID: 283564 (history)  
Age: 23.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2007-06-22
Onset:2007-06-23
   Days after vaccination:1
Submitted: 2007-06-25
   Days after onset:2
Entered: 2007-07-02
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB091CA / 2 RA / IM

Administered by: Military       Purchased by: Unknown
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)

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:

Write-up: Redness and induration on the right deltoid (cellulitis)


VAERS ID: 283605 (history)  
Age: 23.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2007-07-02
Onset:2007-07-02
   Days after vaccination:0
Submitted: 2007-07-02
   Days after onset:0
Entered: 2007-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. ? / 1 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Asthenia, Blood pressure normal, Dizziness, Heart rate normal, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Generic Birth Control
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data: Normal blood pressure, pulse
CDC Split Type:

Write-up: Nausea, dizziness, weakness, fainted


VAERS ID: 283840 (history)  
Age: 23.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-06-27
Onset:2007-06-27
   Days after vaccination:0
Submitted: 2007-06-28
   Days after onset:1
Entered: 2007-07-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Rash, Skin warm, Swelling face, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: B complex tabs, Yasmin, Lactaid, Topicort
Current Illness: None
Preexisting Conditions: Lactose intolerance, environmental allergen, Xerosis
Diagnostic Lab Data:
CDC Split Type:

Write-up: Warmth, swelling, rash of face within minutes of receiving HPV vaccine. Reported there signs and symptoms about 2 hours later. Appearance at time of RX facial redness, swelling, urticaria. Treated with Benadryl PO, Prednisone PO, ranitidine PO.


VAERS ID: 284115 (history)  
Age: 23.0  
Gender: Female  
Location: Georgia  
Vaccinated:2007-07-05
Onset:2007-07-05
   Days after vaccination:0
Submitted: 2007-07-09
   Days after onset:4
Entered: 2007-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 417011C / 1 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Chills, Diarrhoea, Malaise, Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none present
Preexisting Conditions: none reported
Diagnostic Lab Data:
CDC Split Type:

Write-up: vaccine received 07/5/2007 received phone call 7/7/07 from pts husband stating that pt has been sick and they are concerned if related to rabies vaccine symptoms started two hrs after receiving vaccine pt has had chills, fever, diarrhea and has been vomitting. pt is taking motrin and immodium for pain and diarrhea. husband states they are concerned she is not improving. Husband states pt uses gwinnett clinic for medical care, encouraged to take pt to gwinnett clinic or emergency room. 07/09/2007 spoke with pt she reports she did not seek medical attention and is feeling better now.


VAERS ID: 284210 (history)  
Age: 23.0  
Gender: Female  
Location: New York  
Vaccinated:2007-07-03
Onset:2007-07-05
   Days after vaccination:2
Submitted: 2007-07-05
   Days after onset:0
Entered: 2007-07-10
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2329AA / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD C2465AA intradermal left forearm
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Redness at Menactra injection site 2 1/4" long x 1" wide. Induration at Menactra injection side approx. 1/2" diameter.


VAERS ID: 284294 (history)  
Age: 23.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2007-06-22
Onset:2007-06-26
   Days after vaccination:4
Submitted: 2007-07-11
   Days after onset:15
Entered: 2007-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV102 / 1 RA / SC
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 0 LA / ID

Administered by: Military       Purchased by: Military
Symptoms: Cellulitis, Injection site rash
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: NKDA
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt presented to the Medical Clinic on 7/9/07 with c/o rash to arm where she had received the Smallpox vaccination on 6/22/07. Rash developed a few days after vaccination according to patient. Diagnosed with cellulitis and placed on Bactrim. Was also given Ibuprofen and Benadryl.


VAERS ID: 284358 (history)  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-06-04
Onset:2007-06-05
   Days after vaccination:1
Submitted: 2007-06-05
   Days after onset:0
Entered: 2007-07-11
   Days after submission:36
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B47442F / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site warmth, Pain, Tenderness
SMQs:

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:
CDC Split Type:

Write-up: Left upper arm is very tender, hurts to raise arm up. Mild hear at injection site. Pt applied heart to area, then cool compresses.


VAERS ID: 284602 (history)  
Age: 23.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-06-04
Onset:2007-06-04
   Days after vaccination:0
Submitted: 2007-07-06
   Days after onset:32
Entered: 2007-07-13
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2734AA / 0 - / IM

Administered by: Public       Purchased by: Private
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:
CDC Split Type:

Write-up: Entire body rash ---$g Sent to ED


VAERS ID: 284635 (history)  
Age: 23.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-06-15
Onset:2007-07-11
   Days after vaccination:26
Submitted: 2007-07-13
   Days after onset:2
Entered: 2007-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y1030 / - RA / SC
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1323F / - RA / SC
TDAP: TDAP (ADACEL) / SANOFI PASTEUR LC2632AA / - LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

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:

Write-up: Patient received Tdap Ipol on 6/11/07. Pt received MMR on 6/15/07. Her mother in law called office on 7/11/07 to report a positive pregnancy test. This would be pregnancy within 28 days of vaccination.


VAERS ID: 284909 (history)  
Age: 23.0  
Gender: Female  
Location: Georgia  
Vaccinated:2007-04-03
Onset:2007-04-18
   Days after vaccination:15
Submitted: 2007-10-08
   Days after onset:173
Entered: 2007-07-13
   Days after submission:87
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0384U / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Pericardial effusion, Ultrasound scan abnormal
SMQs:, Systemic lupus erythematosus (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Mole excision
Diagnostic Lab Data: ultrasound 04/18?/07 - pericardial effusion
CDC Split Type: WAES0706USA00394

Write-up: Information has been received from a physician concerning a healthy 23 year old female nurse with a history of mole removal who on 03-APR-2007 was vaccinated intramuscularly into the left deltoid with her first dose of GARDASIL (lot # 657617/0384U). On approximately 18-APR-2007, fifteen days post vaccination, while being used as a model for an ultrasound, it was detected that the patient had pericardial effusion. The patient sought medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/6/2007. Initial and follow-up information has been received from a physician concerning a healthy 23 year old white female registered nurse with a history of mole removal who on 03-APR-2007 was vaccinated intramuscularly into the left deltoid with her first dose of GARDASIL (lot # 657617/0384U). On approximately 18-APR-2007, fifteen days post vaccination, while being used as a model for an ultrasound, it was detected that the patient had pericardial effusion. The patient sought medical attention. The patient had no symptoms and the pericardial effusion resolved spontaneously. Additional information is not expected.


VAERS ID: 285045 (history)  
Age: 23.0  
Gender: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-07-06
Entered: 2007-07-13
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Oedema peripheral, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0706USA01138

Write-up: Information has been received from a registered nurse, concerning a 23 year old female patient, with no known allergies and no significant medical history, who was vaccinated (date unspecified) with the third dose, 0.5ml, IM, of Gardasil, two months after the second dose. There was no concomitant medication. Following the vaccination (duration of time not specified), she developed hand swelling, and a rash that developed on her arms. At the time of this report, the patient had recovered (date unspecified). Additional information has been requested. Initial and follow up information has been received from a registered nurse, concerning a 22 year old female patient, with no known allergies and no significant medical history, who on 22-JAN-2007, was vaccinated with the second dose of GARDASIL vaccine (lot # 653937/0637F). Following the vaccination on 01-FEB-2007, she developed hand swelling, and a rash on both hands. At the time of this report, the patient was vaccinated with the third dose, 0.5 ml, IM of GARDASIL vaccine, two months after the second dose. No further information is expected.


VAERS ID: 285046 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-03-06
Onset:2007-03-06
   Days after vaccination:0
Submitted: 2007-07-06
   Days after onset:121
Entered: 2007-07-13
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Unknown
CDC Split Type: WAES0706USA01149

Write-up: Information has been received from a physician''s assistant, concerning a 23 year old female patient, who on approximately 06-MAR-2007 ("three months ago"), was vaccinated with the third dose, 0.5ml, of Gardasil. Following the vaccination (duration not specified), the patient developed raised hives on all of her extremities, but not her trunk. Treatment included prednisone (manufacturer not specified). At the time of this report, the PA indicated the patient had not recovered. Additional information has been requested.


VAERS ID: 284879 (history)  
Age: 23.0  
Gender: Male  
Location: South Carolina  
Vaccinated:2007-06-29
Onset:2007-07-01
   Days after vaccination:2
Submitted: 2007-07-09
   Days after onset:8
Entered: 2007-07-17
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0599U / 0 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Injection site anaesthesia, Injection site mass, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)

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: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: 2 days after vaccine c/o "lump under (L) arm" followed by numbness/tingling down (L) arm into 4th and 6th fingers" has continued without stopping since 7/1/07. Spoke to PCP and was told to report to health dept. denies any changes in activities, bug bites, injuries, fever, illness, etc.


VAERS ID: 285000 (history)  
Age: 23.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2007-06-29
Onset:2007-07-01
   Days after vaccination:2
Submitted: 2007-07-18
   Days after onset:17
Entered: 2007-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0599U / 4 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Injection site anaesthesia, Injection site mass, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Denies
Preexisting Conditions: Denies
Diagnostic Lab Data: NONE
CDC Split Type: SC0710

Write-up: 7/01/2007; 2 days following vaccination patient called health department and complained of "lump under left arm followed by numbness/tingling down left arm into 4th and 5th fingers". Symptoms have continued without relief since 7/1/07. Patient called private care provider and was instructed ti report to health department. Denies any recent changes in activities, insect bites, injuries, fever, or any recent illnesses.


VAERS ID: 285425 (history)  
Age: 23.0  
Gender: Female  
Location: Alabama  
Vaccinated:2007-06-12
Onset:2007-06-12
   Days after vaccination:0
Submitted: 2007-07-16
   Days after onset:34
Entered: 2007-07-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Face injury, Fall, Laboratory test, Malaise, Tooth injury
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Diagnostic laboratory 06/12/07 - results not provided
CDC Split Type: WAES0706USA02309

Write-up: Information has been received from a nurse practitioner concerning a 23 year old female who on 12-JUN-2007 received the first dose of Gardasil. Immediately upon injection, the patient complained of not feeling well and collapsed as the nurse was removing the needle from her arm. The patient fell on the side of her face and was rushed to the emergency room of a local hospital where she received 20 stitches in her face and mouth. Also, two of her front teeth were knocked loose. An unspecified blood test was performed (results not provided). It was also reported that the patient did not have anything to eat all day and the dose was given at 2:00 pm. The patient recovered on 12-JUN-2007. Additional information has been requested.


VAERS ID: 285434 (history)  
Age: 23.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-06-13
Onset:2007-06-13
   Days after vaccination:0
Submitted: 2007-07-16
   Days after onset:33
Entered: 2007-07-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0212U / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: YASMIN; AMBIEN
Current Illness: Sulfonamide allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA02389

Write-up: Information has been received from a physician, via a company representative, concerning a 23 year old female patient, with a sulfonamide allergy, who on 13-JUN-2007, was vaccinated with the second dose of Gardasil (Lot #0212U). Concomitant therapy included YASMIN and AMBIEN. Forty five minutes after the vaccine had been administered, the mother of the patient called the office to report her daughter was "violently vomiting." At the time of this report, the patient was recovering from the event. Additional information has been requested.


VAERS ID: 285476 (history)  
Age: 23.0  
Gender: Female  
Location: Maryland  
Vaccinated:2007-01-22
Onset:2007-01-22
   Days after vaccination:0
Submitted: 2007-07-16
   Days after onset:174
Entered: 2007-07-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abnormal weight gain, Alpha 1 foetoprotein normal, Cervical dysplasia, Colposcopy, Drug exposure during pregnancy, Hydronephrosis, Hypoglycaemia, Loop electrosurgical excision procedure, Smear cervix abnormal, Ultrasound scan
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (narrow), Reproductive premalignant disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (broad), Uterine and fallopian tube malignant tumours (broad), Hypoglycaemia (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamins (unspecified)
Current Illness: Pregnancy NOS (LMP = 1/20/2007); Sulfonamide allergy; Drug hypersensitivity; Weight increased; Hypoglycemia; Cervical intraepithelial neoplasia
Preexisting Conditions: Smoker; Anxiety; Attention deficit/hyperactivity disorder; Pregnancy;
Diagnostic Lab Data: cervical smear 02/??/07 - cervical intra-eithelial neoplasia 3; colposcopy 02/??/07 - results not provided; ultrasound 04/??/07, reason NT and screen; loop electrosurgical, 01/10/07, reason CIN 3 result, patient doing fine; renal ultrasound, 10/11/07, performed on baby and was normal; ultrasound, 10/01/07, results- bilateral pyelectasia comments- follow up for size greater than dates; serum alpha-fetoprotein, 05/02/07, negative
CDC Split Type: WAES0706USA03134

Write-up: Information has been received for the Merck Pregnancy Registry for Gardasil via a registered nurse concerning a 23 year old female with a sulfonamide allergy and drug hypersensitivity to erythromycin, BACTRIM and ZITHROMAX who on 22-JAN-2007 was vaccinated with the first dose of Gardasil (lot # 655619/1427F). Concomitant therapy included pre-natal vitamins. It was reported that the patient may have been pregnant when she received the vaccination on 22-JAN-2007. The patient reported the date of her last menstrual period as approximately 20-JAN-2007. The patient''s estimated date of delivery is 27-OCT-2007. The patient sought unspecified medical attention. In February 2007, a "pap smear" revealed cervical intraepithelial neoplasia 3 and the patient underwent colposcopy (results not provided). The reporter indicated that the pregnancy has been normal to date. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007, 04/07/2008. Initial and follow up information has been received for the Merck Pregnancy Registry for GARDASIL via a registered nurse concerning a 23 year old female smoker of 1 pack per day with hypoglycemia, cervical intraepithelial neoplasia, excessive weight gain, a sulfonamide allergy and drug hypersensitivity to erythromycin, BACTRIM and ZITHROMAX, and with a history of 2 previous pregnancies (1 full term delivery and 1 spontaneous abortion, anxiety, colposcopy, and attention deficit/hyperactivity disorder, a maternal mother (grandmother) that had platelets with a defective release mechanism, a maternal father (grandfather) with high blood pressure before 50 and a fraternal father (grandfather) with diabetes, who on 22-JAN-2007 was vaccinated with the first dose of GARDASIL (lot # 655639/1427F). Concomitant therapy included pre-natal vitamins starting in February 2007, once a day. It was reported that the patient may have been pregnant when she received the vaccination on 22-JAN-2007. The patient reported the date of her last menstrual period as approximately 20-JAN-2007. The patient''s estimated date of delivery is 27-OCT-2007. The patient quit smoking with a positive urine pregnancy test. The patient sought unspecified medical attention. In February 2007, a "pap smear" revealed cervical intraepithelial neoplasia 1 and the patient underwent colposcopy. The colposcopy showed cervical intraepithelial neoplasia 1. The reporter indicated that the pregnancy has been normal to date. On 04-APR-2007 an ultrasound was performed for "NT and screen" and the results were normal. On 02-MAY-2007 a Maternal Serum Alpha-Fetoprotein Screening was performed and the results were negative. On 01-OCT-2007 an ultrasound was performed and the results indicated bilateral pyelectasis with comments to "follow-up for size greater than dates". Follow-up indicated that on 10-OCT-2007 the patient gave birth to a normal female infant (39 weeks LMP). The infant weighted 7 pounds 4 ounces, was 19 1/3 inches long, and her apgar score was 8/9. There were no congenital anomalies. As previously reported an ultrasound performed on 01-OCT-2007 showed the baby to have moderate bilateral pyelectasis. Postnatal antibiotics and a possible renal sonogram were recommended. It was reported that complications during pregnancy were hypoglycemia and excessive weight gain. There were no complications during labor and delivery. There were no birth defects and no infant complications in previous pregnancies. Follow-up information that on 11-OCT-2007 a renal sonogram was performed on the baby and the results were normal. On 12-DEC-2007 the patient was seen in the office for a postpartum exam. The patient was prescribed YAZ for twelve months and the Loop Electrosurgical Excision Procedure (LEEP) procedure was scheduled. In regards to the patient''s cervical intraepithelial neoplasia 3, it was reported that on 10-JAN-2008 the patient came back to the office for a Loop Electrosurgical Excision Procedure (LEEP) proce


VAERS ID: 285654 (history)  
Age: 23.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2007-06-11
Onset:2007-06-11
   Days after vaccination:0
Submitted: 2007-07-16
   Days after onset:35
Entered: 2007-07-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0523U / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Body temperature increased, Lip blister, Musculoskeletal stiffness, Pyrexia, Skin exfoliation, Swelling
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Loestrin 24 FE
Current Illness: Drug hypersensivity
Preexisting Conditions:
Diagnostic Lab Data: body temp 100-101F
CDC Split Type: WAES0706USA03494

Write-up: Information has been received from a office assistant concerning a 23 year old female with drug hypersensitivity to aspirin who on 11-JUN-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 657868/0523U). Concomitant therapy included ethinyl estradiol (+) ferrous fumarate (+) Norethindrone acetate (LOESTRIN 24 FE). On 11-JUN-2007 in the evening, the patient experienced fever 100-101F, stiff limbs, joint aches and pains, and swollen, sore, blistery, and peeling lips. Unspecified medical attention was sought. The patient''s fever 100-101F and stiff limbs, joint aches and pains, and swollen, sore, blistery, and peeling lips persisted. There were no laboratory or diagnostic tests performed. Additional information has been requested.


VAERS ID: 285655 (history)  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-06-18
Onset:2007-06-18
   Days after vaccination:0
Submitted: 2007-07-16
   Days after onset:28
Entered: 2007-07-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0210U / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Nausea, No reaction on previous exposure to drug
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

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: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA03513

Write-up: Information has been received from a certified medical assistant concerning a 23 year old female, with no pertinent medical history, who on 20-APR-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 0210U). On 18-JUN-2007 was vaccinated IM into the right deltoid with a 0.5 ml second dose of Gardasil (lot # 0210U). There was no concomitant medication. On 15-JUN-2007 at 3:00 pm, (previously reported as later that evening), the patient experienced dizziness and nausea. Unspecified medical attention was sought. The patient''s dizziness and nausea persisted. The certified medical assistant reported that the patient did not experience any difficulties with the 20-APR-2007 first dose. Additional information has been requested. Additional infromation is not expected.


VAERS ID: 285806 (history)  
Age: 23.0  
Gender: Female  
Location: Texas  
Vaccinated:2006-11-16
Onset:0000-00-00
Submitted: 2007-07-16
Entered: 2007-07-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 0 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Drug exposure during pregnancy, Headache, Menstruation irregular, Ultrasound abdomen, Urine human chorionic gonadotropin positive, Vaccine positive rechallenge
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Fertility disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: WELLBUTRIN; LOESTRIN 24 FE
Current Illness: Pregnancy NOS (LMP = 4/4/07); Depression; Contraception
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound 05/30/07 - approximately 8 weeks pregnant; Urine beta-human 05/??/07 - positive
CDC Split Type: WAES0706USA04092

Write-up: Information has been received, via the Merck pregnancy registry, from a registered nurse, concerning her 23 daughter with depression, who on 16-NOV-2006 was vaccinated with the first dose of Gardasil (Lot #654540/0800F), and following vaccination (onset date not specified), experienced a slight headache. Concomitant therapy included LOESTRIN 24 FE and WELLBUTRIN. On 16-JAN-2007, she was vaccinated with the second dose of Gardasil (Lot #657005/0314U), and again following vaccination she experienced a slight headache. The nurse indicated her daughter had unknowingly become pregnant on approximately 04-APR-2007, and on 16-MAY-2007, was administered the third dose of Gardasil (Lot #657005/0314U). Again, following the vaccination, she experienced a headache, though this headache was "stronger." The patient sought treatment for the headache with her primary physician, and a urine pregnancy test at that time (date unspecified) indicated she was pregnant. The nurse confirmed that her daughter had been taking the birth control pills (specified above), and had experienced a light menstrual cycle throughout his time period. On 30-MAY-2007, the patient had an ultrasound that confirmed she was approximately 8 weeks pregnant, and "all looked fine." The estimated date of delivery was 09-JAN-2008. At the time of this report, the outcome of headache was unknown. Additional information has been requested.


VAERS ID: 285823 (history)  
Age: 23.0  
Gender: Female  
Location: New York  
Vaccinated:2007-06-16
Onset:2007-06-20
   Days after vaccination:4
Submitted: 2007-07-16
   Days after onset:26
Entered: 2007-07-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0389U / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Rash vesicular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0706USA04397

Write-up: Information has been received from a registered nurse concerning a 23 year old female patient with a penicillin allergy and no medical history who on 20-APR-2007, was vaccinated IM into the left arm with a first 0.5ml dose of Gardasil. On 16-JUN-2007, the patient was vaccinated with a second dose of Gardasil (Lot# 657736/0389U). There was no concomitant medication. On 20-JUN-2007, the patient developed a vesicular rash which was described as spreading from the lower lip to surrounding both lips and spreading to cheek and around a naris. The patient showed the rash to the psychiatrist. No medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 285872 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-07-16
Entered: 2007-07-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Facial palsy
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA04943

Write-up: Information has been received from consumer her 23 year old daughter who on unspecified date was vaccinated with a second dose of Gardasil. Two weeks post vaccination with the second dose of Gardasil. Two weeks post vaccination with the second dose of Gardasil, the patient developed "bells palsy, which freezes one side of the face" as reported by the patient''s mother. The patient sought unspecified medical attention. Subsequently, the patient recovered from bells palsy on an unspecified date. Additional information has been requested.


VAERS ID: 285884 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-06-22
Onset:2007-06-25
   Days after vaccination:3
Submitted: 2007-07-16
   Days after onset:21
Entered: 2007-07-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0181U / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site streaking
SMQs:

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: Unknown
CDC Split Type: WAES0706USA05076

Write-up: Information has been received from a nurse concerning a 23 year old female who in April 2007, was vaccinated with a first dose of Gardasil. On 22-JUN-2007, the patient received her second dose of Gardasil (Lot# 656371/0181U). On 25-JUN-2007, the patient developed red streaks moving away from the injection site area. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 285894 (history)  
Age: 23.0  
Gender: Female  
Location: Florida  
Vaccinated:2006-09-22
Onset:2006-10-31
   Days after vaccination:39
Submitted: 2007-07-16
   Days after onset:257
Entered: 2007-07-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Menstruation delayed
SMQs:, Fertility disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA05150

Write-up: Information has been received from a physician concerning a female patient who was vaccinated IM on 22-SEP-2006 with a first dose of GARDASIL. The physician reported that the patient received her first dose of GARDASIL and "claimed it affected her menstrual cycle". She said her cycle went from being every four weeks to being every six weeks. The patient refused to go on to get the second and third doses. The physician did not believe the adverse experience was related to GARDASIL. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. In follow up information it was indicated that "patient said her periods became irregular after receiving the first dose of GARDASIL vaccine." The patient recovered. Additional information is not expected.


VAERS ID: 285986 (history)  
Age: 23.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2007-01-19
Onset:2007-01-26
   Days after vaccination:7
Submitted: 2007-07-16
   Days after onset:170
Entered: 2007-07-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0524U / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness: Vertigo
Preexisting Conditions: Panic attack 8/01/07-records received- PMH: vestibulitis and pelvic pain.
Diagnostic Lab Data: Unknown 8/10/07-records received-MRI head normal. EEG normal. 8/20/07-records received-8/20/07-CT of abdomen and pelvis report
CDC Split Type: WAES0707USA00101

Write-up: Information has been received from a licensed practical nurse concerning a 23 year old female patient with a history of panic attacks who on 19-JAN-2007, was vaccinated into the left deltoid with a first dose of Gardasil (Lot# 658094/0524U). Concomitant therapy included hormonal contraceptives (unspecified). On 26-JAN-2007, the patient experienced dizziness and numbness on the left side of her body. Unspecified medical attention was sought. At the time of this report, the patient has not recovered. No product complaint was involved. Additional information has been requested. 8/1/07-copy of report received includes lot #0524U left deltoid. C/O dizziness, vertigo, numbness left side of body, palpitations, pain in jaw, ongoing intermittent to date.received for DOS 01/25/07-clinical information included pain left groin lymph nodes increasing in size and number, right lower quadrant pain, evaluate for lymphoma. Impression: bilatareal adnexal cystic lesions, improved on right with an increased 2.5 cm left adnexal cyst for which follow up is suggestion. No other records available from facility. This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a licensed practical nurse concerning a 23 year old female patient with vertigo from oral contraceptives and a history of panic attacks, vestibulitis and pelvic pain who on 19-JUN-2007 at approximately 13:00, was vaccinated IM into the left deltoid with a first dose of GARDASIL (Lot# 658094/0524U). Concomitant therapy included hormonal contraceptives (unspecified). On 26-JUN-2007, the patient experienced (dizziness, numbness on the left side of her body, vertigo, palpitations and pain in the jaw. Unspecified medical attention was sought. Laboratory diagnotic studies included an electrocardiogram and an magnetic resonance imaging (MRI) which were both reported to be normal. It was reported that these experiences have been intermittantly ongoing to date. No product quality complaint was involved. Additional information is not expected.


VAERS ID: 285204 (history)  
Age: 23.0  
Gender: Female  
Location: Arizona  
Vaccinated:2007-06-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2007-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV105 / 0 LA / -
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 0 RA / -
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z11202 / 0 LA / -

Administered by: Military       Purchased by: Unknown
Symptoms: Burning sensation, Erythema, Injection site erythema, Injection site rash, Injection site swelling, Musculoskeletal pain, Oedema peripheral, Pain, Pruritus
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Seasonal allergies
Diagnostic Lab Data: LABS: CT scan of chest & right arm revealed miltiple axillary lymph nodes & skin thickening. US of right arm Urine C/s (+). Blood & wound c/s (-). CBC & diff were WNL. Chemistry was WNL. Right shoulder & CXR were WNL.
CDC Split Type:

Write-up: 0000 hrs SAT 30 July 07 (admitted to hospital). Symptoms: vaccine area spread, red line going to under arms, all of infected areas on right arm was swollen, red and bumpy. Pain in right shoulder. Infected area was itchy and felt like it was burning pain under arm and by right breast. 8/17/07 Received hospital medical records which reveal patient experienced redness, swelling, streaking & pain of right upper arm, a pimple & recent cough. Admitted 6/30-7/2/07 for cellulitis/abscess. Tx w/IV antibiotics w/good response. D/C to home on continued oral antibiotics. FINAL DX: Vaccinia vs superinfection; adenopathy in healthy military patient s/p smallpox vaccine.


VAERS ID: 285394 (history)  
Age: 23.0  
Gender: Female  
Location: Illinois  
Vaccinated:2007-06-25
Onset:2007-07-20
   Days after vaccination:25
Submitted: 2007-07-20
   Days after onset:0
Entered: 2007-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB030BA / 0 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Injection site nodule, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Diflucan 150mg once 6/19/07
Current Illness: Dx''d with vaginal yeast infection 6/19/07
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Palpable nodule remains at injection site close to one month after administration. Client complains of pain with certain arm movements.


VAERS ID: 285552 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2002-11-28
Onset:2003-02-01
   Days after vaccination:65
Submitted: 2007-07-23
   Days after onset:1632
Entered: 2007-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER FAV 066 / 2 RA / UN

Administered by: Military       Purchased by: Unknown
Symptoms: Coeliac disease
SMQs:

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: Everything in the book
CDC Split Type:

Write-up: Received the anthrax vaccine on 28 Nov 02 and 5 May 03 that contained squalene. Developed numerous symptoms, resulting in the eventual diagnosis of Celiac Disease and currently experiencing other symptoms that have not been diagnosed.


VAERS ID: 286354 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-07-18
Onset:2007-07-18
   Days after vaccination:0
Submitted: 2007-07-20
   Days after onset:2
Entered: 2007-07-31
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / IJ

Administered by: Military       Purchased by: Military
Symptoms: Chills, Diarrhoea, Injection site erythema, Injection site swelling, Nausea, Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Macrobid 50mg QD
Current Illness: None
Preexisting Conditions: Amoxicillin, Levaquin, PCOS, frequent UTI''s
Diagnostic Lab Data:
CDC Split Type:

Write-up: Nausea, vomiting, diarrhea, body aches, moderate swelling and redness at injection site, headaches, fever, chills, symptoms have persisted for 48-72 hours, Motrin 800mg TID, Tylenol 325mg QID.


VAERS ID: 286428 (history)  
Age: 23.0  
Gender: Female  
Location: Maryland  
Vaccinated:2007-06-05
Onset:2007-07-02
   Days after vaccination:27
Submitted: 2007-07-27
   Days after onset:25
Entered: 2007-08-01
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH FAV106 / 0 UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Menstruation irregular, Pregnancy test positive, Smear cervix normal
SMQs:, Normal pregnancy conditions and outcomes (narrow), Fertility disorders (broad)

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: Diagnostic Tests: 19 Jul 07 - HCG positive. 31 May 07 - PAP test-Normal
CDC Split Type:

Write-up: Received AVA #1 in preparation for deployment on 5 Jun 07. On 19 Jun 07 she had a positive HCG test. Her LMP was 7 May 07. She says her periods are irregular. She was seen for well-woman evaluation on 31 May 07 that was recorded as normal. A PAP test was done which was also normal. She was started on pre-natal vitamins on 2 Jul 07 and advised to call for an OB appointment.


VAERS ID: 287000 (history)  
Age: 23.0  
Gender: Female  
Location: Illinois  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-07-30
Entered: 2007-08-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0675F / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site swelling, Oedema peripheral, Pain in extremity, Skin warm
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Sickle cell anaemia
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0610USA13544

Write-up: Information has been received from a pharmacist and a registered nurse concerning a 23 year old female with sickle cell anaemia who was vaccinated with Pneumovax 23 (Lot # 654982/0675F). Subsequently the patient experienced excessive swelling in the mid upper arm injection site, that was all the way down to the elbow, that was 1 and 1/2 times the size of the normal circumference of the arm. The arm was warm to the touch, tender and there was pain with the swelling. The patient was examined in the emergency room (ER) and released. The patient was instructed to put a hot pack on the affected area and take basic analgesic or nonsteroidal anti-inflammatory drug (unspecified) NSAID. There was no fever and no induration at the site of injection. The patient was instructed to take acetaminophen or NSAIDS to manage the discomfort. At the time of the report, it was unknown if the patient recovered. Additional information has been requested.


VAERS ID: 286853 (history)  
Age: 23.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2007-07-24
Onset:2007-08-01
   Days after vaccination:8
Submitted: 2007-08-06
   Days after onset:5
Entered: 2007-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 0 LA / ID

Administered by: Military       Purchased by: Military
Symptoms: Chills, Dehydration, Diarrhoea, Lymphadenopathy, Nausea, Pyrexia, Tilt table test
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Tilt test positive
CDC Split Type:

Write-up: Nausea, diarrhea, fever, chills x 5d. Pt had enlarged lymph nodes x 7d. Pt dehydrated x3d. Pt tx with 2L LR. Advised to hydrated, eat clear diet advance to BRAT diet as tolerated


VAERS ID: 286917 (history)  
Age: 23.0  
Gender: Female  
Location: Wyoming  
Vaccinated:2007-07-25
Onset:2007-07-26
   Days after vaccination:1
Submitted: 2007-08-06
   Days after onset:11
Entered: 2007-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB360CA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: nuva ring
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: after patient received vaccine the next morning she noticed itching, swelling, erythema about 4 inches by 2 inches on arm. No other symptoms. She came so we at the clinic could check it out on 7/27. pt given some zyrtec syrup.


VAERS ID: 287369 (history)  
Age: 23.0  
Gender: Female  
Location: Virginia  
Vaccinated:2007-04-27
Onset:2007-06-01
   Days after vaccination:35
Submitted: 2007-08-06
   Days after onset:66
Entered: 2007-08-08
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Contusion, Epistaxis, Idiopathic thrombocytopenic purpura, Immunoglobulins, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Hormonal contraceptives; Tetracycline
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Platelet count 06/??/07 - 2000; Platelet count 07/26/07 - 8000
CDC Split Type: WAES0707USA04986

Write-up: Information has been received from a physician concerning a 23 year old female patient who during the last week of April 2007 was vaccinated IM with a first dose of Gardasil. Concomitant therapy included tetanus toxoid, tetracycline and hormonal contraceptives (unspecified brand). In June 2007, the patient developed nose bleed and bruising of her body. The patient''s platelet count reached 2000 and was hospitalized for ITP (Idiopathic Thrombocytopenic Purpura). The patient was treated with intravenous immunoglobulin and high dose corticosteroids (unspecified). The patient responded to the corticosteroids (unspecified) but became intolerant to the side effects. There have been more than one attempts to taper the patient off the corticosteroid but the platelets decreased each time. As of 26-JUL-2007, the patient''s platelet count was 8000. No other details were provided. Physician did not provide specifics on corticosteroid side effects that the patient developed. The patient had not recovered. The events nose bleeds, bruising of patient''s body, and Idiopathic Thrombocytopenic Purpura (ITP) were considered to be life-threatening. Additional information has been requested.


VAERS ID: 287643 (history)  
Age: 23.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2007-08-08
Onset:2007-08-08
   Days after vaccination:0
Submitted: 2007-08-09
   Days after onset:1
Entered: 2007-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS UNKNOWN / 1 LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pain in extremity, Pyrexia, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: coumadin, POP
Current Illness: none
Preexisting Conditions: minocycline
Diagnostic Lab Data:
CDC Split Type:

Write-up: Soreness in arm and bad headache 4-5 hours after injection. Woke in the morning feeling like I''d been hit by a truck - body (muscle and joint) aches, bad headache, extreme soreness in arm (difficult to move and tender to the touch), fatigue, fever, and blurry vision. Symptoms still present at time of form submission.


VAERS ID: 288093 (history)  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-08-14
Onset:2007-08-14
   Days after vaccination:0
Submitted: 2007-08-14
   Days after onset:0
Entered: 2007-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. INFO N/A / 1 LA / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Blood electrolytes normal, Diarrhoea, Full blood count, Nausea, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth Control Pill
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: CBC with WBC 15.1 and electrolytes normal.
CDC Split Type:

Write-up: Nausea and Vomiting and Diarrhea within one hour of vaccine administration. $g5 episodes of vomiting and 6-7 episodes of diarrhea.


VAERS ID: 288170 (history)  
Age: 23.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-07-10
Onset:2007-07-13
   Days after vaccination:3
Submitted: 2007-08-15
   Days after onset:33
Entered: 2007-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0336U / 0 LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Erythema, Pruritus, Skin warm, Swelling, Throat irritation
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: none
Preexisting Conditions: unknown
Diagnostic Lab Data: none
CDC Split Type:

Write-up: She received a varicella shot as a part of the community college requirements on 7/10/2007.Three days after received this shot she developed a 2 x 2 in swelling that was red and hot to the touch abd itched as did her throat. She went to the MD and received a steroid shot and 3 steroid pills to take. This reaction resolved within 2 days of having the steroid shot. She subsequently decided to have the 2nd varicella shot on 8/14/07 and was asked to call if this reaction repeated.


VAERS ID: 288279 (history)  
Age: 23.0  
Gender: Female  
Location: Missouri  
Vaccinated:2007-08-15
Onset:2007-08-15
   Days after vaccination:0
Submitted: 2007-08-16
   Days after onset:1
Entered: 2007-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0927U / 0 LA / IM

Administered by: Public       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), Hypoglycaemia (broad)

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: none
CDC Split Type:

Write-up: After receiving vaccine, patient fainted as needle was being removed. Patient responded within seconds of fainting. B/P 90/60


VAERS ID: 288713 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-08-14
Entered: 2007-08-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Lymphadenopathy, Malaise
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Unknown
CDC Split Type: WAES0707USA00346

Write-up: Information has been received from a physician, concerning a 23 year old female who was vaccinated on an unspecified date at another facility, with the first dose of Gardasil (Lot # not provided). Ten days after the vaccine was administered, the patient developed redness and swelling at the injection site. She also developed general malaise and dizziness (onset timeframe not specified), and 17 days after the vaccine administration, she developed bilateral lymphadenopathy. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. No further information is available.


VAERS ID: 288743 (history)  
Age: 23.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-06-28
Onset:2007-06-29
   Days after vaccination:1
Submitted: 2007-08-14
   Days after onset:46
Entered: 2007-08-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0245U / 0 AR / IM

Administered by: Private       Purchased by: Other
Symptoms: Chills, Cold sweat, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ADDERALL tablets
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0707USA00925

Write-up: Information has been received from a physician concerning a 23 year old female with no pertinent medical history or drug reactions/allergies who on approximately 02-JUL-2007 was vaccinated with a dose of Gardasil (lot3 656050/0245U) 0.5mL IM. Concomitant medication included amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (ADDERALL). On approximately 03-JUL-2007 "within 24 hours" the patient experienced fever, chills and cold sweats. Medical attention was sought. At the time of reporting it is unknown if the patient had recovered. Additional information has been requested. 01/07/2008 This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a physician concerning a 23 year old female with no pertinent medical history or drug reactions/allergies who on approximately 02-JUL-2007 (also reported as 28-JUN-2007) was vaccinated with a first dose of GARDASIL (lot# 656050/0245U) 0.5mL IM in the deltoid. Concomitant medication included ADDERALL. On approximately 03-JUL-2007 (also reported as 29-JUN-2007) "within 24 hours" after the injection the patient developed a fever of 101, chills, body aches, nausea and cold sweats. Medical attention was sought. At the time of reporting it is unknown if the patient had recovered. The patient recovered on 30-JUN-2007 in "48 hours". Additional information is not expected.


VAERS ID: 288889 (history)  
Age: 23.0  
Gender: Female  
Location: New York  
Vaccinated:2007-07-03
Onset:2007-07-03
   Days after vaccination:0
Submitted: 2007-08-14
   Days after onset:42
Entered: 2007-08-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0525U / 0 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Diplopia, Dizziness, Head injury, Immediate post-injection reaction, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Ocular motility disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LEXAPRO
Current Illness: Depression
Preexisting Conditions:
Diagnostic Lab Data: physical examination 07/03/07
CDC Split Type: WAES0707USA01602

Write-up: Information has been received from a registered nurse concerning a 23 year old female with a history of depression who on 03-JUL-2007 was vaccinated with a first dose of Gardasil (lot # 658100/0525U) 0.5mL IM. Concomitant therapy included LEXAPRO. On 03-JUL-2007 the patient experienced lightheadedness immediately after vaccination with Gardasil. the patient then fainted and hit her head. She subsequently complained of double vision. Medical attention was sought. The patient was transported to the local emergency room by ambulance. The nurse reported that she is unaware of the details of the evaluation in the emergency room but the patient was not admitted to the hospital. At the time of reporting it is unknown if the patient has recovered. No further information is available. Additional information has been requested. Additional information was received. On an unspecified date the patient recovered and was discharged from the emergency room. Additional information is not expected.


VAERS ID: 289284 (history)  
Age: 23.0  
Gender: Female  
Location: Virginia  
Vaccinated:2007-06-04
Onset:2007-06-29
   Days after vaccination:25
Submitted: 2007-08-14
   Days after onset:46
Entered: 2007-08-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Liver function test abnormal
SMQs:, Liver related investigations, signs and symptoms (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLEGRA; TOPROL XL TABLETS
Current Illness: Hypertension; Hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: serum alanine 06/29/07 289; serum aspartate 06/29/07 102; serum aspartate 08/??/06 - normal; serum alanine 08/??/06 - normal
CDC Split Type: WAES0707USA01826

Write-up: Information has been received from a pharmacist concerning a 23 year old female with hypertension and allergies who on 04-JUN-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included TOPROL XL TABLETS and ALLEGRA. On 29-JUN-2007 the laboratory data revealed elevated liver enzymes tests. The serum alanine aminotransferase (ALT) test reported 289 and serum aspartate aminotransferase (AST) test reported 102 (in August 2006 the ALT/AST tests were both reported to be in the normal range). Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Additional information has been requested.


VAERS ID: 289520 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-01-01
Onset:2007-01-01
   Days after vaccination:0
Submitted: 2007-08-14
   Days after onset:224
Entered: 2007-08-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Carbohydrate antigen 125 increased, Condition aggravated
SMQs:, Tumour markers (narrow), Uterine and fallopian tube malignant tumours (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: [therapy unspecified]
Current Illness:
Preexisting Conditions: Cancer
Diagnostic Lab Data: cancer antigen 125 test 24; cancer antigen 125 test 14
CDC Split Type: WAES0707USA03753

Write-up: This is in follow-up to report(s) previously submitted on 8/14/2007. Information has been received from a father concerning his 23 year old daughter with a history of cancer who in early 2007 was vaccinated with the first dose of 0.5 ml of Gardasil. The patient completed the three vaccination series of Gardasil (dates not reported). Concomitant therapy included tetanus toxoid and "other medications she has been on for a long time" (therapies were unspecified). Subsequently the patient''s CA 125 levels increased from 14 to 24 over the four month period of treatment with Gardasil and the patient experienced anxiety. The patient sought unspecified medical treatment. At the time of the report the patient had not recovered. Additional information has been requested.


VAERS ID: 289530 (history)  
Age: 23.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-03-09
Onset:2007-03-10
   Days after vaccination:1
Submitted: 2007-08-14
   Days after onset:156
Entered: 2007-08-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / 0 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Chills, Nausea, Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0707USA03895

Write-up: Information has been received from a health professional concerning a 23 year old female who on 09-MAR-2007 at 1:00 PM was vaccinated with a first dose of Gardasil (Lot # 656049/0187U). There was no concomitant medication. On 10-MAR-2007 at 7:00 PM the patient developed body aches, fever, chills, nausea and vomiting. It was reported the patient could not work. There was no rash or diarrhea. Unspecified medical attention was sought. There were no laboratory or diagnostic testing performed. On 13-MAR-2007, the patient recovered. Additional information has been requested.


VAERS ID: 288362 (history)  
Age: 23.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-08-10
Onset:2007-08-10
   Days after vaccination:0
Submitted: 2007-08-13
   Days after onset:3
Entered: 2007-08-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0515U / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Feeling abnormal, Pharyngeal oedema, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Dementia (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Junel
Current Illness: None
Preexisting Conditions: NKDA - denies others
Diagnostic Lab Data: None
CDC Split Type:

Write-up: I received the first shot of the Gardasil vaccine series on Friday, August 10 at 12:30pm. The nurse asked me to stay five minutes to see if I had any reaction to the vaccine, but I chose not to and left after I scheduled my second shot for October 5, 2007. A few minutes after I got in my car to leave, I started to feel strange and it felt as if my throat and tongue were swelling. It was not severe, but enough to make me question what was happening. I waited to see if it would subside, it did not, and 15 minutes later I took a Benadryl and that helped. After an hour of sleep, I felt fine. I just wanted to let you know about this experienced and I have called your office this morning to discuss with the nurse if I should proceed with the next two shots. I am waiting on a call back from the nurse.


VAERS ID: 288509 (history)  
Age: 23.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-07-06
Onset:2007-07-07
   Days after vaccination:1
Submitted: 2007-07-30
   Days after onset:23
Entered: 2007-08-20
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB294AA / 1 LA / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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:

Write-up: Swelling at injection site and down same arm. No treatment given by pharmacy.


VAERS ID: 288676 (history)  
Age: 23.0  
Gender: Female  
Location: Georgia  
Vaccinated:2007-08-13
Onset:2007-08-13
   Days after vaccination:0
Submitted: 2007-08-22
   Days after onset:9
Entered: 2007-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0928U / 2 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Hypotension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad)

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: tb-1994
Diagnostic Lab Data:
CDC Split Type:

Write-up: Dizziness after injection. Bp 80/60. Rechecked after 5 minutes-94/62.


VAERS ID: 288874 (history)  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-07-05
Onset:2007-07-05
   Days after vaccination:0
Submitted: 2007-08-14
   Days after onset:40
Entered: 2007-08-23
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0469U / - - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site haemorrhage, Medical device complication
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

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: Unknown
CDC Split Type: WAES0707USA01381

Write-up: Information has been received from a Licensed Visiting Nurse concerning a 23 year old female who on 05-JUL-2007 was vaccinated with Gardasil (Lot #0469U). On 05-JUL-207 the prefilled syringe plunger locked when the patient was administered the injection. The patient''s arm bled a small amount when the needle was removed. Additional information has been requested.


VAERS ID: 289231 (history)  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-08-13
Onset:0000-00-00
Submitted: 2007-08-28
Entered: 2007-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest pain, Echocardiogram normal, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Troponin I of .24 at LRMC on 27 August 2007. ECG showed nonspecific ST changes and the echo was normal.
CDC Split Type:

Write-up: This is a deployed soldier who received the small pox vaccine on 13 Aug 2007. On 21 August 2007 he developed chest pains consistent with pericarditis. Only objective finding was a measureable troponin I of .24 at LRMC on 27 August 2007. ECG showed nonspecific ST changes and the echo was normal. Chest pain is responding well to indocin. Patient is AD Air Force. The vaccine was administered down range.


VAERS ID: 289322 (history)  
Age: 23.0  
Gender: Female  
Location: Oregon  
Vaccinated:2007-08-20
Onset:2007-08-20
   Days after vaccination:0
Submitted: 2007-08-29
   Days after onset:9
Entered: 2007-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0927U / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Allergy to vaccine, Erythema, Rash morbilliform, Rash papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CAH, Ortho Tri-Cyclen lo Glucosamine Complex
Current Illness: not ill
Preexisting Conditions: Dapsone allergy; asthma
Diagnostic Lab Data: None
CDC Split Type:

Write-up: On 8/20/07 received and dose of Gardasil; Pt reports 4-5 hrs later got fine papular eruption not welts; no itch, no prev allergies or hives. Dermatologist examined on 8/23/07 1700 for Morbilliform eruption so far forearms and lower abdomen minimal erythema Dx: Eruption probably due to Gardasil sensitivity


VAERS ID: 289341 (history)  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-08-28
Onset:2007-08-28
   Days after vaccination:0
Submitted: 2007-08-29
   Days after onset:1
Entered: 2007-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0952F / - RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1301F / - LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Dizziness, Fall
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: N/A~ ()~NULL~~In Patient|N/A~ ()~NULL~~In Sibling1|N/A~ ()~NULL~~In Sibling2
Other Medications:
Current Illness: None Known
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: patient came in clinic for vaccintion and stated she didn''t like needle at all.After recieving MMR and Varicella vaccination she complained of dizziness. At 3:23 patientfloor and legs up position. patient was alert and oriented BP100/80Respiration rate:18.ammonia administered as precaution.patient left clinic at 3:38pm on own ability ambulating and stating she is fine.


VAERS ID: 289678 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-08-31
Entered: 2007-09-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Drug exposure during pregnancy, Foetal disorder
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = Unknown)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0708USA04507

Write-up: Initial and follow-up information has been received from the Merck Pregnancy Registry via a 23 year old female who was vaccinated on an unspecified date with a dose of Gardasil when she was a month pregnant. Subsequently, the patient gave birth to an infant with a cleft palate. At the time of the report the patient had recovered. The infant''s outcome is unknown. Additional information has been requested.


VAERS ID: 289939 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-05-18
Onset:2007-05-18
   Days after vaccination:0
Submitted: 2007-09-05
   Days after onset:110
Entered: 2007-09-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Haemorrhage, Ultrasound scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness: Pregnancy NOS (LMP=5/6/2007) Asthma
Preexisting Conditions:
Diagnostic Lab Data: ultrasound 07/30/07, beta-human chorionic 06/04/07 positive;
CDC Split Type: WAES0708USA04041

Write-up: Information has been received from a registered nurse concerning a 23 year old female with asthma who on 12-MAR-2007 was vaccinated with a first dose of Gardasil. On 18-MAY-2007, the patient was vaccinated with a second dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). The nurse reported that the patient was given the second dose of Gardasil when she was possibly pregnant. Date of LMP was 06-MAY-2007. On 04-JUN-2007, a pregnancy test was positive. Subsequently, a small amount of bleeding was noted. On 30-JUL-2007, an ultrasound was performed (results not reported). At the time of the report on 21-AUG-2007, the patient was still pregnant. The patient''s bleeding was considered an other important medical event by the registered nurse. Additional information has been requested.


VAERS ID: 290189 (history)  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-05-15
Onset:2007-06-15
   Days after vaccination:31
Submitted: 2007-09-07
   Days after onset:84
Entered: 2007-09-10
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac monitoring, Convulsion, Dizziness, Electrocardiogram, Electroencephalogram, Feeling abnormal, Hyperhidrosis, Hypoaesthesia, Loss of consciousness, Nuclear magnetic resonance imaging, Paraesthesia, Sinus tachycardia, Syncope, Ultrasound scan
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (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), Supraventricular tachyarrhythmias (narrow), Dementia (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol; ORTHO TRI-CYCLEN; FLOVENT; SEREVENT; prednisone
Current Illness: Allergic reaction to antibiotics; Asthma
Preexisting Conditions:
Diagnostic Lab Data: magnetic resonance 06/15/07; electroencephalography 06/15/07; electrocardiogram 06/15/07; ultrasound 06/15/07; cardiac monitoring 06/15/07
CDC Split Type: WAES0708USA04775

Write-up: Information has been received from a 23 year old female patient with allergic reaction to an unknown antibiotic (hives, rash) and asthma who on 15-MAY-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included ORTHO TRI-CYCLEN, prednisone, FLOVENT, SEREVENT, and albuterol. On 15-JUN-2007 the patient began to feel very sweaty, experienced dizziness and convulsions and lost consciousness. She was taken to a hospital and treated by the emergency department. She was not admitted as an inpatient. On 22-JUN-2007 she again became very dizzy, experienced convulsions, her hands and arms were tingling, her arms felt numb, and again she lost consciousness. She was taken to the hospital again and was treated by the emergency department. She was not admitted as an in-patient. On 30-JUN-2007 same thing occurred. She felt a "weird rush to her head," felt tingling and dizzy, and again lost consciousness. She went to a hospital again and treated by the emergency department. Again, she was not admitted as an in-patient. She reported that the only diagnoses made were "inappropriate sinus tachycardia and syncope". Since these three trips to the hospital, she had episodes of her hands beginning to tingle, "rushes to her head," and dizziness. She did not lose consciousness again. She still has dizziness all the time. It was reported the following tests were done: magnetic resonance imaging (MRI), electroencephalography (EEG), electrocardiogram (EKG), sonogram and heart monitor diagnostic tests were done but the results not available. At the time of this report the patient was recovering. Upon internal review, convulsion was determined to be an other important medical event. Additional information has been requested.


VAERS ID: 290272 (history)  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2006-12-14
Onset:2006-12-14
   Days after vaccination:0
Submitted: 2007-09-10
   Days after onset:269
Entered: 2007-09-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Foetal disorder
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy NOS (LMP = 11/29/2006)
Preexisting Conditions:
Diagnostic Lab Data: beta-human chorionic 12/14/06 - positive
CDC Split Type: WAES0701USA00363

Write-up: Information has been received from a registered nurse concerning a 23-year-old female with no known drug allergies, who on 14-DEC-2006 was vaccinated with a subcutaneous dose of MMR II. There was no concomitant medication. A pregnancy test revealed the patient was 2 weeks pregnant (LMP= 29-NOV-2007, EDD=05-SEP-2007) at the time of vaccination. The patient sought unspecified medical attention. No other information was provided. Follow up information received indicated that there were no diagnostic tests, infections or illnesses during the pregnancy, and that no prescription drugs were taken. On 24-Aug-2007, at 39 weeks of pregnancy, a live, normal, female infant was born that weighed 8 pounds 9 ounces. There were no complications during the pregnancy, labor or delivery. However, it was also reported that the baby had unspecified congenital anomalies. The congenital anomalies were the only known complications for the infant. Additional information has been requested.


VAERS ID: 290296 (history)  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-09-11
Onset:2007-09-11
   Days after vaccination:0
Submitted: 2007-09-11
   Days after onset:0
Entered: 2007-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 10634 / 0 LA / IM

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), Hypoglycaemia (broad)

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:
CDC Split Type:

Write-up: pt fainted after vacc. and recovered after 5 min


VAERS ID: 290331 (history)  
Age: 23.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2007-08-07
Onset:2007-08-14
   Days after vaccination:7
Submitted: 2007-09-05
   Days after onset:22
Entered: 2007-09-12
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0525U / 1 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Blood creatine phosphokinase increased, Lymphadenopathy, Myalgia, Red blood cell sedimentation rate normal, Trismus
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Dystonia (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Developed lymph swelling in neck~HPV (Gardasil)~1~23.00~In Patient
Other Medications: Allegra, Zoloft, Flonase, Albuterol, BCP
Current Illness: None known
Preexisting Conditions: Celexa= nightmares PMH: mono, allergic rhinitis, asthma, hx of suppressed immune system. TMJ tx w/night guard.
Diagnostic Lab Data: Sed rate = nl; CPK - was 471 (8/21) - 179 (8/30/07) LABS: WBC 8.2, lymphs # (H) 3.2. CT scan of neck revealed slightly enlarged bilateral lymph nodes. CPK 500. Monospot & strep screen neg.
CDC Split Type:

Write-up: This was pt''s second Gardasil vaccine on 8/7/07. She developed symptoms 8/14 and was seen at hospital 8/20, 8/21, 8/22/07. She was suffering from myalgias, trismus, "lockjaw" and slight neck adenopathy. Her neck CT was normal. 9/18/07 Received hospital medical records which reveal patient experienced severe neck pain & swelling w/inability to open her mouth. After 1st vax 6/07 had tenderness in right clavicle & neck area. Saw pcp & dx w/reaction to vax. Resolved over approx 1-2 mos. Received 2nd vax in 8/07. Approx 1 week later developed severe pain in right neck & axilla w/enlarged lymph nodes. States pain was so severe that she could not open her mouth. Saw pcp who again dx w/reaction to vax but referred to ER due to severity. Exam revealed full ROM of neck w/tenderness & palpable tender lymph nodes of neck & right axillary. D/C to home. No improvement & returned to ER on 9/21. Tx w/IVF, pain med & IV steroids. Improved in ER & d/c to home. Returned to ER on 8/22 for repeat labs & recheck of symptoms. CPK improved but continued w/same symptoms but no adenopathy noted on exam. Right arm exam WNL but w/increased tone to bicep/tricep area w/good ROM, strength & sensation. Tx w/pain med & benzodiazapam w/excellent relief. D/C to home & f/u w/pcp. Final ER DX: 8/20/07 reactive lymphadenopathy, probable viral illness, ? TMJ syndrome, questionable AE to vaccine. Final ER DX: 8/21/07 myalgias w/extremely low grade rhabdomyolysis & ? serum immune complex type hypersensitivity reaction to vaccine. Final ER DX: 8/22/07 myalgias w/low grade rhabdomyalisis.


VAERS ID: 290422 (history)  
Age: 23.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2003-08-05
Onset:0000-00-00
Submitted: 2007-09-05
Entered: 2007-09-12
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 3350A4 / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)

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: N/A
CDC Split Type:

Write-up: None. Received 2 doses of pediatric Hepatitis B vaccine.


VAERS ID: 290426 (history)  
Age: 23.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2006-08-15
Onset:0000-00-00
Submitted: 2007-09-06
Entered: 2007-09-12
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB141AA / 1 RA / IM
TD: TD ADSORBED (NO BRAND NAME) / MASS. PUB HLTH BIOL LAB TD138 / 0 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Incorrect dose administered
SMQs:, Medication errors (narrow)

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: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received 2 doses of pediatric Hepatitis vaccine


VAERS ID: 290480 (history)  
Age: 23.0  
Gender: Male  
Location: Illinois  
Vaccinated:2007-09-11
Onset:2007-09-12
   Days after vaccination:1
Submitted: 2007-09-12
   Days after onset:0
Entered: 2007-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2632AA / 0 LA / IM

Administered by: Unknown       Purchased by: Public
Symptoms: Chills, Headache, Inappropriate schedule of drug administration, Pain, Pyrexia, Wrong drug administered
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: folic acid, allipurinol, lipitor, nexium
Current Illness: none
Preexisting Conditions: GERD, high cholesterol, high uric acid
Diagnostic Lab Data: none at this time
CDC Split Type:

Write-up: Pt woke up at 0400 w/ chills and fever "up to 102", also c/o headache, body aches


VAERS ID: 290490 (history)  
Age: 23.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-09-11
Onset:2007-09-12
   Days after vaccination:1
Submitted: 2007-09-13
   Days after onset:1
Entered: 2007-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV105 / 3 LA / SC

Administered by: Military       Purchased by: Unknown
Symptoms: Erythema, Fatigue, Local reaction, Pyrexia, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: alergic to erithemicin, sulfer drugs. ultram, viacadin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Local reaction Left Arm 13 Sept 07, Swelling,Redness, Warm to touch, Had fever on 12 Sept. C/O fatigue. Given Anthrax 4 11 Sept 2007


VAERS ID: 290654 (history)  
Age: 23.0  
Gender: Male  
Location: Virginia  
Vaccinated:2007-09-14
Onset:2007-09-14
   Days after vaccination:0
Submitted: 2007-09-16
   Days after onset:2
Entered: 2007-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER FAV110 / 3 RA / SC

Administered by: Military       Purchased by: Military
Symptoms: Hypokinesia, Injection site swelling, Paraesthesia, Skin warm
SMQs:, Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad)

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:

Write-up: SWELLING BELOW THE INJECTION SITE THAT IS APPROX 120 MM IN CIRCUMFRANCE, HOT TO THE TOUCH AND CAUSES A DULL PAIN EVEN IF NOT COMPRESSED. SWELLING LIMITS MOVEMENT. PT STATES HE FEELS TINGLING IN FINGERS ON RIGHT HAND. PT IS DEPLOYING AND HIS SYMPTOMS HAVE NOT GONE AWAY YET SO I WILL MARK NO FOR THE ANSWER TO PATIENT RECOVERED. BIOPORT CORP WAS THE MANUFACTURER.


VAERS ID: 290778 (history)  
Age: 23.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2007-07-26
Onset:0000-00-00
Submitted: 2007-08-16
Entered: 2007-09-18
   Days after submission:33
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB118AA / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0927U / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Diagnostic procedure, Dizziness, Nausea, Tenderness, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

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: Balance solution-Multiple test for dizziness-all normal
CDC Split Type:

Write-up: Tenderness in Lt deltoid x 2 wks nausea/vomiting/dizziness x 2 wks (intermittent) Tx-Meclizine/Valium 1/3 testing @ medical center.


VAERS ID: 290791 (history)  
Age: 23.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-09-15
Onset:2007-09-16
   Days after vaccination:1
Submitted: 2007-09-18
   Days after onset:2
Entered: 2007-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2068AA / - LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Erythema, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:

Write-up: redness, swelling, tender to touch


VAERS ID: 290830 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-09-12
Onset:2007-09-12
   Days after vaccination:0
Submitted: 2007-09-18
   Days after onset:6
Entered: 2007-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER FAV108 / 4 RA / SC
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0211U / 0 LA / SC

Administered by: Military       Purchased by: Unknown
Symptoms: Erythema, Pruritus, Rash papular, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Celexa
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Development of red, pruritic papules and hives beginning on her legs on the day of the immunization and spreading to her arms on the next day. Pt seen in clinic 5 days later; pruritis treated with atarax.


VAERS ID: 290850 (history)  
Age: 23.0  
Gender: Male  
Location: Oklahoma  
Vaccinated:2007-08-20
Onset:2007-08-28
   Days after vaccination:8
Submitted: 2007-08-30
   Days after onset:2
Entered: 2007-09-18
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV109 / 0 RA / SC
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR A0221 / 0 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Erythema, Infection
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Given Keflex
CDC Split Type:

Write-up: Red line going to lymph node. ER doctor said it was a lymphatic infection due to vaccination and sweat.


VAERS ID: 291462 (history)  
Age: 23.0  
Gender: Female  
Location: Oregon  
Vaccinated:2007-05-09
Onset:0000-00-00
Submitted: 2007-08-08
Entered: 2007-09-20
   Days after submission:43
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2690A / 0 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Musculoskeletal stiffness, Neck pain
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)

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: The patient had no illness at the time of vaccination and no pre-existing medical conditions.
Diagnostic Lab Data:
CDC Split Type: 200702496

Write-up: A 23-year-old female patient, who no pre-existing medical conditions and no illness at the time of vaccination, had received a first dose, intramuscular injection of Adacel, lot number C2690AA, on 09 May 2007. At an unspecified amount of time post-vaccination, the patient experienced severe left neck pain and stiffness. She did not experience fever or headache. Other medications were "not available." The patient recovered from the event. Additional medically relevant information was not provided. The reporter in this case is the same as in cases 2007-02489, 2007-02495, 2007-02497, 2007-02498, and 2007-02499.


VAERS ID: 292026 (history)  
Age: 23.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-08-02
Onset:2007-08-07
   Days after vaccination:5
Submitted: 2007-09-17
   Days after onset:41
Entered: 2007-09-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0186U / 0 UN / IM

Administered by: Public       Purchased by: Other
Symptoms: Axillary mass, Breast pain, Nodule
SMQs:, Lipodystrophy (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Breast examination - normal
CDC Split Type: WAES0708USA01893

Write-up: Information has been received from a physician concerning a 23 year old female, who on 02-AUG-2007 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL (Lot# 655618/0186U). There was no concomitant medication. On 07-AUG-2007 the patient developed a lump in the axilla of her left side which was causing pain that radiates to her left breast. The patient was given a breast examination that showed to be normal. A pea size nodule was found in the patient''s left axilla. At the time of the report the patient had not recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. There were no illnesses at the time of the vaccination. No laboratory diagnostics were performed. At the time of the report the patient''s outcome was unknown (previously reported as had not recovered). No product quality complaint was involved. Additional information is not expected.


VAERS ID: 292092 (history)  
Age: 23.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-06-25
Onset:2007-06-27
   Days after vaccination:2
Submitted: 2007-09-17
   Days after onset:82
Entered: 2007-09-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0708USA01599

Write-up: Information has been received from a registered nurse concerning a 23 year old female who on 25-JUN-2007 was vaccinated with a third dose of Gardasil (Lot # 657737/0522U). On 27-JUN-2007 the patient developed unusual swelling of the upper left forearm, and the injection site was very hard and red. The patient contacted the physician and went for a follow-up visit and was treated with ADVIL, BENADRYL, and ice. On 29-JUN-2007 the patient recovered. Additional information has been requested.


VAERS ID: 292982 (history)  
Age: 23.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2007-08-14
Onset:2007-08-14
   Days after vaccination:0
Submitted: 2007-09-17
   Days after onset:34
Entered: 2007-09-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0929U / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Dizziness
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Vestibular disorders (broad)

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: was vaccinated with the first dose of Gardasil with no difficulties reported
Diagnostic Lab Data: None
CDC Split Type: WAES0709USA00098

Write-up: Information has been received from a nurse, via a company representative, concerning a 23 year old ("about 23 years old") female patient, who on 13-JUN-2007 was vaccinated with the first dose of Gardasil with no difficulties reported, and on 14-AUG-2007, was vaccinated with the second dose, 0.5 ml, of Gardasil (lot #658282/0929U). Concomitant therapy included ADACEL. On 14-AUG-2007, following the second vaccination, a family member called the office to report the patient felt dizzy and was "acting loopy." Subsequently, the patient recovered (date and duration not specified). The patient''s 14 year old sister also experienced a similar event as described above, when vaccinated with Gardasil (lot #658282/0929U) (WAES # 0709USA00082). Additional information has been requested.


VAERS ID: 293052 (history)  
Age: 23.0  
Gender: Female  
Location: New York  
Vaccinated:2007-06-15
Onset:2007-07-15
   Days after vaccination:30
Submitted: 2007-09-17
   Days after onset:64
Entered: 2007-09-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0210U / 1 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Migraine
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: YASMIN
Current Illness: Stress
Preexisting Conditions: Migraine
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0708USA03111

Write-up: Information has been received from a physician concerning a 23 year old female with no pertinent medical history, who on 03-APR-2007 was vaccinated IM with a first dose of Gardasil (lot # 655322/0092U). On 15-JUN-2007 was vaccinated IM with a second dose of Gardasil (lot # 0210U). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 15-JUL-2007 the patient experienced migraine headache. The patient was evaluated by a neurologist. At the time of the report, the status was unknown. Additional information has been requested. 01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a physician concerning a 23 year old female with migraines, who on 03-APR-2007 was vaccinated IM with a first dose of GARDASIL (lot # 655322/0092U). On 15-JUN-2007 the patient was vaccinated IM with a second dose of GARDASIL (lot # 0210U). Concomitant therapy included YASMIN. On approximately 15-JUL-2007 the patient experienced a migraine headache. It was reported that the patient experienced her first migraine followed by nausea caused by flashing lights for several minutes during her junior year of college every week lasting several hours for one month and sought no medical attention at that time. Since then the patient did not experience a migraine until receiving her first dose of GARDASIL. The patient reported that she experienced migraines in early April 2007 that lasted 4 to 5 hours, then every 1 to 2 weeks until early July 2007. It was noted that the patient was under severe stress at work. The patient was evaluated by a neurologist and no prescription was given. The neurologist advised the patient that she was having migraines. It was reported that the patient was under significant stress at that time. The patient had not experienced a migraine headache since early July 2007 but was concerned that the migraines were caused by the vaccination. At the time of the report, the status was unknown. Additional information is not expected.


VAERS ID: 293673 (history)  
Age: 23.0  
Gender: Female  
Location: Oregon  
Vaccinated:2007-08-20
Onset:2007-08-21
   Days after vaccination:1
Submitted: 2007-09-17
   Days after onset:27
Entered: 2007-09-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: dermatologic (unspecified)
Current Illness: Drug hypersensitivity
Preexisting Conditions: Vulval lesion
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0708USA04094

Write-up: Information has been received from a nurse concerning a 23 year old female with an allergic reaction to dapsone and a history of vulval lesion who on 19-JUN-2007 was vaccinated with a first dose of Gardasil (lot# 656050/0245U) 0.5mL IM. Concomitant therapy included dermatologic (unspecified) therapy for acne. On 20-AUG-2007 the patient was vaccinated with a second dose of Gardasil (lot# unknown) 0.5mL IM. On 21-AUG-2007 the patient developed an itchy rash on both arms an abdomen. Medical attention was sought. The patient''s itchy rash on both arms and abdomen persisted. No other information was available at this time. Additional information has been requested.


VAERS ID: 293703 (history)  
Age: 23.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-08-28
Onset:2007-08-29
   Days after vaccination:1
Submitted: 2007-09-17
   Days after onset:19
Entered: 2007-09-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1060U / 2 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Gait disturbance, Impaired work ability, Laboratory test normal, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LAMICTAL; CHANTIX
Current Illness: Sulfonamide allergy; Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: diagnostic laboratory - negative
CDC Split Type: WAES0709USA00048

Write-up: Information has been received from a physician concerning a 23 year old female with a sulfonamide and penicillin allergy and no other pertinent medical history who on an unspecified date received her second dose of Gardasil. Subsequently, she had joint pain. She was seen by a rheumatologist, but unspecified tests came back negative. Subsequently, she recovered. on 28-AUG-2007 the patient was vaccinated with her third dose of Gardasil, 0.5 mL (Lot # 658556/1060U). Concomitant therapy included lamotrigine (LAMICTAL) and varenicline tartrate (CHANTIX). On 29-AUG-2007 after receiving her third dose of Gardasil, the patient complained of generalized joint and muscle pain. The pain was so strong that she could not walk. She had to stay in bed and was not able to go to work. The physician noted the patient had no problems with the first dose of Gardasil and only had joint pain after second dose and after the third dose, pain reappeared all over her body. The patient called the physician and sought medical attention. Patient Quality Complaints (PQC) were not involved. The physician considered generalized joint and muscle pain to be disabling because the patient could not walk. Additional information has been requested. In follow-up it was reported by the physician, that the patient a 23 year old, female with a sulfonamide and penicillin allergy and no pertinent medical history and no illness at the time of vaccination who on 28-AUG-2007 was vaccinated intramuscularly into the left arm with the third dose of GARDASIL, (Lot # 658556/1060U). It was reported that on 29-AUG-2007, the patient at first had joint pain in both hands and then generalized muscle pain and joint pain throughout the whole body. It was reported that the patient felt better and recovered on 31-AUG-2007. Additional information has been requested.


VAERS ID: 291207 (history)  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-09-11
Onset:2007-09-12
   Days after vaccination:1
Submitted: 2007-09-25
   Days after onset:13
Entered: 2007-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER FAV105 / 2 RA / SC

Administered by: Military       Purchased by: Military
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: MEMBER BROKE IN RASH FROM NECK DOWN AFTER 3RD ANTHRAX SHOT


VAERS ID: 291283 (history)  
Age: 23.0  
Gender: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-09-24
Entered: 2007-09-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Neoplasm malignant, Smear cervix
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Pap test
CDC Split Type: WAES0709USA02008

Write-up: Information has been received from a Nurse Practitioner concerning a 23 year old female who on an unspecified date was vaccinated by injection with the first dose of with Gardasil. The Nurse Practitioner reported that the patient was diagnosed with cancer. The patient was in the office to receive her second dose at the time of the diagnosis. The patient had sought unspecified medical attention. The patient had a Papanicolaou test ("pap smear"). At the time of the report, the patient had not recovered and Gardasil had not been reintroduced. Upon internal review, it was determined that cancer was an other important medical event. Additional information has been requested.


VAERS ID: 291422 (history)  
Age: 23.0  
Gender: Female  
Location: Virginia  
Vaccinated:2007-09-25
Onset:2007-09-25
   Days after vaccination:0
Submitted: 2007-09-26
   Days after onset:1
Entered: 2007-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1008U / 1 LA / SC

Administered by: Unknown       Purchased by: Private
Symptoms: Erythema, Feeling hot and cold, Injection site pruritus, Injection site rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KARIVA, NASOCORT, SINGULAIR
Current Illness: NONE
Preexisting Conditions: ALLERGY TO AUGMENTIN (RASH), MVP(SINCE BIRTH), ENVIRONMENTAL ALLERGIES, ACNE, SCOLIOSIS, CHRONIC YEAST/BACTERIAL INFECTIONS SINCE 2002
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Presented with c/o rash, itch, at sight of vaccination L triceps area. States feeling hot/cold, yesterday. Onset noticed about 11pm, 9/25, reaction larger when seen at clinic 2:30pm, 9/26. raised erythematous area L triceps, 50X60 mm. No pox noted, no body rash. T-98.5, no respiratory symptoms. Top hydrocortisone 1% applied. Suggest oral benadryl 25mg, or try tylenol or advil to help decrease symptoms. Call if increase in symptoms, return to clinic 9/28 to recheck


VAERS ID: 291500 (history)  
Age: 23.0  
Gender: Female  
Location: Missouri  
Vaccinated:2007-03-21
Onset:0000-00-00
Submitted: 2007-09-26
Entered: 2007-09-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 02244U / - LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site rash, Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Eruptions, red and scabbed on Rt and Lt deltoid started after first injection was given 3-21-07 Did not report until 3 rd inj.


VAERS ID: 291509 (history)  
Age: 23.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-09-25
Onset:2007-09-25
   Days after vaccination:0
Submitted: 2007-09-27
   Days after onset:2
Entered: 2007-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0742U / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Disorientation, Dizziness, Electrocardiogram, Fall, Head injury, Hyperhidrosis, 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), Accidents and injuries (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: nortrell oral contraceptive, zoloft 100mg
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: electrocardiogram, 09/25/07, result not available; blood pressure, 09/25/07, 131/6 mmHg; body temp, 09/25/07, 97.8; total heartbeat count, 09/25/07/ 93; respiratory rate, 09/25/07, 20.
CDC Split Type:

Write-up: patient came to office for second Gardasil injection on 9/25/07 at 11:00 am. The injection was administered to the patient IM Left deltoid without difficulty by Registered Medical Assistant. Patient was advised to wait 10 minutes in the waiting area after the injection as per protocal after receiving the gardasil injection. Five minutes later triage nurses were paged to the front desk by office staff, patient was found on the floor awake but slightly disoriented, diaphoretic and stating that she felt lightheaded. Front desk staff reports that patient was in the process of checking out and asked for orange juice because she felt a bit dizzy but then immediately passed out, fell forward onto front desk and then fell to the floor. At which time front desk staff called nurses for help. Nurses and Medical Assistants immediately used ammonia salts to help awaken patient and monitored vital signs, which were stable at BP-100/70 P-80 office staff also immediately called 911. Ems arrived less than 10 minutes later and patient was transported to the ER. Information has been received from a Registered nurse concerning a 23 year old female student who on 24-JUL-2007 was vaccinated IM with a first dose of GARDASIL lot #654539/0742U, with no reaction noted. On 25-SEP-2007 at 11:00 a.m. she was vaccinated IM in the left deltoid with the second dose of GARDASIL (lot #654539/0742U). The nurse reported that the patient fainted after receiving the second injection, passed out about 5 minutes after the vaccination, and hit her head on the wall. Treatment included administration of "smelling salt". She was sent to an emergency room for evaluation for a head injury. Follow up information indicated that the patient was "awake, oriented, anicteric and conversational," with mo photophobia. The treating physician noted that the patient "needs something to eat. She had a vasovagal epidode." and added that there was no indication for laboratory tests or studies. Vital signs were as follows: temperature 97.8, pulse 93, respirations 20, blood pressure 131/67 mmHg. an electrocardiagram was ordered (results not provided). At the time of this report, the patient had recovered from the events (duration not specified). Additional information is not expected.


VAERS ID: 291528 (history)  
Age: 23.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2003-11-06
Onset:0000-00-00
Submitted: 2007-09-27
Entered: 2007-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS UNK / 1 UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Alopecia, Blood cholesterol increased, Headache, Hearing impaired, Sleep disorder, Stress, Visual disturbance
SMQs:, Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Lipodystrophy (broad), Hypoglycaemia (broad)

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: NONE
Diagnostic Lab Data: HIGH CHOLESTEROL
CDC Split Type:

Write-up: STRESS, HIGH CHOLESTEROL, HEARING AND VISUAL DISORDERS, HEADACHE, HAIR LOSS, SLEEPING PROBLEM.


VAERS ID: 291762 (history)  
Age: 23.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2007-08-16
Onset:2007-08-17
   Days after vaccination:1
Submitted: 2007-10-01
   Days after onset:45
Entered: 2007-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH FAV110 / 1 UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Dizziness, Headache, Pruritus, Rash pruritic, Tunnel vision, Urticaria, Vision blurred
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: NKDA; No medical conditions; No birth defects
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 23 y/o female AD SM is referred to the VHC by physician for possible ''urticaria'' and other systemic symptoms after AVA #1 and #2. Pruritus Start: 08/17/2007 Comment: Patient developed itching across the upper chest/clavicular area the day following AVA #1. Rash, pruritic Start: 08/18/2007 End: 08/20/2007 Comment: Patient developed clusters of itchy, red bumps in patches across her upper chest, neck and upper back. Blurred Vision start: 09/12/2007 Comment: Patient described ''hazy vision'' and ''like seeing in a tunnel'' about 20 minutes after the 2nd AVA shot. Dizziness Start 09/12/2007 Comment: Patient describes a ''little dizzy'' about 20 minutes after the 2nd AVA. No presyncope or syncope. Headache, general Start: 09/12/2007 Comment: Patient developed a headache about 2 hours after the 2nd AVA shot. No nausea, vomiting, photo- or phonophobia associated with this HA. Pruritus Start: 09/12/2007 End: 09/13/2007 Comment: Patient developed itching in the neck, upper chest area again after AVA #2 but no associated skin rash.


VAERS ID: 291858 (history)  
Age: 23.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2007-09-27
Onset:2007-09-29
   Days after vaccination:2
Submitted: 2007-10-02
   Days after onset:3
Entered: 2007-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0930U / 0 LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Dizziness, Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: nuvaring vaginal ring
Current Illness:
Preexisting Conditions: latex allergy
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe headache 2days after vaccine, then nausea and vomiting with dizziness 3 days after vaccine


VAERS ID: 292000 (history)  
Age: 23.0  
Gender: Male  
Location: Virginia  
Vaccinated:2007-09-23
Onset:2007-10-03
   Days after vaccination:10
Submitted: 2007-10-03
   Days after onset:0
Entered: 2007-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV105 / - - / SC
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020072 / - - / ID

Administered by: Military       Purchased by: Military
Symptoms: Incorrect route of drug administration, Inflammation, Injection site streaking, Lymphadenopathy
SMQs:, Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:
CDC Split Type:

Write-up: Pt was given inproper vaccination at site insted of one injection three were given in the form of a triangel. Pt has had major lymphadnopathy with inflammation and streaking from sight to lymphnode in left axillary. Pt given IV Ancef with Toradol and 2000 ml.


VAERS ID: 292418 (history)  
Age: 23.0  
Gender: Female  
Location: Michigan  
Vaccinated:2007-10-03
Onset:2007-10-06
   Days after vaccination:3
Submitted: 2007-10-08
   Days after onset:2
Entered: 2007-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0389U / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Mean platelet volume decreased, Platelet count normal, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Nuvaring; Valtrex
Current Illness: None
Preexisting Conditions: NKDA, recurrent genital herpes
Diagnostic Lab Data: CBC - Plt 446/ul, MPV 5.8 fL,
CDC Split Type:

Write-up: Onset rash - Saturday 10-6-07. Rec''d vaccine (HPV #2) on 10-3-07. Rash now over arms, legs, feet, some on back - itching on same day. Was to be seen by clinician. Also - end of initial HSV infection - on Valtrex.


VAERS ID: 292610 (history)  
Age: 23.0  
Gender: Female  
Location: Virginia  
Vaccinated:2007-10-04
Onset:2007-10-10
   Days after vaccination:6
Submitted: 2007-10-10
   Days after onset:0
Entered: 2007-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH FAV111 / 1 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Cellulitis
SMQs:

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: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: CELLULITIS 8X9 CM


VAERS ID: 292940 (history)  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-10-12
Onset:2007-10-12
   Days after vaccination:0
Submitted: 2007-10-12
   Days after onset:0
Entered: 2007-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV113 / 1 UN / SC

Administered by: Military       Purchased by: Military
Symptoms: Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: 45 minutes after second anthrax immunization the patient developed a bilateral raised erythematous pruritic rash that persisted six hours later although it had improved. No treatment instituted. Temporary medical exemption (MT) issued. Will see allergist after return CONUS before third immunization.


VAERS ID: 296741 (history)  
Age: 23.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-07-02
Onset:2007-07-04
   Days after vaccination:2
Submitted: 2007-10-08
   Days after onset:96
Entered: 2007-10-12
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Body temperature, Fatigue, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YASMIN
Current Illness:
Preexisting Conditions: Dysmenorrhoea
Diagnostic Lab Data: body temp Results not reported
CDC Split Type: WAES0709USA00630

Write-up: Information has been received from a medical assistant concerning a 23 year old female with a history of dysmenorrhoea and no known drug allergy who on 02-JUL-2007 was vaccinated intramuscularly into the right deltoid with a 0.5 ml first dose of Gardasil (Lot #657737/0522U). Concomitant therapy included YASMIN. On 04-JUL-2007 the patient experienced fever and fatigue. It was reported by the medical assistant that the patient was instructed to call the physician''s office if experiencing any injection site pain. The patient did not report injection site pain. There were no other symptoms noted. The patient did not seek medical attention. On approximately 07-JUL-2007 the patient recovered. Additional information has been requested.


VAERS ID: 298136 (history)  
Age: 23.0  
Gender: Female  
Location: New York  
Vaccinated:2007-08-13
Onset:2007-08-13
   Days after vaccination:0
Submitted: 2007-10-12
   Days after onset:60
Entered: 2007-10-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0515U / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: No reaction on previous exposure to drug, Shock, Syncope, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA01481

Write-up: Information has been received from a physician concerning a female patient who was vaccinated with a second dose of Gardasil. The physician reported that post vaccination patient fainted and wet herself. She was monitored and recovered. She did not have this adverse event after her first dose of Gardasil. No other information was available. Additional information has been requested. 01/07/2008 This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow up information has been received from a physician concerning a female patient who on 13-AUG-2007, at 01:00 PM was vaccinated with a second dose of GARDASIL lot #657872/0515U. The physician reported that post vaccination patient fainted and wet herself. She was monitored and recovered. She did not have this adverse event after her first dose of GARDASIL. No other information was available. In the follow up it was reported that "fainting resulted from shock of injection not from vaccine". Additional information is not expected.


VAERS ID: 298145 (history)  
Age: 23.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-09-10
Onset:2007-09-11
   Days after vaccination:1
Submitted: 2007-10-12
   Days after onset:31
Entered: 2007-10-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1061U / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chills, No reaction on previous exposure to drug, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: Vaginal infection
Diagnostic Lab Data: None
CDC Split Type: WAES0709USA01537

Write-up: Information has been received from a nurse concerning a 23 year old female with a history of vaginal infection (treated for this in August 2007) and no drug reactions/allergies who 08-MAR-2007 was vaccinated with a first dose of GARDASIL (lot# unknown) 0.5mL IM. Concomitant therapy included hormonal contraceptives (unspecified). On 10-MAy-2007 the patient was vaccinated with a second dose of GARDASIL 0.5mL IM. There were no adverse events noted with the first and second dose. On 10-SEP-2007 the patient was vaccinated with third dose of GARDASIL (lot# 658558/1061U) 0.5mL IM. On 11-SEP-2007 the patient called the office and stated that in early AM she developed chills, fever and general aches. Medical attention was sought via phone. The patient''s chills and fever and general aches persisted. no additional information at this time. Additional information has been requested.


VAERS ID: 298408 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-09-13
Onset:2007-09-13
   Days after vaccination:0
Submitted: 2007-10-12
   Days after onset:29
Entered: 2007-10-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site extravasation
SMQs:, Extravasation events (injections, infusions and implants) (narrow)

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: Unknown
CDC Split Type: WAES0709USA02228

Write-up: Information has been received from a physician concerning a 23 year old female who on 13-SEP-2007 was vaccinated with GARDASIL 0.5 ml. On 13-SEP-2007, upon leaving the office after the injection, the patient had liquid on her arm. The medication was leaking from her arm. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 298415 (history)  
Age: 23.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-09-06
Onset:2007-09-06
   Days after vaccination:0
Submitted: 2007-10-12
   Days after onset:36
Entered: 2007-10-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / SC

Administered by: Private       Purchased by: Other
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0709USA02268

Write-up: Information has been received from a certified medical assistant (CMA) /healthcare student concerning a female with no pertinent medical history and no prior drug reactions who on 06-SEP-2007 was vaccinated subcutaneously in the right upper arm with a first dose of GARDASIL. There was no concomitant medication. The CMA reported that the patient was recently vaccinated with GARDASIL via subcutaneous (SQ) route. The patient also developed mild redness and warmth at injection site. The patient sought medical attention in the form of an office visit. No other symptoms were noted. Subsequently, the patient recovered from mild redness and warmth at injection site. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a certified medical assistant (CMA)/healthcare student concerning a 23 year old female registered nurse with no pertinent medical history and no prior drug reactions, who on 06-SEP-2007 at 11:00, was vaccinated subcutaneously in the right upper arm with a first dose of GARDASIL vaccine (Lot # 1061). There was no concomitant medication. There were no inllnesses at the time of the vaccination. On 06-SEP-2007 the patient developed redness, warmth, and swelling at the injection site. The patient sought medical attention in the form of an office visit. No other symptoms were noted. The patient recovered on an unspecified date a few days later (also reported as recovered immediately). Additional information has been requested.


VAERS ID: 298437 (history)  
Age: 23.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2007-08-27
Onset:2007-08-29
   Days after vaccination:2
Submitted: 2007-10-12
   Days after onset:44
Entered: 2007-10-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0927U / 0 LA / UN

Administered by: Public       Purchased by: Other
Symptoms: Anogenital warts
SMQs:

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: WAES0709USA02689

Write-up: Information has been received from a nurse practitioner concerning a 23 year old female with no allergies or medical history, and no illness at the time of vaccination, who on 27-AUG-2007 at 10:00, was vaccinated in the left deltoid with a 0.5mL first dose of Gardasil (Lot# 658222/0927U). On 29-AUG-2007 the patient experienced visible condyloma. It was noted that the patient had not had intercourse in five months. The patient was seen at the office. No laboratory diagnostics were performed. At the time of the report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 298565 (history)  
Age: 23.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-09-01
Onset:2007-09-01
   Days after vaccination:0
Submitted: 2007-10-12
   Days after onset:41
Entered: 2007-10-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Acne, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Latex allergy; Seasonal allergy
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA03203

Write-up: Initial and follow-up information has been received from a nurse practitioner concerning a 22 year old female with latex and seaonal allergies who in September 2007, was vaccinated with a first dose of GARDASIL. On approximately 18-SEP-2007 the patient presented to the nurse practitioner with pain at the injection site, (unknown which arm), and acne of the face and opposite arm. The patient does not have a history of acne. At the time of the report the patient''s outcome was unknown. Additional information is not expected.


VAERS ID: 298628 (history)  
Age: 23.0  
Gender: Female  
Location: New York  
Vaccinated:2007-09-17
Onset:2007-09-21
   Days after vaccination:4
Submitted: 2007-10-12
   Days after onset:21
Entered: 2007-10-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0530U / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pruritus generalised, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA03955

Write-up: Information has been received from a physician concerning a 23 year old female who on 17-SEP-2007 was vaccinated with a third dose of Gardasil (Lot # 0530U). There was no concomitant medication. On 21-SEP-2007 the patient developed a rash and had itchiness over her body. Unspecified medical attention was sought. The patient''s outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007. Information has been received from a physician concerning a 23 year old female who on 17-SEP-2007 was vaccinated with a third dose of GARDASIL (Lot # 0530U) intramuscularly in the right arm. There was no concomitant medication. On 20-SEP-2007 the patient developed raised colorless macules over her arms and chest for three days. The patient recovered from this adverse event. On 21-SEP-2007 the patient developed a rash and had itchiness over her body. Unspecified medical attention was sought. The patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 298640 (history)  
Age: 23.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-09-18
Onset:2007-09-18
   Days after vaccination:0
Submitted: 2007-10-12
   Days after onset:24
Entered: 2007-10-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0742U / 0 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Blood pressure decreased, Dizziness, Headache, Heart rate
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: blood pressure, 09/18/07, 112/7; blood pressure, 09/18/07, 102/7; total heartbeat count, 09/18/07, 80
CDC Split Type: WAES0709USA04271

Write-up: Information has been received from a licensed practical nurse concerning a 23 year old female with no medical history and no illness at the time of being vaccinated. On 18-SEP-2007, the patient was vaccinated with a first dose of Gardasil (lot # 654539/0742U) IM in the left deltoid. There was no concomitant medication. On 18-SEP-2007, 5 minutes after being vaccinated, the patient experienced dizziness and she needed to lie down. Her blood pressure was 112/76 after 20 minutes blood pressure was 102/78, pulse 80 and her dizziness resolved. She experienced a slight headache. On 18-SEP-2007, the patient recovered from the dizziness and slight headache. No additional information is expected.


VAERS ID: 298647 (history)  
Age: 23.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2007-09-21
Onset:2007-09-21
   Days after vaccination:0
Submitted: 2007-10-12
   Days after onset:21
Entered: 2007-10-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0742U / 0 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Blood pressure, Headache, Nausea, Syncope
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), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LUNESTA; lorazepam
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Blood pressure, stable
CDC Split Type: WAES0709USA04345

Write-up: Information has been received from a certified medical assistant concerning a 23 year old female with no drug allergies, who on 21-SEP-2007 was vaccinated with a first dose of Gardasil (lot# 654539/0742U). Concomitant therapy included LUNESTA and lorazepam. On 21-SEP-2007 the patient fainted at 15:40 in the physician''s office, at check out desk, and later that night the patient felt nauseous and had a headache. On 25-SEP-2007 a follow-up phone call was made and the patient reported feeling fine. The patient''s blood pressure was taken and was stable. No other symptoms were noted. The patient reported tht this has not happened in a long time. The patient''s vital signs were stable and there was no evidence of trauma. On 22-SEP-2007 the patient recovered from the headache and nausea. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a certified medical assistant concerning a 23 year old female with no drug allergies, who on 21-SEP-2007 at 15:30 was vaccinated intramuscularly in the left upper arm with a first dose of GARDASIL vaccine (lot# 654539/0742U). On 21-SEP-2007 the patient recovered from fainting. Additional information is not expected.


VAERS ID: 298756 (history)  
Age: 23.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2007-08-28
Onset:2007-09-25
   Days after vaccination:28
Submitted: 2007-10-12
   Days after onset:17
Entered: 2007-10-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0930U / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site urticaria, Muscular weakness, Oedema peripheral, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: radiographic contrast medium
Current Illness: drug hypersensitivity
Preexisting Conditions: astroparesis; panic disorder; syncope
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA04572

Write-up: Information has been received from a medical assistant concerning a female patient who on approximately 27-AUG-2007 "one month ago", was vaccinated with a first dose of GARDASIL. Concomitant therapy included contrast dye. On approximately 27-SEP-2007 "one month later", the patient presented with a welt at the injection site. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007. Information has been received from a medical assistant concerning a female patient with history of gastropharesis, panic disorder, recurrent syncope and allergies to pseudoephedrine and IV contrast who on 28-Aug-2007, was vaccinated IM into the left arm with a first dose of GARDASIL (lLot # 658488/0930U). On 25-Sep-2007 one month after injection, the patient presented with one day sudden onset of soreness, swelling, stinging in arm and weakness down arm and a welt at the injection site. Unspecified medical attention was sought. At the time of this report, the patient recovered. No product quality complaint was involved. This is one of two reports form the same source. Additional information is not expected.


VAERS ID: 298860 (history)  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-09-04
Onset:2007-09-11
   Days after vaccination:7
Submitted: 2008-01-07
   Days after onset:118
Entered: 2007-10-15
   Days after submission:84
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0530U / 0 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Muscular weakness, Nuclear magnetic resonance imaging, Sensory loss
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 18 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MOLTRIN; PROVERA
Current Illness: 12/18/07-records received-Vaginal bleed for 2 weeks after IUD placement. History of diarrhea one week ago which remained for 3 days and resolved spontaneously.
Preexisting Conditions: Pregnancy termination. 12/18/07-records received-HX cervical cancer 6 years ago.
Diagnostic Lab Data: Magnetic resonance 09/07/07 results not reported 12/18/07-records received-Labs: lymphs 51.2, mono 11.6, sed rate 25. Urinalysis WBC 188, RBC 27, e. coli. Pregnancy test positive. CSF protein 56, culture negative.
CDC Split Type: WAES0709USA01558

Write-up: Information has been received from a physician concerning a 23 year old female with a history of being seen in the emergency room with "IUD pregnancy terminated" on 27-AUG 2007. On 04-SEP-2007, the patient was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5ml (# of doses not reported). Concomitant therapy was unspecified. On 04-SEP-2007, the patient was given a prescription to fill for medroxyprogesterone acetate (PROVERA) and ibuprofen (MOTRIN) at the same visit that the HPV rL1 6 11 16 18 VLP vaccine (yeast) was administered. It was unknown if the prescriptions were taken by the patient. On 07-SEP-2007, the patient experienced loss of feelings in her extremities and weakness that progressed until she was examined in the emergency room. On 07-SEP-2007, the patient was hospitalized for possible Guillain-Barre syndrome. The patient had a magnetic resonance imaging performed that was being evaluated. At the time of reporting the patient had not recovered and was in the intensive care unit. The reporting physician felt that the event was serious (Other Important Medical Event), immediately life-threatening, required hospitalization and was disabling. Additional information has been requested. 12/18/07-records received for DOS 9/10-9/28/07- DC DX: Guillain-Barre syndrome, quadriparesis, improving at time of discharge. Decreased mobility in self care. pregnancy has resolved. Urinary tract infection. See in ED wit 2 day history of weakness started in fingers/hands and leg pains. Difficulty walking, can not get up wlk or move legs and arms. Short of breath when she tries to talk. PE: reflexes absent in both lower and upper extremities. This is in follow-up to report(s) previously submitted on 10/12/2007 1/7/2008. Initial and follow-up information has been received from two physicians concerning a 23 year old female with a history of bein seen in the emergency room with "IUD-pregnancy terminated" on 27-AUG-2007. On 04-SEP-2007, the patient was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (Lot #0530U) # of doses not reported. On 14/SEP/2007, the patient was given a prescription to PROVERA and MOTRIN at the same time that GARDASIL was administered. It was unknown if the prescriptions wore taken by the patient. On approximately, 11-SEP-2007, the patient experienced loss of feelings in her extremities and weakness that progressed. She presented to the emergency room, with Guillain Barre syndrome where she was examined. On approximately, 11-SEP-2007, the patient was hospitalized for possible Guillain-Barre syndrome. The patient had a magnetic resonance imaging performed that was being evaluated. At the time of reporting, the patient had not recovered and was in the intensive care unit. The reporting physician felt that the event was serious (Other Important Medical Event) immediately life-threatening, required hospitalization, and was disabling. A review of the release testing data revealed that 0530U conformed to all required testing at the time of product release. Additional information is not expected.


VAERS ID: 293256 (history)  
Age: 23.0  
Gender: Female  
Location: New York  
Vaccinated:2007-05-07
Onset:2007-05-08
   Days after vaccination:1
Submitted: 2007-10-16
   Days after onset:161
Entered: 2007-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. AHAVB118AA / 0 LA / IM
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD 3001173 / 0 - / PO
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UF045AA / 0 LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body temperature increased, Chills, Convulsion, Liver function test abnormal, Pyrexia
SMQs:, Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: no
Preexisting Conditions: seasonal allergies
Diagnostic Lab Data: 11/26/07-records received- Hepatitis serology, HIV and CT scan of abdomen all normal. Monospot positive. Lymphoctes elevated.
CDC Split Type:

Write-up: Chills and felt feverish one day after receiving Hep. A and yellow fever vaccines. One week later, pt. started oral typhoid and was still experiencing chills. No temp. measurement done up to this time. After 3rd oral typhoid, pt. experienced "convulsions." One week later her temp. was measured at 103.9 and she had inc. LFT''s. She was hospitalized for 5 days in Chicago. As of 7/20/2007, LFT''s have returned to normal according to pt. 11/26/07-records received for DOS 5/24-5/27/07- DC DX: fever of unknown origin, abnormal liver transaminases, adenopathy. Seen for acute febrile illness of unknown etiology. Two week HX of fevers chills and rigors.


VAERS ID: 293330 (history)  
Age: 23.0  
Gender: Female  
Location: Maryland  
Vaccinated:2007-10-09
Onset:2007-10-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2007-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0243U / 0 LA / UN

Administered by: Public       Purchased by: Public
Symptoms: Nausea, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Allergy IV dye, Compazine, Crohn''s disease, Asthma
Diagnostic Lab Data:
CDC Split Type:

Write-up: Nausea, vomiting, facial hives (2) in evening after vaccine, states too Benadryl and improved next AM. Pt states she gets hives frequently: always carries Benadryl.


VAERS ID: 293384 (history)  
Age: 23.0  
Gender: Male  
Location: Delaware  
Vaccinated:2007-10-05
Onset:2007-10-05
   Days after vaccination:0
Submitted: 2007-10-10
   Days after onset:5
Entered: 2007-10-16
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV111 / 3 LA / SC

Administered by: Military       Purchased by: Military
Symptoms: Chills, Dizziness, Fatigue, Headache, Hyperaesthesia, Nausea, Oedema peripheral, Pruritus, Pyrexia, Skin tightness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe fever 103.1, chills, fatigue, severe headaches, nausea, swelling of arm from tricep to inside of bicep which made skin tight, severe pain if touched also, itchiness, dizziness.


VAERS ID: 293432 (history)  
Age: 23.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-10-08
Onset:2007-10-08
   Days after vaccination:0
Submitted: 2007-10-09
   Days after onset:1
Entered: 2007-10-17
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0515U / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control; Multivitamin
Current Illness:
Preexisting Conditions: NKDA - CP - Asthma
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Numbness on (L) arm started after Gardasil injection 10/8/07. Numbness on top of arm - goes to fingers.


VAERS ID: 293582 (history)  
Age: 23.0  
Gender: Female  
Location: Georgia  
Vaccinated:2002-08-07
Onset:2002-11-01
   Days after vaccination:86
Submitted: 2007-10-18
   Days after onset:1811
Entered: 2007-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - LA / IM
TD: TETANUS DIPHTHERIA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, Blood test, Fibromyalgia, Joint stiffness, Rheumatoid arthritis, Tinnitus, X-ray
SMQs:, Hearing impairment (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad)

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 12/19/07-records received-developed problems with back from an injury 4 years ago
Diagnostic Lab Data: x-rays, blood tests 12/19/07-records received-Rheumatoid factor negative. ANA negative, parvo titers normal, inflammatory markers normal.
CDC Split Type:

Write-up: Within a few months of being vaccinated, I started experiencing joint stiffness which steadily worsened in severity and duration for a year before I was diagnosed by two different rheumatologists as having polyarthralgia, and possibly rheumatoid arthritis. Autoimmune diseases do not run in my family; I was the only one who received these vaccines, and the only one who suffers from this. It''s so bad that holding a toothbrush in the morning is painful and difficult. I''ve tried 11 prescription drugs for arthritis so far in the last 5 years. 12/19/07-records received for DOS 1/16/04-1/24/06-seen by rheumatologist-Impression: seroregative rheumatoid arthritis. PE: Low grade synovitis over PIP joints bilaterally, cystic like lesion noted over lateral aspect of right 3rd PIP joint. No tenderness or warmth noted. Symptoms began 1 year ago, . Stiffness in hands. Per 60 day follow up: Residual symptoms arthritis and fibromyalgia. Also rec''d flu shot 11-13-03 (manufacturer was Khiron or Aventis). Lot # W254AA or 254AA. Given at clinic. Follow-up: On my original form, I put my symptom start date as November, but after checking records I have found that the symptoms actually started in early December of 2003. I verified this by checking with my Human Resource department at work - I remembered distinctly that the symptoms started the first week of starting a new position with my company, and started that new position 12/2/03. Also found information on the other vaccine I received. I got a flu shot on 11/13/03 at clinic. The doctor who signed my chart administered the shot at 9:05 in my left arm, intramuscular. They were using two different manufacturers at the time, Khiron and Aventis, and they are not sure which one was used, but it was lot number V1254AA. This vaccine was purchased with my own money, and I did not have any illnesses at the time. Please let me know if you need any more information. I''m not sure what type of medical records would be helpful, but I have office notes and results from bloodwork I''ve had done in the last 4 years. Also, is there any way for me to find out if there have been other adverse reactions associated with this particular lot number? I''d like to know if I''m the only one who had this sort of reaction, or if there are others with similar or other problems after getting vaccinated with this lot number. 1/13/2010 Rheumatoid Arthritis, Fibromyalgia, and Tinnitus.


VAERS ID: 293801 (history)  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-09-23
Onset:2007-09-30
   Days after vaccination:7
Submitted: 2007-10-01
   Days after onset:1
Entered: 2007-10-19
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / -

Administered by: Military       Purchased by: Military
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Left axillary lymphadenopathy.


VAERS ID: 294445 (history)  
Age: 23.0  
Gender: Female  
Location: Louisiana  
Vaccinated:2007-10-22
Onset:2007-10-22
   Days after vaccination:0
Submitted: 2007-10-25
   Days after onset:3
Entered: 2007-10-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. UNKNOWN / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Ear pain, Fatigue, Headache, Injection site pruritus, Insomnia, Malaise, Nausea, Pharyngolaryngeal pain, Presyncope, Pyrexia, Rash erythematous, Rash macular, Rash pruritic, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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: no known drug allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: site of injection - pruritis, headache, insomnia, pruritic macular erythematous rash on face neck trunk and arms, near syncope, fatigue, sore throat, ear ache, fever-subjective, joint aches, nausea, vomiting, malaise


VAERS ID: 294846 (history)  
Age: 23.0  
Gender: Female  
Location: Maryland  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-10-30
   Days after onset:1
Entered: 2007-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2730AA / - RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Erythema, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~ ()~NULL~~In Patient|None~ ()~NULL~~In Sibling1|None~ ()~NULL~~In Sibling2
Other Medications: Multivitamins-1 q day, Iron 325mg qday, Zoloft 50mg qday Also received PPD (Tubersol) .1cc 10/29/2007 @ 12:15pm
Current Illness:
Preexisting Conditions: Latex allergy, depression, low platelets per employee (Note: Employee was given TDaP-vis and consent form stating "talk with physician prior to receiving vaccine if you are/have a severe allergy to latex..." She signed consent and never mentioned she had an allergy to latex before being given vaccine.
Diagnostic Lab Data: None
CDC Split Type:

Write-up: At 3pm, employee reports having redness on both forearms that "comes and goes" since 9pm last night. Also states after redness disappears he has small "bumps" that remain on forearms. Last "flareup" of redness was approx 12 noon today. On assessment, small reddened, elevated area approx. 12mm x 12mm on R forearm where PPD was placed 10/29/07. Three pin-head sized elevated "bumps" on L forearm, none on right forearm.


VAERS ID: 295020 (history)  
Age: 23.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2007-10-18
Onset:2007-10-18
   Days after vaccination:0
Submitted: 2007-10-31
   Days after onset:13
Entered: 2007-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 80686 / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Hypoaesthesia oral, Lip swelling, Paraesthesia oral
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:

Write-up: Received flu vaccine at 0200, 10/18/07. By 1530, 10/18/07, lips became tingly and numb. Top lip became swollen. Took a Benadryl and by 10/19/07, symptoms had subsided.


VAERS ID: 295037 (history)  
Age: 23.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2007-10-31
Onset:2007-10-31
   Days after vaccination:0
Submitted: 2007-10-31
   Days after onset:0
Entered: 2007-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500484P / 2 - / IN

Administered by: Military       Purchased by: Military
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: None~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling1|none~ ()~NULL~~In Sibling2
Other Medications: None noted
Current Illness: No
Preexisting Conditions: None by record
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient complained of minor shortness of breath, no wheezing or tightness noted. Patient states he "felt like he had been running for a while" after receiving influenza, live, intranasal vaccination.


VAERS ID: 295055 (history)  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-10-25
Onset:2007-10-25
   Days after vaccination:0
Submitted: 2007-10-25
   Days after onset:0
Entered: 2007-10-31
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2515AA / - LA / IM

Administered by: Other       Purchased by: Private
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), Hypoglycaemia (broad)

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:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Passed out about 1 minute after injection. Sent for ER only as a precaution. Per EMT, pt stable.


VAERS ID: 295058 (history)  
Age: 23.0  
Gender: Male  
Location: Oklahoma  
Vaccinated:2007-10-23
Onset:2007-10-23
   Days after vaccination:0
Submitted: 2007-10-24
   Days after onset:1
Entered: 2007-10-31
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 80060 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Body temperature increased, Headache
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hx Cerebral palsy, Peg tube, Spasticity Neurogenic Bladder
Preexisting Conditions: Penicillin, Had rx to DPT but has had flu and Pneumonia shots
Diagnostic Lab Data: Treated in Claremore emergency room
CDC Split Type:

Write-up: c/o severe headache, abd pain, increased temperature 2 hours after vaccine T 99 deg administration


VAERS ID: 295156 (history)  
Age: 23.0  
Gender: Male  
Location: Hawaii  
Vaccinated:2007-10-12
Onset:2007-10-13
   Days after vaccination:1
Submitted: 2007-10-22
   Days after onset:9
Entered: 2007-10-31
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV105 / 1 RA / SC

Administered by: Military       Purchased by: Military
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: After receiving the shot, entire body was extremely sore, large red swelling around shot area, general feeling of illness for about one week.


VAERS ID: 295199 (history)  
Age: 23.0  
Gender: Male  
Location: Washington  
Vaccinated:2007-10-30
Onset:2007-10-30
   Days after vaccination:0
Submitted: 2007-11-01
   Days after onset:2
Entered: 2007-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV111 / 3 RA / SC
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500496P / 5 - / IN

Administered by: Military       Purchased by: Military
Symptoms: Oedema peripheral, Pain in extremity, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: observation
CDC Split Type:

Write-up: pain in arm, swelling/itching of R upper arm. cold pack/motrin


VAERS ID: 295212 (history)  
Age: 23.0  
Gender: Male  
Location: Georgia  
Vaccinated:2007-10-16
Onset:2007-10-24
   Days after vaccination:8
Submitted: 2007-11-01
   Days after onset:8
Entered: 2007-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV110 / 0 RA / SC
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500483P / - - / IN
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB0994A / 1 RA / IM
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 0 LA / OT
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z11022 / 0 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Asthenia, Blood creatine phosphokinase increased, Blood creatinine normal, Blood culture negative, C-reactive protein increased, Chest X-ray normal, Chills, Confusional state, Culture throat negative, Culture wound positive, Drug hypersensitivity, Dyspnoea, Echocardiogram abnormal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Hyperhidrosis, Inflammation, Injection site erythema, Injection site swelling, Lymphadenopathy, Malaise, Neutrophil count increased, Pain, Pyrexia, Skin ulcer, Streptococcus identification test, Tonsillar inflammation, Tricuspid valve incompetence, Troponin I increased, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None reported
Preexisting Conditions: Morphine (Anaphlaxis)
Diagnostic Lab Data: WBC (10/24)-11.4, (10/25)-11.4, neutrophils-83%, creat-1.2 (10/25), trop I- 0.08 (10/25 @ 0850), trop I-0.53 (10/25 @ 1112), wound culture gram positive cocci-coagulase negative on final reading. EKG in ER significant for sinus tachycardia rate 113, per dictation right axis deviation, no ST segment changes--a second EKG was performed, NSR and no ST segment changes. Blood Cultures were completed and found to be negative. Rapid strep and throat culture were completed and found to be negative for group A streptococcus. (These are abnormal labs from civilian ER. Labs from Medical Cnt (abnl)-- trop I: (10/25 @ 1711)-0.893, (@ 1839)-0.774, (@ 2256)-0.555, (10/27 @ 0645)-0.429, (10/28 @ 0750)- 0.089; CRP-US: (10/25)--10.18, (10/27)-4.78, (10/28
CDC Split Type:

Write-up: Patient presented on 10/24/2007 to ER 8 days post vaccination series as listed in #13. Per ER report he noted approx 4 days previously (20 Oct) to have began experiencing redness and swelling in L-deltoid vaccination site, along with vague malaise and achiness. Day prior to ER presentation he noted obvious enlarging redness and small ulceration. Additional symptoms included chills. Upon ER presentation it was noted that he was afebrile but had elevated WBC (11.4)--he was treated with IV ABX (Unasyn 3 gm), Toradol for his achiness, and sent home for ER follow-up in am. He returned the next day with reported high fever, aching, chills, and per his wife weak, shortness of breath, confused during night. T-101, P-120, R-18 BP 140/87. ER doctor felt he was toxic appearing upon this presentation. Other clinical findings include diaphoretic, mild-moderate ill appearing, erythematous tonsillar pillars with positive exudate, shoddy anterior adenopathy, L-supraclavicular adenopahty, L-deltoid 10 X 8 cm erythema that surrounds a 1 cm ulcerated area with lymphangitis extending to shoulder, marked L-axillary adenopathy. Patient was then transferred to Medical Center for inpatient care and further evaluation. Upon arrival patient was stable, non-toxic appearing with vitals: T-97.5, R-18, P-86, BP-139/86 P/O-100% RA. L-deltoid erythema noted to be 9cm X 8cm with 1cm ulceration at vaccination site with lymphangitis extending superiorly onto shoulder. Adenopathy was noted bilaterally shoddy anterior cervical, L-supraclavicular, and moderate L-axillary. Bilateral tonsillar pillars noted to be erythematous, no exudates, no petichia noted. Marked improvement in symptoms by hospital day 1 noted (post vaccine day 10). Upon admission patient was placed on Contact Isolation, IV fluids for hydration secondary to increased creatinine until it normalized, IV AB-Unasyn continued until results returned coag neg staph (wound culture), and blood cultures negative. An ECHO was perfomed and consultation was obtained with Cardiology immediatly upon patient arrival given elevated troponin--diagnosis was given for myopericarditis (mild) secondary to small pox vaccination given elevated troponin. Patient was treated with 7 days of Ibuprofen 600mg every 6 hours. Contact was made with Health Center and recommendations for myopericarditis protocol initiated to include cardiology follow-up. Patient was discharged on HD #3 when troponin was trended down and under the normal range as per protocol. During presentation and hospitatlization denied any symptoms of chest pain/discomfort, no shortness of breath or difficulty breathing. Planned follow-up includes Hospital follow up in 1 week, Cardiology follow-up in 4 weeks, follow-up Medical Center or Medical Center-- Health Care Center.


VAERS ID: 295705 (history)  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-11-02
Onset:2007-11-02
   Days after vaccination:0
Submitted: 2007-11-06
   Days after onset:4
Entered: 2007-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 79489 / 0 RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Dyspnoea, Heart rate increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: unk
Current Illness: unk
Preexisting Conditions: unk
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Patient experienced elevated heart rate and shortness of breath.


VAERS ID: 295751 (history)  
Age: 23.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-10-25
Onset:2007-10-26
   Days after vaccination:1
Submitted: 2007-10-26
   Days after onset:0
Entered: 2007-11-06
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER AFLLA030AA / 0 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Abdominal pain, Chills, Diarrhoea
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Cramping, Diarrhea, Chills


VAERS ID: 295791 (history)  
Age: 23.0  
Gender: Male  
Location: Arizona  
Vaccinated:2007-11-01
Onset:0000-00-00
Submitted: 2007-11-02
Entered: 2007-11-06
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Private       Purchased by: Public
Symptoms: Unevaluable event
SMQs:

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:

Write-up: None stated.


VAERS ID: 296329 (history)  
Age: 23.0  
Gender: Female  
Location: Missouri  
Vaccinated:2007-11-05
Onset:2007-11-05
   Days after vaccination:0
Submitted: 2007-11-11
   Days after onset:6
Entered: 2007-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 02488AA / - LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0963U / 0 LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Nausea, Pain, Pain in extremity, Pyrexia, Vision blurred
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: I am going on day 7 of random and inconsistent: Dizziness Body aches Chills Fever Sweats Blurred Vision Nausea Extreme Arm Pain (In the injected arm) Head Ache I went to my Dr. on 11-07-07. My Dr. gave me Tamadol for the pain and MethylPREDSNISolone for the infection. I have also been treating with IBProfen, heat, and cold packs.


VAERS ID: 296440 (history)  
Age: 23.0  
Gender: Female  
Location: Missouri  
Vaccinated:2007-11-08
Onset:2007-11-09
   Days after vaccination:1
Submitted: 2007-11-12
   Days after onset:3
Entered: 2007-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - LA / -

Administered by: Public       Purchased by: Public
Symptoms: Abdominal pain upper, Diarrhoea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:

Write-up: Received vaccination on 11/8/07 at 1:30pm and felt symptoms on 11/9/07 at 8:30pm. Had stomach ache, which led to vomiting off and on for 6 hours. Had diarrhea for 24 hours and a fever 2 degrees above normal. Only lasted for 24 hours. Drank pedialite & water, took advil, and had light foods. Recovered quickly from most symptoms - still had slight fever second day.


VAERS ID: 296478 (history)  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-09-19
Onset:2007-09-19
   Days after vaccination:0
Submitted: 2007-10-30
   Days after onset:41
Entered: 2007-11-12
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1063U / 2 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Local reaction, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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: NKDA, asthma, allergic rhinitis
Diagnostic Lab Data:
CDC Split Type:

Write-up: Localized swelling R arm S/P HPV/Gardasil #3 vaccine. Non-tender.


VAERS ID: 299932 (history)  
Age: 23.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-08-30
Onset:2007-08-31
   Days after vaccination:1
Submitted: 2007-11-14
   Days after onset:75
Entered: 2007-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 654539/0742U / 0 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Body temperature increased, Chills, Eyelid oedema, Headache, Pain, White blood cell count decreased
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: KARIVA PROZAC
Current Illness:
Preexisting Conditions: Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES0710USA00753

Write-up: Information has been received from a physician concerning a 23 year old female student with an allergy to CEFZIL who on 30-AUG-2007 was vaccinated IM with a first dose of GARDASIL at 08:30 am. Concomitant therapy included PROZAC and KARIVA. There was no known illness at the time of vaccination. On 31-AUG-2007 at 7:00 pm the patient developed swollen eye lids, chills, body aches, temperature of 102.5 a low wbc and a headache. She was seen in the emergency room and subsequently, she was feeling better and the patient recovered on 20-SEP-2007. It was reported that her sister had an experience following vaccination with GARDASIL (WAES # 0711usa01667). Additional information is not expected.


VAERS ID: 299938 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-10-03
Onset:2007-10-04
   Days after vaccination:1
Submitted: 2007-11-14
   Days after onset:41
Entered: 2007-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Headache
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: WAES0710USA00826

Write-up: Information has been received from a mother concerning her 23 year old daughter with no pertinent medical history who on 03-OCT-2007 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL. Concomitant therapy included "birth control pills" (manufacturer unknown). On 04-OCT-2007 the patient woke up in the morning with a severe headache. There were no laboratory or diagnostic test performed. The patient did not seek medical attention. At the time of the report the patient had not recovered. Additional information is not expected.


VAERS ID: 296835 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-11-05
Onset:2007-11-05
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:9
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1265U / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness, Muscle twitching
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), Dyskinesia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA02099

Write-up: Information has been received from a physician''s assistant concerning a 23 year old female who on 05-NOV-2007 was vaccinated with a third dose of Gardasil (lot# 659435/1265U). About ten minutes post-vaccination, the patient experienced loss of consciousness for about 15 seconds, felt dizzy, and when she came to consciousness she had a little twitch like a mini seizure. It was reported that the patient was not hospitailzed and no intervention was needed. Subsequently the patient recovered, three days later and was feeling fine. Upon internal review, mini seizure was determined to be an other important medical event. Additional information has been requested.


VAERS ID: 299607 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-09-05
Onset:2007-09-05
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:70
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Influenza like illness
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0710USA04003

Write-up: Information has been received from a physician concerning a 23 year old female who on 05-SEP-2007 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently for 24 hours post vaccination the patient experienced flu like symptoms and GI upset. Unspecified medical attention was sought. Subsequently, after 24 hours the patient recovered from the flu like symptoms and GI upset. Additional information has been requested.


VAERS ID: 299643 (history)  
Age: 23.0  
Gender: Female  
Location: Hawaii  
Vaccinated:2007-10-09
Onset:2007-10-09
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:36
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0515U / 0 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Muscular weakness, Nausea, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO TRI-CYCLEN, MACROBID
Current Illness: Urinary tract infection
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA04543

Write-up: Information has been received from a physician concerning a 23 year old white female who on 09-OCT-2007 was vaccinated intramuscularly, into the left deltoid, with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #657872/0515U). Illness at the time of vaccination included a urinary tract infection. Concomitant therapy included nitrofurantoin (MACROBID) and ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN). On 09-OCT-2007, in th evening, the patient experienced nausea, left arm pain and weakness. At the time of the report, the patient''s outcome was unknown. No further information is available.


VAERS ID: 299650 (history)  
Age: 23.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2007-10-18
Onset:2007-10-18
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:27
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1265U / 0 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Fall, Head injury, 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), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA04624

Write-up: Information has been received from a health professional concerning a female patient who was vaccinated with first dose of GARDASIL, 0.5mL intramuscularly (IM). The patient was unable to wait in the office for 15 minutes after receiving GARDASIL. As the patient was walking out, she felt faint, fell and bumped her head. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a health professional concerning a 23 year old female patient (65 inches, 144 pounds) who on 19-OCT-2007, at 16:15 was vaccinated with first dose of GARDASIL, 0.5mL intramuscularly (IM) to the right deltoid. The patient was unable to wait in the office for 15 minutes after receiving GARDASIL. As the patient was walking out, she felt faint, had a vasovagal reaction, fell and bumped her head. Vital signs were within normal limits after "passing out". Unspecified medical attention was sought. Subsequently, the patient recovered on 18-OCT-2007. The product quality complaint unit was not involved. Further information is not expected.


VAERS ID: 299680 (history)  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-10-16
Onset:2007-10-17
   Days after vaccination:1
Submitted: 2007-11-14
   Days after onset:28
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site mass, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

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: No reaction on previous exposure to vaccine
Diagnostic Lab Data: None
CDC Split Type: WAES0710USA04923

Write-up: Initial and follow up information has been received form a receptionist in a physician''s office, via a company representative, concerning a 23 year old female student (presumed relative), patient with a history of no reaction on previous exposure to the first and second dose of GARDASIL, who was vaccinated IM on 16-OCT-2007 in the morning, with the third dose, 0.5 ml, of GARDASIL. On 17-OCT-2007 in the morning, the student developed a baseball sized lump with soreness at the injection site. The student did not seek medical attention. At the time of this report, the outcome of the event was unknown On 27-OCT-2007, the patient had recovered from the events. Additional information has been requested. Additional information is not expected.


VAERS ID: 299713 (history)  
Age: 23.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-09-13
Onset:2007-09-14
   Days after vaccination:1
Submitted: 2007-11-14
   Days after onset:61
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 78720515U / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Flushing, Nausea, No reaction on previous exposure to drug, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow)

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: Concurrent Conditions: Allergic reaction to antibiotics
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA00623

Write-up: Information has been received from a Registered Nurse concerning a 23 year old female patient with allergic reaction to antibiotics (Biaxin), who on 13-SEP-2007 was vaccinated IM with a second dose of Gardasil vaccine, lot #657872/0515U. The nurse reported that on 14-SEP-2007 the patient called the office complaining of nausea, vomiting, flushed face and diarrhea. It was reported that the patient did not have any reaction when she received her first injection. No further information was available. The patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 299808 (history)  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-08-06
Onset:2007-10-01
   Days after vaccination:56
Submitted: 2007-11-14
   Days after onset:44
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0929U / 2 UN / SC

Administered by: Private       Purchased by: Other
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
SMQs:

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: Cervix HPV DNA assay- Positive Cervix HPV DNA assay, 10/??/07, positive; Cervix HPV DNA assay, 11/??/07, negative; Cervix HPV DNA, 10/??/06, negative
CDC Split Type: WAES0710USA06557

Write-up: Information has been received from a nurse practitioner concerning a 23 year old female who was vaccinated (date, route and site were not reported) with GARDASIL vaccine (yeast) (lot # not reported). The patient was HPV negative prior to receiving GARDASIL vaccine (yeast) and after receiving the 3rd dose the patient has tested HPV positive. The patient did not seek medical attention. Per nurse practitioner, the patient has not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. Information has been received from a nurse practitioner concerning a 23 year old female with no known allergies who on 08-FEB-2007 was vaccinated SQ wiht the first dose of GARDASIL vaccine (lot #654885/1424F). On 09-APR-2007 the patient was vaccinated SQ with the second dose of GARDASIL vaccine (lot #656372/0241U). On 06-AUG-2007 the patient was vaccinated SQ with the third dose of GARDASIL vaccine (lot #658282/0929U). The nurse practitioner reported that the patient had normal PAP smears from June, 2001 through October, 2006 and was HPV negative prior to receiving GARDASIL vaccine. On an unknown date in October, 2007 the patient had a positive HPV test. On an unspecified date in November, 2007 it was reported the patient had a negative HPV DNA test. Per nurse practitioner, the event was considered non serious. the nurse practitioner reported that the patient had not recovered from the event. Additional information has been requested.


VAERS ID: 299812 (history)  
Age: 23.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2007-07-05
Onset:2007-07-10
   Days after vaccination:5
Submitted: 2007-11-14
   Days after onset:127
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Dyspnoea, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

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: WAES0710USA06648

Write-up: Information has been received from a registered nurse concerning a 23 year old female patient who on 05-JUL-2007, was vaccinated IM with a first dose of GARDASIL vaccine (yeast). On 10-JUL-2007 5 days later, the patient experienced shortness of breath, muscle ache, dizziness and nausea. It is unknown if medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a registered nurse concerning a 23 year old female patient who on 05-JUL-2007, was vaccinated IM into the left arm with a first dose of GARDASIL (Lot# reported as "09607"). Subsequently, the patient experienced shortness of breath, muscle ache, dizziness and nausea. It was reported on 10-JUL-2007, the patient still had dizziness and some muscle ache. It was recommended that the patient not continue the series. At the line of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information is not expected.


VAERS ID: 300172 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-08-02
Onset:2007-08-07
   Days after vaccination:5
Submitted: 2007-11-14
   Days after onset:99
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 - / -

Administered by: Other       Purchased by: Other
Symptoms: Vertigo
SMQs:, Vestibular disorders (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0710USA02767

Write-up: Information has been received from the mother of a 23 year old female who on 02-Aug-2007 was vaccinated with the first dose of Gardasil vaccine. Concomitant medication was not reported. On approximately 07-AUG-2007 (5 or 7 days after getting the first vaccine), the patient developed vertigo. Unspecified medical attention was sought. On 06-OCT-2007, the patient was vaccinated with the second dose of Gardasil vaccine. On 09-OCT-2007, ("72 hours after second vaccination"), the patient developed vertigo. Subsequently on an unspecified date, the patient recovered from vertigo. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 300225 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-11-14
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Advair
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0710USA03629

Write-up: Information has been received from a physician concerning a 23 year old female who was vaccinated with a third 0.5 mL dose of Gardasil vaccine. Concomitant therapy included Advair. Subsequently, the patient developed a hard lump in her arm where she was vaccinated. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. The patient''s hard lump in the arm persisted. Additional information has been requested.


VAERS ID: 297212 (history)  
Age: 23.0  
Gender: Male  
Location: New York  
Vaccinated:2007-11-17
Onset:0000-00-00
Submitted: 2007-11-19
Entered: 2007-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500477P / 2 - / IN

Administered by: Military       Purchased by: Military
Symptoms: Inappropriate schedule of drug administration, Medication error
SMQs:, Medication errors (narrow)

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:

Write-up: Two live vaccines given 14 days apart. No adverse reaction or treatment sought


VAERS ID: 297521 (history)  
Age: 23.0  
Gender: Female  
Location: Alaska  
Vaccinated:2007-10-16
Onset:2007-10-17
   Days after vaccination:1
Submitted: 2007-11-21
   Days after onset:35
Entered: 2007-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2443AA / 1 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Mobility decreased, Muscle spasms, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (broad), Parkinson-like events (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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:

Write-up: severe myalgias at night and in am after vaccine, resulting in muscle cramping of hands and feet and "locking" of ankles and elbows. Upon waking in am was so impaired that she had to crawl to phone but regained mobility within 1/2 hour. Function nl by 24 hours, Sx resolved by 36 hours


VAERS ID: 297603 (history)  
Age: 23.0  
Gender: Female  
Location: Nebraska  
Vaccinated:2007-11-19
Onset:2007-11-19
   Days after vaccination:0
Submitted: 2007-11-20
   Days after onset:1
Entered: 2007-11-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2457HA / - LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Erythema, Paraesthesia, Pharyngolaryngeal pain, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: past 4 yrs.~ ()~~0.00~In Patient
Other Medications: Birth Control Pill
Current Illness: "none"
Preexisting Conditions: "none"
Diagnostic Lab Data: none
CDC Split Type:

Write-up: 10 hours after receiving flu vaccine, noted a severe throat pain and noted tingling to (L) arm earlier in the evening. Awoke today with a red rash to the injected arm, spreading from deltoid to hand. The client reports the sore throat has persisted. Denies Respiratory distress. Sore throat continues this afternoon; redness to arm is gone.


VAERS ID: 297625 (history)  
Age: 23.0  
Gender: Female  
Location: Illinois  
Vaccinated:2007-10-25
Onset:2007-10-25
   Days after vaccination:0
Submitted: 2007-11-08
   Days after onset:14
Entered: 2007-11-23
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0742U / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

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: NKDA; hx chickenpox; hx mononucleosis 3/05; 1989 s/p appendectomy
Diagnostic Lab Data: None
CDC Split Type:

Write-up: After receiving HPV vaccine/Gardasil (her 3rd dose) patient felt lightheaded; she reclined on exam table. No loss of consciousness, took sips of water, waited about 15 min, B/P monitored. Left ambulatory.


VAERS ID: 297668 (history)  
Age: 23.0  
Gender: Female  
Location: Puerto Rico  
Vaccinated:2007-11-07
Onset:2007-11-07
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:7
Entered: 2007-11-23
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / SANOFI PASTEUR A02392 / - UN / IM

Administered by: Other       Purchased by: Private
Symptoms: Abdominal pain, Activated partial thromboplastin time, Dizziness, Haemoglobin, Monocyte count, Nausea, Pruritus, Rash generalised, Urticaria, Vomiting, White blood cell count
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, Albafort
Current Illness:
Preexisting Conditions: Thyroid cancer, s/p thyroidectomy
Diagnostic Lab Data: Hb 11.3, WBC 6.55, PTT 314,000, Mono 11.40
CDC Split Type:

Write-up: A 23 year old student received a single dose of rabies vaccine on November 7, 2007 at 8:15 a.m. Three hours later presented dizziness, nausea, vomit and abdominal pain. Patient vital signs were observed for one hour and discharged home in stable condition. Twelve hours later, she had to be evaluated at the emergency room when she presented generalized urticarial rash and pruritus. No respiratory distress was referred.


VAERS ID: 297698 (history)  
Age: 23.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-11-20
Onset:2007-11-21
   Days after vaccination:1
Submitted: 2007-11-24
   Days after onset:3
Entered: 2007-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / 0 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Body temperature increased, Cellulitis, Chills, Dizziness, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Nausea, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: SPINA BIFIDA, KIDNEY PROBLEMS, HTN.
Diagnostic Lab Data: WBC 16,100.
CDC Split Type:

Write-up: PT WHO IS A NURSE RECEIVED PNEUMONIA VACCINE ON 11/20/07. PT HAD SOME TENDERNESS AT INJECTION SITE THAT EVENING. FOLLOWING MORNING, PT HAD MORE TENDERNESS AT SITE AND SOME SWELLING. FOLLOWING MORNING ON 11/22/07 PT HAD LOW GRADE TEMPS ALL DAY, SWELLING OF UPPER RIGHT ARM WHERE INJECTION WAS GIVEN, TENDERNESS (PT COULD BARELY LIFT UP ARM) AND SLIGHT REDNESS, PT TOOK TYLENOL. 11/23/07 PT HAD TEMP OF 102 AND HIGHER, DIZZINESS, NAUSEA, VOMITING, CHILLS, MORE TENDERNESS OF RIGHT UPPER ARM (PT COULDNT LIFT UP ARM WITHOUT EXCRUCIATING PAIN, AND REDNESS OVER ENTIRE RIGHT UPPER ARM FROM INJECTION SITE TO ELBOW, PT TOOK TYLENOL. PT TAKEN TO ER AND GIVEN ANTI NAUSEA MEDICATION, MOTRIN, AND ANTIBIOTICS, AND PRESCRIPTION FOR ANTIBIOTICS. PT GIVEN DIAGNOSIS OF CELLULITIS DUE TO PNEUMONIA VACCINE!


VAERS ID: 297896 (history)  
Age: 23.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-11-20
Onset:2007-11-23
   Days after vaccination:3
Submitted: 2007-11-24
   Days after onset:1
Entered: 2007-11-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / - UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body temperature increased, Cellulitis, Injected limb mobility decreased, Injection site erythema, Pain in extremity, Pyrexia, Tenderness, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Spina Bifida, kidney problems
Diagnostic Lab Data: wbc 16,000
CDC Split Type:

Write-up: Pneumonia vaccine given to pt who is a nurse on 11/20/07. Pt had some tenderness that evening more tenderness the following morning. 11/22/07 in the morning pt developed low grade fever with redness around injection site. By 11/23/07 redness spread to entire arm, temp of 102.6 and arm so tender pt could not lift arm. Pt taken to er, given antibiotics and sent home with diagnosis of cellulitis due to pneumovac


VAERS ID: 298355 (history)  
Age: 23.0  
Gender: Female  
Location: Washington  
Vaccinated:2007-11-27
Onset:2007-11-27
   Days after vaccination:0
Submitted: 2007-11-29
   Days after onset:2
Entered: 2007-11-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLLA067 / 1 UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1382U / 0 UN / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2842AA / - UN / IM

Administered by: Public       Purchased by: Public
Symptoms: Chills, Myalgia, Pain, Pyrexia, Swelling, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Acute sinusitis
Preexisting Conditions: Diabetes Type 1
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Febrile, shaking chills, myalgias, local swelling and pain.


VAERS ID: 298486 (history)  
Age: 23.0  
Gender: Female  
Location: Missouri  
Vaccinated:2007-11-27
Onset:2007-11-27
   Days after vaccination:0
Submitted: 2007-11-27
   Days after onset:0
Entered: 2007-12-03
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2466AA / - RA / UN

Administered by: Public       Purchased by: Private
Symptoms: Dysphagia, Pharyngeal oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: receiving allergy shots - physician OK''d flu shot
Diagnostic Lab Data:
CDC Split Type:

Write-up: 25 min after injection client complains of feeling throat swelling (on inspection throat was swollen) - difficulty swallowing. Lungs clear by auscultation - no respiratory distress at that time. Benadryl 50mg PO given - monitored - pt. recovered.


VAERS ID: 298738 (history)  
Age: 23.0  
Gender: Female  
Location: Vermont  
Vaccinated:2007-10-23
Onset:2007-10-26
   Days after vaccination:3
Submitted: 2007-12-05
   Days after onset:40
Entered: 2007-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2448AA / 0 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Full blood count, Injection site erythema, Laboratory test, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~~0.00~Patient
Other Medications: synthroid, methadone
Current Illness: none
Preexisting Conditions: hypothyroidism
Diagnostic Lab Data: CBC, CMP drawn today, results are pending.
CDC Split Type:

Write-up: Red circle appeared 2-3 days after vaccine administration on Left Deltoid where vaccine was given. Skin changes noted and still evident 6 weeks later. Skin is rough and scaly, no masses or thickening noted at site. No enlarged L axillary nodes. Patient c/o feeling weak for last month.


VAERS ID: 298927 (history)  
Age: 23.0  
Gender: Male  
Location: California  
Vaccinated:2007-11-20
Onset:2007-11-29
   Days after vaccination:9
Submitted: 2007-11-29
   Days after onset:0
Entered: 2007-12-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020676 / 1 LA / OT

Administered by: Military       Purchased by: Military
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Motrin
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Erythema about 14x7cm distal to vaccination site noted 11/28/07, resolving by 29Nov07.


VAERS ID: 299029 (history)  
Age: 23.0  
Gender: Female  
Location: Illinois  
Vaccinated:2007-10-31
Onset:2007-10-31
   Days after vaccination:0
Submitted: 2007-12-06
   Days after onset:36
Entered: 2007-12-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1062U / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Metrorrhagia, Migraine, Nausea
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho tri-cyclen
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0711USA06529

Write-up: Information has been received from a physician and healthcare worker concerning a 23 year old female who on 31-OCT-2007 was vaccinated with a first dose of Gardasil (Lot #658560/1062U). Concomitant therapy included ORTHO TRI-CYCLEN. On 31-OCT-2007 the patient experienced severe nausea, migraines, dizziness and "breakthrough bleeding". The physician was going to double the dose of the ORTHO TRI-CYCLEN for 3-4 days. There was no laboratory or diagnostic tests performed. Subsequently, the patient recovered from severe nausea, migraines and dizziness, but had been spotting for a month. Upon internal review, nausea, dizziness, breakthrough bleeding and migraines were considered to be other important medical events. Additional information has been requested.


VAERS ID: 299053 (history)  
Age: 23.0  
Gender: Female  
Location: Virginia  
Vaccinated:2007-12-07
Onset:2007-12-07
   Days after vaccination:0
Submitted: 2007-12-07
   Days after onset:0
Entered: 2007-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500502P / 1 - / IN
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB107BA / 2 RA / IM
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UE912AA / 0 LA / SC

Administered by: Military       Purchased by: Military
Symptoms: Dyspnoea, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:
CDC Split Type:

Write-up: Patient exhibited hives difficulty breathing and felt like her throat was closing up greater than a hour after receiving vaccinations. Pt went to facility and recieved Benadryl, Solumedrol and epinephrine and albuterol nebulizer and IV Fluids.


VAERS ID: 299122 (history)  
Age: 23.0  
Gender: Female  
Location: Maryland  
Vaccinated:2007-12-08
Onset:2007-12-08
   Days after vaccination:0
Submitted: 2007-12-10
   Days after onset:2
Entered: 2007-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / 22 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Asthenia, Dizziness, Nausea, Pain in extremity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPOPROVERA, PRENATALS, B-12 1000 MCG, CALCUIM 1000 IU, VITAMIN D 400 IU, IBUPROPHEN 800 MG, METHOCARBAMOL 500 MG, PERCOCET 5 EQ
Current Illness: LOWER BACK PAIN
Preexisting Conditions: DEGENERATIVE DISK DISEASE, HERNIATED DISKS, NURSING
Diagnostic Lab Data:
CDC Split Type:

Write-up: LIGHTHEADED, FAINTNESS, WEAKNESS, NAUSEA, COLAPSING, DIZZINESS, LEG PAIN


VAERS ID: 299224 (history)  
Age: 23.0  
Gender: Female  
Location: Virginia  
Vaccinated:2007-12-03
Onset:2007-12-04
   Days after vaccination:1
Submitted: 2007-12-07
   Days after onset:3
Entered: 2007-12-10
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 972001 / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Docusate sodium prn
Current Illness: + hepatitis C
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Rash over torso.


VAERS ID: 299352 (history)  
Age: 23.0  
Gender: Female  
Location: Maryland  
Vaccinated:2007-11-20
Onset:2007-11-21
   Days after vaccination:1
Submitted: 2007-12-12
   Days after onset:21
Entered: 2007-12-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB100AA / 0 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0503U / 0 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ORAL CONTRACEPTIVES
Current Illness: TINGLING L ARM
Preexisting Conditions: NONE
Diagnostic Lab Data: Pt scheduled f/u with PCM
CDC Split Type:

Write-up: Pt c/o tingling x1day.


VAERS ID: 299398 (history)  
Age: 23.0  
Gender: Male  
Location: Texas  
Vaccinated:2006-12-08
Onset:2007-09-07
   Days after vaccination:273
Submitted: 2007-12-11
   Days after onset:95
Entered: 2007-12-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2259AA / 2 UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Albumin urine, Antinuclear antibody positive, Aspartate aminotransferase decreased, Blood cholesterol increased, Blood creatine phosphokinase normal, Blood creatinine increased, Blood culture negative, Blood glucose increased, Blood triglycerides normal, Carbon dioxide increased, Epstein-Barr virus antibody positive, Full blood count normal, Glucose urine present, Glycosylated haemoglobin increased, Low density lipoprotein increased, Mononucleosis heterophile test negative, Neutrophil percentage increased, Pollakiuria, Protein total increased, Red blood cell sedimentation rate increased, Rheumatoid factor increased, Thirst, Total cholesterol/HDL ratio normal, Troponin I, Type 1 diabetes mellitus, Urine ketone body present, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Lipodystrophy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Pericarditis
Diagnostic Lab Data: 6/21/2007: Mono - test, neg ESR 34 (0-15), CBC - normal x elevated Neut 74.8%, CMP - elevated Glu 233 - elevated total protein 8.5, elevated Creat 1.4, elevated Co2 32.5, decreased AST 10, decreased Alb/Glob 0.8, elevated RF 15.9 (0-13.9), EBV capsid IgG + IgM, EBV NA igG, ANA less than 1:80, 6/21/2007 - 6/25/2007: ESR 52 (0-20); Trop-1 less than 0.1 (less than 0.1 neg), CPK normal; CBC normal, peak Gluc 263 (70-110); peak Creat 1.4 (0.6-1.3); RA neg, BC x 3 neg, 9/27/2007 Urine Microalb 9.7, Alb/Creat Ratio 5.4; Creat 179.0, Thyrotropin Sensitive 1.46 (0.34-4.82); HgbA1c greater than 16.1% (4.8-6.0); FBS 225 (74-106); CBCd normal; Chol 213 (0-200) Trig 83 (30-150) HDL 50 (39-60), LDL 146.4 (less than -130) Chol/HDL 4.3 (0.17-8.17); UA Gl
CDC Split Type:

Write-up: In early September 2007, patient began to experience unexplained weight loss, increased thirst and frequent urination. He was diagnosed with diabetes at a local hospital on 09/21/2007; diagnosis of Type 1 based on positive GAD antibodies obtained on 9/27/2007.


VAERS ID: 299399 (history)  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-08-27
Onset:2007-08-27
   Days after vaccination:0
Submitted: 2007-12-11
   Days after onset:106
Entered: 2007-12-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH FAV111 / 1 UN / UN
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 1 - / ID

Administered by: Military       Purchased by: Military
Symptoms: Asthenia, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

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: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: SM with left upper arm pain, paresthesias, mild weakness, with onset of symptoms in late Aug to Sep 2007. Pain is migratory, focal, non radicular, not isolated to particular nerve distribution; paresthesias in ulnar distribution.


VAERS ID: 299421 (history)  
Age: 23.0  
Gender: Female  
Location: Michigan  
Vaccinated:2007-10-08
Onset:2007-10-17
   Days after vaccination:9
Submitted: 2007-12-04
   Days after onset:48
Entered: 2007-12-12
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U1943CA / 1 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Blood electrolytes, Blood glucose, Convulsion, Laboratory test
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, Tegretol, Cortef, Phenobarbital, DDAV
Current Illness: None known
Preexisting Conditions: Cerebral palsy, cerebral cyst, blindness, hypothy., hypopituitary seizure disorder. Allergies - Pnc, Bactrim, Septra, peanuts, Dilantin per mother.
Diagnostic Lab Data: 10/17/07 Tegretol & Phenobarbital level, electrolytes & glucose.
CDC Split Type:

Write-up: Seizure on 10-17-07 at 9:30am & 11:30am. Tx with incr. dosages of Phenobarbital & Tegretol.


VAERS ID: 299481 (history)  
Age: 23.0  
Gender: Male  
Location: Michigan  
Vaccinated:2007-12-06
Onset:2007-12-06
   Days after vaccination:0
Submitted: 2007-12-13
   Days after onset:7
Entered: 2007-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / SANOFI PASTEUR A0239-0 / 2 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin
Current Illness: None
Preexisting Conditions: None that patient is aware of
Diagnostic Lab Data: None
CDC Split Type:

Write-up: On Thursday December 6th in the AM patient began experiencing urticaria. He started taking Benadryl 50 mg Q3 hours except when sleeping. He stopped taking the Benadryl on Sunday because symptoms were improving and patient states symptoms were gone by Monday December 10th. For patient''s remaining vaccines (2 total) he will receive Rabavert. Today, December 13th, he received his 4th shot with Rabavert (Novartis) Lot # 419011A EXP 07/10.


VAERS ID: 299923 (history)  
Age: 23.0  
Gender: Male  
Location: Texas  
Vaccinated:2007-12-04
Onset:2007-12-10
   Days after vaccination:6
Submitted: 2007-12-14
   Days after onset:4
Entered: 2007-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV158 / 0 UN / UN
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA316BA / 2 UN / UN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z0664 / 0 UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Abdominal pain, Dehydration, Diarrhoea, Dyspnoea, Muscle spasms, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: denies
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: no testing
CDC Split Type:

Write-up: Description: I received the spv last Thurs. Since last night I have been nauseated and have diarrhea. Also, notes cramping, diarrhea x5 denies bld. Stated everything goes through him including water. Is feeling dehydrated. Denies fever, and chest pn. Noted SOB, stated a co-worker had stomach flu last week. Symptom: Diarrhea Start: 12/10/2007; Symptom: Nausea w/o vomiting Start: 12/11/2007; Symptom: Abdominal Pain Start: 12/10/2007 Comment: described as cramping; Symptom: Dyspnea (shortness of breath) Start: 12/11/2007 Comment: told by ER it was due to dehydration


VAERS ID: 300106 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2001-06-09
Onset:2001-07-01
   Days after vaccination:22
Submitted: 2007-12-14
   Days after onset:2357
Entered: 2007-12-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 5 UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Dermatitis, Dermatitis atopic, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Allergic rhinitis, allergic to formaldehyde, multiple other allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Developed atopic eczema after AVA #3. Symptom: Dermatitis, diffuse, generalized. Follow-up: It took me so long to report this because I was not aware the reason I was having problems was adverse effect from the Anthrax Vaccine. I had a chemical test in 2006, and my results stated that I am allergic to a chemical in the Vaccine, which may have given me this skin disease. My symptoms are rashes, which I later found out was eczema. My first episode of eczema was when I was deployed in 2001. I started breaking out after the third Anthrax Vaccine was administered. I came back to the states, and saw my primary doctor numerous times and he told me I had a "desert funk". The rash was so bad that I was bleeding on my arms, legs and stomach. My face had numerous rashes, which caused my left eye to swell shut. After numerous doctor visits, they finally referred me to an off base dermatologist. He took one glance at me and told me it was eczema. After numerous steroid shots and pills, I finally got it somewhat under control. To this day, I still have to see a dermatologist on a regular basis. I use numerous steroid creams to keep the eczema somewhat under control. I always have lesions on my hands and rashes on my legs and arms. My skin itches to the point that it sometimes feels like it is crawling. No one in the history of my family has ever had any skin problems. I truly believe my eczema is an adverse effect of the Anthrax Vaccine.


VAERS ID: 300231 (history)  
Age: 23.0  
Gender: Male  
Location: Virginia  
Vaccinated:2007-12-07
Onset:2007-12-09
   Days after vaccination:2
Submitted: 2007-12-18
   Days after onset:9
Entered: 2007-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500502P / 1 - / IN

Administered by: Military       Purchased by: Military
Symptoms: Nasopharyngitis, Respiratory tract congestion, Upper respiratory tract infection
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Complained of chest congestion and feeling feverish prior to flu mist administration.
Preexisting Conditions: Complained of chest congestion and feeling feverish prior to flu mist administration.
Diagnostic Lab Data: Upper respiratory infection common viral cold.
CDC Split Type:

Write-up: States he felt congested and feverish prior to flu mist administration. Temp was taken prior to flu mist was 98.8 by medical rep. Went to another medical rep for the flu mist administration and answered all questions on the flu mist questionnaire as no. After being administered the flu mist, states he progressively felt worse until Sunday night about 7 PM, he headed to the ER. Stated his chest was further congested and he was feeling even more feverish. At ER, he was diagnosed with an upper respiratory infection and told to go home and drink fluids and rest. By Tuesday Dec 11th, was feeling better.


VAERS ID: 300261 (history)  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-12-06
Onset:2007-12-06
   Days after vaccination:0
Submitted: 2007-12-13
   Days after onset:7
Entered: 2007-12-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / SANOFI PASTEUR A0239 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: On Thursday December 6th in the AM patient began experiencing urticaria. He started taking Benadryl 50 mg Q3 hours except when sleeping. He stopped taking Benadryl on Sunday because symptoms were improving and patient states symptoms were gone by Monday December 10th. For patient''s remaining vaccines - 2 total - he will receive Rabavert. Today December 13th, he received his 4th shot with Rabavert - Lot # 419011A, EXP 07/10.


VAERS ID: 300320 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-12-03
Onset:2007-12-03
   Days after vaccination:0
Submitted: 2007-12-10
   Days after onset:7
Entered: 2007-12-18
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1209U / 2 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Nasopharyngitis, Pharyngolaryngeal pain, Vaccine positive rechallenge
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zovia OCA
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient stating sore throat with cold symptoms at night after #2 and #3 Gardasil vaccinations. #2 given 7-26-07 and #3 given 12-03-07.


VAERS ID: 300502 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-10-25
Onset:2007-11-12
   Days after vaccination:18
Submitted: 2007-12-14
   Days after onset:32
Entered: 2007-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA00253

Write-up: Information has been received from a physician, via a company representative, concerning a 23 year old female patient, who on 25-Oct-2007 was vaccinated with the third dose of Gardasil (lot # not reported). Concomitant therapy included hormonal contraceptives (unspecified). On 12-Nov-2007, the patient visited her physician with swollen inguinal lymph nodes, and was sent to the emergency room (ER). The ER sent the patient to surgery, as they considered that she had a hernia, however, it was then confirmed that the patient did not have a hernia but only the swollen inguinal lymph nodes. It was unclear if the patient had surgery. At the time of this report, the outcome of the event was unknown. The physician considered swollen inguinal lymph nodes to be serious as an other important medical event (intervention required). Additional information has been requested.


VAERS ID: 300532 (history)  
Age: 23.0  
Gender: Female  
Location: Illinois  
Vaccinated:2007-10-25
Onset:2007-10-25
   Days after vaccination:0
Submitted: 2008-04-07
   Days after onset:165
Entered: 2007-12-18
   Days after submission:110
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0742U / 2 UN / IM

Administered by: Private       Purchased by: Other
Symptoms:
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0711USA00629

Write-up: Information has been received from a registered nurse, via a company representative, concerning a female patient (age not specified) who in October 2007 ("last week"), was vaccinated IM with a 0.5 ml dose of Gardasil. Following the vaccination, the patient fainted, and received unspecified treatment in the office. At the time of this report, the patient had recovered from the event (duration not specified). Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow up information has been received from a registered nurse, concerning a 23 year old female college student with no medical conditions, who 25-OCT-2007, at 3:00 PM, was vaccinated IM in deltoid with the third dose, 0.5 ml. of GARDASIL (lot #654539/0742U). There was no illness at the time of vaccination. Immediately following the vaccination, the patient felt lightheaded (previously reported as fainted), and had to lie down for 15 minutes. At the time of this report, the patient had recovered from the event. Additional information is not expected.


VAERS ID: 300683 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-12-14
Entered: 2007-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA01720

Write-up: Information has been received from a health professional concerning a 23 year old female who was vaccinated with her first dose of GARDASIL IM. The patient experienced a fever of 104. Subsequently, the patient recovered from the fever of 104. Additional information has been requested.


VAERS ID: 300730 (history)  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-11-08
Onset:2007-11-08
   Days after vaccination:0
Submitted: 2007-12-14
   Days after onset:36
Entered: 2007-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1266U / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Injection site mass, Injection site pruritus, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0711USA02945

Write-up: Information has been received from a Medical Assistant concerning a 23 year old female with no known drug or food allergies who, on 08-NOV-2007, was vaccinated with the second dose of Gardasil (Lot #659437/1266U). Concomitant therapy included a contraceptive ring. On 08-NOV-2007, the patient experienced a pruritic rash at the injection site. The rash was approximately the size of a "silver dollar." Subsequently, the rash improved, however, a lump remained at the injection site. The Medical Assistant reported that the patient tolerated her first dose of Gardasil well. As of 17-NOV-2007, the patient was recovering from the rash and lump. Additional information has been requested.


VAERS ID: 300847 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-11-15
Onset:2007-11-16
   Days after vaccination:1
Submitted: 2007-12-14
   Days after onset:28
Entered: 2007-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Headache, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Alcohol interaction
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0711USA03591

Write-up: Information has been received from a 23 year old consumer, who on 15-NOV-2007 was vaccinated with the first dose, 0.5 ml, of Gardasil (lot # not provided). There was no concomitant medication. Following the vaccination, the consumer ingested an unspecified amount of alcohol. On 16-NOV-2007, she developed a headache and nausea. At the time of this report, the consumer had not recovered. The consumer did not seek medical attention. Additional information is not expected.


VAERS ID: 300893 (history)  
Age: 23.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-10-20
Onset:0000-00-00
Submitted: 2007-12-14
Entered: 2007-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Familial risk factor, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA04192

Write-up: Information has been received from a physician, via a company representative, concerning a 23 year old female patient, who on approximately 20-Oct-2007 ("a month ago") was vaccinated IM with the first dose, 0.5 ml, of Gardasil (lot # not provided). After an unknown duration of time, the patient experienced stomach pain and vomiting. Subsequently, the patient recovered from stomach pain and vomiting (duration not specified). The patient sought unspecified medical attention. The patient''s 17 year old sister also experienced the events as described above, when vaccinated with Gardasil (WAES #0711USA04358). Further information is not available.


VAERS ID: 301231 (history)  
Age: 23.0  
Gender: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-12-14
Entered: 2007-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Local reaction, Pain in extremity, Skin burning sensation
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA05038

Write-up: Information has been received from a physician concerning a 23 year old female nurse patient who on an unspecified date was vaccinated IM with the third dose of Gardasil vaccine (Lot number not provided). Concomitant therapy included hepatitis B virus vaccine (unspecified) and hepatitis A virus vaccine (unspecified). Subsequently, the patient experienced localized pain and burning on her left arm. It was reported that the pain went away shortly after receiving the vaccine. The patient outcome was recovered. Unknown medical attention was sought. No product quality complaint was involved. Additional information has been requested. Information has been received from a physician, and from a 23 year old female medical assistant with no known allergies, who on 26-NOV-2007 was vaccinated IM with the third dose of HPV vaccine (lot number not provided). Subsequently the MA experienced localizedpain and burning of the injection site on her left arm. In addition, she felt "slightly dizzy." The MA reported the symptoms lasted "approximately 10 minutes," and she recovered. Unknown medical attention was sought. No product quality complaint was involved.


VAERS ID: 301308 (history)  
Age: 23.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-10-17
Onset:2007-10-17
   Days after vaccination:0
Submitted: 2007-12-14
   Days after onset:58
Entered: 2007-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 658282/1263U / 0 - / SC

Administered by: Private       Purchased by: Private
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site induration, Injection site pain, Wrong drug administered
SMQs:, Extravasation events (injections, infusions and implants) (broad), Medication errors (narrow)

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: None
Diagnostic Lab Data: None
CDC Split Type: WAES0711USA06004

Write-up: Information has been received from a licensed practical nurse concerning 4 females (age not reported) with no pertinent medical history or drug reactions/allergies who on an unspecified date were vaccinated with GARDASIL vaccine (yeast) (lot# unknown). There was no concomitant medication. The nurse reported that 4 patients received GARDASIL vaccine (yeast) due to nursing error. Each patient received 0.25 mL dose of GARDASIL vaccine (yeast) given subsequently near the wrist on 17-OCT-2007. The person was administered the doses split a 0.5mL dose of GARDASIL vaccine (yeast) equally among the 4 patients. They were supposed to receive a tuberculin test. The day after administration, each patient developed an injection site reaction right above the wrist. The injection site was red, hard to the touch and painful. One of these patients was seen by the nurse and the other 3 patients called her office. Medical attention was sought. At the time of reporting the patient had not recovered. Follow-up information was received. A 24 year old white female patient who on 17-OCT-2007 was vaccinated with GARDASIL vaccine (yeast) (lot# 658282/1263U). On 18-OCT-2007 the patient was given a 1/4 dose of GARDASIL vaccine (yeast) by mistake. The patient was to receive a tuberculin test instead. On an unspecified date one week later the patient recovered. Follow-up information was received from a licensed practical nurse. The LPN reported that one vial of purified protein derivative (PPD) was delivered to one office one day. On the following day one vial of GARDASIL vaccine (yeast) was delivered to the same office. The medical assistant who was located in the office, in error drew the medication that would be used for the PPD test from GARDASIL vaccine (yeast) vial instead of the prescribed PPD vial. The LPN stated that the error was not due to Product Confusion. As a result of this error, the GARDASIL vaccine (yeast) vaccination would only be administered at another office and not in the current office to assure that this error would no occur again. The patient that received GARDASIL vaccine (yeast) was treated with cold/warm compresses and recovered. Additional information is not expected.


VAERS ID: 300824 (history)  
Age: 23.0  
Gender: Unknown  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2007-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / MASS. PUB HLTH BIOL LAB TD182 / - LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Hyperhidrosis, Pallor
SMQs:, Neuroleptic malignant syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: syncope~Vaccine not specified (no brand name)~UN~0.00~In Patient
Other Medications:
Current Illness: None
Preexisting Conditions: Hx of syncope with vaccination
Diagnostic Lab Data: None
CDC Split Type: MA0714

Write-up: Patient became pale and diaphoretic after Td vaccination.


VAERS ID: 301022 (history)  
Age: 23.0  
Gender: Female  
Location: Michigan  
Vaccinated:2007-12-11
Onset:0000-00-00
Submitted: 2007-12-18
Entered: 2007-12-26
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2769AA / 0 UN / UN

Administered by: Public       Purchased by: Private
Symptoms: Unevaluable event
SMQs:

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:

Write-up: None stated


VAERS ID: 301052 (history)  
Age: 23.0  
Gender: Male  
Location: California  
Vaccinated:2007-12-09
Onset:0000-00-00
Submitted: 2007-12-13
Entered: 2007-12-26
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA316BA / 0 UN / IM

Administered by: Military       Purchased by: Military
Symptoms: Incorrect route of drug administration, Medication error
SMQs:, Medication errors (narrow)

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: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: IM influenza vaccine was mistaken for "Flu Mist" and administered to the nasal passage as a liquid. Once mistake was determined it was given IM.


VAERS ID: 301085 (history)  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-12-10
Onset:2007-12-12
   Days after vaccination:2
Submitted: 2007-12-27
   Days after onset:15
Entered: 2007-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 69690 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Vaccination complication
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MA20071674

Write-up: We received on 13 DEC 2007 the following information from a health care professional: A 23-year-old male patient, born on 29 AUG 1984, was vaccinated i.m. with Fluvirin 2006/2007 (expired on 30 JUN 2006), batch no. 69690, on 10 DEC 2007. On 12 DEC 2007 the patient developed an adverse vaccination reaction (not further specified) and was hospitalized. The patient was still hospitalized at time of reporting. Further information was requested. Company assessment: seriousness criterion: hospitalization. Causality: insufficient data. The amount of data is insufficient to assess causality of this case. Expectedness assessment: Administration of expired vaccine is not expected. No change in benefit-risk-ratio. No measures necessary. Ref no.: NA07-007052.


VAERS ID: 301403 (history)  
Age: 23.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-12-20
Onset:2007-12-21
   Days after vaccination:1
Submitted: 2008-01-02
   Days after onset:12
Entered: 2008-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1383U / 0 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aggression, Erythema, Induration, Injection site swelling, Joint range of motion decreased, Movement disorder, Pain, Pruritus, Pyrexia, Rash macular
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: sprintec-28. ranitidine-300 mg
Current Illness: no
Preexisting Conditions: fibromyalgia/chronic fatigue syndrome. vaso-motor rhinitis
Diagnostic Lab Data:
CDC Split Type:

Write-up: Extreme area of redness-5 inch oval. Fever-101. Very bad temper, shouting, slamming doors, for 2 days after shot. Swelling of site, 1 1/2 inches bigger than other arm. Unable to raise arm to shoulder height for 10 days. No range of motion for 5 days. Severe pain-needed 4 ibuprofen (200mg. ea) and 3 extra strength Tylenol every 6 hours for 4 days following shot. Arm is still red and blotchy in an oval about 4 inches by 2 inches. In the center is still a hard lump. The site has been very itchy for the past 7 days.


VAERS ID: 301436 (history)  
Age: 23.0  
Gender: Male  
Location: Utah  
Vaccinated:2007-12-13
Onset:2007-12-13
   Days after vaccination:0
Submitted: 2007-12-18
   Days after onset:5
Entered: 2008-01-02
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UE933AA / 0 LA / SC

Administered by: Public       Purchased by: Private
Symptoms: Chills, Influenza like illness, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: allergic to certain grasses
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Hive like rash over entire body lasting 3 days. Chills "flu like symptoms" Took Benadryl x 3 days after talking to physician via telephone. s/s gone after 3 days.


VAERS ID: 301496 (history)  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-11-08
Onset:0000-00-00
Submitted: 2007-12-21
Entered: 2008-01-02
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV110 / 2 UN / SC

Administered by: Military       Purchased by: Military
Symptoms: Expired drug administered
SMQs:, Medication errors (narrow)

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:

Write-up: Anthrax lot #FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per authority direction.


VAERS ID: 301517 (history)  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-11-15
Onset:0000-00-00
Submitted: 2007-12-21
Entered: 2008-01-02
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV110 / 5 UN / SC

Administered by: Military       Purchased by: Military
Symptoms: Expired drug administered, No adverse reaction
SMQs:, Medication errors (narrow)

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:

Write-up: Anthrax Lot # FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per agency direction.


VAERS ID: 301541 (history)  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-11-07
Onset:0000-00-00
Submitted: 2007-12-21
Entered: 2008-01-02
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV110 / 2 UN / SC

Administered by: Military       Purchased by: Military
Symptoms: Expired drug administered
SMQs:, Medication errors (narrow)

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:

Write-up: Anthrax lot #FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per authority direction.


VAERS ID: 301555 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-11-08
Onset:0000-00-00
Submitted: 2007-12-21
Entered: 2008-01-02
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV110 / 3 UN / SC

Administered by: Military       Purchased by: Military
Symptoms: Expired drug administered, No adverse reaction
SMQs:, Medication errors (narrow)

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:

Write-up: Anthrax Lot # FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per agency direction.


VAERS ID: 301564 (history)  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-11-06
Onset:0000-00-00
Submitted: 2007-12-21
Entered: 2008-01-02
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV110 / 1 UN / SC

Administered by: Military       Purchased by: Military
Symptoms: Expired drug administered, No adverse reaction
SMQs:, Medication errors (narrow)

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: Allergy: Sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: Anthrax Lot # FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per agency direction.


VAERS ID: 301575 (history)  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-12-05
Onset:0000-00-00
Submitted: 2007-12-21
Entered: 2008-01-02
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV110 / 3 UN / SC

Administered by: Military       Purchased by: Military
Symptoms: Expired drug administered, No adverse reaction
SMQs:, Medication errors (narrow)

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:

Write-up: Anthrax Lot # FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per agency direction.


VAERS ID: 301752 (history)  
Age: 23.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2007-08-07
Onset:2007-08-07
   Days after vaccination:0
Submitted: 2008-01-04
   Days after onset:150
Entered: 2008-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. ? / 0 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dizziness, Fatigue, Injection site pain, Injection site swelling, Injection site urticaria, Nausea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Orthotricyclen
Current Illness: None
Preexisting Conditions: IVP Dye
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swelling, hives, shoulder pain on arm where injection was received (began 1 hr post injection and continued for 4 days). Nausea, dizziness, fever, fatigue (continued for 4-5 days after injection). Treated with Benadryl.


VAERS ID: 301890 (history)  
Age: 23.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-11-14
Onset:2007-11-14
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:0
Entered: 2008-01-08
   Days after submission:55
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA294EA / - LA / UN

Administered by: Other       Purchased by: Private
Symptoms: Blood pressure, Dizziness, Feeling hot, Heart rate normal, Hyperhidrosis, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

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: Sulfa allergy
Diagnostic Lab Data: BP 12/79, pulse 99; recheck 125/79, pulse 89
CDC Split Type:

Write-up: Patient has had flu shot in past. Hot, sweating, shaking, dizzy. BP 120/79, pulse 99. 10 min later recheck 125/79, pulse 89. Cold compress, orange juice, crackers given.


VAERS ID: 301893 (history)  
Age: 23.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-11-14
Onset:2007-11-14
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:0
Entered: 2008-01-08
   Days after submission:55
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA294EA / 0 RA / UN

Administered by: Other       Purchased by: Private
Symptoms: Blood pressure increased, Dizziness, Flushing, Heart rate, Heart rate increased, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Vestibular disorders (broad), Hypersensitivity (broad)

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: N/A
Diagnostic Lab Data: BP 141/93, Pulse 93; 5 min later 125/83, EMS 110/74
CDC Split Type:

Write-up: Patient''s first time getting flu shot. Patient felt flushed, dizzy, nauseated 5-10 minutes after flu shot. BP 141/93, Pulse 93. Recheck 5 min, 125/83, Pulse 83. Called corporate. Found out patient had not eaten yet, gave