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VAERS ID: 296678 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-10-23
Onset:2007-11-03
   Days after vaccination:11
Submitted: 2007-11-07
   Days after onset:4
Entered: 2007-11-14
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z1102 / 1 LA / IM
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UF191AA / 1 LA / SC

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

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

Write-up: In evening of 11/3/07, pt noticed itching & hives on upper body & face. No breathing or swallowing difficulty. Seen in ER and Rx''d w/ Benadryl.


VAERS ID: 299514 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Colorado  
Vaccinated:2006-10-20
Onset:2006-10-20
   Days after vaccination:0
Submitted: 2007-02-07
   Days after onset:110
Entered: 2007-11-14
   Days after submission:280
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2240AA / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MERTAZAPINE
Current Illness:
Preexisting Conditions: Received previously Fluzone. The patient had no illnesses at the time of vaccination. No concomitant medications were reported. Follow-up information received on 31 January 2007. The patient received Fluzone previously in the fall of ''05, ''04 and ''03. She received 0.1ml of Tubersol (lot number C2079AA) subdermally in the left forearm on 19 September 2006. She did not have any illness at the time of Fluzone vaccination, she was taking mirtazapine 7.5 mg daily.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200603095

Write-up: Initial report received from a health care professional, on 13 November 2006. A 21 year old female patient, received on 20 October 2006, intramuscular vaccination of Fluzone (lot number U2240AA) (multidose vial), into the left deltoid. 4 hours post vaccination, on 20 October 2006, the patient had pain in her left arm. The patient was seen in the office, three days later, on 13 November 2006 and the pain continued. The patient did not have swelling, redness or weakness. The patient was prescribed Advil and heat. No concomitant vaccines were reported. The patient had no illnesses at the time of vaccination. No concomitant medications were reported. The patient received Fluzone previously. No information on adverse events was reported. Follow-up information received on 31 January 2007. The patient received Fluzone previously in the fall of ''05, ''04 and ''03. She received 0.1ml of Tubersol (lot number C2079AA) subdermally in the left forearm on 19 September 2006. She did not have any illness at the time of Fluzone vaccination, she was taking mirtazapine 7.5 mg daily. On 13 November 2006, the patient complained of left arm pain. She complained of weakness in the entire arm with an inability to lift arm completely above head. The plan was a trial of ibuprofen 400 mg BID and heat 20 minutes two times daily. On 14 November 2006, the patient complained the arm was numb. On 27 November 2006, she visited a physician for the same complaints. On 25 January 2007, the patient reported her arm was slowly getting better. She almost has full range of motion, except for anything up high. She still can''t hold anything heavy using only that arm, and some days it will ache all day. She still has some tenderness in the area of the shot. She is not on any medication now or seeing a physician for her arm. She has not had a doctors visit since November. She did not have physical therapy. Follow-up information received on 23 February 2007 from a health care professional. Demographic information was received. Per the reporter, the case was reviewed and no additional information is available at this time.


VAERS ID: 299931 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-06-01
Onset:2007-06-01
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:166
Entered: 2007-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1062U / 2 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Full blood count normal, Haematology test normal, Injection site discharge, Pilonidal cyst, Rash pruritic, Skin infection
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Benzaclin
Current Illness: Acne
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: complete blood cell normal; hematology normal serum ICG
CDC Split Type: WAES0710USA00741

Write-up: Information has been received from a nurse practitioner concerning a 21 year old female with acne who in June 2007, was vaccinated with the first dose of Gardasil, 0.5 ml, IM. Concomitant therapy included BENZACLIN. In June 2007, the patient experienced a yellow milky discharge soon after the vaccination on the injection site. She also developed some very itchy rash on legs two to three weeks later. The patient eventually recovered from these symptoms on an unspecified date. on 10-SEP-2007, the patient was vaccinated with the second dose of Gardasil (lot# 658560/1062U). On approximately 24-SEP-2007 "two weeks after the second dose", the patient developed an itchy rash which started on both of her arms and spread to her legs. The patient also had some pilonidal cysts or skin infections on her body. Unspecified medical attention was sought. On an unspecified date, a complete blood count and serum ICG were performed which the results were normal. The patient''s itchy rash arms and legs and pilonidal cysts or skin infections on her body persisted. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 299934 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2007-05-01
Onset:0000-00-00
Submitted: 2007-11-14
Entered: 2007-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Contusion, Skin disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA00793

Write-up: Information has been received from a physician concerning his 21 year old daughter, who in MAY-2007 was vaccinated with a first dose of Gardasil. Subsequently, the patient developed "dark discoloration" or "bruising" to her ankles and the bottom of her feet. The discoloration was most prominent during June and July 2007. On an unspecified date, the patient received her second dose of Gardasil. The patient was evaluated by her family physician. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 299942 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Indiana  
Vaccinated:2007-09-21
Onset:2007-09-21
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:54
Entered: 2007-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1063U / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram, Dizziness, Lymphadenopathy, Malaise, Nausea, Neck pain, Nuclear magnetic resonance imaging, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: computed axial, 09/21/07; magnetic resonance, 09/21/07
CDC Split Type: WAES0710USA00903

Write-up: This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a nurse concerning a 21 year old female patient who on 21-SEP-2007 was vaccinated with a dose of GARDASIL (lot # 658563/1063U). Within one hour of vaccination the patient had nausea and dizziness. The patient had hand tingling and feet tingling as well as general malaise. The patient then progressed to neck pain and had swollen glands. The patient went to ER and had a CT scan and MRI done. The patient was not admitted to the hospital The patient''s outcome was unknown. No further information is expected.


VAERS ID: 299965 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Michigan  
Vaccinated:2007-10-04
Onset:2007-10-04
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:41
Entered: 2007-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0962F / UNK UN / IM
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0710USA01446

Write-up: Information has been received from a registered nurse concerning a 20 year old female who on 04-OCT-2007 was vaccinated with a first dose of GARDASIL 0.5 ml IM. Concomitant therapy also given on 04-OCT-2007 included TDAP. On 04-OCT-2007, the patient experienced a migraine and dizziness. The patient sought medical attention by calling the nurse. At the time of reporting, the patient''s migraine and dizziness persisted. Additional information has been requested.


VAERS ID: 296893 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Male  
Location: Michigan  
Vaccinated:2007-10-14
Onset:2007-10-18
   Days after vaccination:4
Submitted: 2007-11-05
   Days after onset:18
Entered: 2007-11-15
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV111 / 1 RA / SC
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 1 LA / ID
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR A0221 / 1 RA / IM

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

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

Write-up: Redness spread couple inches below site and into armpit. Very hot and itchy. Sought medical care and received a shot in buttock, also provided antibiotic - does not recall name of meds.


VAERS ID: 296917 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Indiana  
Vaccinated:2007-10-24
Onset:2007-10-24
   Days after vaccination:0
Submitted: 2007-11-07
   Days after onset:14
Entered: 2007-11-15
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA296FA / 2 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injected limb mobility decreased, Pain
SMQs:

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

Write-up: Patient has aching, decreased Range of Motion in shoulder where vaccine was administered. Saw Dr. 11-7-07 for these complaints - given RX for antiinflammatory medication and physical therapy


VAERS ID: 299599 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: New York  
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. - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA03967

Write-up: Information has been received from a physician concerning a 21 year old female patient who was vaccinated with a first dose of Gardasil. Subsequently the patient experienced patient experience redness and blotchy spots on her chest and arms and thighs. The patient sought unspecified medical attention. The outcome was unknown. Additional information has been requested.


VAERS ID: 299609 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-10-17
Onset:2007-10-17
   Days after vaccination:0
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 RA / SC

Administered by: Other       Purchased by: Other
Symptoms: Cellulitis, Erythema, Haematoma, Injection site discolouration, Injection site erythema, Injection site swelling, Rash
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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0710USA04012

Write-up: This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a registered nurse concerning a 21 year old female with no relevant medical history reported who in August 2007, was vaccinated intramuscularly with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) with no reaction. On 17-OCT-2007, the patient was vaccinated subcutaneously with a 0.5 mL second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient developed a black and blue mark at the injection site on the same day of vaccination. The area turned red and swollen within 24 hours. The total area was larger than a 50 cents coin. The patient sought medical attention from the nurse. At the time of reporting, the patient had not recovered. Additional information has been requested. Follow-up information was received from the registered nurse. The patient reported that on 17-OCT-2007 the GARDASIL injection was given at the primary care physician''s office in the right tricep arm area. On 18-OCT-2007, the hematoma appeared with a red hot area on the edge of the hematoma by the evening. The area was less hard by the morning. The patient also reported a red rash on the chest area which occurred in the morning which resolved. The patient also had local cellulitis from immunization. The patient was given KEFLEX and to do cold compress. The patient had no illness at the time of vaccination. On an unspecified date the patient recovered. Additional information is not expected.


VAERS ID: 299624 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-10-08
Onset:2007-10-08
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:37
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 pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0710USA04319

Write-up: Information has been received from the father of a 21 year old female who on 08-OCT-2007 was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) and, right afterwards, experienced soreness at the injection site which lasted until the time of reporting. There was no concomitant medication. The patient had not recovered. Additional information is not expected.


VAERS ID: 299638 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2007-08-14
Onset:2007-08-15
   Days after vaccination:1
Submitted: 2007-11-14
   Days after onset:91
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0827U / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Injection site swelling
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: (therapy unspecified)
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0710USA04402

Write-up: Information has been received from a healthcare worker concerning a 21 year old female with no known drug allergies, who on 14-AUG-2007 at 11:30 a.m., was vaccinated IM in the left deltoid with the first dose 0.5 ml, of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #658222/0827U). Concomitant therapy included unspecified birth control medication. On 14-AUG_2007 (previously reported as 15-AUG-2007) the patient developed an egg shaped swelling at the injection site that lasted 1 week and dizziness that lasted for 2 days after her first immunization with HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no illness reported at the time of vaccination. The patient mentioned the adverse event at the next office visit. No laboratory/diagnostic tests were performed. Subsequently, the patient recovered from an egg shaped swelling at the injection site and dizziness. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. Additional information is not expected.


VAERS ID: 299644 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-08-01
Onset:2007-10-08
   Days after vaccination:68
Submitted: 2007-11-14
   Days after onset:37
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1061U / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain upper, Feeling hot, Malaise, Sleep disorder
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA04544

Write-up: Information has been received from a physician concerning a 21 year old female who on 08-OCT-2007 was vaccinated IM with a second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 658558/1061U). There was no concomitant medication. On 09-OCT-2007 the patient''s mother called the office to report that the patient believed that she was having a reaction to the vaccine. The patient was called by the physician. It was reported that the patient woke up through the night with severe abdominal cramps. She had no nausea, diarrhea or vomiting. She possibly had a fever "I felt warm." The patient stated that she didn''t feel right. She didn''t want to eat because her "stomach kind of hurts." The patient was told that if she experienced any signs of wheezing, trouble breathing or swallowing or if she had a fever she needed to go to the emergency room. The physician reported that this may be influenza type of symptoms but the patient should call her mother to let the office know how she was feeling. The patient recovered. On 01-AUG-2007 the patient was vaccinated with first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) and there were no concerns. Additional information has been requested.


VAERS ID: 299648 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Indiana  
Vaccinated:2007-07-24
Onset:2007-08-28
   Days after vaccination:35
Submitted: 2007-11-14
   Days after onset:78
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0680U / 3 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Hypersensitivity
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA04606

Write-up: Information has been received from a consumer concerning a 11 year old female patient with a history of hypersensitivity to illosone who in July 2007, was vaccinated with her third dose of GARDASIL vaccine. Since August 2007, the patient experienced severe hives. The patient did not have any reactions with the first and second doses of GARASIL vaccine. The patient has been seen by a dermatologist and a allergist. In either late August or early September 2007, the patient''s hands and feet began to swell requiring a visit to the emergency room. The patient has been on prednisone (manufacturer unknown), doxepin (manufacturer unknown), ranitidine (manufacturer unknown), ALLERGRA, and ZYRTEC. The medications were not helping. The patient did not recover from severe hives nor hands and feet swelling. Additional information has been requested.


VAERS ID: 299709 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-09-01
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. UNK / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Hepatic enzyme increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: vitamins (unspecified)
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: diagnostic laboratory-results not reported
CDC Split Type: WAES0710USA00478

Write-up: Information has been received from the mother of a 21 year old female consumer with pertinent medical history and drug reactions/allergies reported as none, who on September 2007, was vaccinated with a dose of Gardasil vaccine, injection (form), 0.5 mL. Concomitant therapy included vitamins (unspecified). Subsequently on an unspecified date, the patient experienced elevated liver enzymes (AST & ALT) and fatigue. On an unspecified date, a blood test was performed with results not reported. Unspecified medical attention was sought. The patient''s elevated liver enzymes (AST & ALT) and fatigue persisted. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 299733 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Rhode Island  
Vaccinated:2007-10-24
Onset:2007-10-24
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:21
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0802U / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Dizziness, Immediate post-injection reaction, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Anxiety
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: electrocardiogram, 10/24/07, normal;
CDC Split Type: WAES0710USA05632

Write-up: Information has been received from a nurse practitioner concerning a female who on 24-OCT-2007 was vaccinated intramuscularly with the first dose of Gardasil vaccine (0.5 mL). On 24-OCT-2007, immediately after receiving the vaccine, the patient became dizzy and nauseous. The patient was rushed to the emergency room by ambulance. No further details were provided. At the time of this report, the outcome of the events was unknown. The reporter felt that the events were serious for an other important medical event. Additional information has been requested. This is an amended report. The route of intramuscular was added to the report. This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a nurse practitioner concerning a 21 year old female student with anxiety who on 24-OCT-2007 at 1:00 PM was vaccinated intramuscularly in the left deltoid with the first dose of GARDASIL (0.5 ml) (lot # 658490/0802U). There were no illnesses at the time of vaccination and no adverse events following prior vaccinations. On 24-OCT-2007, at 1:15 PM the patient experienced lightheadedness and nausea times one and a half hours. The patient was rushed to the emergency room by ambulance. An EKG in the ER was noted to be normal. The patient subsequently recovered the same day. In follow-up the nurse practitioner did not report the events as other important medical events. No further information is expected.


VAERS ID: 299792 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Idaho  
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. - / 1 UN / IJ

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NICON
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0710USA06125

Write-up: Information has been received from a health care provider concerning a female patient who was vaccinated with GARDASIL vaccine (yeast). There was no concomitant medication. Subsequently the patient experienced tingling in her fingers on her injected arm. Lot number was not provided. No further information was available. The patient sought unspecified medical treatment. Additional information has been requested. Information has been received from a health care provider concerning a female patient who on 15-Oct-2007, was intramuscularly vaccinated in the right deltoid, with a first dose of GARDASIL. Concomitant medication included ethinyl estradiol (+) norethindrone 1/35. Subsequently, three days later, the patient reported numbness and tingling in her right fingertips to the first joint on all fingers with the least n/t in the pinky finger. Lot number was not provided. The patient was seen in the office on 29-Oct-2007 with continuation of symptoms. She has not reported any history of carpal tunnel symtoms in the past, but has reported recent use of the computer/typing alot since the injection. The HCP evaluated her and she was diagnosed with paraesthesia of IP joint/palmer side of hand without anatomical diagnosis. 04-NOV-2007 called patient for follow-up and all symptoms are resolved. The NCP lists the recovery date as approximately 05-NOV-2007. Additional information has been reuested.


VAERS ID: 299803 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-10-15
Onset:2007-10-16
   Days after vaccination:1
Submitted: 2007-11-14
   Days after onset:29
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: Headache, Influenza like illness
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA06532

Write-up: Information has been received from a nurse concerning her 21 year old daughter, who, on an unspecified date, was vaccinated with a second dose of GARDASIL vaccine (yeast). Subsequently, one day post vaccination the patient experienced flu like symptoms and a headache. The patient fully recovered the next day. It was reported that the patient will go on to receive the third dose. The patient did not seek medical attention. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 299850 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-08-30
Onset:2007-09-02
   Days after vaccination:3
Submitted: 2007-11-14
   Days after onset:73
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0742U / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Body temperature increased, Culture negative, Eye swelling, Laboratory test, Lip swelling, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Bilirubin increased, chills, General body pain, Infectious mononucleosis, Jaundice, swollen eyelid, White blood cell count~HPV (
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: body Temp 100; diagnostice labortory, 09/02/07, negative for mono
CDC Split Type: WAES0711USA01667

Write-up: Information has been received from a physician concerning a 21 year old female who was vaccinated with a first dose of GARDASIL vaccine. Subsequently, the patient developed generalized body aches, swollen lips and a temperature of 100 which lasted 1-2 days. Additional information has been requested. It was reported that her sister had an experience following vaccination with GARDASIL vaccine (WAES # 0710USA00753). This is in follow-up to report (s) previously submitted on 11/14/2007). Initial and follow up information has been received from a physician and a nurse practitioner, concerning a 21 year old female student, who on 30-AUG-2007, was vaccinated IM in the left deltoid, with the first dose of GARDASIL (lot #654539/0742U). There was no illness at the time of vaccination. Subsequently the student developed generalised body aches (date not specified), and on 02-SEP-2009, she devolped swollen lips, swollen eyes, and a fever of 100 degrees. The patient visited the physician or emergency room. Treatment included TYLENOL. The physician noted the symptoms lasted for 1-2 days, but the NP reported that on 04-SEP-2007 ("Tuesday"), the swelling had "decreased." The NP added that the patient''s sister had developed "mono" during this time, however the patient tested negative for mono. At the time of this report, the patient had recovered from the events. Additional information is not expected. It was reported that her sister had an experience following vaccination with GARDASIL (WAES # 0710USA00753).


VAERS ID: 300141 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-07-09
Onset:2007-10-01
   Days after vaccination:84
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. 657737/0522U / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Rheumatoid arthritis
SMQs:, Arthritis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ENBREL, ORTHO EVRA
Current Illness: Rheumatoid arthritis, Anemia
Preexisting Conditions: Hip replacement
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA02356

Write-up: Information has been received from a nurse concerning a 21 year old female patient with rheumatoid arthritis, chronic anemia and a history of hip replacement in 2003 due to Rheumatoid arthritis who in 09-JUL-2007 was vaccinated 0.5 ml IM with a dose of GARDASIL vaccine (yeast) (lot # 657737/0522U). Concomitant therapy included etanercept (ENBREL), ethinyl estradiol (+) norelgestromin (ORTHO EVRA). In October 2007, about 2-3 months post vaccination of GARDASIL vaccine (yeast) the patient developed Rheumatoid arthritis flare up that was not controlled with the etanercept (ENBREL) therapy. The patient switched to infliximab (REMICADE) therapy which controlled her symptoms. At the time of this report the patient recovered. Additional information has been requested.


VAERS ID: 300150 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2007-09-07
Onset:2007-09-08
   Days after vaccination:1
Submitted: 2007-11-14
   Days after onset:67
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1063U / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injection site pain, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA02519

Write-up: Information has been received from a nurse concerning a 21 year old female who in September 2007, was vaccinated intramuscularly in the left deltoid with a 0.5 dose of GARDASIL vaccine (yeast) and has had pain at the injection site since the vaccination. On 08-Oct-2007 the patient went to doctor''s office and complained of injection site pain and weakness at the injection site. At the time of this report, the patient''s pain and weakness at injection site persisted. 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 concerning a 21 year old female with no pertinent medical history or drug reactions/allergies who on 07-SEP-2007, was vaccinated intramuscularly in the left deltoid with the 1st 0.5 dose of GARDASIL vaccine (lot#658563/1063U) and has had pain at the injection site since the vaccination. On 08-OCT-2007 (approx), the patient went to doctor''s office and complained of injection site pain, weakness at the injection site, left shoulder pain, a achy arm at night and reduced range of motion. The patient saw a physical therapist and the pain resolved. The patient received the 2nd GARDASIL vaccine and had no problem. No additional information is expected.


VAERS ID: 300164 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: California  
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. 656051/0244U / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARINEX, hormonal contraceptives
Current Illness: Anemia
Preexisting Conditions: Wrist fracture
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA02681

Write-up: Information has been received from a certified medical assistant concerning a 21 year old female patient with anemia and a history of wrist fracture who on 19-MAR-2007 was vaccinated IM with a first 0.5ml dose of GARDASIL vaccine (yeast) (Lot reported as 656051/0244U, "0367U", 658282/0929U). Concomitant therapy included desloratadine (CLARINEX) and oral hormonal contraceptives (unspecified). About 4 weeks after the vaccination, the patient experienced fatigue and bilateral numbness in her upper arms. Unspecified medical attention was sought. It was reported that the patient has received cyanocobalamin (VITAMIN B-12) injections for pre-existing anemia, that seem to have improved the symptoms. 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: 300170 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-09-07
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. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Headache, Local swelling, Rash generalised
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA02755

Write-up: Information has been received from a 21 year old female consumer who on 07-SEP-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). Subsequently the patient experienced body rash, head swollen and headache. Unknown medical attention was sought. The patient was recovering. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 300177 (history)  
Form: Version 1.0  
Age: 21.0  
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. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram, Neck mass
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: computed axial - no results available
CDC Split Type: WAES0710USA02809

Write-up: Information has been received from a nurse concerning a 21 year old female who was vaccinated with GARDASIL vaccine (yeast). Subsequently the patient experienced a lump on her neck after receiving the vaccine. A CT scan was performed to check the lump but no results were available. No further details were provided.


VAERS ID: 300199 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-04-01
Onset:2007-04-03
   Days after vaccination:2
Submitted: 2007-11-14
   Days after onset:225
Entered: 2007-11-15
   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: Injection site atrophy, Injection site bruising
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0710USA03194

Write-up: Information has been received from a medical assistant concerning a 21 year old female who in approximately April 2007, "6 months ago", was vaccinated with the first dose of Gardasil vaccine (lot# not reported). There was no concomitant medication. In approximately April 2007, "2 days after vaccination", the patient developed bruised skin and skin atrophy at the injection site. The patient sought unspecified medical attention. No laboratory diagnostic testes were performed. Subsequently, the patient recovered from bruised skin but the indentation from skin atrophy is still noticeable on her arm. There was no product quality complaint. Additional information has been requested.


VAERS ID: 300223 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-08-03
Onset:2007-08-03
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:103
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA03613

Write-up: Information has been received from a Nurse Practitioner concerning a 21 year old female patient who on 03-AUG-2007 was vaccinated in the left arm with a first dose of Gardasil vaccine. Concomitant therapy included hormonal contraceptives (unspecified). The patient experienced tingling, numbness and pain in her arm within minutes of receiving the dose. The patient sought medical attention. On 04-AUG-2007, the patient recovered. The Nurse Practitioner requested information on whether she should administer the 2nd dose, but was not involved in the administration of the first dose which was received at a health clinic. Additional information has been requested.


VAERS ID: 297523 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Utah  
Vaccinated:2007-11-16
Onset:2007-11-16
   Days after vaccination:0
Submitted: 2007-11-21
   Days after onset:5
Entered: 2007-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U 2497 AA / 1 RA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Abdominal discomfort, Burning sensation, Injection site pruritus, Pyrexia, Rash generalised
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: An antiinflamatory
Current Illness: Experiencing some ''kidney problems''
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approx. 1-2 hrs after flu vaccine, employee noticed arm where vacccine administered itching, then became aware of itching, stinging rash over entire body.Sts fever next day, abd discomfort since onset.Employee seen 5 days after symptom onset-treated with tapering dose Prednisone, Zantac OTC suggested.Offered eval by Wrk Md.11/20/07, empl. chose to come here to Empl. Health office.


VAERS ID: 297911 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2007-11-16
Onset:2007-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2007-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2862AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Chills, Cold sweat, Erythema, Pain, Pyrexia, 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), Hypoglycaemia (broad)

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

Write-up: Pain started next day, got red. Noticed a lump. Went to Urgent Care got an antibiotic and pain relief Rx''s. Swelling started w/in 24 hours. Redness with in 12, fever, chills, hot and cold sweats. Redness almost gone. Lump still.


VAERS ID: 298168 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Alabama  
Vaccinated:2007-10-30
Onset:2007-11-17
   Days after vaccination:18
Submitted: 2007-11-29
   Days after onset:12
Entered: 2007-11-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. UNSURE / 3 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Arrhythmia, Blood test, Chest pain, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Fatigue, Heart rate increased, Palpitations
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ortho tri cyclen
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Holter Monitor, Echocardiogram, blood test. Event monitor, EKG
CDC Split Type:

Write-up: Became SOB, Expected Chest pain, Chest Soreness, Abnormal EKG-Abnormal holter monitor with arrhythmia, Sent to cardiologist, Put on Toprol to control fast heart rate.Had Echocardiogram which was normal,Still having SOB with heart racing and feeling tired. Feels not like her self.Very fatigued.


VAERS ID: 298332 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: California  
Vaccinated:2007-11-26
Onset:2007-11-28
   Days after vaccination:2
Submitted: 2007-11-30
   Days after onset:2
Entered: 2007-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2425AA / 1 LA / UN

Administered by: Public       Purchased by: Public
Symptoms: Chills, Erythema, Pyrexia, Swelling, Tracheomalacia
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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Tracheomalacia, Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swelling, erythema, fever and chills 2 days after vaccine given. Gave Keflex 10 day course for possible cellulitis.


VAERS ID: 298363 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Male  
Location: Minnesota  
Vaccinated:2007-11-26
Onset:2007-11-27
   Days after vaccination:1
Submitted: 2007-11-28
   Days after onset:1
Entered: 2007-11-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2842AA / UNK LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Headache, Injection site swelling, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Pt received Tdap 11-26-07 AM. Pt states on 11-27-07 he had fever $g 102 F, body aches, headache and swelling at injection site.


VAERS ID: 298447 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-05-17
Onset:2007-07-15
   Days after vaccination:59
Submitted: 2007-11-30
   Days after onset:138
Entered: 2007-12-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Diaphragmalgia, Gallbladder disorder, Gastric disorder, Ileus paralytic, Laboratory test, Liver scan
SMQs:, Acute pancreatitis (broad), Gastrointestinal obstruction (narrow), Gallbladder related disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: diagnostic laboratory - paralysis of stomach and slow down of gallbladder; hepatic radionuclear - "liver scan" results not reported; diagnostic laboratory - "gallbladder" (no stones); diagnostic laboratory - "scleroderma" (results not provided); diagnostic laboratory - "diabetes" (results not reported)
CDC Split Type: WAES0711USA04695

Write-up: Information has been received from a mother concerning her 21 year old daughter with no known drug allergies who on 17-MAY-2007 was vaccinated with her first dose of Gardasil, injection. Concomitant therapy included hormonal contraceptives (unspecified). In the "middle of July" estimated to be approximately 15-JUL-2007, "about two months" after the first dose of Gardasil, the patient experienced paralysis of the stomach, slow down of the gallbladder, chest pain and pain in the diaphragm. The chest pain extended to her diaphragm area. At first, the physician thought the patient had acid reflux. Further testing showed that she had paralysis of the stomach and a slow down of the gallbladder. The patient started to "get better" about 4 weeks before the third dose, estimated to be 21-OCT-2007. On 21-NOV-2007 the patient received her third dose of Gardasil. The patient''s symptoms came back. The patient underwent the following tests: diabetes (results not provided), scleroderma (results not provided), gallbladder (no stones) and liver scan (results not provided). The patient''s paralysis of the stomach, slow down of the gallbladder, chest pain and pain in the diaphragm persisted. Unspecified medical attention was sought. OME statement: Upon internal review, paralysis of the stomach was determined to be an other important medical event. Additional information has been requested.


VAERS ID: 298538 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Idaho  
Vaccinated:2007-11-13
Onset:2007-11-15
   Days after vaccination:2
Submitted: 2007-11-28
   Days after onset:13
Entered: 2007-12-03
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA294BA / 1 LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, Rash
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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Reddened rash like area to (L) deltoid states "a little itchy" at site. Benadryl taken by pt 11/15/07. Spoke to pt 11-16-07 1430 and rash beginning to fade. 11-28-07 Resolved.


VAERS ID: 298552 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: New York  
Vaccinated:2007-11-20
Onset:2007-11-21
   Days after vaccination:1
Submitted: 2007-11-27
   Days after onset:6
Entered: 2007-12-03
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0646U / 1 - / IM
RAB: RABIES (IMOVAX) / SANOFI PASTEUR A0208 / 1 - / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Chills, Dizziness, Malaise, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D, B12, Grape Seed Acidophilus
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 11/26, reported Myalgia, chills, dizziness, nausea and malaise that onset 24 hours after injection and lasted for 24 hours. Didn''t check temperature. Used Tylenol , Ibuprofen but felt wasn''t helpful in relief. Stopped series her request.


VAERS ID: 298707 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Male  
Location: Washington  
Vaccinated:2007-11-15
Onset:2007-11-16
   Days after vaccination:1
Submitted: 2007-11-26
   Days after onset:10
Entered: 2007-12-04
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 80825 / UNK RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Arthralgia, Chills, Headache, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Recurring chills, headache, myalgias, arthralgias which started 1 day after receiving flu vaccine. Sx persistent at 2 weeks.


VAERS ID: 298978 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-11-30
Onset:2007-12-02
   Days after vaccination:2
Submitted: 2007-12-03
   Days after onset:1
Entered: 2007-12-06
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Headache, Oedema peripheral, Pyrexia, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hx of smoking, mild social alcohol use, no liver problems, one pregnancy, no children, no known allergies.
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient is a 21 yr old hispanic female was given the Gardasil vaccine on Right arm on Friday Nov 30, 2007 at 2:30 p.m. She reports mild fever was given Two Advils P.O. On Sat Dec 1, 2007, she reports mild headache and mild coughing no meds taken at this point. On Sunday Dec 2, 2007 she reports mild ongoing coughing with mild rash on body she reports no meds taken. On Monday Dec 3, 2007 she reports swollen hands with lid edema on right leg and a moderate rash on body. At this point she took Benadryl 2 tablets P.O. every 4 hours, with plenty of liquids.


VAERS ID: 299170 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-10-30
Onset:0000-00-00
Submitted: 2007-11-28
Entered: 2007-12-10
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500489P / 1 NS / IN

Administered by: Military       Purchased by: Military
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
SMQs:, 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline; Ortho Tricyclen
Current Illness: None
Preexisting Conditions: Dysthymic disorder; Depression
Allergies:
Diagnostic Lab Data: (+) HCG on 8 Nov 2007
CDC Split Type:

Write-up: Received Flumist on 30 Oct 2007. Did not know she was pregnant.


VAERS ID: 299260 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Male  
Location: Colorado  
Vaccinated:2007-12-03
Onset:2007-12-03
   Days after vaccination:0
Submitted: 2007-12-11
   Days after onset:8
Entered: 2007-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB449AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Anxiety, Dyspnoea, Hyperventilation, Hypoaesthesia, Nausea, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none known
Current Illness: none
Preexisting Conditions: NKDA; "Insomnia"
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: approximately 2 hours after admin of Engerix B, he returned to the clinic reported shortness of breath, numbness and tingling in extremities, and nausea. He was transferred to the ER where he was given Benadryl, Solu-Medrol, Pepcid and Phenergan. The ER doc noted he was hyperventilating and "A large component of his symptoms are anxiety related."


VAERS ID: 299312 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Georgia  
Vaccinated:2007-10-23
Onset:2007-10-23
   Days after vaccination:0
Submitted: 2007-11-13
   Days after onset:21
Entered: 2007-12-11
   Days after submission:28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. M500522U / 2 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Erythema, Rash, Skin nodule
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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: unsure with care Drs office gave her.
CDC Split Type: GA07073

Write-up: 10/23/07 Client call to report to nurse that she developed red hard painful bumps over her body after her #2 Gardasil. Went to medical center for exam and treatment. Given steroids and antihistamines.


VAERS ID: 299367 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Georgia  
Vaccinated:2007-10-01
Onset:2007-10-02
   Days after vaccination:1
Submitted: 2007-12-12
   Days after onset:71
Entered: 2007-12-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER AHBVB308AA / 2 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 2 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Similar reaction on previous exposure to drug
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tricyclen birth control pills daily and Dailyvite multivitamin daily
Current Illness: None
Preexisting Conditions: Allergic to PCN, Hx of gestational diabetes and abnormal PAP tests
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient reports injection site became red and swollen the day after 2nd dose of HPV vaccine given, and remained swollen and painful for several days. Patient states the injection site left a "dark spot" on her arm with both the 1st and 2nd doses of the vaccine, but much worse with the 2nd. None visibly seen by nurse today.


VAERS ID: 299414 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Male  
Location: Texas  
Vaccinated:2004-03-17
Onset:2004-04-11
   Days after vaccination:25
Submitted: 2007-12-11
   Days after onset:1339
Entered: 2007-12-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH FAV081 / 6 UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Chest X-ray normal, Chest pain, Dyspnoea, Full blood count normal, Metabolic function test normal, Pericarditis, Red blood cell sedimentation rate increased
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~ ()~~0.00~In Patient|None~ ()~~0.00~In Sibling
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: 4/14/2004 CXR PA/LAT - Frontal and lateral views of the erect chest show their expansion with no infiltrates or effusions. The airway is clear and the cardiac and mediastinal contours are normal. There''s no evidence of free air beneath the diaphragm. The musculoskeletal structures are unremarkable. Impression: 1. Normal chest X-ray. 4/14/2004 BMP normal, CBC normal, ESR 19 (0-15)
CDC Split Type:

Write-up: Patient received a fifth dose of anthrax vaccine on 3/17/2004. He was well prior to vaccination and did not recall immediate local or systemic symptoms. On 4/14/2004 he presented to a military treatment facility with a 3-day history of chest pain and SOB. He was diagnosed and treated for acute pericarditis based on clinical presentation and elevated ESR; no ECG was obtained. Chest pain, sub-sternal start: 03/11/2004. Dyspnea (shortness of breath) start: 03/11/2004.


VAERS ID: 299417 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Male  
Location: Michigan  
Vaccinated:2005-06-27
Onset:0000-00-00
Submitted: 2007-12-05
Entered: 2007-12-12
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVA065AA / UNK RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Immunology test, Incorrect dose administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Tested immune on 11/19/07
CDC Split Type:

Write-up: Patient was given 3 pediatric doses instead of full adult doses.


VAERS ID: 299531 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Male  
Location: Unknown  
Vaccinated:1999-05-04
Onset:2004-04-07
   Days after vaccination:1800
Submitted: 2007-12-13
   Days after onset:1345
Entered: 2007-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER FAV041 / 1 LA / ID

Administered by: Military       Purchased by: Military
Symptoms: Amnesia, Arthralgia, Asthenia, Diarrhoea, Hypoaesthesia, Memory impairment, Myalgia, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: None.
Preexisting Conditions: PCN Allergy
Allergies:
Diagnostic Lab Data: According to a filed report of vaccinations at Dover AFB: "include systemic (occurring at sites other than the injection site) symptoms, such as vomiting, diarrhea, severe muscle and joint pain, memory loss, fever, weakness and numbness, and these problems can occur well after the usual reporting period for vaccine adverse effects."
CDC Split Type:

Write-up: Over the course of the last two years, patient has realized that he is losing memory of certain events, developing both long term and short term memory problems. Coupled with severe joint problems in both the knees and wrists, ie cracking, poping, and soreness. Lot# FAV041 Left Arm


VAERS ID: 300281 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-12-11
Entered: 2007-12-18
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2439AA / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: 10/22/07 - received influenza vaccine 11/19/07 - presented with right shoulder pain and weakness for 24 hours


VAERS ID: 300506 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2007-03-23
Onset:2007-03-23
   Days after vaccination:0
Submitted: 2007-12-14
   Days after onset:266
Entered: 2007-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Amniotic fluid volume decreased, Anaemia, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Nausea, Ultrasound abdomen
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Tumour markers (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acetaminophen
Current Illness:
Preexisting Conditions: Cervical dysplasia; headache
Allergies:
Diagnostic Lab Data: Ultrasound - 07/05/07 - within normal limits, fetal growth appropriate Ultrasound - 11/02/07 - decreased amniotic fluid Diagnostic laboratory - 11/12/07 - biophysical profile Serum beta-human - 04/02/07 - pregnant
CDC Split Type: WAES0704USA01541

Write-up: Information has been received from a registered nurse through the Merck pregnancy registry concerning a 21 year old hispanic female patient with a history of cervical dysplasia and headaches with no allergies who on 23-Mar-2007, was vaccinated with a first dose of Gardasil (Lot #656049/0187U). Concomitant therapy included acetaminophen as needed. The nurse reported that the patient had a blood pregnancy test on 02-Apr-2007 and was confirmed to be pregnant. Her last menstrual period was 24-Feb-2007 and her estimated due date was 01-Dec-2007. It was reported that her pregnancy was normal to date. On 11-May-2007, cetirizine hydrochloride (Zyrtec) 10 mg as needed was prescribed for nausea. On 05-Jul-2007, the patient had an ultrasound for a fetal survey. The results of the test were within normal limits; fetal growth was appropriate. On 30-Aug-2007, iron (unspecified) 65mg daily, was prescribed for anemia. On 02-Nov-2007, a second ultrasound was performed for a fetal survey and the result of this test was low amniotic fluid or oligohydramnios. On 12-Nov-2007, a biophysical profile test was performed. On 25-Nov-2007, the patient delivered a female baby weighing 6 pounds 6 ounces and measuring 19 inches in length. The patient was reported to be 39 weeks from her last menstrual period. The infant was reported to be normal with no congenital anomalies or other complications. At the time of this report, the patient''s outcome was unknown. Additional information is not expected.


VAERS ID: 300669 (history)  
Form: Version 1.0  
Age: 21.0  
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. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arrhythmia
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0711USA01345

Write-up: Information has been received from a pharmacist (PHARM D) concerning a 21 year old female who in October 2007, was vaccinated with GARDASIL (lot# unknown). On an unspecified date the patient experienced cardiac arrythmias. Medical attention was sought at the physician''s office. At the time of reporting it was unknown if the patient had recovered. No further information was available.


VAERS ID: 300670 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Pennsylvania  
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. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cough, Respiratory tract congestion
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA01349

Write-up: Information has been received from a physician concerning a 21 year old female who in August 2007, was vaccinated with the second dose of GARDASIL (no lot# reported), 0.5mL injection. In October 2007, the patient experienced nasal symptoms, coughing and congestion. Unspecified medical attention was sought. Additional information has been requested.


VAERS ID: 300677 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-07-18
Onset:2007-07-18
   Days after vaccination:0
Submitted: 2007-12-14
   Days after onset:149
Entered: 2007-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0711USA01683

Write-up: Information has been received from a nurse practitioner concerning a 21 year old female who on 18-JUL-2007 was vaccinated with Gardasil. At around 2300 on the night of the vaccination, the patient developed a fever. Two days later, the patient recovered from fever. Additional information has been requested.


VAERS ID: 300701 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: New Mexico  
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. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Menorrhagia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0711USA02058

Write-up: Information has been received from a physician concerning a 21 year old female who was vaccinated with intramuscularly in the arm with the first dose of GARDASIL (Lot # not reported). In approximately October 2007, the patient experienced menorrhagia. No other symptoms were reported. Patient outcome was not reported. Additional information has been requested.


VAERS ID: 300844 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Colorado  
Vaccinated:2007-10-01
Onset:2007-10-01
   Days after vaccination:0
Submitted: 2007-12-14
   Days after onset:74
Entered: 2007-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1060U / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site induration, Injection site mass, Injection site pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPO-PROVERA
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA03487

Write-up: Information has been received from a company representative from a Nurse practitioner concerning a female, who in October 2007, was vaccinated by injection with the first dose of Gardasil. Concomitant therapy included DEPO-PROVERA. In October 2007, the patient experienced a 2 millimeter, hard circular area on the left posterior deltoid area which is tender occasionally. Lot number was not available. The patient sought unspecified medical attention. No further information available. Additional information has been requested. Follow-up received 04/16/2008. Information has been received from a nurse practitioner concerning a female, with no known drug allergies, who on 05-OCT-2007, was vaccinated in the left deltoid with the first dose of GARDASIL (lot# 658556/1060U). Concomitant therapy included DEPU-PROVERA. In October 2007, the patient experienced a 3 millimeter, lump on left posterior deltoid, subcutaneous-occasionally tender. Medical attention was sought. Not tender on date of visit. The patient stated that she was rubbing and checking frequently since 05-OCT-2007. Advised to stop frequent daily checks. Warm soak to area daily. The patient was recovered from the lump. Arm sore after lifting. Additional information has been requested.


VAERS ID: 300854 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: New Hampshire  
Vaccinated:2007-10-25
Onset:2007-10-27
   Days after vaccination:2
Submitted: 2007-12-14
   Days after onset:48
Entered: 2007-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1063U / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KLINDAN (Clindamycin Phosphate); SPRINTEC
Current Illness:
Preexisting Conditions: Papanicolaou smear abnormal, hypersensitivity
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0711USA03673

Write-up: Information has been received from a health professional concerning a 21 year old female with a history of papanicolaou smear abnormal and hypersensitivity to latex, peaches, blue dye, and green dye, who on 25-Oct-2007 was vaccinated intramuscularly with her first dose of Gardasil (lot #658563/1063U). Concomitant therapy included CLINDAMYCIN PHOSPHATE (Klindan (clindamycin phosphate)) and ethinyl estradiol/norgestimate (SPRINTEC). On 27-Oct-2007 the patient experienced an unspecified rash. The patient contacted the office by phone and no details about the rash were provided. The patient was not examined in the office and no treatment was required. No further details available. 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 (RN) concerning a 21 (reported as "20" year old in follow up) year old white female student with a history of papanicolaou smear abnormal and hypersensitivity to latex, peaches, blue dye, and green dye, who on 25-OCT-2007 at 03:00 PM was vaccinated intramuscularly into right deltoid with her first dose of GARDASIL (Lot # 650563/1063U). Concomitant therapy included KLINDAN and SPRINTEC. On 27-OCT-2007 the patient experienced an unspecified rash. The patient contacted the office by phone and no details about the rash were provided. The patient was not examined in the office and no treatment was required. No further details available. In follow up it was reported that on 05-NOV-2007 a follow up phone call was made to discuss how long the rash lasted. No response from patient was available at the time of this report. The outcome was unknown. Additional information is not expected.


VAERS ID: 300861 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Colorado  
Vaccinated:2007-09-21
Onset:2007-09-24
   Days after vaccination:3
Submitted: 2008-04-07
   Days after onset:196
Entered: 2007-12-18
   Days after submission:110
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1063U / 1 RA / IM

Administered by: Private       Purchased by: Other
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site swelling, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROVENTIL; ADVAIR, TYLENOL
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Body temp, 101;
CDC Split Type: WAES0711USA03910

Write-up: Information has been received from a physician concerning an 18 year old female who on 21-Sep-2007 was vaccinated with a first dose of Gardasil (lot #658563/1063U) injection. Concomitant therapy included Advair, Proventil and "clindesse" (therapy unspecified). On 24-Sep-2007 the patient called the office and on an unspecified date the patient developed swelling at reaction site and pain. Medical attention was sought. The patient had a fever of 101 for 2 days and took acetaminophen (Tylenol) for the fever. The physician also reported that the patient visited the office on 17-Nov-2007 to receive a second dose and reported that the swelling was the size of a golf ball. The vaccine was not given and it is not known whether the series will be completed. On an unspecified date that patient had recovered. Additional information has been requested. Follow-up information was received from the physician. It was also reported that the patient had a large lump where the patient''s shot was given. The patient also had redness at the injection site. Additional information is not expected.


VAERS ID: 301209 (history)  
Form: Version 1.0  
Age: 21.0  
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. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Cardiac monitoring, Cardioversion
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0711USA04423

Write-up: Information has been received from a health professional concerning a 21 year old female who was vaccinated with the first dose of Gardasil. "About two weeks" after receiving the first dose of Gardasil the patient experienced heart defibrillation. The patient sought unspecified medical attention in the physician''s office. Per the reporter, the patient is going to a cardiologist and is now on a heart monitor. No further AE information. Additional information has been requested.


VAERS ID: 301227 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Michigan  
Vaccinated:2007-09-24
Onset:2007-09-27
   Days after vaccination:3
Submitted: 2007-12-14
   Days after onset:78
Entered: 2007-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Breast pain, Ear infection, Gait disturbance, Headache, Muscle spasms, Myalgia, Nasal congestion, Ultrasound scan
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Lipodystrophy (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: (therapy unspecified), hormonal contraceptives, EFFEXOR
Current Illness:
Preexisting Conditions: Hypersensitivity, Mycotic allergy, Pollen allergy, Allergy to animal dander, House dust mite allergy
Allergies:
Diagnostic Lab Data: ultrasound
CDC Split Type: WAES0711USA04975

Write-up: Information has been received from a consumer concerning her 21 year daughter with a history of tree allergy, mycotic allergy, pollen allergy, allergy to animal dander and house dust mite allergy who in approximately April or May 2007, was vaccinated with her first dose of GARDASIL vaccine (yeast). On approximately 24-SEP-2007 the patient was vaccinated with her third dose of GARDASIL vaccine (yeast). Concomitant therapy included venlafaxine HCL (EFFEXOR), water pills (therapy unspecified) and hormonal contraceptives (unspecified). On 27-SEP-2007 the patient experienced severe muscle pain in which she can hardly walk, cramps, severe breast pain, headache and stuffy nose. The patient had gone to her OB/GYN for a breast ultrasound. The patient also had an ear infection the day of her vaccine. The patient''s severe muscle pain and cramps and severe breast pain, and headache and stuffy nose persisted. Additional information has been requested.


VAERS ID: 301320 (history)  
Form: Version 1.0  
Age: 21.0  
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
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Body temperature, Influenza like illness, Nausea, 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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: temperature measurement-Results not reported
CDC Split Type: WAES0711USA06524

Write-up: Information has been received from a physician concerning a 21 year old female who on approximately 29-MAY-2007 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil vaccine. There was no adverse events reported. On an unspecified date the patient was vaccinated with a second dose of Gardasil vaccine. Subsequently, one day after vaccination the patient experienced flu-like symptoms including fever and nausea. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested. 02/12/2010 The patient was vaccinated with a third dose of GARDASIL on an unspecified date. It was reported that the patient did not experience any symptoms after the first and third vaccinations. Additional information is not expected.


VAERS ID: 301327 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: California  
Vaccinated:2007-11-20
Onset:2007-11-24
   Days after vaccination:4
Submitted: 2007-12-14
   Days after onset:20
Entered: 2007-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1063U / 1 RA / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA06623

Write-up: Information has been received from a medical assistant concerning a 21 year old female patient with no medical history and no known drug reactions or allergies who on 20-NOV-2007 was vaccinated in the right arm with the first dose of GARDASIL (Lot # 658563/1063U). There was no concomitant medication. The reporter indicated that on 24-NOV-2007, the patient developed an irritation from her bra line to her neck and from shoulder to shoulder after her first dose of the vaccine. She was unable to describe what kind of irritation the patient had. On 27-NOV-2007, the irritation became red and raised. On 28-NOV-2007, the area of irritation spread to her right arm and left breast. No treatment was prescribed. At the time of reporting the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007. Follow up information was received from the doctor on 29-JAN-2008 indicating the muscle pain was not at the injection site and was unrelated. Additional information has been requested.


VAERS ID: 301340 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Massachusetts  
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. 1266U / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIRAPEX
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA00203

Write-up: Information has been received from a physician''s assistant concerning a 21 year old female with no known drug or food allergies who on an unspecified date was vaccinated with a second dose of Gardasil (lot#659437/1226U). Concomitant therapy included MIRAPEX. On an unspecified date, 2 days after receiving Gardasil the patient experienced a generalized rash. Medical attention was sought. At the time of reporting it was unknown if the patient had recovered. No other information was available. Additional information has been requested.


VAERS ID: 300750 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Louisiana  
Vaccinated:0000-00-00
Onset:2007-11-13
Submitted: 2007-12-20
   Days after onset:37
Entered: 2007-12-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Balance disorder, Cranial nerve infection, Dizziness, Nuclear magnetic resonance imaging normal, Rhinorrhoea, Visual disturbance
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness: allergy to animal
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: magnetic resonance 11?/??/07 - negative
CDC Split Type: WAES0712USA07882

Write-up: Information has been received from a pharmacist, concerning her 21 year old daughter with an allergy to animals, who was vaccinated IM (date not reported), with the first dose of Gardasil (lot # not reported). Concomitant therapy included hormonal contraceptives (unspecified). On 13-NOV-2007 and after the first vaccination (time duration to onset not indicated), her daughter developed a runny nose, followed by dizziness, balance problems and impaired vision. Her daughter missed classes due to the dizziness. She visited the physician''s office, and was diagnosed with an infection of the 8th cranial nerve. A diagnostic magnetic resonance imaging (MRI) of the head was negative. At the time of this report, the pharmacist''s daughter was recovering from the events. The pharmacist considered the events to be disabling/incapacitating, due to the associated dizziness. Additional information has been requested.


VAERS ID: 300780 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Missouri  
Vaccinated:2007-10-29
Onset:2007-11-05
   Days after vaccination:7
Submitted: 2007-12-22
   Days after onset:47
Entered: 2007-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2478AA / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Complex partial seizures, Computerised tomogram normal, Electroencephalogram normal, Grand mal convulsion, Nuclear magnetic resonance imaging normal, Thrombophlebitis
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Differin (adapalene gel) topical for acne on face. Alclometasone Dipropionate cream USP 0.05% topical for eczema on hands and legs.
Current Illness: None.
Preexisting Conditions: Eczema on hands and legs.
Allergies:
Diagnostic Lab Data: CAT scan, MRI and EEG of head are negative. 12/26/07-records received-MRI brain negative. CT head/brain negative. EEG normal.
CDC Split Type:

Write-up: On 11/5/07 at approximately 11am I had a Grand Mal seizure for the first time in my life with no prior symptoms or signalment. I was taken to the emergency room at the University of Missouri Hospital. In the emergency room at 2:15pm I had another seizure, a complex partial with secondary generalization seizure. I had a MRI, CAT scan and EEG, all of which were negative. I was treated with Dilantin 100mg 3 times per day, but have been switched to carbamazepine (Tegretol) 300mg orally per day for at least 6 months. I had to stay in the hospital three additional days due to thrombophlepitis of my upper left arm where a cathether had been placed. I was treated with Ibuprofen and Bactrim DS tablet orally for the thrombophlepitis. 12/26/07-records received for DOS 11/10-11/11/07-DC DX: Seizure.Seen in ED on 11/5 and 11/6 for new onset of sezure. After visit to ED and subsequent DC she was found near the pharmacy hypersomnolent. In ED on 11/5/07 observed generalized tonic-clonic seizure. Developed pruritis, rash, left orbital swelling presumably from Vancomycin. 02/03/2010 Petite Mal Seizure 12/21/07.


VAERS ID: 300944 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: New York  
Vaccinated:2007-12-03
Onset:2007-12-06
   Days after vaccination:3
Submitted: 2007-12-13
   Days after onset:7
Entered: 2007-12-26
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR 209602 / 2 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Eosinophil count abnormal, Eye swelling, Headache, Myalgia, Pallor, Pyrexia, Rash erythematous, Rash macular, Swelling face, Urticaria, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nuvaring
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Normal WBC (8.2) but with 11? eosinophils
CDC Split Type:

Write-up: About 36 hr after injection, felt feverish, myalgias, headache. Had exam 12/6/07. Red, blanching macular rash & facial/periorbital swelling started 12/9/07 & hives.


VAERS ID: 301102 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Maine  
Vaccinated:2007-12-21
Onset:2007-12-21
   Days after vaccination:0
Submitted: 2007-12-27
   Days after onset:6
Entered: 2007-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1062U / 3 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Back pain, Chills, Headache, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~ ()~NULL~~In Patient
Other Medications: OCPs
Current Illness: None
Preexisting Conditions: Anxiety, migraine
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Global headache, malaise at 7PM Fever to 102F orally with chills, backache, bilateral hip pain at 11PM All resolved with ibuprofen, acetaminophen at home. Fever recurred at 5AM, resolved with ibuprofen. No fever on presentation.


VAERS ID: 301495 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-11-20
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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
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 Milvax direction.


VAERS ID: 301506 (history)  
Form: Version 1.0  
Age: 21.0  
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 / 2 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: PPD converter
Allergies:
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: 301519 (history)  
Form: Version 1.0  
Age: 21.0  
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 / 3 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
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: 301520 (history)  
Form: Version 1.0  
Age: 21.0  
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 / 2 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
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: 301543 (history)  
Form: Version 1.0  
Age: 21.0  
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 / 3 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
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: 301549 (history)  
Form: Version 1.0  
Age: 21.0  
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 / 4 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
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 milvax direction.


VAERS ID: 301583 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Washington  
Vaccinated:2007-12-26
Onset:2007-12-27
   Days after vaccination:1
Submitted: 2007-12-27
   Days after onset:0
Entered: 2008-01-02
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Rocephin/Iodine
Allergies:
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: 12/26/07 Vaccination (R) arm. 12/27/07 - Local edema with TTP, no adenopathy, + rash upper torso with pruritus, no SOB, no peripheral edema other than noted.


VAERS ID: 301632 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: New York  
Vaccinated:2007-12-20
Onset:2007-12-20
   Days after vaccination:0
Submitted: 2008-01-03
   Days after onset:14
Entered: 2008-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1210U / 1 LA / IM

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

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

Write-up: Pt received injection, 5 minutes post injection she c/o dizziness, nausea, ears ringing lasting 10 minutes. No other c/o. Discharged to home with no further symptoms or c/o.


VAERS ID: 301933 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-12-02
Onset:2007-12-07
   Days after vaccination:5
Submitted: 2008-01-07
   Days after onset:31
Entered: 2008-01-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = Unknown); Migraine
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Beta-human chorionic - positive
CDC Split Type: WAES0712USA07866

Write-up: Information has been received from a 21 year old female with a history of severe migraines, who on 02-DEC-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included hepatitis A virus vaccine (unspecified) and tetanus toxoid. On 07-DEC-2007, five days after the vaccination the patient found out that she was pregnant. Medical attention was sought. The patient''s outcome was not recovered. No product quality complaint was involved. Follow up information received on 31-DEC-2007 from the patient indicated that she had a miscarriage on 22-Dec-2007. No additional information provided. Upon internal review miscarriage considered to be an other important medical event. Additional information has been requested.


VAERS ID: 302477 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Male  
Location: Colorado  
Vaccinated:2008-01-03
Onset:2008-01-09
   Days after vaccination:6
Submitted: 2008-01-11
   Days after onset:2
Entered: 2008-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV158 / UNK RA / SC
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 1 LA / ID
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR A0221 / 1 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Dizziness, Fatigue, Feeling abnormal, Lymphadenopathy
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Major take with smallpox vaccine with lymphadenopathy. Feeling lousy with some dizziness and fatigue. Recommended quarters for rest of today and tommorrow due to his complaints. I submit this VAERS due to quarters and not due to unexpected symptoms.


VAERS ID: 302654 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2007-12-31
Onset:0000-00-00
Submitted: 2008-01-04
Entered: 2008-01-14
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID (NO BRAND NAME) / SANOFI PASTEUR U1856AA / 1 LA / IM

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

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

Write-up: Tetanus injection site red, swollen, warm to touch, Donor went to her Doctor - Antibiotic prescribed


VAERS ID: 303282 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2000-04-12
Onset:2007-02-23
   Days after vaccination:2508
Submitted: 2008-01-08
   Days after onset:319
Entered: 2008-01-16
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 3075A2 / 3 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Hepatitis B surface antigen negative, No therapeutic response
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject was reported to be in good health. The subject''s concurrent medications were not reported. The reporting physician did not know whether the subject had experienced any adverse events following previous vaccinations.
Allergies:
Diagnostic Lab Data: 23 February 2007: "Random titer" results, including hepatitis B surface antibody titer, were negative. Hepatitis B surface antibody titer results were less than 5 mU/ml.
CDC Split Type: A0642502A

Write-up: This case was reported by a physician and described a 21-year-old female subject who did not respond to immunization with Engerix B for prophylaxis. The subject received her first, second, and third dose of Engerix B on 29 September 1999, 29 October 1999, and 12 April 2000 respectively. On 23 February 2007, approximately 7 years after her third vaccination with Engerix B, random titer results which included hepatitis B surface antibody titer were negative. Follow-up was received from reporting physician on 09 April 2007. The subject was reported to be in good health. The subject''s diagnosis was reported as "no detectable titer on 23 March 2007". The lot number of Engerix B was reported as 3075A2 0098 SKB. The physician considered the event was related to vaccination with Engerix B. He indicated the event was not serious, but considered that it jeopardized the subject or required intervention. The immunization series with Engerix B was not discontinued or delayed. At the time of reporting, the event was unresolved.


VAERS ID: 303430 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-10-08
Onset:2007-10-08
   Days after vaccination:0
Submitted: 2008-01-07
   Days after onset:91
Entered: 2008-01-16
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0314U / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA01214

Write-up: Information has been received from a nurse concerning a 21 year old female who on 08-OCT-2007 was vaccinated with a dose of Gardasil (lot # 657005/0314U). Concomitant therapy included hormonal contraceptives (unspecified). On 08-OCT-2007 the patient experienced redness, swelling and water blisters around the injection site. The patient''s status was not reported. There was no product quality complaint involved. Additional information has been requested.


VAERS ID: 303446 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-11-19
Onset:2007-11-19
   Days after vaccination:0
Submitted: 2008-01-07
   Days after onset:49
Entered: 2008-01-16
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Penicillin allergy; allergic reaction to antibiotics
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA01413

Write-up: Information has been received from a nurse concerning a 21 year old female with amoxicillin allergy and allergic reaction to BIAXIN who in August 2007, was vaccinated with her first dose of GARDASIL. There was no concomitant medication. The nurse reported that her daughter had injection site reactions after receiving her second dose of GARDASIL by subcutaneous route on 19-NOV-2007. The patient experienced localized pain, redness and small lump at the injection site. The patient had not yet received the third dose. Three days after the vaccination, the patient recovered from localized pain, redness and small lump at the injection site. Additional information has been requested.


VAERS ID: 303486 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Illinois  
Vaccinated:2007-03-20
Onset:2007-03-20
   Days after vaccination:0
Submitted: 2008-01-18
   Days after onset:304
Entered: 2008-01-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA02722

Write-up: Information has been received from a nurse practitioner concerning a 21 year old black female with allergies to guaifenesin (ROBITUSSIN) and doxycycline who on 20-Mar-2007 was vaccinated IM, into the right deltoid, with a first dose of Gardasil (lot #654702/0011U). On 20-Mar-2007, the patient experienced pain at the injection site. The pain lasted for 1 week and then on 27-Mar-2007, the patient resolved without treatment. On 16-Aug-2007 the patient was vaccinated IM, into the right deltoid with a second dose of Gardasil. On 16-Aug-2007, the patient developed a sore muscle and arm at and around the site of injection. On 23-Aug-2007, the patient recovered. No further information is available.


VAERS ID: 303914 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: New York  
Vaccinated:2007-10-12
Onset:2007-10-13
   Days after vaccination:1
Submitted: 2008-01-15
   Days after onset:94
Entered: 2008-01-21
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EFFEXOR
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA08564

Write-up: Information has been received from a 21 year old female who on 12-OCT-2007 was vaccinated with a first dose of Gardasil (Lot # not reported). Concomitant therapy included venlafaxine HC1 (EFFEXOR). The patient reported that on 13-OCT-2007, the day after her vaccination with Gardasil, her fingers and lips were swollen and itchy. The patient reported that she recovered on 14-OCT-2007. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 304000 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Arizona  
Vaccinated:2007-11-20
Onset:2007-11-20
   Days after vaccination:0
Submitted: 2008-01-15
   Days after onset:56
Entered: 2008-01-21
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1267U / 2 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood glucose normal, Blood pressure, Bronchitis, Chest X-ray normal, Culture urine, Dizziness, Fatigue, Full blood count, Heart rate normal, Laboratory test, Oxygen saturation normal, Presyncope, Respiratory rate, Urine human chorionic gonadotropin
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Xanax; Nuvaring; Zoloft
Current Illness: Cold; Upper respiratory tract congestion; cough; sputum bloody
Preexisting Conditions: Depression
Allergies:
Diagnostic Lab Data: Blood pressure 11/20/07 (value) 102/6; blood pressure 11/20/07 (value) 102/6; blood pressure 11/20/07 (value) 108/7; chest x-ray 11/20/07 no acute disease; blood pressure 11/20/07 (value) 99/68; body temp 11/20/07 (value) 97.2; total heartbeat count 11/20/07 (value) 62; arterial blood O2 11/20/07 (value) 100%; full blood chemistry 11/20/07; urine beta-human 11/20/07; blood glucose 11/20/07 (value) 100; urine culture 11/20/07; complete blood cell 11/20/07; total heartbeat count 11/20/07 (value) 57; total heartbeat count 11/20/07 (value) 61; total heartbeat count 11/20/07 (value) 70; respiratory rate 11/20/07 (value) 18; respiratory rate 11/20/07 (value) 16
CDC Split Type: WAES0801USA01331

Write-up: Information has been received from a certified medical assistant concerning a 21 year old white female nonsmoker with a history of depression, no significant social history, no sexual activity, and no drug allergies, who on 20-NOV-2007 at 09:30 was vaccinated intramuscularly in the left deltoid with a second dose of Gardasil (Lot #659439/1267U). Concomitant therapy included sertraline HC1 (ZOLOFT), alprazolam (XANAX), and ethinyl estradiol (+) etonogestrel (NUVARING). On 20-NOV-2007 at 09:45 (also reported as about 10 minutes post vaccination) the patient felt lightheaded and nearly had a syncopal episode while sitting in the chair. The patient never fell out of the chair and there was no injury. The patient was "slow to come to" and felt fatigued. The patient had a head cold followed by a cough and chest congestion that had developed over the past week. The patient had no fever, chest pain, abdominal pain, shortness of breath. The patient was taken to the emergency room where she was treated with normal saline 1000cc, 500cc/hour. Laboratory diagnostics were performed (results located in laboratory section). The patient was diagnosed with being near syncope and bronchitis. It was reported that the patient was feeling better and was discharged to home. The patient''s condition was stable. The patient was advised to follow up with physician. On 20-NOV-2007 the patient recovered from the near syncopal episode, fatigue, and lightheaded/dizziness. The outcome of bronchitis was unknown. Additional information is not expected.


VAERS ID: 303268 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Male  
Location: Florida  
Vaccinated:1998-09-16
Onset:1998-09-16
   Days after vaccination:0
Submitted: 2008-01-14
   Days after onset:3407
Entered: 2008-01-22
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV043 / 4 - / -

Administered by: Military       Purchased by: Military
Symptoms: Dizziness, Headache, Hypoaesthesia, Nausea, Pain, Pain in extremity, Pyrexia, Vision blurred
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe headache, fever, body aches, arm pain, numbness in hand extremity, dizziness, nausea and sometimes blurry vision.


VAERS ID: 303273 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Illinois  
Vaccinated:2008-01-15
Onset:2008-01-16
   Days after vaccination:1
Submitted: 2008-01-18
   Days after onset:2
Entered: 2008-01-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB100AA / 2 LA / IM

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

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

Write-up: Faint rash upper left arm approx 2" from sight of injection - No other complaints or concerns


VAERS ID: 303324 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: New York  
Vaccinated:2007-08-17
Onset:2007-10-13
   Days after vaccination:57
Submitted: 2008-01-15
   Days after onset:94
Entered: 2008-01-23
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0927U / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion
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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA01720

Write-up: Information has been received from a licensed practical nurse concerning a 22 year old female who on 15-JAN-2007 was vaccinated with a first dose of Gardasil (lot # 654741/1208F) 0.5 ml IM. On an unspecified date, the patient was vaccinated with a second dose of Gardasil (lot # 656049/0187U) 0.5 ml IM. On 17-AUG-2007, the patient was vaccinated with the third dose of Gardasil (lot # 658222/0927U) 0.5 ml. IM. Concomitant therapy included hormonal contraceptives (unspecified). On 13-OCT-2007 and 29-DEC-2007, the patient experienced a seizures. On an unspecified date, the patient was seen at the emergency room. The patient was not hospitalized. The outcome of the seizures was not reported. Upon internal review, seizure was considered to be an Other Important Medical Event. Additional information has been requested.


VAERS ID: 303497 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Illinois  
Vaccinated:2008-01-14
Onset:2008-01-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2008-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0659U / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: no meds
Current Illness: no
Preexisting Conditions: nka/nkda - no medical history
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Client came in 1/16/08 with macular erythematous lesion on lower extremities, macular erythematous pinpoint lesions to bilateral arms and stomach - Patient received Hep B #2 on 1/14/08 - left deltoid - no redness or swelling noted at injection site - Client did just change soap - Diagnosed by APNP with Rash - treated with Benadryl - on 1/18/08 - Rash was gone


VAERS ID: 303600 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2008-01-18
Onset:2008-01-20
   Days after vaccination:2
Submitted: 2008-01-25
   Days after onset:5
Entered: 2008-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1377U / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2904AA / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Pain, Pyrexia, Viral pericarditis
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: mild URI
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: EKG showed pericarditis
CDC Split Type:

Write-up: Patient received Adacel in left arm and Havrix in right arm on 1/18/08. Patient had had mild URI prior to visit. Temp at time of injections was 98.6 Fahrenheit. He developed pain and fever the following day, along with mild chest pain. The pain increased on the second day, necessitating an ER visit. Patient was diagnosed with viral pericarditis on basis of EKG with ST elevations across pericardium. ECHO was normal. He was treated with Advil and rest. He was seen by Cardiology on Jan 24. EKG was now normal. The impression was that the pericarditis was secondary to the antecendant viral illness and not the two injections.


VAERS ID: 303770 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Missouri  
Vaccinated:2008-01-22
Onset:2008-01-22
   Days after vaccination:0
Submitted: 2008-01-28
   Days after onset:6
Entered: 2008-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Cardiac flutter, Diarrhoea, Dizziness, Headache, Nausea, Oedema peripheral
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Tachyarrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)

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

Write-up: Day one: (by the time I got home from receiving the vaccination, Gardasil) Headache, Dizzy, Weak, fluttering in chest, and that night swelling in my feet. (Fluttering in chest continued into days 2-6). Day 4: Dirrhea. Day 5: Nausea.


VAERS ID: 304076 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-04-12
Onset:2007-04-13
   Days after vaccination:1
Submitted: 2008-01-16
   Days after onset:278
Entered: 2008-01-29
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / MASS. PUB HLTH BIOL LAB TD162 / UNK LA / ID

Administered by: Other       Purchased by: Other
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site pain, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~~0.00~In Patient
Other Medications: Asacol
Current Illness: None
Preexisting Conditions: allergy to phemerentan
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: AE0707

Write-up: Patient received 0.1cc Td injection intradermally instead of a PPD test on 4/12/07. On 4/13/07 the patient contacted Dr''s office with a complaint of a local adverse reaction of erythema, induration and pain at the injection site. On 5/24/07, the doctor''s office confirmed that the patient recovered.


VAERS ID: 304176 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Virginia  
Vaccinated:2007-12-10
Onset:2007-12-10
   Days after vaccination:0
Submitted: 2007-12-14
   Days after onset:4
Entered: 2008-01-29
   Days after submission:46
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB171AA / UNK LA / IM
TD: TD ADSORBED (NO BRAND NAME) / MASS. PUB HLTH BIOL LAB TD168 / UNK LA / ID
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2860AA / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Incorrect route of drug administration, Induration, Local reaction, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~ ()~~0.00~Patient
Other Medications: Ortho Tricyclen-Lo
Current Illness: None
Preexisting Conditions: Exercise induced asthma
Allergies:
Diagnostic Lab Data: None
CDC Split Type: AE0734

Write-up: The patient received Td vaccine intradermally in her left forearm by mistake on 12/10/07; she was supposed to have received PPD. Two days later, on 12/12/07, the patient returned to the doctor''s office to have her PPD test read; it was at this time that it was discovered that Td had been injected instead of the PPD. The patient had a local site reaction approximately the size of a silver dollar consisting of swelling, redness, hardness, and pain. She has to systemic adverse reactions, and the patient was walking, talking, and acting normal. The patient will be returning to the doctor''s office to receive the PPD correctly in one week. The local reaction will also be monitored at this time. Follow up information received 01/02/2008: A representative from the practice stated that the patient had recovered from the local site reaction.


VAERS ID: 303968 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2008-01-30
Onset:2008-01-30
   Days after vaccination:0
Submitted: 2008-01-30
   Days after onset:0
Entered: 2008-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body temperature increased, Chills, Muscle spasms, Presyncope
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Almost fainted after having Gardasil vaccination. In the 5-6 hours following vaccination had 100 + temperature as well as chilling and muscle cramps.


VAERS ID: 303978 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2007-12-19
Onset:2007-12-20
   Days after vaccination:1
Submitted: 2008-01-25
   Days after onset:36
Entered: 2008-01-30
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0515U / 1 LA / IM

Administered by: Other       Purchased by: Public
Symptoms: Oedema peripheral, Paraesthesia, Skin tightness
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Pt woke the next day after receiving inj with symptom of swelling in L hand + also L foot. Fell skin was tight, ring tight on L hand. Top of L foot felt tight. Sl. tingling in toes/fingers - no numbness. Reports symptom was gone by next day. This was pt 1st Gardasil injection, pt came into clinic for 2nd inj and reported above incident. 2nd dose was not given.


VAERS ID: 303988 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Oklahoma  
Vaccinated:2007-09-25
Onset:2007-09-25
   Days after vaccination:0
Submitted: 2008-01-29
   Days after onset:126
Entered: 2008-01-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Body temperature increased, Dyspnoea, Fatigue, Gastrooesophageal reflux disease, Pain in extremity, Postnasal drip
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific dysfunction (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Patient complained of tiredness and exhaustion. Also low grade temp, slight shortness of breath, post nasal drip and s/s of GERD. Patient also complained of right foot pain between 3 and 4th toes.


VAERS ID: 304047 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Male  
Location: Michigan  
Vaccinated:2008-01-25
Onset:2008-01-25
   Days after vaccination:0
Submitted: 2008-01-25
   Days after onset:0
Entered: 2008-01-31
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB208AA / 1 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Convulsion, Dysarthria, Gaze palsy, Moaning, Syncope, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

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

Write-up: 15 minutes after administration, pt collapsed and seized. Was able to moan after 10 seconds, slurred words after 30 seconds. Then was able to sit up. Pt lost control of bladder and rolled eyes during seizure. B/P 88/60, Sa O2 99%, pale. Laid down and had B/P checked. Ambulance called, pt refused; family took pt to hospital.


VAERS ID: 304145 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Nebraska  
Vaccinated:2008-01-29
Onset:2008-01-30
   Days after vaccination:1
Submitted: 2008-02-03
   Days after onset:4
Entered: 2008-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dizziness, Dyspnoea, Stomach discomfort, Tenderness, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho-Tricyclen Lo
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Dizziness, shortness of breath, tenderness in arm, felt like fainting, upset stomach, shakiness.


VAERS ID: 304406 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-08-07
Onset:2007-08-07
   Days after vaccination:0
Submitted: 2008-02-05
   Days after onset:182
Entered: 2008-02-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0929U / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Haematology test normal, Nuclear magnetic resonance imaging normal, Syncope, Tremor, X-ray normal
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (broad), 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Magnetic resonance negative; electroencephalography negative; x-ray negative; computed axial negative; hematology negative
CDC Split Type: WAES0709USA01297

Write-up: This report was identified from a line listing obtained on request by the Company from the FDA. A 21 year old female patient, on 07-AUG-2007, was vaccinated with the third dose of Gardasil (lot# 658282/0929U). On 07-AUG-2007, two hours after the injection, she fainted, and had "shaking" seizure activity. The patient was taken to the emergency room. At the time of this report, the outcome of the events was unknown. The original reporting source was not provided. No further information is available. Follow up information had been received, via a company representative, in the form of a newspaper article containing a statement made by the patient''s mother, who had been present when her daughter had the seizure. The mother noted that the seizure occurred approximately 3 hours after vaccination. She reported that her daughter was followed up by a neurologist, had a computed tomography (CT) scan, magnetic resonance imaging (MRI), blood work, electroencephalogram (EEG), and X-rays, all of which were negative. She added that "none of the physicians would say it was from the vaccine," though she reported her "daughter is perfectly healthy, no medical problems, so I know it was from the vaccine." The outcome of seizures was not specified. Upon internal review, "seizure activity 2 hours after injection" was considered to be serious, as an other important medical event. This report was filed with the FDA. The ISR number is 1-2273704943.


VAERS ID: 304698 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Male  
Location: California  
Vaccinated:2008-02-02
Onset:2008-02-05
   Days after vaccination:3
Submitted: 2008-02-11
   Days after onset:6
Entered: 2008-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR A0221 / UNK RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Abdominal pain, Fatigue, Full blood count, Haematochezia, Incorrect dose administered, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: naprosyn
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: CBC done, pending at this time.
CDC Split Type:

Write-up: Pt. recieved double dose (1.0 mL) Typhoid vaccine. Developed nausea, vomiting, fatigue, abdominal pain and passage of bloody stools about 2-3 days after recieving vaccine, and continued until today (4 days later).


VAERS ID: 304716 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-07-19
Onset:2008-02-03
   Days after vaccination:199
Submitted: 2008-02-11
   Days after onset:8
Entered: 2008-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV110 / 3 UN / SC
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 1 UN / ID
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z0663 / 1 UN / IM

Administered by: Military       Purchased by: Military
Symptoms: Amenorrhoea, Drug exposure during pregnancy, Premature baby
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Fertility disorders (broad)

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

Write-up: Delivered at 33-34 wks gestation. Was vaccinated during pregnancy. LMP ? May or June on depo. Has been registered in registry. Symptom: Amenorrhea. Start: 06/2007


VAERS ID: 304736 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-08-01
Onset:2007-08-01
   Days after vaccination:0
Submitted: 2008-02-11
   Days after onset:194
Entered: 2008-02-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Foetal disorder, Pregnancy test positive, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy NOS (LMP = 8/25/2007); penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: ultrasound - see narrative; beta-human chorionic 10/07/07 - positive
CDC Split Type: WAES0802USA00286

Write-up: Information has been received from a consumer concerning her 21 year old daughter with a history of penicillin allergy who in "the beginning of" August 2007, was vaccinated intramuscularly with her first dose of Gardasil. At "the end of" September 2007, the patient was vaccinated intramuscularly with her second dose of Gardasil. There was no concomitant medication. On 07-OCT-2007, the patient had a pregnancy test which was positive, and showed that she was 6 weeks pregnant. An ultrasound showed that the baby had no kidneys (not further specified). On 22-JAN-2008 the patient experienced a miscarriage and was hospitalized. The reporter also stated there may have been "fluid on the brain". Additional information has been requested.


VAERS ID: 304754 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Male  
Location: Indiana  
Vaccinated:2008-02-01
Onset:2008-02-02
   Days after vaccination:1
Submitted: 2008-02-05
   Days after onset:3
Entered: 2008-02-12
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB208AA / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2863AA / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Blister, Erythema, Pain in extremity
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Celebrex 200; Cipro 500; Nexium 40
Current Illness: none
Preexisting Conditions: Penicillin. History of ulcerative colitis, Rheumatoid Arthritis
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Received Tdap and Hepatitis A on 2-1-08. Right arm was sore 2-1-08 and 2-2-08. Patient removed band aid on 2-2-08 and area over right deltoid was red with speckled appearance, there was an open area that looked like broken blister. Arm stayed red, painful with open area to today when he came back to see us


VAERS ID: 304969 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Male  
Location: California  
Vaccinated:2008-01-28
Onset:2008-02-10
   Days after vaccination:13
Submitted: 2008-02-14
   Days after onset:4
Entered: 2008-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV158 / 1 RA / SC
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 1 LA / OT

Administered by: Military       Purchased by: Military
Symptoms: Cow pox, Post vaccination autoinoculation
SMQs:

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

Write-up: Autoinoculation with Vaccinia. Location: Forehead and upper lips.


VAERS ID: 305010 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Illinois  
Vaccinated:2007-11-20
Onset:2007-11-20
   Days after vaccination:0
Submitted: 2008-02-14
   Days after onset:86
Entered: 2008-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1266U / 3 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA01039

Write-up: Medical assistant mentioned that a patient mentioned to the physician regarding her neighbor''s daughter who was vaccinated with a dose of GARDASIL. Concomitant therapy included MENACTRA. Subsequently the patient became paralyzed. Unknown medical attention was sought. The patient''s outcome is unknown. No product quality complaint was involved. Upon internal review paralysis is considered to be an other important medical event. This is a hearsay report in the absence of an identifiable patient. Attempts are being made to verify the existence of a patient." Additional information has been requested. 7/10/08-records received -11/20/07-collapsed on floor of doctor office, hit head, alert oriented. 11/21/07-follow up phone call sutures in head, returning to school.


VAERS ID: 305059 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2008-01-11
Onset:2008-01-13
   Days after vaccination:2
Submitted: 2008-02-17
   Days after onset:35
Entered: 2008-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV158 / 3 LA / SC

Administered by: Military       Purchased by: Military
Symptoms: Pallor, Pruritus, Rash macular
SMQs:, Anaphylactic reaction (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: 2 DAYS AFTER ADMINISTRATION OF ANTHRAX. PT HAD AN ONSET OF A RASH. PT WENT TO MEDICAL CENTER. RASH WAS FINE MACULAR W/ POSITIVE BLANCHING TO TORSO, NECK, AND FACE. POSITIVE PRURITIC. PT WAS TREATED W/ PREDNISONE 40 MG DAILY X 4 DAYS, ZANTAC 150 BID X 10-14 DAYS, GIVEN BENADRYL 25 PRN, SIQ X 24HRS


VAERS ID: 305281 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-12-28
Onset:2007-12-28
   Days after vaccination:0
Submitted: 2008-02-14
   Days after onset:48
Entered: 2008-02-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1266U / 3 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol; ADVAIR
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA00100

Write-up: Information has been received concerning a 21 year old female who on 04-JUN-2004 was vaccinated with her first dose of Gardasil (lot 657617/0384U) and her second dose of Gardasil (lot 658222/0927U) on 23-AUG-2007 without any ill effects. Concomitant therapy included ADVAIR and albuterol. On 28-DEC-2007 the patient was vaccinated with her third dose of Gardasil (lot 659437/1266U) and experienced a full body rash. She was sent to her primary health care provider. Additional information has been requested.


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