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Found 3,132 cases where Vaccine targets HPV (HPV2 or HPV4 or HPV9 or HPVX) and Disabled and Vaccination Date on/before '2019-05-31'

Case Details

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VAERS ID: 277669 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: California  
Vaccinated:2007-04-18
Onset:2007-04-18
   Days after vaccination:0
Submitted: 2007-04-30
   Days after onset:12
Entered: 2007-05-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0384U / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure normal, Dizziness, Fatigue, Feeling hot, Heart rate normal, Pallor, Paraesthesia, Sensation of heaviness, Syncope, Thirst
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (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: Unknown
Current Illness:
Preexisting Conditions: Syncope; Immunisation
Allergies:
Diagnostic Lab Data: Blood pressure 04/19/06 90/60, total heartbeat count 04/19/06 60
CDC Split Type: WAES0704USA04219

Write-up: Information has been received from a physician concerning a 17 year old female patient with past episodes of fainting with vaccinations who on 18-APR-2007 was vaccinated IM in the left arm with her first dose of Gardasil, lot #657617/0384U. After receiving the injection the patient fainted, which lasted a few seconds. The patient was completely white in the face and she complained that entire body felt like she was burning up. She was not warm to touch and did not have a fever. The patient kept asking for water. She regained color to her face 15 minutes later. She felt tingling for one hour or so both legs and arms and was very dizzy. Her eyes were closed for approximately 1 hour and she felt exhausted. The patient was given smelling salts and when asked if she was aware of what was being done to her, she "smelled violets". She had a fan on her for 30 minutes and she started to feel better. Her blood pressure was taken 2 or 3 times for approximately one hour and her pulse was also monitored. "Blood pressure reading (90/60 normal for patient). Pulse (60 normal for patient) for first 15 to 30 minutes after reaction was very faint." She was very alert one hour later (eyes open and talking) but complained of her legs feeling heavy. The patient had to be wheeled out to her car. The physician did not believe the patient hyperventilated to bring these reactions on herself. The physician believed giving the patient smelling salts, monitoring the blood pressure, pulse and putting the patient in front of a fan to cool her down was another medical event and the patient''s experience was disabling because she went to bed and not able to do anything for rest of the day. Additional information has been requested.


VAERS ID: 277816 (history)  
Form: Version 1.0  
Age: 35.0  
Sex: Female  
Location: Georgia  
Vaccinated:2007-04-04
Onset:2007-04-04
   Days after vaccination:0
Submitted: 2007-05-02
   Days after onset:28
Entered: 2007-05-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 3 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Injected limb mobility decreased, Insomnia, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO TRI-CYCLEN, ALLEGRA-D
Current Illness:
Preexisting Conditions: Papilloma viral infection
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0704USA06106

Write-up: Information has been received from a registered nurse concerning a 35 year old female with a history of papilloma viral infection who on unspecified dated, was vaccinated with the first and second dose of Gardasil. 04-APR-2007, the patient was vaccinated with a third dose of Gardasil (lot # 654702/0011U) 0.5 ml IM into the left deltoid. Concomitant therapy included ORTHO TRI-CYCLEN, and ALLEGRA-D. On 05-APR-2007, the patient sought medical attention by contacting the physician''s office. The patient reported that on 04-APR-2007, immediately after being vaccinated with the third dose of vaccine, she noticed symptoms. She had severe shoulder pain. The patient could not lift her arm laterally and could not sleep due to the pain. The patient was ordered MEDROL DOSE PACK, heat, and LORCET PLUS. The patient had also been seen at an orthopedics office. She was given 2 steroid injections and she is being set up for physical therapy. The patient did not have any symptoms with the first two doses of vaccine. At the time of reporting, the patient had not recovered. No further information was available at the time of reporting. The reporter felt that the events were disabling. Additional information has been requested.


VAERS ID: 277902 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Arizona  
Vaccinated:2007-04-19
Onset:2007-04-20
   Days after vaccination:1
Submitted: 2007-05-03
   Days after onset:13
Entered: 2007-05-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0384U / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Ear pain, Injection site erythema, Injection site swelling, Malaise, Nasal congestion, Pharyngeal oedema, Pharyngolaryngeal pain, Tinnitus
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hearing impairment (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOESTRIN, LEVOXYL
Current Illness: Sexually active
Preexisting Conditions: Thyroid cancer
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA05125

Write-up: Information has been received from a health Medical Assistant (N.A.) concerning a 22 year old female patient who is currently sexually active and had a history of thyroid cancer in OCT-2006. On 19-APR-2007 patient was vaccinated IM in left deltoid with a first dose of Gardasil, lot #657617/0384U. Concomitant therapy included LOESTRIN and LEVOXYL. The medical assistant reported that one or two days post injection the patient''s injection site was little red, swollen and puffy. On 23-APR-2007 patient called the office saying she had not felt good since getting the injections. The injection site was no longer red or swollen and she had no fever but her throat was swollen and she was having trouble breathing (unknown time period injections site reaction resolved and new symptoms occurred). The patient was complaining of a stuffy nose, sore throat, ears ache and ringing of the ears. She wanted to "pull her hair out" because of the ringing of the ears. The patient was instructed to go to the Emergency room (ER) or walk in clinic for treatment. The outcome of trouble breathing, ear pain, feeling unwell, nasal congestion, throat was swollen, sore throat and ringing of the ears was not recovered. The reporter considered the event "difficulty breathing" to be life threatening. The reporter felt the events to be disabling because the patient was not able to go to work or school. Additional information has been requested.


VAERS ID: 278266 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2007-03-28
Onset:2007-04-02
   Days after vaccination:5
Submitted: 2007-05-08
   Days after onset:36
Entered: 2007-05-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Erythema, Hypersensitivity, Hypoaesthesia, Pain, Pain in extremity, Pruritus generalised, Rash generalised
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (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? Yes
Recovered? No
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: WAES0705MYS00002

Write-up: Information has been received from a physician concerning a female who on approximately 15-JAN-2007 was vaccinated with Gardasil. On 28-MAR-2007, the patient was vaccinated with a second dose of Gardasil. On 02-APR-2007 the patient experienced itchiness and red spots on whole body. After seven days of itchiness, the patient received an injection to reduce the allergic response on the whole body. On approximately 28-APR-2007 the patient still experienced itchy palms and feet. Additionally the patient experienced aching and numbness in both hands and feet. She complained that it was hard to complete the housework due to aching and numbness. On approximately 01-MAY-2007 the patient experienced red spots and itchiness on face. Subsequently, the patient recovered from itchiness and red spots on whole body. However, the patient''s itchy palms and feet as well as aching and numbness persisted. The red spots and itchiness on face also persisted. The reporter felt that itchiness and red spots on whole body, itchy palms and feet, aching, numbness, red spots and itchiness on face were related to therapy with Gardasil. Aching and numbness were considered to be disabling. No further information is available.


VAERS ID: 278267 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-04-24
Onset:2007-04-24
   Days after vaccination:0
Submitted: 2007-05-08
   Days after onset:14
Entered: 2007-05-09
   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: Anorexia, Asthenia, Dizziness, Immediate post-injection reaction, Mobility decreased, Muscular weakness, Nausea, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Sulfonamide allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0705USA00095

Write-up: Information has been received from a health professional concerning a 26 year old female with sulfonamide allergy who on 22-FEB-2007 was vaccinated, in the left arm, with a first dose of Gardasil (lot # 655849/0263U). There was no concomitant medication. There were no adverse symptoms reported after the first dose. On 24-APR-2007 the patient was vaccinated with Gardasil a second dose. Immediately after the vaccination, the patient experienced left arm pain, nausea, dizziness and loss of appetite. On 25-APR-2007 the patient experienced a lot of pain in her left arm that radiated down to her hand. Her fingers were weak and she was unable to use her hand. Also on that same day the pain radiated to the patient''s left leg for a half an hour. Patient was treated with ice and ibuprofen. On 26-APR-2007 the patient recovered. The reporting registered nurse considered unable to use her hand, nausea, loss of appetite, dizziness, fingers were weak, pain in left arm that radiated down her hand, and left leg pain to be disabling.


VAERS ID: 278788 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-04-01
Onset:2007-04-06
   Days after vaccination:5
Submitted: 2007-05-16
   Days after onset:40
Entered: 2007-05-17
   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: Abdominal pain upper, Blood bilirubin increased, Dysstasia, Full blood count, Hypoventilation
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (narrow), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Hypersensitivity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: complete blood cell 04/06?/07 - results not reported, total serum bilirubin 04/06?/07 - bilirubin was elevated
CDC Split Type: WAES0705USA02024

Write-up: Information has been received from a mother concerning her 12 year old daughter with hypersensitivity to red dye who in February 2007, was vaccinated with a first dose of Gardasil. In April 2007, the patient was vaccinated with her second dose of Gardasil there were no concomitant medications. On approximately 06-APR-2007 the patient experienced stomach pain, difficulty standing, and shallow breathing. The patient went to the emergency room where laboratory data revealed bilirubin was elevated. At the time of the report, the patient was recovering from the stomach pain, difficulty standing, shallow breathing, and elevated bilirubin. The consumer considered stomach pain, difficulty standing, shallow breathing, and elevated bilirubin to be disabling. Additional information has been requested.


VAERS ID: 279592 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-05-24
Entered: 2007-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
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: WAES0705USA01964

Write-up: Information has been received from a licensed visiting nurse via a nurse practitioner. The nurse practitioner was told by a friend that a female patient was vaccinated with Gardasil and two weeks alter developed a blood clot. Subsequently the patient died. The cause of death was from the blood clot. The reporting licensed visiting nurse considered the blood clot to be immediately life-threatening and disabling. Additional information has been requested.


VAERS ID: 281880 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2007-01-16
Onset:2007-01-17
   Days after vaccination:1
Submitted: 2007-05-16
   Days after onset:118
Entered: 2007-05-24
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK RA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1150F / 2 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Body temperature increased, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? Yes
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: body temp 01/17/07 102.5 F
CDC Split Type: WAES0701USA03067

Write-up: Information has been received from a physician assistant concerning a 10 year old female with no allergies or medical history who on 22-APR-2002 was vaccinated with a first dose of Varivax without any problems and on 16-JAN-2007 was vaccinated SC in the left deltoid with a 0.5 mL second dose of Varivax (lot # 654131/1150F). Concomitant vaccination on the same day included a dose of Gardasil in the other arm. There was no illness at the time of vaccination. On 17-JAN-2007, the patient developed an injection site rash. The rash was described as a cellulitis that was swollen, warm, and tender to the touch. The patient was seen in the office on 18-JAN-2007 and the cellulitis was determined to be 4 cm in diameter and reported to be larger than it was on 17-JAN-2007. The patient had a fever of 102 degrees Fahrenheit on 18-JAN-2007. Unspecified medical attention was sought and the patient was told to take Benadryl and to use a warm compress. No diagnostic laboratory tests were performed. At the time of the report the patient had not recovered. Follow-up information was received from the physician assistant who reported that on 17-JAN-2007, the patient had red, indurated, warm cellulitis of the left upper extremity around the injection site. It was greater than four inches in diameter with a central vesicle. Her temperature was 102.5. She was treated with Rocephin and Augmentin. The patient recovered on 19-JAN-2007. The patient''s experiences were considered to be disabling and other important medical events by the reporter. No further information is expected.


VAERS ID: 279693 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-05-24
Entered: 2007-05-25
   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: Abdominal pain, Chills, Computerised tomogram normal, Myalgia, Nausea, X-ray normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: Unk
Allergies:
Diagnostic Lab Data: X-ray negative; computed axial negative; diagnostic laboratory negative
CDC Split Type: WAES0705USA04056

Write-up: Information has been received from a physician concerning a 22 year old female who on an unspecified date was vaccinated with Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). Approximately two and half weeks after the vaccination, the patient experienced abdominal pain, nausea, chills and muscle aches. She was hospitalized for 5-6 days. Multiple unspecified CT-scans, x-rays and blood tests were performed. All the results were negative. She was treated with an unspecified antibiotic. Subsequently, the patient recovered. The physician felt that the abdominal pain, nausea, chills and muscle aches were disabling. Additional information has been requested.


VAERS ID: 279815 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: New York  
Vaccinated:2007-05-25
Onset:2007-05-25
   Days after vaccination:0
Submitted: 2007-05-25
   Days after onset:0
Entered: 2007-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 1 UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2278AA / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Dyspnoea, Flushing, Food allergy, Laboratory test, Seasonal allergy, Skin test positive, Throat irritation, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Conjunctival disorders (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None; Unknown
Current Illness: None
Preexisting Conditions: None; Nasal congestion; Sneezing
Allergies:
Diagnostic Lab Data: allergen skin test, 06/18/07, positive reaction to Kiwi and grass pollen; diagnostic laboratory, 06/18/07, ImmunoCap testing to Kiwi pending
CDC Split Type: WAES070USA06515

Write-up: About 1 hour and 15 minutes prior to receiving Menatra and Gardasil vaccinations in our office, the patient felt acute onset of throat tightness, throat burning, flushed face and trouble breathing. 05/30/07-records received-5/27/07-trouble breathing. shortness of breath. flushed face. lips slightly swollen. DC: anaphylactic reaction most likely to either Gardasil or Menactra This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a physician, his office manager and an allergist via medical records concerning an 18 year old (previously reported as 17 year old) female with no known drug allergies and a history of nasal congestion and sneezing after exposure to cut grass who on 25-MAY-2007 was vaccinated IM with the first 0.5mL dose of GARDASIL (lot #657737/0522U) and concomitant suspect therapy MENACTRA (lot #U2278AA). Additionally, information has been received through the Freedom of Information Act pertaining to this case. It was reported that the patient left the physician''s office feeling fine after the vaccinations, and subsequently, returned home. The patient ate a turkey sandwich and a kiwi, and "I hour after receiving the vaccine", the patient experienced an acute onset of throat tightness, throat burning, flushed face and trouble breathing. The patient returned to the physician''s office with throat tightness, throat burning, flushed face, shortness of breath and lips were slightly swollen. The patient was diagnosed with an anaphylactic reaction and was treated with one EPI-PEN injection, prednisone, 60 mg and BENADRYL, 50 mg. The patient''s breathing returned to normal, and subsequently, the patient recovered from the anaphylactic reaction. On 18-JUN-2007, the patient was seen by an allergist who reported that percutaneous skin testing was performed on the patient and revealed positive reactions to kiwi and grass pollen. The patient was diagnosed with a kiwi allergy and grass pollen allergy with seasonal allergic rhinitis. ImmunoCap allergy testing to kiwi, other fruits, pollens and Latex was also performed on the patient (results pending). The patient was instructed on the proper technique and indications for EPI-PEN use and follow-up was pending laboratory results. The reporting physician considered the anaphylactic reaction to be a disabling immediately life-threatening and medically significant event and felt it was most likely related to either therapy with GARDASIL or MENACTRA, although, the allergist felt that the "vaccines were not likely the cause of her reaction" and recommended that an attempt to proceed with the GARDASIL series "can be done in a closely monitored and equipped setting." A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.


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