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This is VAERS ID 283761

Case Details

VAERS ID: 283761 (history)  
Age: 26.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-01-31
Onset:2007-01-31
   Days after vaccination:0
Submitted: 2007-06-14
   Days after onset:133
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 654540/1162F / 0 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Erythema, Hypersensitivity, Immediate post-injection reaction, Injection site erythema, Injection site haematoma, Injection site swelling, Oedema peripheral, Pain in extremity, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0705USA00962

Write-up: Information has been received from a physician concerning a female patient who was vaccinated with Gardasil. Subsequently the patient experienced severe swelling and redness at the injection site. Subsequently, the patient recovered. Additional information has been requested. 03/18/2010 follow up - OEDEMA PERIPHERAL; ERYTHEMA; HYPERSENSITIVITY; SKIN WARM; PAIN IN EXTREMITY; INJECTION SITE BRUISING This is in follow-up to report (s) previously submitted on 06/14/2007 Initial and follow-up information has been received from a physician concerning a 26 year old white female with no pertinent medical history who on 31-JAN-2007 was vaccinated with a first dose of HPV rL1 6 11 18 VLP vaccine (yeast) (lot# 654540/1162P) Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLES). On 31-Jan-2007. Immediately after the vaccination, the patient developed a severe allergic reaction with erythema. Severe swelling and warmth of the left arm and bruising at the injection site. There was no dyspnea, wheezing or throat swelling. Ice was applied to the patient''s arm. The patient recovered from severe allergic reaction with erythema, severe swelling and warmth of the left arm and bruising at the injection site. It was reported that the patient''s arm remained sore for approximately 1 week. The second dose of HPV ILI 6 11 16 18 VLP vaccine (yeast) was not given. No further information is available.


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