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This is VAERS ID 269195

Case Details

VAERS ID: 269195 (history)  
Age: 26.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2006-09-08
Onset:2006-09-08
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:210
Entered: 2006-12-18
   Days after submission:108
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain, Injection site swelling, Wrong technique in drug usage process
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA04279

Write-up: Initial and follow up information has been received from a vaccine coordinator concerning a female (age not reported) who on an unspecified date was vaccinated with 0.5 mL of Gardasil (yeast). Subsequently, the patient experienced pain at the injection site. It was reported that the vaccine hurt the patient more when injected into the arm rather than the upper thigh, hip area. It was reported that the "pain was so great that the patient said they would not finish the series". The patient sought unspecified medical attention. The shot was from a pre-filled safety syringe. The vaccine coordinator thinks "the pain may have something to do with the technique because the shots given from the single dose vials have not experienced as much pain". It was further reported that "she was unsure if the extreme pain was caused by the vaccine, injection site or the technique used with the safety syringes." At the time of this report, the outcome of the events were unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2006. Initial and follow up information has been received from a vaccine coordinator concerning a 26 year old female who on 08-SEP-2006 was vaccinated in the left deltoid with the second 0.5 mL dose of GARDASIL (Lot # 654540/0800F). On 08-SEP-2006, the injection site area filled up with fluid with tennis ball size swelling per the patient. It was reported that the duration was "a couple hours". It was previously reported that the patient had developed pain at the injection site. It was reported that the vaccine hurt the patient more when injected into the arm rather than the upper thigh, hip area. It was reported that the "pain was so great that the patient said they would not finish the series". The shot was from a pre-filled safety syringe. The vaccine coordinator thinks "the pain may have something to do with the technique because the shots given from the single dose vials have not experienced as much pain". It was further reported that "she was unsure if the extreme pain was caused by the vaccine, injection site or the technique used with the safety syringes". The patient stated that this "was not a big deal but preferred the injection in her leg". At the time of this report, the outcome of the events were unknown. Additional information has been requested.


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