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This is VAERS ID 673999

Case Details

VAERS ID: 673999 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-03-14
Onset:2014-03-15
   Days after vaccination:1
Submitted: 2016-09-21
   Days after onset:921
Entered: 2016-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J004978 / 3 UN / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC37B105AD / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Chronic fatigue syndrome, Fatigue, Headache, Insomnia, Myalgia, Nausea, Rash, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), 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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: BOOSTRIX, Dose 1 and Dose 2
Allergies:
Diagnostic Lab Data:
CDC Split Type: IE2016135133

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of rash in a 15-year-old female patient who received BOOSTRIX (batch number AC37B105AD, expiry date unknown). Co-suspect products included GARDASIL (batch number H019633, expiry date unknown), GARDASIL (batch number J004978, expiry date unknown) and GARDASIL (batch number J004978, expiry date unknown). Previously administered products included BOOSTRIX (Dose 1 and Dose 2). Additional patient notes included None. On 14th March 2014, the patient received the 3rd dose of BOOSTRIX (intramuscular). On 16th September 2013, the patient received the 1st dose of GARDASIL (intramuscular). On 13th November 2013, the patient received the 2nd dose of GARDASIL (intramuscular). On 14th March 2014, the patient received the 3rd dose of GARDASIL (intramuscular). In March 2014, 12 hrs after receiving BOOSTRIX, the patient experienced rash (serious criteria hospitalization and disability), headache (serious criteria hospitalization and disability), fainting (serious criteria hospitalization and disability), exhaustion (serious criteria hospitalization and disability), nausea (serious criteria hospitalization and disability), vomiting (serious criteria hospitalization and disability), chronic fatigue syndrome (serious criteria hospitalization and disability), insomnia (serious criteria hospitalization and disability), muscle pain (serious criteria hospitalization and disability) and weakness (serious criteria hospitalization and disability). On an unknown date, the outcome of the rash, headache, fainting, exhaustion, nausea, vomiting, chronic fatigue syndrome, insomnia, muscle pain and weakness were not recovered/not resolved. It was unknown if the reporter considered the rash, headache, fainting, exhaustion, nausea, vomiting, chronic fatigue syndrome, insomnia, muscle pain and weakness to be related to BOOSTRIX. Additional information: The batch number of BOOSTRIX was reported as AC37B105A0. On review, the batch number was corrected to AC37B105AD. The event onset date for all the event was reported as 14th March 2014. Regulatory Authority Verbatim: Initial report was received by the RA on 31/Aug/2016 from a member of the public (MOP) which concerns a 15 year old female patient who experienced Rash, Headache, Syncope, Fatigue, Nausea, Vomiting, Chronic fatigue syndrome, Insomnia, Myalgia and Asthenia following vaccination with GARDASIL and BOOSTRIX. Concomitant medications: Not reported. Medical history/concurrent conditions: None. The patient was vaccinated with GARDASIL via IM route - dose 1 on 16/Sep/2013 (batch no. H019633), dose 2 on 13/Nov/2013 (batch no. J004978) and dose 3 on 14/Mar/2014 (batch no. J004978). The patient was vaccinated with BOOSTRIX (batch no. AC7B105A0) on the same day as dose 3 - 14/Mar/2014. 12 hours post GARDASIL dose 3 and BOOSTRIX vaccines, on 15/Mar/2014, the patient experienced rash, headache, fainting, fatigue/exhaustion, nausea, vomiting, intermittent or chronic fatigue syndrome (CFS), insomnia, muscle pain and weakness. Corrective treatment: Tilt table test - results not provided. At the time of reporting the patient''s symptoms were ongoing.


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