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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Initial unsolicited case received from SPMSD under the reference number- 2016009826. This case was received from regulatory authority (Ref No. IE-HPRA-2016-027877) on 29-Sep-2016. Initial case received from a consumer/other non-health professional which concerns a 13-year-old female adolescent patient who received Gardasil, (batch number K021266, 0.5 ml) administered via intramuscular route in right arm on 16-Sep-2015 and diphtheria, tetanus, and acellular pertussis vaccine (manufacturer unknown, batch number unknown) administered via intramuscular route In left arm on 16-Sep-2015. Medical history/concurrent conditions: None. In a matter of hours, the patient experienced CHRONIC FATIGUE on 17-Sep-2015 1 day Post Administration, BRAIN FOG on 17-Sep-2015 1 day Post Administration, BACK PAIN on 17-Sep-2015 1 day Post Administration, JOINT PAIN on 17-Sep-2015 1 day Post Administration, ONGOING CHRONIC INFLAMMATION on 17-Sep-2015 1 day Post Administration, BACTERIAL INFECTIONS on 17-Sep-2015 1 day Post Administration, VIRAL INFECTIONS on 17-Sep-2015 1 day Post Administration, SWOLLEN, PAINFUL GLANDS IN GROIN AND UNDERARMS on 17-Sep-2015 1 day Post Administration, DIGESTIVE PROBLEMS on 17-Sep-2016 367 days Post Administration, WORSENING OF ALLERGIES on 17-Sep-2015 1 day Post Administration and BRONCHOSPASM on 17-Sep-2015 1 day Post Administration. Upon internal review, the company jugded relevant to consider diphtheria, tetanus, and acellular pertussis vaccine as suspect vaccine but reported as concomitant by the health Authorities. The patient had a scan of her swollen glands but no reason was found. The patient also had a paediatric physio referred for her back pain but no reason was found either. The patient is awaiting a paediatric specialist and immunologist appointments for further review. Additional investigations included Scan N/A on an unknown date. At the time of reporting the patient symptoms were continuing. The patient''s outcome was reported as Not Recovered/Not Resolved. The reporter assessed the causal relationship: between Chronic fatigue, Foggy feeling in head, Back pain, Joint pain, Inflammation NOS, Bacterial infection, Viral infection, Lymphadenitis, Gastrointestinal disorder, Allergy aggravated, Bronchospasm and GARDASIL as Unknown. Sender''s Comments: Most of reported events are unexpected following HPV vaccine and diphtheria, tetanus, and acellular pertussis vaccine. The chronology is compatible with a role both vaccines administered. In the current case, the patient''s medical history, condition at the time of vaccination, concomitant medications, etiological investigations are missing. Insufficient information in this report precludes a complete medical assessment. However as two vaccines were administered concomitantly, the role of each component cannot be fully assessed.
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