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|History of Changes from the VAERS Wayback Machine|
First Appeared on 2/14/2017
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|HPV4: HPV (GARDASIL) / MERCK & CO. INC.||K022803 / -||UN / IM|
Administered by: Other Purchased by: Other
Symptoms: Blood creatine phosphokinase normal, Erythema, Raynaud's phenomenon, Antinuclear antibody positive
Life Threatening? No
Permanent Disability? Yes
ER or Doctor Visit? No
Other Medications: No other medications
Current Illness: Immunisation, HPV vaccination was administered in a healthy teenager
Diagnostic Lab Data: Antinuclear antibody (ANA), (unknown date): 1:320. Blood creatinine phosphokinase (CPK), (unknown date): normal. 01/15/2016, Antinuclear antibody, 27 U/L; 03/15/2016, Antinuclear antibody, 37 U/L
CDC 'Split Type': WAES1609DEU005095
Write-up:Information has been received from Sanofi Pasteur MSD (SPM) (MFR# DE-1577272925-2016009015) on 09-SEP-2016. Spontaneous case report received from a physician via Agency (reference DE-DCGMA-16170726) on 05-SEP-2016: A female 14-year(s)-old patient (weight: 52kg, height: 173 cm), was vaccinated with GARDASIL, (batch no.: K009460) for Primary immunization, Intramuscular on 26-JAN-2015; and GARDASIL, (batch no.: K022803) for Revaccination, Intramuscular on 02-JUN-2015. Concomitant medication was not reported. On 05-NOV-2015 after vaccination the patient developed Erythema facial and Raynaud''s syndrome and Antinuclear antibody positive, lasting for unknown. The patient showed disabling/incapacitating and showed other medically important condition. Diagnosis was confirmed by CPK normal, and Antinuclear antibody titer 1:320 (normal range less than 1:80). The patient''s test results included antinuclear antibody Mi-2 37 U/L on 15-JAN-2016 and on 15-MAR-2016. The reporter considered the events an induction of an autoimmune disease which is intermittent in the cold. Raynaud - Syndrome constituted as dead finger and purple erythema in the face along with significantly increased antinuclear antibodies and evidence of the antibody Mi-2. The patient had not recovered at the date of reporting. No further information awaited.
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