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This is VAERS ID 547670

History of Changes from the VAERS Wayback Machine

First Appeared on 5/14/2015

547670
VAERS Form:
Age:11.0
Gender:Female
Location:Foreign
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted:2014-10-12
Entered:2014-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 AR / SYR

Administered by: Other      Purchased by: Other
Symptoms: CSF electrophoresis normal, Electrocardiogram normal, Erythema, Fatigue, Insomnia, Nuclear magnetic resonance imaging normal, Oedema peripheral, Pain, Pain in extremity, Paraesthesia, Fibromyalgia, Peripheral swelling, Blood test normal, Activities of daily living impaired, Neurological examination normal, Complex regional pain syndrome

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Extensive diagnostic workup was normal. Blood test was negative for infectious, inflammatory, or autoimmune markers. Neurological examination was normal except for severe generalized allodynia. Eighteen of 18 fibromyalgia tender points turned out to be positive. CSF electrophoresis, Normal; Electromyogram, Normal; Nuclear magnetic resonance imaging, Normal; Physical examination, a distressed girl
CDC 'Split Type': WAES1410MEX003498

Write-up:This literature market report has been received from the author of the published literature article. The objective of this communication was to describe 2 previously healthy girls who developed a chronic incapacitating fibromyalgia-like illness after HPV vaccination. Case 1. An 11-year-old girl had a single GARDASIL injection. She did not receive the recommended 3 injections regimen. Eleven months later, her physician prescribed a new complete 3-dosing regimen. Right after the second jab, she developed severe pain in the injected arm that lasted for a week. Two days after the third vaccine shot, she developed again severe pain in the injected arm, now accompanied by a swollen red hand. Two weeks later, her symptoms spread to the opposite arm and then all over her body. Her pain was accompanied by severe paresthesias. She was not able to attend school anymore. She developed insomnia and profound fatigue. Before the onset of her chronic illness, there was no history of trauma or psychiatric or family problems. Extensive diagnostic workup was normal. Blood test was negative for infectious, inflammatory, or autoimmune markers. Cerebrospinal fluid analysis, head and neck magnetic resonance imaging, and electromyography were normal. A bone scan was not done. Different analgesics, anti-inflammatory drugs, corticosteroids, or antineuropathic medications gave her no sustained relief. Seven months after the onset of her illness, widespread pain and paresthesias continued. At this point, physical examination showed a distressed girl. Neurological examination was normal except for severe generalized allodynia. Eighteen of 18 fibromyalgia tender points turned out to be positive. There was no joint swelling. The remainder of the physical examination was unrevealing. The author discussed that in case 1, there was immediate temporal cause-effect relationship between vaccine injection and severe pain. The illness in case 1 began as a complex regional pain syndrome located in the injected arm. She satisfied the International Association for the Study of Pain diagnostic criteria for complex regional pain syndrome that requires (1) preceding noxious event; (2) spontaneous pain or hyperalgesia/hyperesthesia not limited to a single nerve territory and disproportionate to the inciting event; and (3) edema, temperature, and sudomotor abnormalities present in the affected limb, in particular distal sites. This girl''s condition evolved to a widespread fibromyalgia-like illness. Spreading of complex regional pain syndrome to other extremities is a well-recognized phenomenon. The author suggested that the medical community and regulatory agencies by aware of these possible adverse effects in order to define their real magnitude and, if indicated, to take corrective actions. The adverse event was considered as disability because the patient was not able to attend school anymore. This is one of several reports received from the same literature. Additional information has been requested.


Changed on 9/14/2017

547670 Before After
VAERS Form:(blank) 1
Age:11.0
Gender:Female
Location:Foreign
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted:2014-10-12
Entered:2014-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 2 AR / SYR

Administered by: Other      Purchased by: Other
Symptoms: CSF electrophoresis normal, Electrocardiogram normal, Erythema, Fatigue, Insomnia, Nuclear magnetic resonance imaging normal, Oedema peripheral, Pain, Pain in extremity, Paraesthesia, Fibromyalgia, Peripheral swelling, Blood test normal, Activities of daily living impaired, Neurological examination normal, Complex regional pain syndrome

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Extensive diagnostic workup was normal. Blood test was negative for infectious, inflammatory, or autoimmune markers. Neurological examination was normal except for severe generalized allodynia. Eighteen of 18 fibromyalgia tender points turned out to be positive. CSF electrophoresis, Normal; Electromyogram, Normal; Nuclear magnetic resonance imaging, Normal; Physical examination, a distressed girl
CDC 'Split Type': WAES1410MEX003498

Write-up:This literature market report has been received from the author of the published literature article. The objective of this communication was to describe 2 previously healthy girls who developed a chronic incapacitating fibromyalgia-like illness after HPV vaccination. Case 1. An 11-year-old girl had a single GARDASIL injection. She did not receive the recommended 3 injections regimen. Eleven months later, her physician prescribed a new complete 3-dosing regimen. Right after the second jab, she developed severe pain in the injected arm that lasted for a week. Two days after the third vaccine shot, she developed again severe pain in the injected arm, now accompanied by a swollen red hand. Two weeks later, her symptoms spread to the opposite arm and then all over her body. Her pain was accompanied by severe paresthesias. She was not able to attend school anymore. She developed insomnia and profound fatigue. Before the onset of her chronic illness, there was no history of trauma or psychiatric or family problems. Extensive diagnostic workup was normal. Blood test was negative for infectious, inflammatory, or autoimmune markers. Cerebrospinal fluid analysis, head and neck magnetic resonance imaging, and electromyography were normal. A bone scan was not done. Different analgesics, anti-inflammatory drugs, corticosteroids, or antineuropathic medications gave her no sustained relief. Seven months after the onset of her illness, widespread pain and paresthesias continued. At this point, physical examination showed a distressed girl. Neurological examination was normal except for severe generalized allodynia. Eighteen of 18 fibromyalgia tender points turned out to be positive. There was no joint swelling. The remainder of the physical examination was unrevealing. The author discussed that in case 1, there was immediate temporal cause-effect relationship between vaccine injection and severe pain. The illness in case 1 began as a complex regional pain syndrome located in the injected arm. She satisfied the International Association for the Study of Pain diagnostic criteria for complex regional pain syndrome that requires (1) preceding noxious event; (2) spontaneous pain or hyperalgesia/hyperesthesia not limited to a single nerve territory and disproportionate to the inciting event; and (3) edema, temperature, and sudomotor abnormalities present in the affected limb, in particular distal sites. This girl''s condition evolved to a widespread fibromyalgia-like illness. Spreading of complex regional pain syndrome to other extremities is a well-recognized phenomenon. The author suggested that the medical community and regulatory agencies by aware of these possible adverse effects in order to define their real magnitude and, if indicated, to take corrective actions. The adverse event was considered as disability because the patient was not able to attend school anymore. This is one of several reports received from the same literature. Additional information has been requested.


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