Neuropathic pain epidemic among Colombian girls. Carmen de Bolívar.


By Pompilio Martinez., M.D.
Alumnus, School of Medicine, Universidad Nacional de Colombia.
Former researcher Colombian National Institute of Health, Bogotá, Colombia


The presence of neuropathic pain was investigated in 19 adolescents from Carmen de Bolívar (Colombia) and 2 women from the rest of the country with a history of immunization with Gardasil, a human papilloma virus (HPV) vaccine. Presence of neuropathic pain was investigated using the self completed LANSS survey (S-LANSS) in girls who volunteered to participate. Pain scores from each patients’ surveys were correlated with available clinical data. Except for one patient, all girls reported intense pain with S-LANSS scores suggestive of neuropathic pain. In most patients, additional clinical data indicated that neuropathic pain was associated with damage to the peripheral nervous system as suggested by complaints of paresthesia and muscle paresis (tingling / muscle weakness) and syncope presumably of dysautonomic nature due to sympathetic nervous system involvement. Perhaps the underlying cause of neuropathic pain in all patients in this series is peripheral nerve demyelination. Neuropathic pain tends to worsen if left untreated, in contrast no patient from Carmen de Bolívar has received analgesic treatment further supporting neglectful approach the Colombian government has taken to the epidemic of adverse events triggered by HPV immunization since March 2014. Clinical findings reported herein should be thoroughly addressed.   Por favor lee el articulo original en español


Most people are familiar with ‘nociceptive pain’ which is the most common type of pain in response to injury, trauma, disease or transient abnormal condition (indigestion, poor posture, exercise, etc.). In all age groups, this is by far the most typical type of pain and it occurs in childhood as a result of infection, trauma, burns, or surgical procedures among the most common. By contrast, ‘neuropathic pain’ is rare and is characterized by direct nerve damage often experienced as electrical or burning, but also with exaggerated pain sensation (hyperalgia) or sensitization to non-painful stimuli like touch (allodynia). It is often disabling, can be progressive and difficult to treat. In children, neuropathic pain is unusual, observed in inherited diseases like Fabry’s disease and Erythromelalgia, or instances of direct nerve damage by traumatic injury or chemotherapy for cancer or even more rare causes (Howard et al, 2013).

Readers of this blog are aware that I’m running a symptom survey among girls from Carmen de Bolívar and elsewhere who developed adverse events to the quadrivalent human papillomavirus (HPV) vaccine Gardasil. A preliminary look at these surveys indicated high pain intensities at multiple body sites, which are unusual findings and much less spread throughout the body. In fact, some surveys show strikingly similarity to the case of María José reported in this blog. María José is a 26-year old Colombian woman who received 3 doses of Gardasil and developed multiple pains, recurrent syncope; muscle weakness and paresthesia in upper and lower limbs. Confirmatory tests demonstrated damage to the Peripheral Nervous System of Autonomic and Somatic branches. A thorough analysis of her symptoms confirmed the diagnosis of ASIA syndrome which means ‘Autoimmune / Inflammatory Syndrome Induced Adjuvants’, also compatible with damage to the peripheral nervous system due to chronic activation of the immune system by vaccination. In fact, a new look at the neurological component of her symptoms suggest that she suffers from a unique form of Guillain-Barré syndrome called Acute Immune-mediated Demyelinating Polyradiculopathy or AIDP. The similarity between María José’s case with cases from the symptom survey suggested a mechanism that may explain severe pain at multiple body sites, i.e., an inflammatory damage to nerves of the autonomic and somatic peripheral system. That is, it suggested pain of neuropathic origin.

Hypothesis: It’s possible that multiple pains suffered by HPV vaccine victims are due to immune-mediated damage to the nervous system and therefore it’s of neuropathic origin.


S-LANSS Survey. To assess neuropathic pain I translated into Spanish the S-LANSS questionnaire or “Self-completed Leeds Assessment of Neuropathic Symptoms and Signs” which can be downloaded here SLANSS-Spanish . This is a survey tool among many (Bennett et al, 2007) to assess the presence of neuropathic pain and has been validated epidemiologically against other more demanding assessments (Türkel et al, 2014). It has the advantage of not requiring a physician and thus it’s suitable for epidemiological or low budget studies. The survey of neuropathic pain begins by asking the patient to localize a body site where he/she has experienced the most intense pain during the week prior. Next the patient is asked to rate this pain on a Visual Analogue Scale of 0-10, where ‘zero’ means no pain to 10 means the worst pain based on how the patient experienced it the week before. The S-LANSS survey then examines 7 features deemed characteristic of neuropathic pain in the chosen region as above:

  1. History of tingling (history of paresthesia)
  2. History of changes in skin color or appearance (vasomotor, autonomic)
  3. History of allodynia (sensitization to non-painful stimulus like touch).
  4. History of shooting pain (electrical zaps, shocks or bursts -paroxysmal character).
  5. History of burning pain (thermal character)
  6. Allodynia triggered by self-examination
  7. Numbness/Tenderness triggered by self-examination.

The presence of these symptoms is assessed in 7 questions, each one receiving a certain number of points as previous research has determined. A total score of 12 or greater identifies the pain of predominantly neuropathic origin with a sensitivity of 74% and specificity 76% (Bennett et al, 2005).

Patients. Two female adult patients who received the 3-dose schedule of Gardasil and developed full-blown cases of adverse events completed the S-LANSS surveys: a young lady from Bogota was referred by journalist Mario Lamo and patient María José whose case was published in this blog (she filled out 3 surveys, each one detailing a particular pain site).

To conduct the survey in the municipality of Carmen de Bolívar, I had to circumvent the poor and ineffective local health infrastructure left unchanged after an ad hoc visit of the Ministry of Health to address HPV-vaccine adverse events. After his visit, the highest health authority in Colombia cast a medieval-like diagnosis: ‘psychogenic hysteria’. So I turned to a humanitarian visit to town that patient Maria Jose made at her own expense and risk. Upon arrival to Carmen de Bolívar, María José was welcome by Blanca Victoria Sabagh, the main representative of the NGO “Organization for the Defense of Citizens’ Rights or ODDC” and both of them got in touch with parents of girls who developed HPV vaccine associated side effects. Parents gave their verbal consent to allow their daughters to participate in this pain survey. Patient selection was not random but relied on knowledge the community has of affected girls who were willing to participate in health initiatives promoted by the NGO ODDC. The S-LANSS survey is blinded in the sense that the surveyor (Pompilio Martinez) is unaware of patients’ identities but all participating girls have been singled out in the community to have developed symptoms after vaccination with two doses of Gardasil and about half of them have also filled out a more comprehensive symptom survey also designed by this author. S-LANSS surveys were completed by patients and were delivered to the ODDC NGO representative, who scanned the forms and anonymized them (replacing the name of the patient with a random code or patient initials). Surveys were emailed to this author. Most pain surveys were filled out in this single visit to the community and this paper was prepared within one week upon arrival of completed surveys.


Surveys from around the country.
Patient resident in Bogotá.

Figure 1. Painful sites identified by the young lady who resides in Bogotá. Even though such an alarming painful syndrome deserves immediate and professional care, the patient’s neurologist disregarded it and summarily attributed to a somatization disorder without first addressing a neuropathic pain vis-a-vis other neurological complaints.

The patient who resides in Bogotá and who received 3 doses of Gardasil filled out her S-LANSS survey and pointed to body places where she has experienced pain. As shown in her drawing (Figure 1) there’s a remarkable compromise of at least 28 painful sites suggesting the diagnosis of fibromyalgia whose criteria only requires 11 out of 18 tender points on palpation as performed by a physician. In the absence of a physical examination, the S-LANSS survey cannot confirm fibromyalgia but its goal is to evaluate the likely origin of each reported pain. So I asked the patient to pick her worst pain and she chose a painful left knee including the popliteal area with an intensity of 8/10. In the S-LANSS survey, the patient from Bogota assigned a maximum score of 24 indicating that this pain has all the characteristics of neuropathic pain consisting of paresthesia (tingling, numbness) at both history and self-provoked by pressure, allodynia by history and self-provoked; experience of shooting / burning pain, with skin color changes (autonomic characteristics).

Figure 2. The left knee was the most painful site chosen by the patient residing in Bogotá and was assigned the highest S-LANSS score thus suggesting a pain of predominantly neuropathic origin. In same limb, the patient had decreased muscle strength and marked knee instability that disturbs her gait (right picture) requiring support with a cane and the need to wear a brace to stabilize her hand on the same side.

This patient had additional complaints of paresthesia (tingling, numbness) in the upper limb and left leg paresis (muscle weakness) which disturbs her gait. Thus these additional findings point to a polyneuropathy to explain her severe neuropathic pain. She was seen by a prominent neurologist in Bogotá who determined that all her symptoms were psychosomatic. As soon as I received her pain survey I referred her to a specialist in chronic pain management as neuropathic pain if untreated, tends to worsen and thus prompt treatment is recommended.

Patient María José. I have already reported María José’s major clinical findings but not the exact nature of her pains. The following graph shows pain scores she assigned to 3 painful sites: scalp, lumbosacral spine, and in both knees which easily crackle with joint movement. The S-LANSS survey shows all pains are intense with scores on a Visual Analogue Scale greater than 7/10 in all cases. The S-score LANSS shows that pains in the scalp pain and lumbosacral spine are predominantly neuropathic with scores of 19 (a score higher than 12 passes as neuropathic). However, knee pain despite being experienced at maximum intensity had an S-LANSS score of 3 which excludes its neuropathic nature and suggests a nociceptive origin, consistent with a history of crepitation and premature joint degeneration due to a likely autoimmune cause. These divergent findings show the specificity of the S-LANSS survey and ability to discriminate between neuropathic versus nociceptive pain. The scalp and lumbosacral spine pains are suggestive of being neuropathic due to damage to the peripheral sympathetic nervous system, parasympathetic and somatic motor / sensory symptoms as shown already in this patient’s nerve conduction studies and tilt-table testing.

Figure 3. Using the survey S-LANSS patient Maria Jose rated the scalp and lumbosacral spine pains as neuropathic, while knee pain was rated as nociceptive pain consistent with crackles and crepitations she suffers when using this joint.
Figure 3. Using the survey S-LANSS patient Maria Jose rated the scalp and lumbosacral spine pains as neuropathic, while knee pain was rated as nociceptive pain consistent with crackles and crepitations she suffers when using this joint.

Patients from Carmen de Bolívar. A total of 23 S-LANSS surveys were filled out by 19 adolescent girls who developed severe adverse events to 2 doses of the HPV vaccine Gardasil and who were recruited by the main representative of the NGO ODDC Blanca Victoria Sabagh in the present study. The first 11 participants also filled out a more comprehensive symptom survey processed during the same humanitarian visit made by patient Maria Jose to the town of Carmen de Bolívar. In other words, of the 23 filled pain surveys there was additional and detailed clinical information for the first 11 participants.

Figure 4. Twenty-three (23) S-LANSS surveys were filled out by 19 girls from Carmen Bolivar who developed pain and other complaints after 2 doses of the HPV vaccine Gardasil. Note that a S-LANSS score greater than 12 suggests pain of predominantly neuropathic origin. Please also note the many different body regions affected with pain.
Figure 4. Twenty-three (23) S-LANSS surveys were filled out by 19 girls from Carmen Bolivar who developed pain and other complaints after 2 doses of the HPV vaccine Gardasil. Note that an S-LANSS score (puntaje) greater than 12 suggests pain of predominantly neuropathic origin. Please also note the many different body regions affected with pain.

In animation format, Figure 4 shows data from each of the 23 S-LANSS surveys filled out by 19 girls from Carmen de Bolívar whose average age was 14 years. As noted, frequent sites of worst pains were head, midchest, legs, spine and generally almost all body parts except abdomen and genitals. The author believes that the list of painful site is not exhaustive for two reasons:

  1. Girls were instructed to draw and score only their worst pain according to S-LANSS survey.
  2. There are additional painful sites according to a comprehensive symptom survey completed by 11 participants.

The purpose of shadowing on the drawing is to focus attention on the worst pain that will be evaluated with additional questions per survey instructions. However, this broad range of body parts affected suggest two main scenarios that might explain pain at distant body parts from the vaccinated spot in the shoulder muscle: damage to every one of these distant structures according to the nociceptive model, or damage to nerves that collect sensory input from diverse body areas as explained in the neuropathic model. The latest model is the most consistent with other data reported herein (see below).

Figure 5. S-LANSS survey (A) and pain intensity (B) average scores from 23 surveys filled by 19 girls from Carmen de Bolivar. Values are highly suggestive of severe neuropathic pain, which is rarely observed in epidemic proportions in children but in this series is consistent with the epidemic of adverse events caused by HPV vaccination in this population.
Figure 5. S-LANSS survey (A) and pain intensity (B) average scores from 23 surveys filled by 19 girls from Carmen de Bolivar. Values are highly suggestive of severe neuropathic pain, which is rarely observed in epidemic proportions in children but in this series is consistent with the epidemic of adverse events caused by HPV vaccination in this population.

As illustrated in each drawing, every patient assigned an S-LANSS pain score and if greater than 12 is highlighted in red, which defines as pain of predominantly neuropathic origin. The average score was 18.6 with a 95% confidence interval of 2.53 (16.1 to 21.1). This range means that if the S-LANSS study were repeated in the same group of patients, the average score would be oscillate between 16.1 and 21.1; still above 12 thus a new study in identical patients would still yield pain of neuropathic origin. Assessment of pain intensity rated by patients on a Visual Analogue Scale of 0-10 where 0 is no pain and 10 the worst possible pain was also illustrated in the animation. The average pain intensity was 9.2 out of 10 (Figure 5), indicating near maximal severity of this ​​neuropathic pain.

Figure 6 summarizes S-LANSS scores for all 23 surveys with values were greater than 12 with the exception of one patient who assigned a score of 2 to a chest pain with maximum intensity and which was accompanied by difficult breathing, feeling of choking, asphyxia and crying as a separate symptom survey revealed. A score of 2 assigned to this non-neuropathic pain suggests active inflammation of respiratory muscles like diaphragm and intercostal muscles that might explain the feeling of dyspnea or respiratory distress. Such patient should be investigated independently by pulse oxymetry to detect hypoxia during these painful and dyspneic episodes (hemoglobin unsaturation). However, a neuropathic etiology should also be considered if respiratory muscle nerve roots are likewise affected.

Figure 6. Summary of individual survey scores S-LANSS. A score above 12 classifies as predominantly neuropathic pain origna or nerve damage. Other evidence from medical records of 11 patients show that indeed have peripheral nervous system condition.
Figure 6. Summary of individual survey scores S-LANSS. A score above 12 classifies as predominantly neuropathic pain origin or nerve damage. Other evidence from medical records of 11 patients show that indeed have peripheral nervous system condition.

Although the S-LANSS survey does not investigate mechanisms underlying neuropathic pain, thanks to a more comprehensive symptom survey for the first 13 surveys, there was clinical evidence of nerve damage (neuropathy). The first 13 surveys were filled out by 11 patients (2 patients filled out two pain surveys) among who 10 complained of paresthesia (tingling / numbness) of upper and lower limbs, and paresis (loss of muscle strength / weakness) of upper and lower limbs of varying severity. In addition, symptomatic evidence of syncope / fainting was found in 8 of 11 patients. Such high prevalence of neuropathic symptoms in this small patient series suggest damage to both branches of the somatic and autonomic peripheral nervous system and hence, a peripheral neuropathy.


Neuropathic pain is rarely observed in children and much less in an epidemic fashion. Of the 23 S-LANSS pain surveys filled out by 19 patients from Carmen de Bolivar, 22 identified pain of neuropathic nature with average scores of 18.6; above the minimum threshold of 12. In addition, a subgroup of 10 out of 11 patients who completed a more comprehensive symptom survey reported symptoms consistent with damage to the somatic nervous system with complaints of  bilateral lower limb paresthesia and paresis of varying severity. Of those 11 patients, 8 had symptomatic evidence of fainting / syncope explained by damage to the autonomic nervous system presumably of dysautonomic nature that awaits confirmation. All participants in both surveys shared a history of having developed acute symptoms after being immunized with Gardasil, a vaccine against human papillomavirus (HPV). Hence the epidemic of neuropathic pain observed in Colombian girls coincides with the epidemic of vaccine adverse events in this population. Attack rates of this epidemic must be investigated by independent epidemiological studies. If there is an epidemic of vaccine adverse effects in this population that is accompanied by severe pain, it’s logical to say that there’s also an epidemic of neuropathic pain as reported here since the incidence of the latter is close to 100% in the same target population.

In adults, the most common causes of neuropathic pain are direct nerve damage as in chronic and poorly controlled diabetes mellitus (diabetic neuropathy); alcoholism (alcoholic neuropathy), sequelae of nerve infection by varicella zoster virus (postherpetic neuralgia), and nerve entrapment syndromes such as carpal tunnel, thoracic outlet and sciatica syndromes. However other less common causes are demyelinating diseases like Guillain-Barré type, polyradiculopathies of various causes such as trauma, surgery, toxic or autoimmune, phantom limb syndrome and Complex Regional Pain syndrome I and II. These various causes give rise to the type of pain explored in the S-LANSS survey consisting of pain associated with tingling, allodynia (sensitization to touch), thermal sensations (burning or coldness), electrical sensations in bursts (shooting pain) or vasomotor symptoms with changes in the appearance of the skin. Characteristics of this particular pain were unequivocally found in patients Carmen de Bolivar and two adult patients and thus it deserves a closer look.

In the present series, two adult women developed neuropathic pain following 3 shots of the HPV vaccine Gardasil concomitant with disabling insult to the peripheral nervous system. The specificity of S-LANSS survey was evident by low scores in the non-neuropathic knee pain that patient María José had, which is consistent with nociceptive and inflammatory pain caused by premature knee degeneration possibly due to an HPV-triggered autoimmune disorder. Both adult patients showed evidence of signs and symptoms of peripheral nervous system involvement such as paresis / paresthesia and unstable gait in the patient from Bogota, and a more varied clinical picture in Maria Jose who also suffered from dysautonomia by damage to the sympathetic and parasympathetic nervous systems. All of the above and based on slow nerve conduction velocities in patient Maria Jose yielded the diagnosis of demyelinating neuropathy, specifically acquired immune-mediated demyelinating polyradiculopathy (AIDP) which is a likelly mechanism to explain neuropathic pain in all symptomatic patients after HPV vaccination in this series. This is more suggestive by the wide range and remoteness of painful sites away from the vaccination spot in the deltoid muscle (shoulder). It’s unexpected for a vaccine to migrate its inflammatory foci to distant places such as feet, ankles and knees. Rather, a demyelinating condition like polyradiculopathy that damages nerves in their exit and entry into the spinal cord better explains the wide range and systemic nature of painful sites in the current patient cohort, some of who showed a fibromyalgia-like pattern. Dr. Manuel Martinez-Lavin reported 2 Mexican girls who received Gardasil and developed illness that met the criteria for fibromyalgia (Martinez-Lavin, 2014). Likewise historical data about mass swine flu vaccination campaigns as implemented in 1976 in the United States led to an increase of more than 8-fold the incidence of Guillain-Barré syndrome which is characterized by demyelination of peripheral nerves (Nachamkin et al, 2008). Therefore the neuropathic pain syndrome observed in girls and adult women in the current series is well explained by a demyelinating insult to the nervous system triggered as an autoimmune adverse event to adjuvanted quadrivalent HPV vaccine Gardasil as reported for the ASIA syndrome.

This study has several limitations. It’s a survey-type study and thus clinical findings need to be confirmed by physical examination and further supported by electrodiagnostic and head up tilt-table testing among other confirmatory analyses. In fact, this study could have benefited had it relied on a census of cases and controls from Carmen Bolivar to allow a random selection. Also, I could have calculated attack rates for pain as well as lots of other fancy things. The lack of a census by health authorities after more than 6 months of the onset of epidemic vaccine adverse reactions demonstrates the need for alternative studies since the Colombian state has neglected this population to a degree bordering on the criminal. Even now, we still haven’t seen a formal release of data from the visit paid by the Minister of Health in late August / 2014 nor about the follow-up to 11 girls who had clinical abnormalities as acknowledged by the Deputy Minister in a news conference. Nor do we know the results of a risk factor survey conducted by the Colombian National Institute of Health in Carmen de Bolivar as promised by its Director Dr. Fernando de la Hoz. Given this institutional void and neglect, it’s not far-fetched to say that the present scientific and academic study is the first one on the subject.

The expert consensus for management of severe neuropathic pain is that it should be treated as early as possible due to its disabling nature and also because both Complex Regional Pain Syndrome I (reflex sympathetic dystrophy) and II (causalgia) tends to worsen if left untreated. Pain reported here shares features to the CRPS type II but it must be confirmed by specialists. Currently none of the girls from Carmen de Bolívar has received treatment for neuropathic pain.

GENERAL CONCLUSION. Nineteen girls and 2 adult women vaccinated with Gardasil developed adverse reactions consistent in severe neuropathic pain and damage to neural structures as can be inferred by complaints of upper and lower limbs paresis / paresthesia as well as dysautonomic syncope. All symptoms have an organic and physiologic basis currently ignored by the top national health authority who insists on a psychogenic origin despite lack of evidence.


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Girls from Carmen de Bolívar filling out surveys (S-LANSS neuropathic survey & general symptom survey). This article was written presenting their data and in their dedication. To all the people who participated: Thank you!

Many thanks to girls and their families who participated voluntarily in this pain & symptom survey. Many thanks to the patient who lives in Bogota who shared her photos and case information and also to journalist Mario Lamo for referring her to me.

Thanks a million to patient María José for sharing her case, tests and pictures that have helped to educate HPV vaccine victims through this blog, and especially for making the humanitarian visit to the town of Carmen de Bolivar which was a catalyzing event for the present study. Many thanks to Blanca Victoria Sabagh, the main representative of the NGO “Organization for the Defense of Citizens’ Rights ODDC” based in El Carmen de Bolivar who not only supported María José on her visit; but also printed and distributed surveys to participating families, collated, scanned and emailed them to me. In its entirety, this study was done voluntary by all people who donated their time and resources to make this article a reality. To all of them, thanks a million!. This study proves that even with meager resources but strong will much can be accomplished in contrast to the plentiful resources that the Ministry of Health has who thanks to his purposely deceitful approach has derailed its citizens’ health. 

Translation to the photo on the right: Girls at Carmen de Bolivar filling surveys reported in this study. This article was written in their dedication. To all the people who participated: Thanks!.


  1. Bennett M (2002). La Escala de Dolor de LANSS: la evaluación de síntomas neuropáticos de Leeds.  Rev. Soc. Esp. Dolor 9: 74-87
  2. Bennett MI, Smith BH, Torrance N, Potter J. The S-LANSS score for identifying pain of predominantly neuropathic origin: validation for use in clinical and postal research. J Pain. 2005 Mar;6(3):149-58.
  3. Bennett MI, Attal N, Backonja MM, Baron R, Bouhassira D, Freynhagen R, Scholz J, Tölle TR, Wittchen HU, Jensen TS. (2007) Using screening tools to identify neuropathic pain. Pain. Feb;127(3):199-203.
  4. Howard RF, Wiener S, Walker SM (2014). Neuropathic pain in children. Arch Dis Child. Jan;99(1):84-9. doi: 10.1136/archdischild-2013-304208
  5. Türkel Y, Türker H, Demir IA, Bayrak AO, Onar MK (2014). Validation of self report version of the Leeds Assessment of Neuropathic Symptoms and Signs score for identification of neuropathic pain in patients from northern Turkey. Adv Clin Exp Med. Jul-Aug;23(4):599-603.
  6. Martínez-Lavín M (2014). Fibromyalgia-like illness in 2 girls after human papillomavirus vaccination. J Clin Rheumatol. Oct;20(7):392-3
  7. DOLOR NEUROPÁTICO REUNIÓN DE EXPERTOS Cátedra Extraordinaria del Dolor “FUNDACIÓN GRÜNENTHAL” Salamanca, 17 y 18 de Junio de 2002;  Universidad de Salamanca
  8. Nachamkin I, Shadomy SV, Moran AP, Cox N, Fitzgerald C, Ung H, Corcoran AT, Iskander JK, Schonberger LB, Chen RT. (2008). Anti-ganglioside antibody induction by swine (A/NJ/1976/H1N1) and other influenza vaccines: insights into vaccine-associated Guillain-Barré syndrome. J Infect Dis. Jul 15;198(2):226-33. doi: 10.1086/589624.

 Please see original article published in Spanish.

4 comentarios sobre “Neuropathic pain epidemic among Colombian girls. Carmen de Bolívar.

  1. EMA Reports of CRPS and POTS after HPV vaccination are consistent with what would be expected in this age group

    Haz clic para acceder a hpv-vaccines-article-20-procedure-assessment-report_en.pdf

    The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a detailed scientific review of the evidence surrounding reports of two syndromes, complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women given human papillomavirus (HPV) vaccines. These vaccines are given to protect them from cervical cancer and other HPV-related cancers and pre-cancerous conditions. This review concluded that the evidence does not support a causal link between the vaccines (Cervarix, Gardasil/Silgard and Gardasil-9) and development of CRPS or POTS. Therefore, there is no reason to change the way the vaccines are used or amend the current product information.

    CRPS is a chronic pain syndrome affecting a limb, while POTS is a condition where the heart rate increases abnormally on sitting or standing up, together with symptoms such as dizziness, fainting and weakness, as well as headache, aches and pains, nausea and fatigue. In some patients they can severely affect the quality of life. The syndromes are recognised to occur in the general population, including adolescents, regardless of vaccination.

    PRAC thoroughly reviewed the published research, data from clinical trials and reports of suspected side effects from patients and healthcare professionals, as well as data supplied by Member States. It also consulted a group of leading experts in the field, and took into account detailed information received from a number of patient groups that also highlighted the impact these syndromes can have on patients and families.

    Symptoms of CRPS and POTS may overlap with other conditions, making diagnosis difficult in both the general population and vaccinated individuals. However, available estimates suggest that in the general population around 150 girls and young women per million aged 10 to 19 years may develop CRPS each year, and at least 150 girls and young women per million may develop POTS each year. The review found no evidence that the overall rates of these syndromes in vaccinated girls were different from expected rates in these age groups, even taking into account possible underreporting. The PRAC noted that some symptoms of CRPS and POTS may overlap with chronic fatigue syndrome (CFS, also known as myalgic encephalomyelitis or ME). Many of the reports considered in the review have features of CFS and some patients had diagnoses of both POTS and CFS. Results of a large published study that showed no link between HPV vaccine and CFS were therefore particularly relevant.

    The PRAC concluded that the available evidence does not support that CRPS and POTS are caused by HPV vaccines. Therefore there is no reason to change the way the vaccines are used or amend the current product information.

    The review recognised that more than 80 million girls and women worldwide have now received these vaccines, and in some European countries they have been given to 90% of the age group recommended for vaccination. Use of these vaccines is expected to prevent many cases of cervical cancer (cancer of the neck of the womb, which is responsible for tens of thousands of deaths in Europe each year) and various other cancers and conditions caused by HPV. The benefits of HPV vaccines therefore continue to outweigh their risks. The safety of these vaccines, as with all medicines, will continue to be carefully monitored.

    The PRAC’s recommendations will now be passed to the Committee for Medicinal Products for Human Use (CHMP) for adoption of the Agency’s final position. The evidence supporting the PRAC review will be published in an assessment report following the CHMP opinion.

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