chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Immunoglobulin therapy, Immunology test normal, Nerve conduction studies abnormal, Neurological examination abnormal, Paraesthesia
Clinical narrative: Case number PHHY2013US110239 is an initial literature report received on 26 Sep 2013: In this article, authors have described a case of distal acquired demyelinating symmetric neuropathy (DADS-I) after influenza vaccination. This report refers to a 31-year-old male patient. He was vaccinated with influenza vaccine (manufacturer and batch number: unknown) on an unknown date. Two months after vaccination he developed slowly progressive distal symmetric paresthesias and numbness, poor balance, and gait instability. His symptoms worsened over the following four months. At his nadir, numbness affected his hands below the wrists and legs below the knees. Balance was unsteady, especially in the dark. He was not able to run. Walking short distances could be achieved with minimal support, but he used a wheelchair for longer distances. Examination was notable for decreased vibration and pin sensation in his hands and feet, areflexia, and mild weakness of toes extension. Gait was slow and broad based. Serum laboratory studies revealed normal vitamin B12, anti-Ro, anti-La, and serum immunofixation. MAG antibodies were absent. Cerebral spinal fluid demonstrated mild albuminocytologic dissociation (protein, 55 mg/dL). Nerve conduction study (NCS) showed prolonged distal latency in median, ulnar, peroneal, and tibial motor nerves (30% - 50% above upper limit of normal) and median, ulnar, and sural sensory nerves. The F waves were absent (median) or mildly prolonged. Partial conduction block was present in the right ulnar nerve forearm segment (30% amplitude reduction). Martin Gruber anastomosis was not present. Limb temperature was more than 32 degree Celsius. Two grams per kilogram of IVIG was initiated four months after symptom onset. One gram per kilogram of IVIG was repeated every three weeks. Over the following six months, symptoms and signs improved. He continued to experience mild intermittent paraesthesias in his fingers and toes but numbness resolved. Examination revealed normal perception of vibration and pin in his hands and feet. Reflexes normalized. Gait was narrow, and he could perform tandem gait without difficulty. He was able to resume exercise, and reported running three consecutive miles at 8 hours and 30 minutes per mile pace. IVIG was discontinued without relapse in symptoms. The authors commented that vaccine-associated DADS-I may suggest a vaccine-triggered immunologic event directed against MAG below detectable concentrations. More likely, they suspected that vaccination in this patient triggered an immune response against currently unrecognized antigens and manifested as restricted chronic inflammatory demyelinating polyradiculoneuropathy in the form of DADS-I.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Sensory disturbance, Vitamin B12 normal, Wheelchair user
Clinical narrative: Case number PHHY2013US110239 is an initial literature report received on 26 Sep 2013: In this article, authors have described a case of distal acquired demyelinating symmetric neuropathy (DADS-I) after influenza vaccination. This report refers to a 31-year-old male patient. He was vaccinated with influenza vaccine (manufacturer and batch number: unknown) on an unknown date. Two months after vaccination he developed slowly progressive distal symmetric paresthesias and numbness, poor balance, and gait instability. His symptoms worsened over the following four months. At his nadir, numbness affected his hands below the wrists and legs below the knees. Balance was unsteady, especially in the dark. He was not able to run. Walking short distances could be achieved with minimal support, but he used a wheelchair for longer distances. Examination was notable for decreased vibration and pin sensation in his hands and feet, areflexia, and mild weakness of toes extension. Gait was slow and broad based. Serum laboratory studies revealed normal vitamin B12, anti-Ro, anti-La, and serum immunofixation. MAG antibodies were absent. Cerebral spinal fluid demonstrated mild albuminocytologic dissociation (protein, 55 mg/dL). Nerve conduction study (NCS) showed prolonged distal latency in median, ulnar, peroneal, and tibial motor nerves (30% - 50% above upper limit of normal) and median, ulnar, and sural sensory nerves. The F waves were absent (median) or mildly prolonged. Partial conduction block was present in the right ulnar nerve forearm segment (30% amplitude reduction). Martin Gruber anastomosis was not present. Limb temperature was more than 32 degree Celsius. Two grams per kilogram of IVIG was initiated four months after symptom onset. One gram per kilogram of IVIG was repeated every three weeks. Over the following six months, symptoms and signs improved. He continued to experience mild intermittent paraesthesias in his fingers and toes but numbness resolved. Examination revealed normal perception of vibration and pin in his hands and feet. Reflexes normalized. Gait was narrow, and he could perform tandem gait without difficulty. He was able to resume exercise, and reported running three consecutive miles at 8 hours and 30 minutes per mile pace. IVIG was discontinued without relapse in symptoms. The authors commented that vaccine-associated DADS-I may suggest a vaccine-triggered immunologic event directed against MAG below detectable concentrations. More likely, they suspected that vaccination in this patient triggered an immune response against currently unrecognized antigens and manifested as restricted chronic inflammatory demyelinating polyradiculoneuropathy in the form of DADS-I.
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Monoplegia
Clinical narrative: This medically confirmed spontaneous report (initial receipt 27-Sep-2013) concerns a female patient. On an unknown date, the patient received influenza vaccine (batch and manufacturer unspecified). The patient got shortness of breath from the flu vaccine and experienced short term arm paralysis after administration of PNEUMOVAX 23. Flu vaccine and PNEUMOVAX 23 were administered at another site. The reporter had no information about the administration of the flu vaccine or the PNEUMOVAX 23, including when they were administered or if they were administered together or separately. The event outcome was recovered.
Age: 21.0
Sex: F
Vaccine: FLUX
Symptoms: Multiple sclerosis
Clinical narrative: This consumer report (initial receipt 26-Sep-2013) concerns a 21-year-old female patient. On an unspecified date ('one year ago' from initial reporting), the patient received a one-time injection of unspecified flu vaccine (manufacturer and batch number not reported) that she was 'forced to get'. On an unspecified date ('about one year ago' from initial reporting), the patient developed Multiple Sclerosis. The patient sought medical attention through a doctor's visit. The patient underwent the laboratory diagnostic study of 'Litnia test'. Outcome was reported as not yet recovered. (Linked to TC-704).
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt reported hives all over abdomen, back and legs after 1 day.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccination with the second dose of GARDASIL (route, dose, lot number and expiration date not provided). In the unspecified days following the administration of GARDASIL the patient started experiencing unspecified symptoms of Neurocardiogenic syncope (NCS). The patient's mother alerted the physician to these symptoms, on an unspecified date, and the patient was brought to the physician office, on an unspecified date, for evaluation. The physician reports that the patient "had her good days and bad days". The outcome of neurocardiogenic syncope (NSC) was reported as not recovered/not resolved. The relatedness between vaccination with GARDASIL and Neurocardiogenic syncope (NCS) was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction
Clinical narrative: This spontaneous report as received from a 60 year old female patient regarding herself who is also a registered nurse. The patient was allergic to erythromycin and tetracycline. Patients medical history was none. On 24-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number expiry date, route and dose were not reported) vial in the left arm. Concomitant therapies included PRILOSEC and PAXIL. On 24-SEP-2013, the patient experienced injection site reaction. On 24-SEP-2013, later in the day noticed the patient noticed that the injection site of her left arm was beginning to show redness and was becoming itchy. The patient noted that on 25-SEP-2013, when she woke up, her injection site had "a great deal of redness, was much more itchy than the previous day and a hard area of approximately 2 and a half inches across had formed. The patient did not seek medical attention right away. But on 30-SEP-2013 she did when she was still nothing the injection site reaction and she returned to the unspecified pharmacy where she had received the ZOSTAVAX to speak with the unspecified pharmacist about her arm. Lab Diagnostics Studies performed was none. No treatment was given. The outcome of all the events was reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender was not reported). On 06-OCT-2013 the patient was vaccinated with an expired dose of PNEUMVOAX 23 (lot # 0217AE, exp. date 22-AUG-2013) (dose and route not reported). No adverse effect reported. It was unknown if the patient sought medical attention or not. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash morbilliform
Clinical narrative: This spontaneous report as received from a pharmacy intern. The pharmacy intern reported that the mother of a 1 year old patient stopped by the pharmacy and mentioned her daughter received "all of her vaccinations" which included MMR II (lot #, dose, route and indication was not reported) at her "one year appointment" with the pediatrician. The patient received other unspecified vaccinations (unspecified number of vaccines, unspecified manufacturers) during the same visit. On an unknown date, the patient developed a fever and measles-like rash on her face and a rash "inside her mouth" after three or four days received "all of her vaccinations" which included MMR II. The pharmacy intern said the mother would be contacting the pediatrician. At the time of reporting, the outcome of the events was not recovered.The patient's mother sought medical attention through the way of informed the pharmacy. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report has been received from a 29 year old female healthcare student, for VARIVAX (Merck), a Pregnancy Registry product, concerning herself with no drug reactions or allergies. It was reported that in approximately 2013 (reported as "over 3 months ago") she was taking metformin and letrozole to help assist with becoming pregnant due to having polycystic ovarian disease but reported that the medications were stopped in approximately June 2013 (reported as "3 months ago"). On 20-JUN-2013 the patient was vaccinated subcutaneously with the first 0.5 ml dose of VARIVAX (Merck) (lot # was not reported). On 25-JUL-2013 the patient was vaccinated subcutaneously with the second 0.5 ml dose of VARIVAX (Merck) (lot # was not reported). The reason she received the VARIVAX (Merck) was due to titers being drawn before starting stool and the titers showed that she was not immune to varicella. There was no concomitant medication. It was reported the patient was currently 9 weeks pregnant. The patient became pregnant with LMP of approximately 22-JUL-2013 and EDD of approximately 28-APR-2014. At the time of reporting, the patient was at first trimester of exposure. No treatment was given for the event. The patient was seen by an unspecified endocrinologist on approximately 16-SEP-2013 (reported as"about a week ago"). At the time of report, the outcome of the pregnancy was unknown. Additional information is not expected.
Age: 5.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 5 year old patient. On 30-SEP-2013, the patient was vaccinated with a first dose of an expired dose of PNEUMOVAX 23 (lot # 0491AE, expired date 15-SEP-2013). No adverse event was reported. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician assistant via a company representative refers to a female patient "in her 20's". No medical history provided. On an unknown date the patient was vaccinated with PNEUMOVAX23. No concomitant medications were reported. Then, she was inadvertently administered a second dose of PNEUMOVAX23 on an unspecified date 1 year later. No adverse events were reported. No outcome was reported. PNEUMOVAX23 was administered by another unspecified practice. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster
Clinical narrative: This spontaneous report as received from a female patient of unknown age regarding herself. On an unknown date in early August 2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). On an unknown date within the last week on an unknown date in September 2013, the patient experienced shingles-like symptoms which included burning on her left side in the area of lower hip. Patient sought medical attention-spoke with unspecified pharmacist. The outcome of shingles-like symptoms which included burning on her left side in the area of lower hip was reported as recovering. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a 50 year old female consumer concerning herself. There was no pertinent medical history and no drug reactions/allergies. On 23-SEP-2013 the patient was vaccinated with ZOSTAVAX, (lot number and expiration date unknown), dose, route and anatomical location unspecified. Concomitant medications were not reported. On 23-SEP-2013, the patient reported that she had redness at the injection site on her left arm, it was hard, hot and itching and getting larger each day. The patient did not seek medical attention and no treatment was given. No lab diagnostics tests were performed. The outcome of redness at the injection site on her left arm and it was hard, hot and itching and getting larger each day was reported as not recovered/not resolved. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Diagnostic procedure, Diarrhoea, Dizziness, Gastrointestinal disorder
Clinical narrative: Information has been received from the authors in a published literature article concerning an a 22-year-old previously healthy female experienced a sudden onset of diarrhea, nausea and weight loss approximately 2 months after receiving the third GARDASIL. A thorough gastrointestinal diagnostic workup failed to reveal any underlying etiology, and the patient was diagnosed with irritable bowel syndrome. In addition to persistent gastrointestinal symptoms, the patient also developed lightheadedness, dizziness, pre-syncope and episodic tachycardia. A tilt table test revealed a rise in heart rate from 90 bpm supine to 134 bpm standing within 1 min of tilt. At the twentieth minute of tilt, the patient experienced a drop in blood pressure to 88/43 accompanied by symptoms of pre-syncope. The tilt table test was consistent with Postural orthostatic tachycardia syndrome (POTS) and neurocardiogenic syncope (NCS). Further autonomic testing revealed normal heart rate variability and Valsalva response, and quantitative sudomotor test showed mild reduction in the distal leg suggestive of a small fiber neuropathy. In addition to an increased fluid/salt intake, the patient was treated with midodrine for vasoconstriction and fludrocortisone for volume expansion, and her symptoms have gradually improved over the course of 2 years. The reporter stated that nevertheless, none of the patients experienced complete resolution of symptoms, and all patients continued to experience some residual symptoms. Possible pathogenesis of the new onset POTS after vaccination may include the mechanism of molecular mimicry, whereas HPV vaccine epitopes may induce formation of cross-reacting antibodies against potential targets of the autonomic ganglia, neurons, cardiac proteins or 31/2-adrenergic and M2/3 muscarinic receptors. Additionally, induction of bystander lymphocyte lymphocyte activation and a broad spectrum of cytokine responses elicited by the HPV vaccine may also be involved. The reporter stated that the temporal association between vaccination with GARDASIL and the onset of symptoms of POTS in healthy young women is significant and deserves further investigation for assessment of a possible casual relationship. The reporter stated that other related conditions, such as small fiber neuropathy, autonomic neuropathy, complex regional pain syndrome and fibromyalgia have been reported after immunization with various vaccines, including GARDASIL. This is one of several reports from the same literature article: 1310USA000643, 1007USA02012, 1310USA003813, 1310USA003799. 1310USA003819. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Irritable bowel syndrome, Laboratory test abnormal, Nausea, Postural orthostatic tachycardia syndrome, Presyncope
Clinical narrative: Information has been received from the authors in a published literature article concerning an a 22-year-old previously healthy female experienced a sudden onset of diarrhea, nausea and weight loss approximately 2 months after receiving the third GARDASIL. A thorough gastrointestinal diagnostic workup failed to reveal any underlying etiology, and the patient was diagnosed with irritable bowel syndrome. In addition to persistent gastrointestinal symptoms, the patient also developed lightheadedness, dizziness, pre-syncope and episodic tachycardia. A tilt table test revealed a rise in heart rate from 90 bpm supine to 134 bpm standing within 1 min of tilt. At the twentieth minute of tilt, the patient experienced a drop in blood pressure to 88/43 accompanied by symptoms of pre-syncope. The tilt table test was consistent with Postural orthostatic tachycardia syndrome (POTS) and neurocardiogenic syncope (NCS). Further autonomic testing revealed normal heart rate variability and Valsalva response, and quantitative sudomotor test showed mild reduction in the distal leg suggestive of a small fiber neuropathy. In addition to an increased fluid/salt intake, the patient was treated with midodrine for vasoconstriction and fludrocortisone for volume expansion, and her symptoms have gradually improved over the course of 2 years. The reporter stated that nevertheless, none of the patients experienced complete resolution of symptoms, and all patients continued to experience some residual symptoms. Possible pathogenesis of the new onset POTS after vaccination may include the mechanism of molecular mimicry, whereas HPV vaccine epitopes may induce formation of cross-reacting antibodies against potential targets of the autonomic ganglia, neurons, cardiac proteins or 31/2-adrenergic and M2/3 muscarinic receptors. Additionally, induction of bystander lymphocyte lymphocyte activation and a broad spectrum of cytokine responses elicited by the HPV vaccine may also be involved. The reporter stated that the temporal association between vaccination with GARDASIL and the onset of symptoms of POTS in healthy young women is significant and deserves further investigation for assessment of a possible casual relationship. The reporter stated that other related conditions, such as small fiber neuropathy, autonomic neuropathy, complex regional pain syndrome and fibromyalgia have been reported after immunization with various vaccines, including GARDASIL. This is one of several reports from the same literature article: 1310USA000643, 1007USA02012, 1310USA003813, 1310USA003799. 1310USA003819. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Small fibre neuropathy, Syncope, Tachycardia, Tilt table test positive, Weight decreased
Clinical narrative: Information has been received from the authors in a published literature article concerning an a 22-year-old previously healthy female experienced a sudden onset of diarrhea, nausea and weight loss approximately 2 months after receiving the third GARDASIL. A thorough gastrointestinal diagnostic workup failed to reveal any underlying etiology, and the patient was diagnosed with irritable bowel syndrome. In addition to persistent gastrointestinal symptoms, the patient also developed lightheadedness, dizziness, pre-syncope and episodic tachycardia. A tilt table test revealed a rise in heart rate from 90 bpm supine to 134 bpm standing within 1 min of tilt. At the twentieth minute of tilt, the patient experienced a drop in blood pressure to 88/43 accompanied by symptoms of pre-syncope. The tilt table test was consistent with Postural orthostatic tachycardia syndrome (POTS) and neurocardiogenic syncope (NCS). Further autonomic testing revealed normal heart rate variability and Valsalva response, and quantitative sudomotor test showed mild reduction in the distal leg suggestive of a small fiber neuropathy. In addition to an increased fluid/salt intake, the patient was treated with midodrine for vasoconstriction and fludrocortisone for volume expansion, and her symptoms have gradually improved over the course of 2 years. The reporter stated that nevertheless, none of the patients experienced complete resolution of symptoms, and all patients continued to experience some residual symptoms. Possible pathogenesis of the new onset POTS after vaccination may include the mechanism of molecular mimicry, whereas HPV vaccine epitopes may induce formation of cross-reacting antibodies against potential targets of the autonomic ganglia, neurons, cardiac proteins or 31/2-adrenergic and M2/3 muscarinic receptors. Additionally, induction of bystander lymphocyte lymphocyte activation and a broad spectrum of cytokine responses elicited by the HPV vaccine may also be involved. The reporter stated that the temporal association between vaccination with GARDASIL and the onset of symptoms of POTS in healthy young women is significant and deserves further investigation for assessment of a possible casual relationship. The reporter stated that other related conditions, such as small fiber neuropathy, autonomic neuropathy, complex regional pain syndrome and fibromyalgia have been reported after immunization with various vaccines, including GARDASIL. This is one of several reports from the same literature article: 1310USA000643, 1007USA02012, 1310USA003813, 1310USA003799. 1310USA003819. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Pruritus generalised
Clinical narrative: Vaccine administered 10/03/13. Presented next day with warmth and redness at site and extending approx 1 1/2 inches below site. Later on second day, at approx. 5:00 PM experienced whole body, intensive itch, lasting approx. 4 hours. Slight erythema remains today, 10/7/13.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from an health care worker to 5 patients of unknown age and gender. Medical history was not provided. Between 19-SEP-2013 and 23-SEP-2013 the patients were vaccinated with 2 ml ROTATEQ lot # 1539AA with expiration date 15-JUN-2013. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker: vaccine coordinator of health department and refers to a patient of unknown age (gender not reported). Healthcare worker stated that registered nurse reported to her that on an unknown date, the patient was vaccination with an expired dose of GARDASIL (dose, route, lot number and exp. date was not reported). No adverse effects reported. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old male patient with diabetes and no drug reactions/allergies. On 26-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H021941, expiration date 11-JUL-2014, 0.5 ml, intramuscular in the right arm). There was no concomitant therapies reported. On 26-SEP-2013 ("at an unspecified time later in the day"), the patient experienced tenderness at the injection site on his right arm, fever and chills. The patient then returned to see the pharmacist on 27-SEP-2013 ("today"), to inform that he was experiencing severe pain at the injection site and extremely limited mobility of his right arm. There was no treatment given for the events. No lab test was performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody positive, Diarrhoea, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Information has been received from the authors in a published literature article, concerning a healthy 14-year-old female who five days after receiving the first injection of GARDASIL vaccine, experienced numbness and tingling in the toes. Over the following 2 weeks, the numbness and tingling increased to involve the lower extremities and pelvis. Other symptoms, such as fatigue, headache, nausea, diarrhea, weight loss and tachycardia ensued. Nuclear magnetic resonance imaging (MRI) of the brain and cervical spine were unremarkable, and laboratory testing showed positive antinuclear antibodies (ANA) with titers I: 160 with speckled pattern. Rheumatological evaluation was unrevealing raising a possibility of fibromyalgia. A tilt table test demon striated a supine heart rate of 72 bpm which increased to a maximum of 123 bpm within 10 min of tilt without evidence of orthostatic hypotension. Heart rate responses to the Valsalva maneuver and deep breathing test were unremarkable, and sweat output in the leg with the quantitative sudomotor test was borderline reduced. The results of the autonomic testing indicated Postural orthostatic tachycardia (POTS) and possible small fiber neuropathy, and the patient was started on metoprolol tartrate to control the tachycardia. Over the following 2 years, her symptoms had improved with the use of metoprolol tartrate for Postural orthostatic tachycardia syndrome (POTS) and amitriptyline. The reporter stated that neurocardiogenic syncope (NCS) was diagnosed during the tilt table test. The reporter stated nevertheless, none of the patients experienced complete resolution of symptoms, and all patients continued to experience some residual symptoms. Possible pathogenesis of the new onset POTS after vaccination may include the mechanism of molecular mimicry, whereas HPV vaccine epitopes may induce formation of cross-reacting antibodies against potential tarts of the autonomic ganglia, neurons, cardiac proteins or 231/2-adrenergic and M2/3 muscarinic receptors. Additionally, induction of bystander lymphocyte lymphocyte activation and a broad spectrum of cytokine responses elicited by the HPV vaccine may also be involved. The reporter stated that the temporal association between vaccination with GARDASIL and the onset of symptoms of POTS in healthy young women is significant and deserves further investigation for assessment of a possible casual relationship. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test abnormal, Nausea, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Paraesthesia
Clinical narrative: Information has been received from the authors in a published literature article, concerning a healthy 14-year-old female who five days after receiving the first injection of GARDASIL vaccine, experienced numbness and tingling in the toes. Over the following 2 weeks, the numbness and tingling increased to involve the lower extremities and pelvis. Other symptoms, such as fatigue, headache, nausea, diarrhea, weight loss and tachycardia ensued. Nuclear magnetic resonance imaging (MRI) of the brain and cervical spine were unremarkable, and laboratory testing showed positive antinuclear antibodies (ANA) with titers I: 160 with speckled pattern. Rheumatological evaluation was unrevealing raising a possibility of fibromyalgia. A tilt table test demon striated a supine heart rate of 72 bpm which increased to a maximum of 123 bpm within 10 min of tilt without evidence of orthostatic hypotension. Heart rate responses to the Valsalva maneuver and deep breathing test were unremarkable, and sweat output in the leg with the quantitative sudomotor test was borderline reduced. The results of the autonomic testing indicated Postural orthostatic tachycardia (POTS) and possible small fiber neuropathy, and the patient was started on metoprolol tartrate to control the tachycardia. Over the following 2 years, her symptoms had improved with the use of metoprolol tartrate for Postural orthostatic tachycardia syndrome (POTS) and amitriptyline. The reporter stated that neurocardiogenic syncope (NCS) was diagnosed during the tilt table test. The reporter stated nevertheless, none of the patients experienced complete resolution of symptoms, and all patients continued to experience some residual symptoms. Possible pathogenesis of the new onset POTS after vaccination may include the mechanism of molecular mimicry, whereas HPV vaccine epitopes may induce formation of cross-reacting antibodies against potential tarts of the autonomic ganglia, neurons, cardiac proteins or 231/2-adrenergic and M2/3 muscarinic receptors. Additionally, induction of bystander lymphocyte lymphocyte activation and a broad spectrum of cytokine responses elicited by the HPV vaccine may also be involved. The reporter stated that the temporal association between vaccination with GARDASIL and the onset of symptoms of POTS in healthy young women is significant and deserves further investigation for assessment of a possible casual relationship. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Rheumatoid factor negative, Syncope, Tachycardia, Tilt table test positive
Clinical narrative: Information has been received from the authors in a published literature article, concerning a healthy 14-year-old female who five days after receiving the first injection of GARDASIL vaccine, experienced numbness and tingling in the toes. Over the following 2 weeks, the numbness and tingling increased to involve the lower extremities and pelvis. Other symptoms, such as fatigue, headache, nausea, diarrhea, weight loss and tachycardia ensued. Nuclear magnetic resonance imaging (MRI) of the brain and cervical spine were unremarkable, and laboratory testing showed positive antinuclear antibodies (ANA) with titers I: 160 with speckled pattern. Rheumatological evaluation was unrevealing raising a possibility of fibromyalgia. A tilt table test demon striated a supine heart rate of 72 bpm which increased to a maximum of 123 bpm within 10 min of tilt without evidence of orthostatic hypotension. Heart rate responses to the Valsalva maneuver and deep breathing test were unremarkable, and sweat output in the leg with the quantitative sudomotor test was borderline reduced. The results of the autonomic testing indicated Postural orthostatic tachycardia (POTS) and possible small fiber neuropathy, and the patient was started on metoprolol tartrate to control the tachycardia. Over the following 2 years, her symptoms had improved with the use of metoprolol tartrate for Postural orthostatic tachycardia syndrome (POTS) and amitriptyline. The reporter stated that neurocardiogenic syncope (NCS) was diagnosed during the tilt table test. The reporter stated nevertheless, none of the patients experienced complete resolution of symptoms, and all patients continued to experience some residual symptoms. Possible pathogenesis of the new onset POTS after vaccination may include the mechanism of molecular mimicry, whereas HPV vaccine epitopes may induce formation of cross-reacting antibodies against potential tarts of the autonomic ganglia, neurons, cardiac proteins or 231/2-adrenergic and M2/3 muscarinic receptors. Additionally, induction of bystander lymphocyte lymphocyte activation and a broad spectrum of cytokine responses elicited by the HPV vaccine may also be involved. The reporter stated that the temporal association between vaccination with GARDASIL and the onset of symptoms of POTS in healthy young women is significant and deserves further investigation for assessment of a possible casual relationship. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Weight decreased
Clinical narrative: Information has been received from the authors in a published literature article, concerning a healthy 14-year-old female who five days after receiving the first injection of GARDASIL vaccine, experienced numbness and tingling in the toes. Over the following 2 weeks, the numbness and tingling increased to involve the lower extremities and pelvis. Other symptoms, such as fatigue, headache, nausea, diarrhea, weight loss and tachycardia ensued. Nuclear magnetic resonance imaging (MRI) of the brain and cervical spine were unremarkable, and laboratory testing showed positive antinuclear antibodies (ANA) with titers I: 160 with speckled pattern. Rheumatological evaluation was unrevealing raising a possibility of fibromyalgia. A tilt table test demon striated a supine heart rate of 72 bpm which increased to a maximum of 123 bpm within 10 min of tilt without evidence of orthostatic hypotension. Heart rate responses to the Valsalva maneuver and deep breathing test were unremarkable, and sweat output in the leg with the quantitative sudomotor test was borderline reduced. The results of the autonomic testing indicated Postural orthostatic tachycardia (POTS) and possible small fiber neuropathy, and the patient was started on metoprolol tartrate to control the tachycardia. Over the following 2 years, her symptoms had improved with the use of metoprolol tartrate for Postural orthostatic tachycardia syndrome (POTS) and amitriptyline. The reporter stated that neurocardiogenic syncope (NCS) was diagnosed during the tilt table test. The reporter stated nevertheless, none of the patients experienced complete resolution of symptoms, and all patients continued to experience some residual symptoms. Possible pathogenesis of the new onset POTS after vaccination may include the mechanism of molecular mimicry, whereas HPV vaccine epitopes may induce formation of cross-reacting antibodies against potential tarts of the autonomic ganglia, neurons, cardiac proteins or 231/2-adrenergic and M2/3 muscarinic receptors. Additionally, induction of bystander lymphocyte lymphocyte activation and a broad spectrum of cytokine responses elicited by the HPV vaccine may also be involved. The reporter stated that the temporal association between vaccination with GARDASIL and the onset of symptoms of POTS in healthy young women is significant and deserves further investigation for assessment of a possible casual relationship. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 80 year old female patient. There was no relevant medical history. On 16-SEP-2013 the patient was vaccinated with ZOSTAVAX lot # J001008, subcutaneously. Dose and frequency were not provided. Concomitant therapies included aspirin (manufacturer unknown), losartan (manufacturer unknown), diltiazem CD (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), pravastatin (manufacturer unknown), ropinirole (manufacturer unknown), TEKTURNA 300 (manufacturer unknown), tramadol (manufacturer unknown) and TRAVATAN Z eye drop (manufacturer unknown). On an unspecified date in October 2013, reported as 3 weeks after onset of therapy the patient experienced shingles. Treatment with Acyclovir 800 mg was given. The outcome of shingles was reported as not recovered/not resolved. The reporter causality was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of age and gender unknown. Medical history and drug reactions were not reported. On an unknown recently, in 2013, the patient was vaccinated with PNEUMOVAX 23 1 dose, lot number J007786 Expiration date 25-SEP-2015, (dose, indication, concentration were not reported). Concomitant therapy was not reported. On an unknown date in the past week in September 2013, the patient experienced some itching, edema at injection site swelled to the size of a silver dollar, whole arm swelled like balloon. Laboratory data was unknown. The outcome of edema at injection site, whole arm swelled like balloon, some itching and the site swelled to the size of a silver dollar was unknown. This is one report of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 26-SEP-2013 the patient was mistakenly vaccinated with VARIVAX (Merck) (dose, route and lot# not provided) instead of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age. On 30-SEP-2013, the patient was vaccinated with a dose of PROQUAD which was exposed to 50 Fahrenheit for 32 hours which was not supported. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old male patient who was allergic to penicillin. The patient's medical history included an unspecified surgery. On 16-SEP-2013, the patient was vaccinated with a first dose of PNEUMOVAX23(Lot number, expiry date were not reported), 0.5 ml, intramuscular. On 02-OCT-2013, the patient was vaccinated with a second dose of PNEUMOVAX23 (Lot number was reported as J004387, expiry date was 04-JAN-2014), 0.5 ml, intramuscular. On 02-OCT-2013, the patient also received influenza virus vaccine(manufacturer unknown)(Lot number, expiry date, route and dose were not reported). The reporter was informed by an unspecified nurse that since approximately on an unknown date in October 2013 (reported as currently), the patient had temperature. The patient sought medical attention and was being treated with TYLENOL. Lab Diagnostics Studies Performed was none. The patient was currently residing in an unspecified long term care facility due to an unspecified surgery that he had prior to receiving any doses of PNEUMOVAX23. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPV4, MMR, PPV, RV5, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to unspecified number patients of unknown age. The reporter reported that ROTATEQ, VARIVAX, RECOMBIVAX HB, VAQTA, M-M-R II, GARDASIL and PNEUMOVAX23 which might have gone out of range sometime in April 2013, but nurse was unable to provide the worst case time frame or temperature. The nurse additionally stated that an unspecified number of people have been administered these products. No adverse effects have been reported. Lot numbers and expiration dates unavailable for all products. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. On 18-SEP-2013 the patient was vaccinated with MMR II lot # 670592/0872AA, 0.5 ml, subcutaneous. The healthcare worker reported that the patient received an expired dose of MMR II. No adverse effect reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of Osteopathy refers to a 12 year old female patient. The physician reported that the patient received 0.5 ml GARDASIL at month 0 (June 2013), month 2 (August 2013) and month 3 (September 2013) in the vaccination regimen. The physician was asked if the dose was given subcutaneously, and the physician replied "yeah". No adverse effects were reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash vesicular
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 month old male patient with no pertinent medical history and drug reactions/allergies. On 23-SEP-2013 the patient was vaccinated with dose 1, 0.5 milliliter (ml) of VARIVAX (Merck) (lot # H018782, expiration date 15-OCT-2014) subcutaneously. The patient's mother reported to the office the next day (24-SEP-2013) that the patient had few lesions on his chest. The physician came on the line and described the rash as a "classic" varicella like rash. She stated the patient had 20 lesions on his trunk, and 5 lesions on his lower extremities. She stated that the only treatment she recommended was calamine lotion for itching. No treatment was given for the "classic varicella-like rash" event. No lab diagnostic studies were performed for the event. Patient sought medical attention by office visit. The events did not resolve at the time of this report. Additional information is not expected.
Age: 0.58
Sex: M
Vaccine: FLU3, PNC13, RV5
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: No adverse reaction, sxs, or signs at time of administration or currently. DTAP-IPV component of PENTACEL not mixed with a HIB component. Pt injected with DTAP-IPV only. Pt will be given HIB inj 10/11/13.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age. On 01-OCT-2013, the patient was vaccinated with a dose of PROQUAD which was exposed to 50 Fahrenheit for 32 hours which was not supported. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Full blood count normal, Henoch-Schonlein purpura, Laboratory test normal, Liver function test normal, Red blood cell sedimentation rate normal
Clinical narrative: Child developed Henoch Schonlein Purpura. He is being treated symptomatically with ibuprofen as needed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Renal function test normal, Ultrasound abdomen
Clinical narrative: Child developed Henoch Schonlein Purpura. He is being treated symptomatically with ibuprofen as needed.
Age: 10.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient who, on 04-OCT-2013, was vaccinated subcutaneously with an expired dose of M-M-R II lot # 1404AA, expiry date: 06-SEP-2013 (dose not reported). It was unspecified if that was the first or second dose of M-M-R II this patient had been administered. No known adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: From shoulder (injection site) right elbow -> red, swollen, hot to touch with low grade fever -> taking TYLENOL and ice pack.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Musculoskeletal stiffness
Clinical narrative: Student states she developed a "stiff neck" 1 day after receiving varicella vaccine. No other symptoms experienced.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner (also reproted as physician assistant) refers to a patient (gender unknown) of unknown age. Pertinent medical history or allergies were not reported. In February, 2012 the patient was vaccinated with GARDASIL dose 1. Dose, route of administration, lot number and expiration date were not reported. The second dose of GARDASIL (dose, lot #, expiration date and route were not reported) was given in May 2012 and the third dose of GARDASIL (dose, lot #, expiration date and route were not reported) was given on 11-SEP-2013. Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Tuberculin test positive, Viral titre increased
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old male patient. The patient had no pertinent medical history or drug reactions/allergies. It was reported that the patient received his first dose of VARIVAX (Merck) "as a child". Route of administration and lot number of this vaccination was not reported. There was no concomitant medication. It was reported that the patient had titers drawn on an unspecified date which showed that the patient was low for immunity. The patient was given a second dose of VARIVAX (Merck) intramuscularly on 03-SEP-2013. Lot number was reported as J003705 with an expiration date of 27-MAR-2015. The patient was then administered a PPD test "2 or 3 days prior to 13-SEP-2013. On 13-SEP-2013, the PPD skin test result was "strongly positive". It was reported that no treatment was given for the adverse event. No further information was provided. Additional information has been requested.