chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Exercise tolerance decreased, Fight in school, Fine motor delay, Grip strength decreased
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain, Adjustment disorder with mixed anxiety and depressed mood, Alanine aminotransferase normal, Amnesia, Arthralgia
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Aspartate aminotransferase normal, Asthma, Astigmatism, Blood albumin normal, Blood calcium normal
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood lactate dehydrogenase normal, Blood magnesium normal
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood phosphorus increased, Blood potassium normal, Blood sodium decreased, Blood thyroid stimulating hormone normal, Blood urea normal
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood uric acid normal, C-reactive protein normal, Carbon dioxide normal, Central nervous system lesion, Cerebellar ataxia
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Condition aggravated, Coordination abnormal, Culture urine negative, Decreased appetite, Dizziness
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dyslexia, Dysphagia, Electroencephalogram normal, Fall, Fatigue
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Fine motor delay, Free thyroxine index normal, Gait disturbance, Grip strength decreased, Hallucination, visual
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Headache, Hyperacusis, Hypophagia, Hyporesponsive to stimuli, Lumbar puncture normal
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Mastication disorder, Mental status changes, Metabolic function test normal, Muscular weakness, Neurological examination
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Ophthalmological examination normal, Photophobia, Protein total normal, Red blood cell sedimentation rate normal
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Speech disorder, Thyroxine normal, Tremor, Tri-iodothyronine uptake normal, Upper motor neurone lesion
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Urinary incontinence, Urine analysis normal, Urine output decreased, Visual impairment
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Computerised tomogram, Dysarthria, Dysphagia, Headache, Mental status changes
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Nuclear magnetic resonance imaging, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co-suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headaches, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a patient of unknown age and sex. On 10-APR-2013 date the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency and route not provided) (lot # 0073AE, expiration date: 03-APR-2013). The reporter stated that on 10-APR-2013 the patient received an expired ZOSTAVAX, no adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dermatitis
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. Medical history was not provided, concomitant medications were not reported. In November 2012 the patient was vaccinated with the first dose of GARDASIL (dose and lot number were not provided). IN April 2013 the second dose of GARDASIL was administered. Immediately following both of these administrations the patient experienced macular dermatitis. The outcome of macular dermatitis is unknown. The relatedness of macular dermatitis is unknown and GARDASIL was not reported. Additional information ahs been requested.
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4, MEN, TDAP, UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal discomfort
Clinical narrative: Injection site started out with a bean size red mark and grew to a grapefruit size swelling mark with pain and joint discomfort.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, CSF protein increased, Demyelinating polyneuropathy, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: This case was reported in a literature article and described the occurrence of distal acquired demyelinating symmetric neuropathy in a 74-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Influenza vaccine (unknown route, unknown injection site). Lot number not provided. 2 days after vaccination with Influenza vaccine, the subject experienced proximal and distal numbness and weakness. The subject was diagnosed with distal acquired demyelinating symmetric neuropathy. This case was assessed as medically serious by GSK. Relevant test results included: CSF protein: 166 mg/dL; Nerve conduction studies were performed; slow conduction velocity and conduction block were observed; F waves were absent. The subject was treated with normal immunoglobulin (IVIG) and Corticosteroids. At the time of reporting the outcome of the events was unspecified. Neuropathy after vaccination is a rare event. Chronic immune-mediated polyneuropathy developing in the postvaccination period is distinctly unusual and not well described. Almost all such patients have been reported as having typical chronic inflammatory demyelinating polyneuropathy. Distal acquired demyelinating symmetric neuropathy, unlike classic chronic inflammatory demyelinating polyneuropathy, is characterized by distally predominant sensory symptoms with no or mild distal weakness. Vaccine-associated distal acquired demyelinating symmetric neuropathy (DADS) may suggest a vaccine-triggered immunologic event directed against myelin associated glycoprotein below detectable concentrations. More likely, we suspect vaccination in this subject triggered an immune response against currently unrecognized antigens and manifested as restricted chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in the form of demyelinating symmetric neuropathy. Vaccine-associated CIDP is a rare but poorly characterized event that should not discourage at-risk individuals from being vaccinated. Nonetheless, vaccine safety and public reassurance rely on rapid detection and treatment of adverse outcomes. DADS neuropathy can occur after vaccine. We suggest consideration of this diagnosis for patients with new sensory symptoms after vaccination.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Nerve conduction studies abnormal
Clinical narrative: This case was reported in a literature article and described the occurrence of distal acquired demyelinating symmetric neuropathy in a 74-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Influenza vaccine (unknown route, unknown injection site). Lot number not provided. 2 days after vaccination with Influenza vaccine, the subject experienced proximal and distal numbness and weakness. The subject was diagnosed with distal acquired demyelinating symmetric neuropathy. This case was assessed as medically serious by GSK. Relevant test results included: CSF protein: 166 mg/dL; Nerve conduction studies were performed; slow conduction velocity and conduction block were observed; F waves were absent. The subject was treated with normal immunoglobulin (IVIG) and Corticosteroids. At the time of reporting the outcome of the events was unspecified. Neuropathy after vaccination is a rare event. Chronic immune-mediated polyneuropathy developing in the postvaccination period is distinctly unusual and not well described. Almost all such patients have been reported as having typical chronic inflammatory demyelinating polyneuropathy. Distal acquired demyelinating symmetric neuropathy, unlike classic chronic inflammatory demyelinating polyneuropathy, is characterized by distally predominant sensory symptoms with no or mild distal weakness. Vaccine-associated distal acquired demyelinating symmetric neuropathy (DADS) may suggest a vaccine-triggered immunologic event directed against myelin associated glycoprotein below detectable concentrations. More likely, we suspect vaccination in this subject triggered an immune response against currently unrecognized antigens and manifested as restricted chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in the form of demyelinating symmetric neuropathy. Vaccine-associated CIDP is a rare but poorly characterized event that should not discourage at-risk individuals from being vaccinated. Nonetheless, vaccine safety and public reassurance rely on rapid detection and treatment of adverse outcomes. DADS neuropathy can occur after vaccine. We suggest consideration of this diagnosis for patients with new sensory symptoms after vaccination.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Face hives. Hives to neck, wrist, left arm.
Age: 48.0
Sex: F
Vaccine: TYP, YF
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Red welt at injection site developed over 7-8 days. Recommended: M.D. visit. No tx. M.D. said no tx, no cellulitis, resolving.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Back pain, Burning sensation, Gastritis, Pain
Clinical narrative: 5 minutes after injection tingling/burning sensation came across both arms and entire upper body. Tachycardia and palpitations followed within the hour. 5 days later bleeding from vagina; not related to menses. Back pain and abdominal pain, calf muscle pain, sleep disturbances, sinusitis and chronic body pain. Now cannot function normally. Have lost 25 pounds.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Palpitations, Paraesthesia, Sinusitis, Sleep disorder
Clinical narrative: 5 minutes after injection tingling/burning sensation came across both arms and entire upper body. Tachycardia and palpitations followed within the hour. 5 days later bleeding from vagina; not related to menses. Back pain and abdominal pain, calf muscle pain, sleep disturbances, sinusitis and chronic body pain. Now cannot function normally. Have lost 25 pounds.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia, Vaginal haemorrhage, Ventricular extrasystoles, Weight decreased
Clinical narrative: 5 minutes after injection tingling/burning sensation came across both arms and entire upper body. Tachycardia and palpitations followed within the hour. 5 days later bleeding from vagina; not related to menses. Back pain and abdominal pain, calf muscle pain, sleep disturbances, sinusitis and chronic body pain. Now cannot function normally. Have lost 25 pounds.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Erythema, Haemorrhage subcutaneous, Injection site reaction, Injection site swelling
Clinical narrative: Initial report was received from a healthcare professional on 08 April 2013. A 32-year-old female patient received an injection in the left deltoid of IMOVAX Rabies vaccine (sanofi pasteur, H12581) on 02 April 2013. The patient also received the following vaccinations on 30 March 2013: RABAVERT vaccine (2.5 units, other manufacturer) with Rabies Immunoglobulin infiltrated into the wound (1800 units, MFR Unknown) and Tetanus vaccine (MFR unknown). Later in the day on 02 April 2013, the patient experienced abdominal pain, redness, rash, and swelling of the left arm. There was a "3 finger width" of swelling at the IMOVAX injection site with "blood spots" under the skin. The patient went to the emergency room the next day for the symptoms and was given over-the-counter pain medication. The patient presented to the emergency room on 03 April 2013 for the next dose of rabies vaccine. The emergency room would not give her that dose because she had the reaction prior. The patient was going to the Health Department for continuation of the vaccine series. The patient had no illness at time of vaccination and no pre-existing allergies or medical conditions. The patient's outcome was reported as unknown. Documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Oedema peripheral, Rash
Clinical narrative: Initial report was received from a healthcare professional on 08 April 2013. A 32-year-old female patient received an injection in the left deltoid of IMOVAX Rabies vaccine (sanofi pasteur, H12581) on 02 April 2013. The patient also received the following vaccinations on 30 March 2013: RABAVERT vaccine (2.5 units, other manufacturer) with Rabies Immunoglobulin infiltrated into the wound (1800 units, MFR Unknown) and Tetanus vaccine (MFR unknown). Later in the day on 02 April 2013, the patient experienced abdominal pain, redness, rash, and swelling of the left arm. There was a "3 finger width" of swelling at the IMOVAX injection site with "blood spots" under the skin. The patient went to the emergency room the next day for the symptoms and was given over-the-counter pain medication. The patient presented to the emergency room on 03 April 2013 for the next dose of rabies vaccine. The emergency room would not give her that dose because she had the reaction prior. The patient was going to the Health Department for continuation of the vaccine series. The patient had no illness at time of vaccination and no pre-existing allergies or medical conditions. The patient's outcome was reported as unknown. Documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: Local injection site reaction: Red raised area, hot about 3x6. Resolved in 3-4 days. Systemic Rxn: On Wednesday 4/10/13 patient developed rash, fever, flu-like symptoms, bad body aches, listless, no energy, nausea. No itching or pain with rash.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Listless, Local reaction, Nausea, Pain, Pyrexia
Clinical narrative: Local injection site reaction: Red raised area, hot about 3x6. Resolved in 3-4 days. Systemic Rxn: On Wednesday 4/10/13 patient developed rash, fever, flu-like symptoms, bad body aches, listless, no energy, nausea. No itching or pain with rash.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Local injection site reaction: Red raised area, hot about 3x6. Resolved in 3-4 days. Systemic Rxn: On Wednesday 4/10/13 patient developed rash, fever, flu-like symptoms, bad body aches, listless, no energy, nausea. No itching or pain with rash.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Blood pressure decreased, Cold sweat, Glassy eyes, Hyperhidrosis
Clinical narrative: Pt. got clammy and instantly started sweating. Blood drained from face and eyes glassed over. Pt. stated he was weak and got very quiet. BP dropped to 65/39.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pallor
Clinical narrative: Pt. got clammy and instantly started sweating. Blood drained from face and eyes glassed over. Pt. stated he was weak and got very quiet. BP dropped to 65/39.
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain, Electrocardiogram normal, Myopericarditis, Troponin normal
Clinical narrative: This study case was received from the investigator in a trial on 08 April 2013. A 25-year-old female subject had received the following vaccination on 11 March 2013 in the left arm: ACAM2000 (lot number, and route not reported). Three days later, the subject experienced sharp/mild chest pain during a light jog following intense exercise (running stairs). This reoccurred on 2 subsequent days and stopped. The subject recovered on 16 March 2013. The subject did not seek care. Rapid/lab troponin levels from 18 March 2013 were normal (Result < 0.10 ng/mL). The electrocardiogram from 18 March 2013 was normal. The subject did not have any medical history relevant to the event and took no medications to treat the event. According to the reporter, there was a lower suspicion for myopericarditis, but could not rule out cardiac etiology. The subject was referred for care but did not go. The subject's outcome was reported as recovered on 16 March 2013. According to the Investigator, the event of chest pain was considered an important event and possibly related. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Contusion, Headache, Palpitations
Clinical narrative: Pt called reporting bruise and welt. Also having headache and joint pain heart palpitations. Chills till Sunday.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Pt called reporting bruise and welt. Also having headache and joint pain heart palpitations. Chills till Sunday.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt here 4/15/2013 for TDAP and MCV4 on L/D IM. 4/17/13 L/D swollen and light red site of 11 x 6 cm. Here seen by doctor.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Dermatitis allergic, Musculoskeletal pain, Pain in extremity, Rash generalised
Clinical narrative: This spontaneous report as received from a 72 year old male patient with spinal issues, allergy to VERSED and BENADRYL. The patient's medical history included heart stent in approximately 1997 at age 62 and chicken pox. In approximately March 2008 (about five years ago), the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot # not reported). Concomitant therapies included atenolol and aspirin. About one week after receiving the vaccine, the patient experienced an allergic type, whole body severe rash. The patient was prescribed 85 mg of prednisone for about three years and still took prednisone at the time of report. He was also treated with acyclovir. The patient experienced pain in his arm and shoulder. The patient went to the physician office for medical attention. No lab diagnostics studies were performed. The event did not improve. The outcome of allergic type, whole body severe rash, pain in his shoulder and arm was reported as not recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Oedema peripheral, Skin discolouration
Clinical narrative: Lt arm swollen and purple an hour after the vaccine. BENADRYL 25-50 mg q6 hr PRN.
Age: 18.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Injection site inflammation, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Immunization was given on 4/11/2013 at 2 pm. Client returned to clinic 4/12/2013 at 3:30 pm left upper arm from shoulder to elbow was inflamed, felt hot to touch and swollen. Pt reported pain. Reaction began around 7-9 pm 4/11/13 and continued to worsen until AM 4/12/13. Temp. on 4/12/13 3:30 pm. 98.2 at 7 pm on 4/12/13 101 degrees normal T 97.7 degrees on 4/16/13 10 A.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Arthralgia, Chills, Lymphadenopathy, Pyrexia
Clinical narrative: Pt called office c/o 2 days fever (did not take temperature), chills, joint pain, swollen glands in neck and stomach cramps, no rash.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 25-FEB-2013 the patient was vaccinated with ZOSTAVAX (lot # H018088). Improperly stored ZOSTAVAX (12 for unspecified amount of time) was administered to the patient. No adverse event was reported. Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Injection site pain, Injection site rash, Injection site reaction, Injection site urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 71 year old male patient with depression, no drug reactions or allergies. On 17-APR-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H015749, exp date 02-JUN-2014) dose 1, intramuscular (dosage and anatomical location unspecified). The physician reported that on 17-APR-2013, patient developed an injection site reaction after vaccination with PNEUMOVAX23. The patient developed a rash, hives, induration, pain and possibly cellulitis at the injection site. He also had a cough. At the time of the report the outcome of injection site reaction, rash, hives, induration, pain and possibly cellulitis at the injection site and cough was reported as not recovered. Patient sought medical attention by visiting the office and received treatment with warm compresses, BENADRYL, CLIRITIN and triple antibiotic cream. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: 2 1/2 inches by 2 1/2 inches, slightly raised circular area of induration, red.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Pyrexia, Rash, Rash macular
Clinical narrative: Fever 102.6, rash with red/erythematous macule and single vesicle.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 year old female patient. On 12-APR-2013 the patient should have received the second dose GARDASIL (dosing information and route were not provided). However the patient was inadvertently administered two doses of GARDASIL on the same day (12-APR-2013). The outcome of patient was inadvertently administered two doses of GARDASIL on the same day is unknown. Additional information has been assistant.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Muscle aches, low grade fever, fatigue, mild headaches. Note I did not want flu shot. I was reminded how important it was. Dr was very pushy.