chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Mononucleosis heterophile test negative, Oropharyngeal pain, Pyrexia, Streptococcal identification test negative, Tremor
Clinical narrative: Fever 102 shakes chills abdominal pain sore throat, headache started at 10 pm on 4/6/09.
Age: 41.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Chest pain, Dysphagia, Dyspnoea, Musculoskeletal pain, Neck pain
Clinical narrative: Client reports rash to inner arms approx. 10 minutes after receiving vaccines on 04/09/09. Clients states she began to experience pain in Rt shoulder area which up the Rt side of her neck with "extreme" tenderness and slight difficulty swallowing. Rash continues - widespread - Client experienced 4 episodes of chest pain and shortness of breath 04-11-09 - lasting Approx - 20 minutes CT. Has appt for MD follow up today.
Age: 41.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Rash, Tenderness
Clinical narrative: Client reports rash to inner arms approx. 10 minutes after receiving vaccines on 04/09/09. Clients states she began to experience pain in Rt shoulder area which up the Rt side of her neck with "extreme" tenderness and slight difficulty swallowing. Rash continues - widespread - Client experienced 4 episodes of chest pain and shortness of breath 04-11-09 - lasting Approx - 20 minutes CT. Has appt for MD follow up today.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Crying, Decreased appetite, Diarrhoea, Haematochezia
Clinical narrative: Bloody stools, crying spells, abdominal pain crumps, decreased appetite, diarrhea.  Per mom
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC
Symptoms: Breath sounds abnormal, Rash, Rhinorrhoea
Clinical narrative: 4/18 developed rash behind ears, back of neck and on face then went to arms, torso and legs. Had running nose : raspy breathing. Saw on 4/23.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Erythema, Skin warm, Swelling
Clinical narrative: Pt came back into office. Per mother child had been crying since received vaccine. On examination swelling of the upper R thigh warm to touch red and measuring 6X6cm (red raised spot) Benadryl and Tylenol given did to follow up in office.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Pt administered VARIVAX and DAPTACEL in (R) Thigh on 4/21/09. On 4/22/09 Pt developed quarter size area of redness, swelling, with pruritus. Given ibuprofen and BENADRYL with ice. On 4/23/09 Pt returns from school with 3" area enlarged, red, itching.
Age: 1.3
Sex: F
Vaccine: DTAP, PNC
Symptoms: Urticaria
Clinical narrative: Urticaria generalized 2 days after immunizations
Age: 16.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: DTAP given instead of TDAP.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: -Swelling of LA, tender, hot, itchy - 2nd patient with same reaction to same Immunization
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Diarrhoea, Mucous stools, Rectal tenesmus
Clinical narrative: 3 days after vaccine developed diarrhea, > 10 times per day initially, some mucus - straining noted, no blood.  No fever, no ill contacts.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Large redness, itching & induration @ left thigh surrounding site of immunization within about 24 hrs. of vaccines - treated with BENADRYL
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 81.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Condition aggravated, Fall, Hand fracture, Hernia
Clinical narrative: 2 days later had bad stiffness on back of neck and then it went down both sides of torso.  Called doctor but said not related to vax.  Pain on back subsided after a week; however it made hernia worse to the point that required surgery on 3/4/09.  Weeks after surgery fell backwards and fractured right hand in landing.
Age: 81.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Surgery
Clinical narrative: 2 days later had bad stiffness on back of neck and then it went down both sides of torso.  Called doctor but said not related to vax.  Pain on back subsided after a week; however it made hernia worse to the point that required surgery on 3/4/09.  Weeks after surgery fell backwards and fractured right hand in landing.
Age: 23.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Blood test normal, Computerised tomogram normal, Muscle rigidity, Ophthalmoplegia, Pain in extremity
Clinical narrative: On 4/27 at 8:45am patient was vaccinated at the Health Department with Hepatitis A vaccine at 8:47am patient fainted. Nurse saw her unresponsive, with rigid muscle and during 30 seconds patient could not open her eyes. The ambulance was called when she threw up to rush her to the ER, where blood test and CAT scan were done. Nothing abnormal was found. The IV was given in the same area of the vaccine shot; patient could not move her arm due to pain. Took over the counter medicine TYLENOL and Ibuprofen.
Age: 23.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: On 4/27 at 8:45am patient was vaccinated at the Health Department with Hepatitis A vaccine at 8:47am patient fainted. Nurse saw her unresponsive, with rigid muscle and during 30 seconds patient could not open her eyes. The ambulance was called when she threw up to rush her to the ER, where blood test and CAT scan were done. Nothing abnormal was found. The IV was given in the same area of the vaccine shot; patient could not move her arm due to pain. Took over the counter medicine TYLENOL and Ibuprofen.
Age: 23.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Dyskinesia, Electroencephalogram, Musculoskeletal stiffness, Unresponsive to stimuli, Vomiting
Clinical narrative: On 4/27 at 8:45am patient was vaccinated at the Health Department with Hepatitis A vaccine at 8:47am patient fainted. Nurse saw her unresponsive, with rigid muscle and during 30 seconds patient could not open her eyes. The ambulance was called when she threw up to rush her to the ER, where blood test and CAT scan were done. Nothing abnormal was found. The IV was given in the same area of the vaccine shot; patient could not move her arm due to pain. Took over the counter medicine TYLENOL and Ibuprofen.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Excessive rapid hair loss a month after administration of GARDASIL vaccine
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Headache, Injection site rash, Rash generalised
Clinical narrative: Rash developed 2 days after shot - first on arm where shot was given then all over body. Headache today - 4-28-09.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Rash after HEP A with in 24 hr ATAVAX if needed.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Rash erythematous
Clinical narrative: 1600 Pt bad at clinic c/o having reaction - red rash noted on arms, legs, face - stomach and back approx 2 min hard hot redness area noted at injection site- left health unit to see doctor @ clinic.
Age: 15.0
Sex: M
Vaccine: HEP, TDAP, VARCEL
Symptoms: Erythema, Oedema
Clinical narrative: Pt with redness, edema 3 d after vaccine.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Coordination abnormal, Electroencephalogram, Head lag, Nuclear magnetic resonance imaging, Tremor
Clinical narrative: 3-31-09 Mom reports that client "walks strange, bobs head, hands shake, and coordination is off" after series of hepatitis b vaccines in 2001-2002.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Walking disability
Clinical narrative: 3-31-09 Mom reports that client "walks strange, bobs head, hands shake, and coordination is off" after series of hepatitis b vaccines in 2001-2002.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Redness, swelling and pain at injection site. Tenderness and slight rash also noted.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Body temperature, Erythema, Headache, Pruritus, Scab
Clinical narrative: Received vaccine on 4/13/09- symptoms began morning of 4/18/09, severe headache - 2 reddened areas R shoulder; one just above acromion process irregularly shaped - reddened with pinpoint open area in center - reports clear drainage and itching, approx 1 1/2" below and to the right area approx 2 1/2" L x 3/4" wide with scattered small scabs - area reddened. T 98.8 degrees F.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Wound drainage
Clinical narrative: Received vaccine on 4/13/09- symptoms began morning of 4/18/09, severe headache - 2 reddened areas R shoulder; one just above acromion process irregularly shaped - reddened with pinpoint open area in center - reports clear drainage and itching, approx 1 1/2" below and to the right area approx 2 1/2" L x 3/4" wide with scattered small scabs - area reddened. T 98.8 degrees F.
Age: 0.7
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Local reaction at injection site right thigh - warm, red & swollen Rx'd with MOTRIN & warm packs.  resolving 4/23/09
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Patient presented to clinic on 4/24/09 c/o right arm pain extending to neck and fever. Upon examination, right arm edema from shoulder to elbow. Right arm circumference 1/2 inch larger than the left. Pt is right handed. Temp. 98.3 degrees F.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Dysphonia, Urticaria
Clinical narrative: She was hoarse and hives - She lost her voice I was very scare so I took her to her doctor.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Rash to trunk and back that started about 4 days post smallpox VX.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: PNEUMOVAX administered right deltoid 4/21/09 after leaving office, pt started to develop pain in right upper arm. During rest of day and night, pain increased to involve right upper arm from elbow to shoulder - no redness or local heat - "felt like bursitis" used TYLENOL , local heat pain started to decrease 4/22/09.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dysphonia, Irritability, Urticaria, Vomiting
Clinical narrative: Pt developed hives right after vaccinations and for 1 week has raspy voice - increased vomiting, crankiness and episodic hives. Was treated with 3 days of prednisone and cetirizine.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: Within 24 hours, developed fever - 101.8 degree - Aching joints, headache. Treated with Ibuprofen. Duration - 12 hours.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: CSF test normal, Computerised tomogram abnormal, Fontanelle bulging, Lumbar puncture normal, Upper respiratory tract infection
Clinical narrative: 2 days later, with bulging fontanelle and CT scan with prominence of anterior CSF Spans over both frontal and temporal lobes - No hydrocephalic. This followed 1day of upper respiratory symptoms.
Age: 36.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Red raised rash appox.  1 1/2 " X 1 1/2.  Very itchy.  Pt. observed for one hour post 25mg po Benadryl. 05/12/09 Patient reaction was to the tuberculin skin test, not the HEP B or TDAP she was given on that day. Her reaction was a localized skin reaction which included rash, swelling, and uticaria.
Age: 13.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Erythematous area surrounding injection site 5x5 cm diameter with mild tenderness to palpation no fluctuance. Will try for possible infection. AUGMENTIN 875 bid x 10 days.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Convulsion, Loss of consciousness, Pallor
Clinical narrative: Pt. became pale after the vaccination, lost consciousness for 3 minutes - appeared to have a seizure vital signs stable. Paramedics came and pt. refused transport to ER - (Pt. alert and oriented after the 3 minutes.).
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Abasia, Aphasia, Asthenia, Computerised tomogram, Convulsion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 13 year old female who on 03-NOV-2008 was vaccinated with GARDASIL (lot number, route and site not reported) into her right arm. Approximately 3 weeks after getting 1st set of GARDASIL, on approximately 24-NOV-2008 the patient complained that she was weak and was having a hard time speaking. On 29-NOV-2008 the patient had 2 seizures. She was taken to the emergency room (ER). Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She was on a ventilator & had a feeding tube. She had neurological movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis was a reaction to the GARDASIL vaccine. Magnetic resonance imaging (MRI), Spinal Tap, Computed tomography (CT) scan, electroencephalogram (EEG), Echo gram, Electrocardiography (EKG) and multiple other tests were performed with no results reported. The patient required an emergency room visit and hospitalisation and the reporter considered the events as serious. No further information is available. Abasia, aphasia, asthenia, convulsion, encephalitis, gait disturbance, gastrointestinal tube insertion, mechanical ventilation and unresponsive to stimuli were considered to be disabling and immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 339718. The original reporting source was not provided. The VAERS ID# is 339718. Follow-up information has been received from a nurse practitioner who received an email concerning a 13 year old female who was vaccinated with a dose of GARDASIL and experienced a serious adverse reaction. The email stated that the patient spent 4 months in the intensive care unit in a hospital due to brain infection and swelling. It also stated that the patient has no muscle control, was on oxygen and will never walk again. The nurse practitioner considered brain infection, swelling, no muscle control, never walk again and was on oxygen were considered to be disabling, immediately life-threatening and required intensive care to prevent serious criteria. Additional information has been requested. This report was filed with the FDA. The VAERS number is 339718. Follow-up: As of the present time, patient is diagnosed with viral encephalitis, and also has chronic respiratory issues and also has a tracheostomy. She also has a feeding tube. And has to be tube fed. She is Not able to communicate at all.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Echocardiogram, Electrocardiogram, Electroencephalogram, Encephalitis, Gait disturbance
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 13 year old female who on 03-NOV-2008 was vaccinated with GARDASIL (lot number, route and site not reported) into her right arm. Approximately 3 weeks after getting 1st set of GARDASIL, on approximately 24-NOV-2008 the patient complained that she was weak and was having a hard time speaking. On 29-NOV-2008 the patient had 2 seizures. She was taken to the emergency room (ER). Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She was on a ventilator & had a feeding tube. She had neurological movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis was a reaction to the GARDASIL vaccine. Magnetic resonance imaging (MRI), Spinal Tap, Computed tomography (CT) scan, electroencephalogram (EEG), Echo gram, Electrocardiography (EKG) and multiple other tests were performed with no results reported. The patient required an emergency room visit and hospitalisation and the reporter considered the events as serious. No further information is available. Abasia, aphasia, asthenia, convulsion, encephalitis, gait disturbance, gastrointestinal tube insertion, mechanical ventilation and unresponsive to stimuli were considered to be disabling and immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 339718. The original reporting source was not provided. The VAERS ID# is 339718. Follow-up information has been received from a nurse practitioner who received an email concerning a 13 year old female who was vaccinated with a dose of GARDASIL and experienced a serious adverse reaction. The email stated that the patient spent 4 months in the intensive care unit in a hospital due to brain infection and swelling. It also stated that the patient has no muscle control, was on oxygen and will never walk again. The nurse practitioner considered brain infection, swelling, no muscle control, never walk again and was on oxygen were considered to be disabling, immediately life-threatening and required intensive care to prevent serious criteria. Additional information has been requested. This report was filed with the FDA. The VAERS number is 339718. Follow-up: As of the present time, patient is diagnosed with viral encephalitis, and also has chronic respiratory issues and also has a tracheostomy. She also has a feeding tube. And has to be tube fed. She is Not able to communicate at all.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Gastrointestinal tube insertion, Lumbar puncture, Mechanical ventilation, Nuclear magnetic resonance imaging, Unresponsive to stimuli
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 13 year old female who on 03-NOV-2008 was vaccinated with GARDASIL (lot number, route and site not reported) into her right arm. Approximately 3 weeks after getting 1st set of GARDASIL, on approximately 24-NOV-2008 the patient complained that she was weak and was having a hard time speaking. On 29-NOV-2008 the patient had 2 seizures. She was taken to the emergency room (ER). Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She was on a ventilator & had a feeding tube. She had neurological movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis was a reaction to the GARDASIL vaccine. Magnetic resonance imaging (MRI), Spinal Tap, Computed tomography (CT) scan, electroencephalogram (EEG), Echo gram, Electrocardiography (EKG) and multiple other tests were performed with no results reported. The patient required an emergency room visit and hospitalisation and the reporter considered the events as serious. No further information is available. Abasia, aphasia, asthenia, convulsion, encephalitis, gait disturbance, gastrointestinal tube insertion, mechanical ventilation and unresponsive to stimuli were considered to be disabling and immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 339718. The original reporting source was not provided. The VAERS ID# is 339718. Follow-up information has been received from a nurse practitioner who received an email concerning a 13 year old female who was vaccinated with a dose of GARDASIL and experienced a serious adverse reaction. The email stated that the patient spent 4 months in the intensive care unit in a hospital due to brain infection and swelling. It also stated that the patient has no muscle control, was on oxygen and will never walk again. The nurse practitioner considered brain infection, swelling, no muscle control, never walk again and was on oxygen were considered to be disabling, immediately life-threatening and required intensive care to prevent serious criteria. Additional information has been requested. This report was filed with the FDA. The VAERS number is 339718. Follow-up: As of the present time, patient is diagnosed with viral encephalitis, and also has chronic respiratory issues and also has a tracheostomy. She also has a feeding tube. And has to be tube fed. She is Not able to communicate at all.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Abasia, Asthenia, Blood test, Computerised tomogram, Confusional state
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 13 year old female who on 03-NOV-2008 was vaccinated with GARDASIL (lot number, route and site not reported) into her right arm. Approximately 3 weeks after getting 1st set of GARDASIL, on approximately 24-NOV-2008 the patient complained that she was weak and was having a hard time speaking. On 29-NOV-2008 the patient had 2 seizures. She was taken to the emergency room (ER). Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She was on a ventilator & had a feeding tube. She had neurological movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis was a reaction to the GARDASIL vaccine. Magnetic resonance imaging (MRI), Spinal Tap, Computed tomography (CT) scan, electroencephalogram (EEG), Echo gram, Electrocardiography (EKG) and multiple other tests were performed with no results reported. The patient required an emergency room visit and hospitalisation and the reporter considered the events as serious. No further information is available. Abasia, aphasia, asthenia, convulsion, encephalitis, gait disturbance, gastrointestinal tube insertion, mechanical ventilation and unresponsive to stimuli were considered to be disabling and immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 339718. The original reporting source was not provided. The VAERS ID# is 339718. Follow-up information has been received from a nurse practitioner who received an email concerning a 13 year old female who was vaccinated with a dose of GARDASIL and experienced a serious adverse reaction. The email stated that the patient spent 4 months in the intensive care unit in a hospital due to brain infection and swelling. It also stated that the patient has no muscle control, was on oxygen and will never walk again. The nurse practitioner considered brain infection, swelling, no muscle control, never walk again and was on oxygen were considered to be disabling, immediately life-threatening and required intensive care to prevent serious criteria. Additional information has been requested. This report was filed with the FDA. The VAERS number is 339718. Follow-up: As of the present time, patient is diagnosed with viral encephalitis, and also has chronic respiratory issues and also has a tracheostomy. She also has a feeding tube. And has to be tube fed. She is Not able to communicate at all.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Convulsion, Dizziness, Electrocardiogram, Electroencephalogram, Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 13 year old female who on 03-NOV-2008 was vaccinated with GARDASIL (lot number, route and site not reported) into her right arm. Approximately 3 weeks after getting 1st set of GARDASIL, on approximately 24-NOV-2008 the patient complained that she was weak and was having a hard time speaking. On 29-NOV-2008 the patient had 2 seizures. She was taken to the emergency room (ER). Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She was on a ventilator & had a feeding tube. She had neurological movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis was a reaction to the GARDASIL vaccine. Magnetic resonance imaging (MRI), Spinal Tap, Computed tomography (CT) scan, electroencephalogram (EEG), Echo gram, Electrocardiography (EKG) and multiple other tests were performed with no results reported. The patient required an emergency room visit and hospitalisation and the reporter considered the events as serious. No further information is available. Abasia, aphasia, asthenia, convulsion, encephalitis, gait disturbance, gastrointestinal tube insertion, mechanical ventilation and unresponsive to stimuli were considered to be disabling and immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 339718. The original reporting source was not provided. The VAERS ID# is 339718. Follow-up information has been received from a nurse practitioner who received an email concerning a 13 year old female who was vaccinated with a dose of GARDASIL and experienced a serious adverse reaction. The email stated that the patient spent 4 months in the intensive care unit in a hospital due to brain infection and swelling. It also stated that the patient has no muscle control, was on oxygen and will never walk again. The nurse practitioner considered brain infection, swelling, no muscle control, never walk again and was on oxygen were considered to be disabling, immediately life-threatening and required intensive care to prevent serious criteria. Additional information has been requested. This report was filed with the FDA. The VAERS number is 339718. Follow-up: As of the present time, patient is diagnosed with viral encephalitis, and also has chronic respiratory issues and also has a tracheostomy. She also has a feeding tube. And has to be tube fed. She is Not able to communicate at all.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Intensive care, Malaise, Mechanical ventilation, Mechanical ventilation, Nuclear magnetic resonance imaging
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 13 year old female who on 03-NOV-2008 was vaccinated with GARDASIL (lot number, route and site not reported) into her right arm. Approximately 3 weeks after getting 1st set of GARDASIL, on approximately 24-NOV-2008 the patient complained that she was weak and was having a hard time speaking. On 29-NOV-2008 the patient had 2 seizures. She was taken to the emergency room (ER). Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She was on a ventilator & had a feeding tube. She had neurological movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis was a reaction to the GARDASIL vaccine. Magnetic resonance imaging (MRI), Spinal Tap, Computed tomography (CT) scan, electroencephalogram (EEG), Echo gram, Electrocardiography (EKG) and multiple other tests were performed with no results reported. The patient required an emergency room visit and hospitalisation and the reporter considered the events as serious. No further information is available. Abasia, aphasia, asthenia, convulsion, encephalitis, gait disturbance, gastrointestinal tube insertion, mechanical ventilation and unresponsive to stimuli were considered to be disabling and immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 339718. The original reporting source was not provided. The VAERS ID# is 339718. Follow-up information has been received from a nurse practitioner who received an email concerning a 13 year old female who was vaccinated with a dose of GARDASIL and experienced a serious adverse reaction. The email stated that the patient spent 4 months in the intensive care unit in a hospital due to brain infection and swelling. It also stated that the patient has no muscle control, was on oxygen and will never walk again. The nurse practitioner considered brain infection, swelling, no muscle control, never walk again and was on oxygen were considered to be disabling, immediately life-threatening and required intensive care to prevent serious criteria. Additional information has been requested. This report was filed with the FDA. The VAERS number is 339718. Follow-up: As of the present time, patient is diagnosed with viral encephalitis, and also has chronic respiratory issues and also has a tracheostomy. She also has a feeding tube. And has to be tube fed. She is Not able to communicate at all.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Tracheostomy, Unresponsive to stimuli, X-ray
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 13 year old female who on 03-NOV-2008 was vaccinated with GARDASIL (lot number, route and site not reported) into her right arm. Approximately 3 weeks after getting 1st set of GARDASIL, on approximately 24-NOV-2008 the patient complained that she was weak and was having a hard time speaking. On 29-NOV-2008 the patient had 2 seizures. She was taken to the emergency room (ER). Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She was on a ventilator & had a feeding tube. She had neurological movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis was a reaction to the GARDASIL vaccine. Magnetic resonance imaging (MRI), Spinal Tap, Computed tomography (CT) scan, electroencephalogram (EEG), Echo gram, Electrocardiography (EKG) and multiple other tests were performed with no results reported. The patient required an emergency room visit and hospitalisation and the reporter considered the events as serious. No further information is available. Abasia, aphasia, asthenia, convulsion, encephalitis, gait disturbance, gastrointestinal tube insertion, mechanical ventilation and unresponsive to stimuli were considered to be disabling and immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 339718. The original reporting source was not provided. The VAERS ID# is 339718. Follow-up information has been received from a nurse practitioner who received an email concerning a 13 year old female who was vaccinated with a dose of GARDASIL and experienced a serious adverse reaction. The email stated that the patient spent 4 months in the intensive care unit in a hospital due to brain infection and swelling. It also stated that the patient has no muscle control, was on oxygen and will never walk again. The nurse practitioner considered brain infection, swelling, no muscle control, never walk again and was on oxygen were considered to be disabling, immediately life-threatening and required intensive care to prevent serious criteria. Additional information has been requested. This report was filed with the FDA. The VAERS number is 339718. Follow-up: As of the present time, patient is diagnosed with viral encephalitis, and also has chronic respiratory issues and also has a tracheostomy. She also has a feeding tube. And has to be tube fed. She is Not able to communicate at all.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Abasia, Aphasia, Aphasia, Asthenia, Brain oedema
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 13 year old female who on 03-NOV-2008 was vaccinated with GARDASIL (lot number, route and site not reported) into her right arm. Approximately 3 weeks after getting 1st set of GARDASIL, on approximately 24-NOV-2008 the patient complained that she was weak and was having a hard time speaking. On 29-NOV-2008 the patient had 2 seizures. She was taken to the emergency room (ER). Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She was on a ventilator & had a feeding tube. She had neurological movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis was a reaction to the GARDASIL vaccine. Magnetic resonance imaging (MRI), Spinal Tap, Computed tomography (CT) scan, electroencephalogram (EEG), Echo gram, Electrocardiography (EKG) and multiple other tests were performed with no results reported. The patient required an emergency room visit and hospitalisation and the reporter considered the events as serious. No further information is available. Abasia, aphasia, asthenia, convulsion, encephalitis, gait disturbance, gastrointestinal tube insertion, mechanical ventilation and unresponsive to stimuli were considered to be disabling and immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 339718. The original reporting source was not provided. The VAERS ID# is 339718. Follow-up information has been received from a nurse practitioner who received an email concerning a 13 year old female who was vaccinated with a dose of GARDASIL and experienced a serious adverse reaction. The email stated that the patient spent 4 months in the intensive care unit in a hospital due to brain infection and swelling. It also stated that the patient has no muscle control, was on oxygen and will never walk again. The nurse practitioner considered brain infection, swelling, no muscle control, never walk again and was on oxygen were considered to be disabling, immediately life-threatening and required intensive care to prevent serious criteria. Additional information has been requested. This report was filed with the FDA. The VAERS number is 339718. Follow-up: As of the present time, patient is diagnosed with viral encephalitis, and also has chronic respiratory issues and also has a tracheostomy. She also has a feeding tube. And has to be tube fed. She is Not able to communicate at all.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Chronic respiratory disease, Computerised tomogram, Convulsion, Echocardiogram, Electrocardiogram
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 13 year old female who on 03-NOV-2008 was vaccinated with GARDASIL (lot number, route and site not reported) into her right arm. Approximately 3 weeks after getting 1st set of GARDASIL, on approximately 24-NOV-2008 the patient complained that she was weak and was having a hard time speaking. On 29-NOV-2008 the patient had 2 seizures. She was taken to the emergency room (ER). Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She was on a ventilator & had a feeding tube. She had neurological movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis was a reaction to the GARDASIL vaccine. Magnetic resonance imaging (MRI), Spinal Tap, Computed tomography (CT) scan, electroencephalogram (EEG), Echo gram, Electrocardiography (EKG) and multiple other tests were performed with no results reported. The patient required an emergency room visit and hospitalisation and the reporter considered the events as serious. No further information is available. Abasia, aphasia, asthenia, convulsion, encephalitis, gait disturbance, gastrointestinal tube insertion, mechanical ventilation and unresponsive to stimuli were considered to be disabling and immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 339718. The original reporting source was not provided. The VAERS ID# is 339718. Follow-up information has been received from a nurse practitioner who received an email concerning a 13 year old female who was vaccinated with a dose of GARDASIL and experienced a serious adverse reaction. The email stated that the patient spent 4 months in the intensive care unit in a hospital due to brain infection and swelling. It also stated that the patient has no muscle control, was on oxygen and will never walk again. The nurse practitioner considered brain infection, swelling, no muscle control, never walk again and was on oxygen were considered to be disabling, immediately life-threatening and required intensive care to prevent serious criteria. Additional information has been requested. This report was filed with the FDA. The VAERS number is 339718. Follow-up: As of the present time, patient is diagnosed with viral encephalitis, and also has chronic respiratory issues and also has a tracheostomy. She also has a feeding tube. And has to be tube fed. She is Not able to communicate at all.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Electroencephalogram, Encephalitis, Gait disturbance, Gastrointestinal tube insertion, Hypotonia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 13 year old female who on 03-NOV-2008 was vaccinated with GARDASIL (lot number, route and site not reported) into her right arm. Approximately 3 weeks after getting 1st set of GARDASIL, on approximately 24-NOV-2008 the patient complained that she was weak and was having a hard time speaking. On 29-NOV-2008 the patient had 2 seizures. She was taken to the emergency room (ER). Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She was on a ventilator & had a feeding tube. She had neurological movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis was a reaction to the GARDASIL vaccine. Magnetic resonance imaging (MRI), Spinal Tap, Computed tomography (CT) scan, electroencephalogram (EEG), Echo gram, Electrocardiography (EKG) and multiple other tests were performed with no results reported. The patient required an emergency room visit and hospitalisation and the reporter considered the events as serious. No further information is available. Abasia, aphasia, asthenia, convulsion, encephalitis, gait disturbance, gastrointestinal tube insertion, mechanical ventilation and unresponsive to stimuli were considered to be disabling and immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 339718. The original reporting source was not provided. The VAERS ID# is 339718. Follow-up information has been received from a nurse practitioner who received an email concerning a 13 year old female who was vaccinated with a dose of GARDASIL and experienced a serious adverse reaction. The email stated that the patient spent 4 months in the intensive care unit in a hospital due to brain infection and swelling. It also stated that the patient has no muscle control, was on oxygen and will never walk again. The nurse practitioner considered brain infection, swelling, no muscle control, never walk again and was on oxygen were considered to be disabling, immediately life-threatening and required intensive care to prevent serious criteria. Additional information has been requested. This report was filed with the FDA. The VAERS number is 339718. Follow-up: As of the present time, patient is diagnosed with viral encephalitis, and also has chronic respiratory issues and also has a tracheostomy. She also has a feeding tube. And has to be tube fed. She is Not able to communicate at all.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Intensive care, Laboratory test, Lumbar puncture, Mechanical ventilation, Neurological symptom
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 13 year old female who on 03-NOV-2008 was vaccinated with GARDASIL (lot number, route and site not reported) into her right arm. Approximately 3 weeks after getting 1st set of GARDASIL, on approximately 24-NOV-2008 the patient complained that she was weak and was having a hard time speaking. On 29-NOV-2008 the patient had 2 seizures. She was taken to the emergency room (ER). Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She was on a ventilator & had a feeding tube. She had neurological movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis was a reaction to the GARDASIL vaccine. Magnetic resonance imaging (MRI), Spinal Tap, Computed tomography (CT) scan, electroencephalogram (EEG), Echo gram, Electrocardiography (EKG) and multiple other tests were performed with no results reported. The patient required an emergency room visit and hospitalisation and the reporter considered the events as serious. No further information is available. Abasia, aphasia, asthenia, convulsion, encephalitis, gait disturbance, gastrointestinal tube insertion, mechanical ventilation and unresponsive to stimuli were considered to be disabling and immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 339718. The original reporting source was not provided. The VAERS ID# is 339718. Follow-up information has been received from a nurse practitioner who received an email concerning a 13 year old female who was vaccinated with a dose of GARDASIL and experienced a serious adverse reaction. The email stated that the patient spent 4 months in the intensive care unit in a hospital due to brain infection and swelling. It also stated that the patient has no muscle control, was on oxygen and will never walk again. The nurse practitioner considered brain infection, swelling, no muscle control, never walk again and was on oxygen were considered to be disabling, immediately life-threatening and required intensive care to prevent serious criteria. Additional information has been requested. This report was filed with the FDA. The VAERS number is 339718. Follow-up: As of the present time, patient is diagnosed with viral encephalitis, and also has chronic respiratory issues and also has a tracheostomy. She also has a feeding tube. And has to be tube fed. She is Not able to communicate at all.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging, Unresponsive to stimuli
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 13 year old female who on 03-NOV-2008 was vaccinated with GARDASIL (lot number, route and site not reported) into her right arm. Approximately 3 weeks after getting 1st set of GARDASIL, on approximately 24-NOV-2008 the patient complained that she was weak and was having a hard time speaking. On 29-NOV-2008 the patient had 2 seizures. She was taken to the emergency room (ER). Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She was on a ventilator & had a feeding tube. She had neurological movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis movements. All of the testing done showed that the patient had encephalitis. The cause of the encephalitis was a reaction to the GARDASIL vaccine. Magnetic resonance imaging (MRI), Spinal Tap, Computed tomography (CT) scan, electroencephalogram (EEG), Echo gram, Electrocardiography (EKG) and multiple other tests were performed with no results reported. The patient required an emergency room visit and hospitalisation and the reporter considered the events as serious. No further information is available. Abasia, aphasia, asthenia, convulsion, encephalitis, gait disturbance, gastrointestinal tube insertion, mechanical ventilation and unresponsive to stimuli were considered to be disabling and immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 339718. The original reporting source was not provided. The VAERS ID# is 339718. Follow-up information has been received from a nurse practitioner who received an email concerning a 13 year old female who was vaccinated with a dose of GARDASIL and experienced a serious adverse reaction. The email stated that the patient spent 4 months in the intensive care unit in a hospital due to brain infection and swelling. It also stated that the patient has no muscle control, was on oxygen and will never walk again. The nurse practitioner considered brain infection, swelling, no muscle control, never walk again and was on oxygen were considered to be disabling, immediately life-threatening and required intensive care to prevent serious criteria. Additional information has been requested. This report was filed with the FDA. The VAERS number is 339718. Follow-up: As of the present time, patient is diagnosed with viral encephalitis, and also has chronic respiratory issues and also has a tracheostomy. She also has a feeding tube. And has to be tube fed. She is Not able to communicate at all.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. A 12 week male patient with Gastro esophageal reflux disease and a history of Respiratory syncytial virus bronchiolitis was vaccinated with the second dose of ROTATEQ (lot 661054/0966x) orally on 29-DEC-2008. Concomitant vaccine included the second dose of PREVNAR (Lot #C99098) intramuscularly into the right leg, the second dose of PEDIARIX (Lot #AC21B198BA), intramuscularly into the right leg and the second dose of ACTHIB (Lot # UF520AA) intramuscularly into the left leg. About 2 weeks post vaccination, child had intussusception. The patient was admitted to the hospital for intussusception on 15-JAN-2009. Final diagnostic: intussusception after laparotomy with reduction of ileal segment and appendectomy. Records revealed patient experienced anorexia, diet refusal, increased irritability, occasional emesis for 3 days, no bowel movement for 2 days and abdominal pain for one day. The patient had bloody stool in emergency room. Surgery consult was done. Enema did not reduce ileal segment and the patient was taken to operation room. Progressed well, diet advanced and discharged to home with surgery follow-up. The patient returned to emergency room on 22-JAN-2009 due to vomiting, diarrhea, irritability and apparent abdominal pain. Final diagnostic: gastroenteritis. Surgery consult done. Labs diagnostics performed included: abdominal x-ray negative and abdominal ultrasound positive ileal segment. The listing indicated that one or more of the events required hospitalization and were considered to be immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released. The original reporting source was not provided. The VAERS ID # is 341802. No further information is available.