chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPVX, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Convulsion, Dizziness, Fatigue, Headache, Pain in extremity
Clinical narrative: She fainted after the administration of the last of three vaccines administered that day.  The third was the HPV Vaccine.  She had on convulsion as she came to.  36 hours after the vaccine she started having intense itching which broke in to hives after about 48 hours.  She was very tired, dizzy, and had a bad headache and sore arms for the 24 hours following the vaccines.
Age: 12.0
Sex: F
Vaccine: HPVX, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Pruritus, Syncope, Urticaria
Clinical narrative: She fainted after the administration of the last of three vaccines administered that day.  The third was the HPV Vaccine.  She had on convulsion as she came to.  36 hours after the vaccine she started having intense itching which broke in to hives after about 48 hours.  She was very tired, dizzy, and had a bad headache and sore arms for the 24 hours following the vaccines.
Age: 12.0
Sex: F
Vaccine: HPVX, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: She fainted after the administration of the last of three vaccines administered that day.  The third was the HPV Vaccine.  She had on convulsion as she came to.  36 hours after the vaccine she started having intense itching which broke in to hives after about 48 hours.  She was very tired, dizzy, and had a bad headache and sore arms for the 24 hours following the vaccines.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: Vaccine given 6-4-07. 6/14/07 itching left side of head, erythema left shoulder and upper back, fluid filled vesicle (varicella) Right upper arm.
Age: 18.0
Sex: M
Vaccine: HEP, PNC
Symptoms: Cellulitis, Erythema, Musculoskeletal discomfort, Pyrexia, Skin warm
Clinical narrative: 6/8-Saw doctor. Diagnosis-possible vaccine reaction. Red spot (4-5 inches diameter, warm) on left arm, neck discomfort, feverish (104 degrees). Diagnosis arm cellulitis, Treatment with Augmentin twice a day for 10 days, Tylenol.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Hypokinesia, Injection site erythema, Injection site necrosis, Pain, Skin striae
Clinical narrative: Reaction began with large red bump, size of mothers fist, per mother. Area was hard and red with red lines up shoulder. Child complained of pain and would not move arm. Arm affected was the right arm. Parent called doctor, childs pediatrician for directions. Prescribed prednisone, Benadryl and ibuprofen. Information obtained over phone. Did not visualize reaction. Information from mother.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site inflammation
Clinical narrative: Left upper arm 9cm inflammation, 2 cm induration darker red in center where induration is located.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patients mother phoned stated patient reaction at Varicella injection site. Swollen red (aprox 2-2 1/2 in diameter) and warm to touch. Child continues playful Tylenol (Motrin as needed for pain).
Age: 56.0
Sex: F
Vaccine: ANTH
Symptoms: Asthenia, Full blood count normal, Irritability, Micturition urgency, Pain
Clinical narrative: Patient c/o "skin aches", "sweating", "continual urge to pee", "weakness", and "irritability".  Diagnosed with a urinary tract infection during visit.
Age: 56.0
Sex: F
Vaccine: ANTH
Symptoms: Urinary tract infection, Urine analysis normal
Clinical narrative: Patient c/o "skin aches", "sweating", "continual urge to pee", "weakness", and "irritability".  Diagnosed with a urinary tract infection during visit.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, UNK
Symptoms: Eczema
Clinical narrative: Patient's eczema began one week after receiving a combination of the HIB1 and DTAP vaccines. Since then he has suffered from extreme eczema that prevents normal lifestyle and sleep. His eczema was formally diagnosed on May 18, 2004.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Electromyogram, Muscle atrophy, Neuralgic amyotrophy, Nuclear magnetic resonance imaging
Clinical narrative: Diognosed: Parsonage_Turner Syndrome (Brachial Plexus Neuritis) 100% loss of left biceps muscle and partial loss of deltoid muscle. Symptoms started within 3 weeks of vaccination of pneumococcal vaccines (G0009) and (90732).  6/29/07 Received provider medical records which reveal patient was new to practice as of 1/31/07 initial eval & showed patient in excellent health.  Initially declined pneumo vax then accepted on 2/5/07.  Vax record confirms lot & dose as reported. 7/20/07 Received neurologist medical records which reveal patient initially seen 4/13/07 for complaints of left arm, shoulder & neck  weakness & pain for approx 1 mo.  Patient had noted snapping sensation in left shoulder during work out at gym shortly prior to pain initiation.  Seen by neurosurgeon, MRI done & routine every 2 wks chiropractic treatement was done.  Following chiropractic adjustment, patient felt intensified pain w/paresthesias & weakness of left biceps muscle.  Seen by second chiropractor.  Left arm pain was quite severe over 7-10 days then subsided w/persistent weakness & tingling & left hand weakness.  Neuro exam revealed muscle wasting of left arm, esp biceps; triceps were WNL.   FINAL DX: Brachial plexus neuritis.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The injection site turned pink within 15 minutes of the administration of the vaccine.  It felt slightly warm to the touch.  She did not complain of any dizziness, lightheadedness, or breathing difficulties.  I recommended she take some Benadryl to control the possible allergic reaction.  I advised her to monitor the site for any changes, and to contact her physician or ER if her condition worsened.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood test, Blood test normal, Cold sweat, Dizziness, Electrocardiogram normal
Clinical narrative: Progressive tingling in extremities and lower face/ mouth, random muscle contractions, progressive loss of motor skills over the course of a week, at the end of which patient could not fasten a button. Upon arrival to the ER, patient's extremities were cold, clammy, and colorless. Admitted to Medical Center as an inpatient (Dec. 3, 2006). Diagnosed with Guillain Barre Syndrome, and treated with three courses of plasmapheresis. While hospitalized, patient experienced mild tachycardia and hypotension. 90% recovery as of release from the hospital. One month later (approx. early Jan. 2007) mild relapse with tingling in extremities and moderate loss of motor skills, which subsided within a few days. 2 months after hospitalization (approx. mid-Feb. 2007) another mild relapse, mild tingling in extremities and moderate motor skill loss, again subsided within a few days time. About 3 months after hospitalization (approx. mid-March 2007) more severe relapse (currently unsubsided) with tingling in extremities, loss of motor skills, dizziness, collapsing spells, orthostatic hypotension, shaking/ quakes, clammy hands and feet. Diagnosed by a private neurologist as having vestibular nerve difficulties. Although improved, patient still experiences dizziness, quakes, occasional, uncontrolled single muscle twitches randomly throughout her body. Extremities, including random digits of the hand, occasionally become cold and clammy, which cannot be remedied with heat, but subside by themselves.  09/04/2007 Records received from CDC for DOS 12/3-8/2006.  Patient presented with 1 week hx of paresthesias in her arms and legs.  Symptoms began with runny nose and sore throat, then pt woke the next day with tingling in arms and fingertips.  The following day pt began having difficulty walking, motor weakness and gait imbalance.  Seen by PCP who was unable to elicit any reflexes. Pt presented to the ER with worsening sx, especially with fine motor control in the hands. Asymptomatic tachycardia noted throughout hospital stay likely due to autonomic instability.  Responded well to plasmapharesis. Discharge DX: Preventative (presumptive?) Guillain-Barre syndrome.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Electroencephalogram normal, Electromyogram normal, Guillain-Barre syndrome, Hypotension, Muscle contractions involuntary
Clinical narrative: Progressive tingling in extremities and lower face/ mouth, random muscle contractions, progressive loss of motor skills over the course of a week, at the end of which patient could not fasten a button. Upon arrival to the ER, patient's extremities were cold, clammy, and colorless. Admitted to Medical Center as an inpatient (Dec. 3, 2006). Diagnosed with Guillain Barre Syndrome, and treated with three courses of plasmapheresis. While hospitalized, patient experienced mild tachycardia and hypotension. 90% recovery as of release from the hospital. One month later (approx. early Jan. 2007) mild relapse with tingling in extremities and moderate loss of motor skills, which subsided within a few days. 2 months after hospitalization (approx. mid-Feb. 2007) another mild relapse, mild tingling in extremities and moderate motor skill loss, again subsided within a few days time. About 3 months after hospitalization (approx. mid-March 2007) more severe relapse (currently unsubsided) with tingling in extremities, loss of motor skills, dizziness, collapsing spells, orthostatic hypotension, shaking/ quakes, clammy hands and feet. Diagnosed by a private neurologist as having vestibular nerve difficulties. Although improved, patient still experiences dizziness, quakes, occasional, uncontrolled single muscle twitches randomly throughout her body. Extremities, including random digits of the hand, occasionally become cold and clammy, which cannot be remedied with heat, but subside by themselves.  09/04/2007 Records received from CDC for DOS 12/3-8/2006.  Patient presented with 1 week hx of paresthesias in her arms and legs.  Symptoms began with runny nose and sore throat, then pt woke the next day with tingling in arms and fingertips.  The following day pt began having difficulty walking, motor weakness and gait imbalance.  Seen by PCP who was unable to elicit any reflexes. Pt presented to the ER with worsening sx, especially with fine motor control in the hands. Asymptomatic tachycardia noted throughout hospital stay likely due to autonomic instability.  Responded well to plasmapharesis. Discharge DX: Preventative (presumptive?) Guillain-Barre syndrome.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Muscle twitching, Nuclear magnetic resonance imaging normal, Orthostatic hypotension, Pallor, Paraesthesia
Clinical narrative: Progressive tingling in extremities and lower face/ mouth, random muscle contractions, progressive loss of motor skills over the course of a week, at the end of which patient could not fasten a button. Upon arrival to the ER, patient's extremities were cold, clammy, and colorless. Admitted to Medical Center as an inpatient (Dec. 3, 2006). Diagnosed with Guillain Barre Syndrome, and treated with three courses of plasmapheresis. While hospitalized, patient experienced mild tachycardia and hypotension. 90% recovery as of release from the hospital. One month later (approx. early Jan. 2007) mild relapse with tingling in extremities and moderate loss of motor skills, which subsided within a few days. 2 months after hospitalization (approx. mid-Feb. 2007) another mild relapse, mild tingling in extremities and moderate motor skill loss, again subsided within a few days time. About 3 months after hospitalization (approx. mid-March 2007) more severe relapse (currently unsubsided) with tingling in extremities, loss of motor skills, dizziness, collapsing spells, orthostatic hypotension, shaking/ quakes, clammy hands and feet. Diagnosed by a private neurologist as having vestibular nerve difficulties. Although improved, patient still experiences dizziness, quakes, occasional, uncontrolled single muscle twitches randomly throughout her body. Extremities, including random digits of the hand, occasionally become cold and clammy, which cannot be remedied with heat, but subside by themselves.  09/04/2007 Records received from CDC for DOS 12/3-8/2006.  Patient presented with 1 week hx of paresthesias in her arms and legs.  Symptoms began with runny nose and sore throat, then pt woke the next day with tingling in arms and fingertips.  The following day pt began having difficulty walking, motor weakness and gait imbalance.  Seen by PCP who was unable to elicit any reflexes. Pt presented to the ER with worsening sx, especially with fine motor control in the hands. Asymptomatic tachycardia noted throughout hospital stay likely due to autonomic instability.  Responded well to plasmapharesis. Discharge DX: Preventative (presumptive?) Guillain-Barre syndrome.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Peripheral coldness, Tachycardia, Tremor, Vestibular disorder
Clinical narrative: Progressive tingling in extremities and lower face/ mouth, random muscle contractions, progressive loss of motor skills over the course of a week, at the end of which patient could not fasten a button. Upon arrival to the ER, patient's extremities were cold, clammy, and colorless. Admitted to Medical Center as an inpatient (Dec. 3, 2006). Diagnosed with Guillain Barre Syndrome, and treated with three courses of plasmapheresis. While hospitalized, patient experienced mild tachycardia and hypotension. 90% recovery as of release from the hospital. One month later (approx. early Jan. 2007) mild relapse with tingling in extremities and moderate loss of motor skills, which subsided within a few days. 2 months after hospitalization (approx. mid-Feb. 2007) another mild relapse, mild tingling in extremities and moderate motor skill loss, again subsided within a few days time. About 3 months after hospitalization (approx. mid-March 2007) more severe relapse (currently unsubsided) with tingling in extremities, loss of motor skills, dizziness, collapsing spells, orthostatic hypotension, shaking/ quakes, clammy hands and feet. Diagnosed by a private neurologist as having vestibular nerve difficulties. Although improved, patient still experiences dizziness, quakes, occasional, uncontrolled single muscle twitches randomly throughout her body. Extremities, including random digits of the hand, occasionally become cold and clammy, which cannot be remedied with heat, but subside by themselves.  09/04/2007 Records received from CDC for DOS 12/3-8/2006.  Patient presented with 1 week hx of paresthesias in her arms and legs.  Symptoms began with runny nose and sore throat, then pt woke the next day with tingling in arms and fingertips.  The following day pt began having difficulty walking, motor weakness and gait imbalance.  Seen by PCP who was unable to elicit any reflexes. Pt presented to the ER with worsening sx, especially with fine motor control in the hands. Asymptomatic tachycardia noted throughout hospital stay likely due to autonomic instability.  Responded well to plasmapharesis. Discharge DX: Preventative (presumptive?) Guillain-Barre syndrome.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Arrhythmia, Sudden cardiac death
Clinical narrative: Initial report received on 22 February 2007 that was secondary to information provided by the Immunization Safety office of the centers of disease control and Prevention during a presentation as an Advisory Committee on Immunization Practice conference on 22 February 2007. A 13-year-old male patient with a past medical history of rash following cephalosorin and reactive airway disease, had received a first, intramuscular injection of Adacel on 26 August 2005. The lot number and site of administration were not reported. Fourteen days post-immunization, the patient died suddenly of cardiac arrhythmia while walking a dog. Paramedics attempted resuscitation, but the patient did not respond. The patient was pronounced dead at 17:45 p.m on 09 September 2005. The coroner reported the cause of death as cardiac arrhythmia due to undetermined cause. At the time of this report, all work up has been negative. A full autopsy was performed.
Age: 62.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Arteriosclerosis, Death, Injection site pain, Myocardial infarction
Clinical narrative: Initial report received on 22 February 2007 secondary to information provided during a presentation by the Centers for Disease Control and prevention at the Advisory Committee on Immunization Practice conference held on 22 February 2007 (VAERS# 267810). A 62-year-old male patient, with a history of hyperlipidemia, had received an intramuscular injection of Adacel, lot number not reported; an intramuscular injection of IPOL, lot number not reported; a subcutaneous injection of YF-VAX, lot number not reported; an intramuscular injection of Typhim VI, lot number not reported; and an intramuscular injection of Havrix, manufacturer GSD, lot number not reported; on 17 November 2006. Ten days post-immunization, the patient was found dead in his home as a result of myocardial infraction due to atheroscleotic disease. The patient's son had reported that the patient had been feeling fine, "only has a sore arm after shots." An autopsy was not performed.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Pain, Paraesthesia, Rash
Clinical narrative: Information has been received from a physician concerning a female patient who in February 2007, was vaccinated with a 0.65 ml dose of Zostavax vaccine. The physician reported that the patient was scheduled to have the vaccine and it was put off by the patient for a few days and the patient started to feel pain on her side prior to vaccination. Four to five days after vaccination the patient developed a typical dermatone and rash. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning a 68 year old female patient with hypertension and hypercholesterolemia who on 12-DEC-2006 (initially reported as in February 2007), was vaccinated with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot # 652966/0722F). On 19-DEC-2006 the patient was seen in the office with complaints of pain and swelling of the R side of the scalp with no blisters at that time. On 23-DEC-2006 the patient presented with more frontal region pain and blister were present. She was given VALTREX and by 27-DEC-2006 the patient reported relief of pain and no new blisters. The physician reported that the patient was scheduled to have the vaccine and it was put off by the patient for a few days and the patient started to feel pain on her side prior to vaccination. Four to five days after vaccination the patient developed a typical dermatone and rash. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not available.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Pain, Rash, Swelling
Clinical narrative: Information has been received from a physician concerning a female patient who in February 2007, was vaccinated with a 0.65 ml dose of Zostavax vaccine. The physician reported that the patient was scheduled to have the vaccine and it was put off by the patient for a few days and the patient started to feel pain on her side prior to vaccination. Four to five days after vaccination the patient developed a typical dermatone and rash. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning a 68 year old female patient with hypertension and hypercholesterolemia who on 12-DEC-2006 (initially reported as in February 2007), was vaccinated with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot # 652966/0722F). On 19-DEC-2006 the patient was seen in the office with complaints of pain and swelling of the R side of the scalp with no blisters at that time. On 23-DEC-2006 the patient presented with more frontal region pain and blister were present. She was given VALTREX and by 27-DEC-2006 the patient reported relief of pain and no new blisters. The physician reported that the patient was scheduled to have the vaccine and it was put off by the patient for a few days and the patient started to feel pain on her side prior to vaccination. Four to five days after vaccination the patient developed a typical dermatone and rash. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not available.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Presyncope, Trendelenburg position
Clinical narrative: Information has been received concerning a 12 year old female who on 25-JAN-2007 was vaccination with Gardasil, lot# 653735/0688F in the left arm (second dose). On 25-JAN-2007 after receiving the vaccine and getting off the table the patient felt dizzy and walked to the appointment desk and became very "oozy" - almost fainted. The patient's mother caught her and put her in a Trendelenberg Position. The patient was given orange juice and quickly felt better. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Presyncope
Clinical narrative: Information has been received concerning a 12 year old female who on 25-JAN-2007 was vaccination with Gardasil, lot# 653735/0688F in the left arm (second dose). On 25-JAN-2007 after receiving the vaccine and getting off the table the patient felt dizzy and walked to the appointment desk and became very "oozy" - almost fainted. The patient's mother caught her and put her in a Trendelenberg Position. The patient was given orange juice and quickly felt better. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site mass, Injection site pain, Myalgia, Neuralgia
Clinical narrative: Information has been received from a physician concerning a 22 year old female medical assistant, who on 27-FEB-2007 was vaccinated in the right arm, with the first dose of Gardasil (Lot #656049/0187U). On 01-MAR-2007 the patient experienced neck and arm pain, and the physician question possible neuritis two days later. The patient visited the office and was treated with MEDROL and supportive care, with slow improvement noted. Additional information has been requested. This is is follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a physician concerning a 22 year old white female medical assistant who on 27-FEB-2007 was vaccinated in the right arm with the first dose of GARDASIL (Lot #656049/0187U). On 01-MAR-2007 the patient experienced neck and arm pain, and the physician questioned possible neuritis two days later. The patient visited the office and was treated with MEDROL and supportive care, with slow improvement noted. At the time of the report, the patient was "doing fine - no problems." Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Neck pain, Neuritis, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 22 year old female medical assistant, who on 27-FEB-2007 was vaccinated in the right arm, with the first dose of Gardasil (Lot #656049/0187U). On 01-MAR-2007 the patient experienced neck and arm pain, and the physician question possible neuritis two days later. The patient visited the office and was treated with MEDROL and supportive care, with slow improvement noted. Additional information has been requested. This is is follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a physician concerning a 22 year old white female medical assistant who on 27-FEB-2007 was vaccinated in the right arm with the first dose of GARDASIL (Lot #656049/0187U). On 01-MAR-2007 the patient experienced neck and arm pain, and the physician questioned possible neuritis two days later. The patient visited the office and was treated with MEDROL and supportive care, with slow improvement noted. At the time of the report, the patient was "doing fine - no problems." Additional information is not expected.
Age: 31.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Abnormal loss of weight, Arthralgia, Blindness, Blood glucose increased, Blood ketone body absent
Clinical narrative: Patient concerned that his Type 1 diabetes diagnosed in Jan 2006 could have been caused by the anthrax vaccine received in 1997. SEE CLINICAL SUMMARY
Age: 31.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Constipation, Dependence on enabling machine or device, Diarrhoea, Fatigue, Glucose urine present
Clinical narrative: Patient concerned that his Type 1 diabetes diagnosed in Jan 2006 could have been caused by the anthrax vaccine received in 1997. SEE CLINICAL SUMMARY
Age: 31.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Myalgia, Skin papilloma, Type 1 diabetes mellitus, Urine bilirubin increased, Urine ketone body present
Clinical narrative: Patient concerned that his Type 1 diabetes diagnosed in Jan 2006 could have been caused by the anthrax vaccine received in 1997. SEE CLINICAL SUMMARY
Age: 31.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Aspartate aminotransferase, Blood glucose decreased, Diabetes mellitus insulin-dependent, Glycosylated haemoglobin
Clinical narrative: Patient concerned that his Type 1 diabetes diagnosed in Jan 2006 could have been caused by the anthrax vaccine received in 1997. SEE CLINICAL SUMMARY
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Blood test, Computerised tomogram, Guillain-Barre syndrome, Lumbar puncture, Nerve conduction studies
Clinical narrative: Initial report received on 08 May 2007 from the Centers for Disease Control and Prevention, VAERS# 275936. A 17-year-old male patient had received an injection of Menactra, lot"U2002AC; and an injection of Adacel, lot number not reported; on 07 March 2007. on 27 march 2007, the patient was reported to have GBS which required a 14 day hospitalization. The patient recovered. Additional medically relevant information was not provided. An agency is in the process of following-up on this report.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Initial report received on 08 May 2007 from the Centers for Disease Control and Prevention, VAERS# 275936. A 17-year-old male patient had received an injection of Menactra, lot"U2002AC; and an injection of Adacel, lot number not reported; on 07 March 2007. on 27 march 2007, the patient was reported to have GBS which required a 14 day hospitalization. The patient recovered. Additional medically relevant information was not provided. An agency is in the process of following-up on this report.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial report received on 08 May 2007 from the Centers for Disease Control and Prevention, VAERS# 275936. A 17-year-old male patient had received an injection of Menactra, lot"U2002AC; and an injection of Adacel, lot number not reported; on 07 March 2007. on 27 march 2007, the patient was reported to have GBS which required a 14 day hospitalization. The patient recovered. Additional medically relevant information was not provided. An agency is in the process of following-up on this report.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 4-month-old white female with no known allergies or illness at the time of vaccination who on 16-APR-2007 was vaccinated with Rotateq (Lot # 656101/1231F) 2nd dose po. Concomitant therapy included Pediarix (lot AC21B090AA IM, ActHib (unspecified carrier) (Lot # UF021AA) IM and Prevnar (Lot # B02674C) IM, all second doses. On 17-APR-2007 the patient started with a fever and then on 18-APR-2007 the patient developed diarrhea.  On 20-APR-2007 the patient developed vomiting.  The nurse reported that no one else was sick at home. The patient's diarrhea persisted at the time of the report. The patient was being treated with pedialite and diluted apple juice. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 20 week old patient who on 25-JAN-2007 was vaccinated with the first dose of Rotateq. No problems reported. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 20 week old patient who on 25-JAN-2007 was vaccinated with the first dose of Rotateq. No problems reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lymphadenopathy, White blood cell count increased
Clinical narrative: This is in follow-up to report (s) previously submitted on 6/14/2007. Information has been received from a physician concerning an 18 year old female with tic disorder unspecified who on 27-FEB-2007 was vaccinated with GARDASIL in her left deltoid muscle. Concomitant therapy included TENEX. The physician reported that the patient developed left supraclavicular lymphadenopathy one week after receiving her first dose of GARDASIL vaccine. The patient was referred for evaluation by an ears, nose and throat (ENT) specialist, a chest x-ray was negative and the complete blood cell count (CBC) revealed WBC 16,000. The ENT physician prescribed a course of AUGMENTIN 850 mg bid. The patient had a follow up exam on 04-MAY-2007 which revealed the supraclavicular nodes decreased in size. As of 04-MAY-2007 the patient was recovering. Additional information has been requested.  This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with tic disorder, unspecified who, on 17-FEB-2007, was vaccinated in her left deltoid with GARDASIL. Concomitant therapy included TENEX. On 06-MAR-2007, the patient experienced left supraclavicular lymphadenopathy. The patient ws referred to an ear, nose and throat specialist evaluation. Chest x-ray was negative and complete CBC revealed a WBC of 16,000. Therapy with AUGMENTING 850 mg bid was prescribed. On 04-MAY-2007, follow-up revealed the supraciavicular nodes had decreased in size. As of 04-MAY-2007, the patient was recovering. Additional informationhas been requested. This was orginally reported by a physician.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest X-ray normal, Full blood count, Lymphadenopathy, White blood cell count increased
Clinical narrative: This is in follow-up to report (s) previously submitted on 6/14/2007. Information has been received from a physician concerning an 18 year old female with tic disorder unspecified who on 27-FEB-2007 was vaccinated with GARDASIL in her left deltoid muscle. Concomitant therapy included TENEX. The physician reported that the patient developed left supraclavicular lymphadenopathy one week after receiving her first dose of GARDASIL vaccine. The patient was referred for evaluation by an ears, nose and throat (ENT) specialist, a chest x-ray was negative and the complete blood cell count (CBC) revealed WBC 16,000. The ENT physician prescribed a course of AUGMENTIN 850 mg bid. The patient had a follow up exam on 04-MAY-2007 which revealed the supraclavicular nodes decreased in size. As of 04-MAY-2007 the patient was recovering. Additional information has been requested.  This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with tic disorder, unspecified who, on 17-FEB-2007, was vaccinated in her left deltoid with GARDASIL. Concomitant therapy included TENEX. On 06-MAR-2007, the patient experienced left supraclavicular lymphadenopathy. The patient ws referred to an ear, nose and throat specialist evaluation. Chest x-ray was negative and complete CBC revealed a WBC of 16,000. Therapy with AUGMENTING 850 mg bid was prescribed. On 04-MAY-2007, follow-up revealed the supraciavicular nodes had decreased in size. As of 04-MAY-2007, the patient was recovering. Additional informationhas been requested. This was orginally reported by a physician.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Rheumatoid arthritis, Rheumatoid factor
Clinical narrative: Information has been received from a certified nurse midwife concerning a 16 year old female student who on 26-FEB-2007 was vaccinated intramuscularly with a first 0.5 mL dose of Gardasil (lot # 655849/0263U). Concomitant therapy included hormonal contraceptives (unspecified). On 15-MAR-2007 the patient experienced vague left arm pain, vague leg pain. She was seen by a rheumatologist and serum rheumatoid factor was found to be elevated (positive. She was successfully treated with a course of steroids and her symptoms and blood tests improved. On 25-APR-2007, the patient recovered from left arm pain, vague leg pain, and serum rheumatoid factor elevated.  The reporter felt that left arm pain, vague, leg pain, vague and serum rheumatoid factor elevated could be related to therapy with Gardasil. No product quality complaint was involved. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Rheumatoid factor increased
Clinical narrative: Information has been received from a certified nurse midwife concerning a 16 year old female student who on 26-FEB-2007 was vaccinated intramuscularly with a first 0.5 mL dose of Gardasil (lot # 655849/0263U). Concomitant therapy included hormonal contraceptives (unspecified). On 15-MAR-2007 the patient experienced vague left arm pain, vague leg pain. She was seen by a rheumatologist and serum rheumatoid factor was found to be elevated (positive. She was successfully treated with a course of steroids and her symptoms and blood tests improved. On 25-APR-2007, the patient recovered from left arm pain, vague leg pain, and serum rheumatoid factor elevated.  The reporter felt that left arm pain, vague, leg pain, vague and serum rheumatoid factor elevated could be related to therapy with Gardasil. No product quality complaint was involved. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a physician's assistant from a pregnancy registry for Gardasil concerning a 20 year old female with depression and gastrooesophageal reflux disease with a history of 0 pregnancies and 0 lives births who on 01-MAR-2007 was vaccinated with Gardasil, lot# 6454535/0960F. On 03-MAY-2007 the patient was vaccinated with the second dose of Gardasil (lot # 654535/0960F. Concomitant therapy included PAXIL and PRILOSEC, which was "on hold" as of approximately 07-MAY-2007. On 07-MAY-2007 the patient spotting and she went to her physician's office and was given a urine pregnancy test which was positive. It was reported that there were "no adverse events". There were no other details provided. The patient sought medical attention (not further specified). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug exposure during pregnancy, Metrorrhagia, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician's assistant from a pregnancy registry for Gardasil concerning a 20 year old female with depression and gastrooesophageal reflux disease with a history of 0 pregnancies and 0 lives births who on 01-MAR-2007 was vaccinated with Gardasil, lot# 6454535/0960F. On 03-MAY-2007 the patient was vaccinated with the second dose of Gardasil (lot # 654535/0960F. Concomitant therapy included PAXIL and PRILOSEC, which was "on hold" as of approximately 07-MAY-2007. On 07-MAY-2007 the patient spotting and she went to her physician's office and was given a urine pregnancy test which was positive. It was reported that there were "no adverse events". There were no other details provided. The patient sought medical attention (not further specified). Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Flatulence, Muscle spasms
Clinical narrative: Information has been received from a certified medical assistant concerning a breastfed 10-week-old female with no pertinent medical history (previously health; full term gestational age) who on 19-MAR-2007 was vaccinated PO with the first dose of Rotateq (Lot # 656105/1232F). At the time of vaccination, the patient was recovering from "cold symptoms" and was diagnosed with "fluid" in the ears, but was not treated with antibiotics. Concomitant therapy that day included a dose of Dtap, a dose of ACTHIB, and a dose of PREVNAR. There were no other concomitant medications. Subsequently, the 2-3 hours post-vaccination, the patient was gassy, cramping, and kept pulling up her legs. The mother described a "low grade fever" with the event. The patient went in for the second dose but it was not given due to these side effects. Unspecified medical attention was sought. The patient is currently recovered. There were no reports of diarrhea, vomiting, blood stools, fever, or feeding difficulties. There were no lab diagnostic studies performed. No additional information is available. There was no product quality complaint.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Flatulence, Muscle spasms, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a breastfed 10-week-old female with no pertinent medical history (previously health; full term gestational age) who on 19-MAR-2007 was vaccinated PO with the first dose of Rotateq (Lot # 656105/1232F). At the time of vaccination, the patient was recovering from "cold symptoms" and was diagnosed with "fluid" in the ears, but was not treated with antibiotics. Concomitant therapy that day included a dose of Dtap, a dose of ACTHIB, and a dose of PREVNAR. There were no other concomitant medications. Subsequently, the 2-3 hours post-vaccination, the patient was gassy, cramping, and kept pulling up her legs. The mother described a "low grade fever" with the event. The patient went in for the second dose but it was not given due to these side effects. Unspecified medical attention was sought. The patient is currently recovered. There were no reports of diarrhea, vomiting, blood stools, fever, or feeding difficulties. There were no lab diagnostic studies performed. No additional information is available. There was no product quality complaint.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Cold sweat, Dizziness, Syncope
Clinical narrative: Information has been received from a nurse concerning an 18 year old female who on 14-MAY-2007 was vaccinated with the first dose of Gardasil (lot # 654885/1424F, and experienced syncope. Concomitant therapy included meningitis vaccine. Unspecified medical attention was sought. On the same day, the patient recovered from syncope. No other information was provided. This is one of several reports from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning an 18 year old female who on 14-MAY-2007 was vaccinated with the first dose of Gardasil (lot # 654885/1424F, and experienced syncope. Concomitant therapy included meningitis vaccine. Unspecified medical attention was sought. On the same day, the patient recovered from syncope. No other information was provided. This is one of several reports from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Dizziness, Fatigue, Nausea, Vomiting
Clinical narrative: Information has been received from a licensed visiting nurse, concerning an 18 year old female patient, who on 14-MAY-2007 was vaccinated with the first dose of Gardasil (Lot #654885/1424F). Concomitant therapy included meningococcal vaccine (manufacturer unspecified). On 14-MAY-2007, following the vaccination, the patient experienced vomiting, nausea and dizziness. At the time of this report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Information has been received from a licensed visiting nurse, concerning an 18 year old female patient, who on 14-MAY-2007 was vaccinated with the first dose of Gardasil (Lot #654885/1424F). Concomitant therapy included meningococcal vaccine (manufacturer unspecified). On 14-MAY-2007, following the vaccination, the patient experienced vomiting, nausea and dizziness. At the time of this report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Dizziness, Paraesthesia
Clinical narrative: Information has been received from a nurse concerning an 18 year old female who on 14-MAY-2007 was vaccinated with the first dose of Gardasil lot # 655619/1427F. Concomitant therapy included meningitis vaccine. On 14-MAY-2007 the patient experienced lightheadedness, weakness and tingling in her injection site arm. The patient recovered from lightheadedness, weakness and tingling in her injection site arm on the same day. Unspecified medical attention was sought. No other information was available. This is one of several reports from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Asthenia, Dizziness, Paraesthesia
Clinical narrative: Information has been received from a nurse concerning an 18 year old female who on 14-MAY-2007 was vaccinated with the first dose of Gardasil lot # 655619/1427F. Concomitant therapy included meningitis vaccine. On 14-MAY-2007 the patient experienced lightheadedness, weakness and tingling in her injection site arm. The patient recovered from lightheadedness, weakness and tingling in her injection site arm on the same day. Unspecified medical attention was sought. No other information was available. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female (142 lbs. 5'5") who on 02-MAY-2007 the patient developed a fever of 102.9, muscle aches and shortness of breath and went to the ER for evaluation. The outcome of the events was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Myalgia, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female (142 lbs. 5'5") who on 02-MAY-2007 the patient developed a fever of 102.9, muscle aches and shortness of breath and went to the ER for evaluation. The outcome of the events was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Mouth ulceration
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female with no allergies and no pertinent medical history who on 09-MAY-2007 was vaccinated with 0.5 ml of the first dose of Gardasil (Lot #657622/0388U). On 11-MAY-2007 the patient developed two sores on her tongue, one on top and one on the right side. Subsequently, the patient recovered from the sores on her tongue. Medical attention was sought. Initial and follow-up information has been received from a registered nurse concerning a 25 year olkd female with no known allergies and no pertinent medical history, who on 03-MAY-2007 at 10:30 am was vaccinated subcutaneously with a first dose of GARDASIL (Lot # 657622/0388U) in the right buttocks. On 11-MAY-2007 the patient experinced two sores on her tongue, one on top and on the right side. No medical attention was sought (was previously reported as sought medical attention). On 21-MAY-2007, the patient recovered from two sores on her tongue. No laboratory or diagnostic tests performed. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tongue ulceration
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female with no allergies and no pertinent medical history who on 09-MAY-2007 was vaccinated with 0.5 ml of the first dose of Gardasil (Lot #657622/0388U). On 11-MAY-2007 the patient developed two sores on her tongue, one on top and one on the right side. Subsequently, the patient recovered from the sores on her tongue. Medical attention was sought. Initial and follow-up information has been received from a registered nurse concerning a 25 year olkd female with no known allergies and no pertinent medical history, who on 03-MAY-2007 at 10:30 am was vaccinated subcutaneously with a first dose of GARDASIL (Lot # 657622/0388U) in the right buttocks. On 11-MAY-2007 the patient experinced two sores on her tongue, one on top and on the right side. No medical attention was sought (was previously reported as sought medical attention). On 21-MAY-2007, the patient recovered from two sores on her tongue. No laboratory or diagnostic tests performed. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Asthenia, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning a 16 year old female student (weight 144 lb, height 63") with migraine headaches who on 01-MAY-2007 at 3 pm was vaccinated with the first dose of GARDASIL, injection in right arm and the second dose of hepatitis A virus vaccine (unspecified) (lot #1282F), injection in the left arm. Concomitant medication was not reported. On 02-MAY-2007 within 24 hours of vaccination with the first dose of hepatitis A (also reported as second dose), the patient developed left deltoid muscle pain, swelling and erythema. Within 48 hours, the patient developed numbness and diminished strength in the left hand. The patient sought medical attention (not further specified). On 07-MAY-2007, the patient recovered from the events. Additional follow up information has been received from a RN concerning the patient, who received the first dose of GARDASIL, lot #656050/0245U in the left deltoid (previously reported as right deltoid). At the same time she received the second dose of VAQTA (MSD), lot #656316/1282F and reported that "both were given in the left deltoid". Within 24 hours the patient experienced muscle pain, redness, and erythema in the left deltoid. On the second day she had numbness and diminished strength in left hand. The patient was seen in the office on 04-MAY-2007 and treated with prednisone, hydrocodone, and TYLENOL. On 07-MAY-2007 she was seen with warmth, tingling and pain to left elbow. There was no edema or induration, small amount of firmness in the muscle, full range of motion of arm. On 06-JUN-2007 these symptoms resolved. Additional follow up information was received from the patient's father, who stated that his daughter complained of pain at injection site after GARDASIL was given. The patient's physician provided her with BENADRYL. The patient continued to experience pain the next day and 2 days later the pain began to worsen. The physician gave her a "blast of prednisone". The patient's father reported that his daughter has had her "4th blast of prednisone" and has not recovered from the pain. He also reported that his daughter was having difficulty sleeping and was given hydrocodone so she could go to sleep. Additional informtion is not expected.