chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Optic neuritis, Paresis
Clinical narrative: A 12 year old male pt, with a past medical history of ADHD, had received an IM, left deltoid, first dose injection of Menactra, lot number U1741AB, and IM, right deltoid, first dose injection of Adacel, lot number C2384AA on 2/8/06. There had been no report of adverse events following prior vaccinations. Sixteen days post vaccination, the subject developed severe headache, optic neuritis, Bells palsy and left leg sensory mono paresis. The pt was examined during multiple Dr visits, and was subsequently admitted to the hospital from 3/10/06 to 3/15/06. Relevant diagnostic testing included a MRI, somatic sensory evoked potentials and lumbar puncture. Results of testing were not provided. The pt was later readmitted to the hospital from 4/17/06 to 4/27/06 with the principle diagnosis of encephalitis and secondary diagnosis of optic neuritis, encephalopathy, facial palsy resolved and mycoplasma. At the time of this report, the pt was not recovered.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ, TD
Symptoms: Arteriovenous malformation, Brain operation, Cerebral haemorrhage, Fatigue, Headache
Clinical narrative: A 12 year old male pt, had received an injection of Menactra, lot number reported as 01641AA, on 8/2/05. Other reported vaccinations included Tetanus and Diphtheria vaccine, manufacturer not reported, lot number not reported and PPD, manufacturer not reported, lot number not reported date of administration of these two products was not provided. Routes and sites of administration of vaccines were not reported. One hundred and one days post vaccination, the pt experienced a headache. He subsequently had a ruptured arteriovenous malformation and underwent a craniotomy for evaluation and resection of the hemorrhage and AVM on 11/16/2005. He was hospitalized for 76 days. Per the reporter, the pt had residual weakness in his arm and leg for which he gets therapy four times weekly.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ, TD
Symptoms: Muscular weakness, Orthosis user
Clinical narrative: A 12 year old male pt, had received an injection of Menactra, lot number reported as 01641AA, on 8/2/05. Other reported vaccinations included Tetanus and Diphtheria vaccine, manufacturer not reported, lot number not reported and PPD, manufacturer not reported, lot number not reported date of administration of these two products was not provided. Routes and sites of administration of vaccines were not reported. One hundred and one days post vaccination, the pt experienced a headache. He subsequently had a ruptured arteriovenous malformation and underwent a craniotomy for evaluation and resection of the hemorrhage and AVM on 11/16/2005. He was hospitalized for 76 days. Per the reporter, the pt had residual weakness in his arm and leg for which he gets therapy four times weekly.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ, TD
Symptoms: Angiopathy, Asthenia, Haemorrhage, Headache
Clinical narrative: A 12 year old male pt, had received an injection of Menactra, lot number reported as 01641AA, on 8/2/05. Other reported vaccinations included Tetanus and Diphtheria vaccine, manufacturer not reported, lot number not reported and PPD, manufacturer not reported, lot number not reported date of administration of these two products was not provided. Routes and sites of administration of vaccines were not reported. One hundred and one days post vaccination, the pt experienced a headache. He subsequently had a ruptured arteriovenous malformation and underwent a craniotomy for evaluation and resection of the hemorrhage and AVM on 11/16/2005. He was hospitalized for 76 days. Per the reporter, the pt had residual weakness in his arm and leg for which he gets therapy four times weekly.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Eyelid disorder, Facial palsy, Nausea, Vomiting
Clinical narrative: A 16 year old female pt with no reported medical history had received a first dose of Menactra, lot number U1492AB, administered intra muscularly in the left arm on 4/21/06. Six days post immunization, the pt developed right sided Bells palsy. The pt was seen in the ER and was sent home on Acyclovir and Prednisone. She was admitted to the hospital on 4/29/06 for emesis, nausea and inability to tolerate per OS. She was discharged on 4/30/06 after 24 hours. At the time of this report the pt continued to have Bells palsy and was to be evaluated by a neurologist.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Drug tolerance decreased, Facial palsy, Nausea, Vomiting
Clinical narrative: A 16 year old female pt with no reported medical history had received a first dose of Menactra, lot number U1492AB, administered intra muscularly in the left arm on 4/21/06. Six days post immunization, the pt developed right sided Bells palsy. The pt was seen in the ER and was sent home on Acyclovir and Prednisone. She was admitted to the hospital on 4/29/06 for emesis, nausea and inability to tolerate per OS. She was discharged on 4/30/06 after 24 hours. At the time of this report the pt continued to have Bells palsy and was to be evaluated by a neurologist.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Facial palsy
Clinical narrative: Initial report received from the on 30/May/2006 and follow-up on 05/Jun/2006.  A 13-year-old male patient with a medical history of autism spectrum disorder, attention deficit hyperactivity disorder (ADHD), obsessive-compulsive disorder (OCD) and Compazine allergy, had received a first dose of Menactra, lot number U2003AA, in the left arm on 17/Apr/2006.  12 days later, in the mid-afternoon on 29/Apr/2006, the patient developed Bell's palsy.  No lab testing was done.  The patient was seen by a neurologist, who confirmed the diagnosis.  The patient was reported to be recovering at the time of this request.  Seriousness criteria: other medically significant (OMIC)
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Fatigue, Muscular weakness
Clinical narrative: A 14 year old female pt, with a history of progressive proximal muscle weakness one month prior to vaccination, had received an injection of Menactra, lot number U2003AA, on 4/14/06. Other vaccinations included Adacel, lot number not reported, and date of administration not reported. The same evening post vaccination, the pt experienced fever with increasing fatigue and proximal muscle weakness. Recovery status was not reported. Follow up information VAERS report 255491 on 6/6/06. Per the reporter this case is serious since the pt was hospitalized. Based upon this follow up information, this case has been upgraded to serious (OMIC).
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: A 14 year old female pt, with a history of progressive proximal muscle weakness one month prior to vaccination, had received an injection of Menactra, lot number U2003AA, on 4/14/06. Other vaccinations included Adacel, lot number not reported, and date of administration not reported. The same evening post vaccination, the pt experienced fever with increasing fatigue and proximal muscle weakness. Recovery status was not reported. Follow up information VAERS report 255491 on 6/6/06. Per the reporter this case is serious since the pt was hospitalized. Based upon this follow up information, this case has been upgraded to serious (OMIC).
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Condition aggravated, Fatigue, Muscular weakness, Pyrexia
Clinical narrative: A 14 year old female pt, with a history of progressive proximal muscle weakness one month prior to vaccination, had received an injection of Menactra, lot number U2003AA, on 4/14/06. Other vaccinations included Adacel, lot number not reported, and date of administration not reported. The same evening post vaccination, the pt experienced fever with increasing fatigue and proximal muscle weakness. Recovery status was not reported. Follow up information VAERS report 255491 on 6/6/06. Per the reporter this case is serious since the pt was hospitalized. Based upon this follow up information, this case has been upgraded to serious (OMIC).
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, MNQ
Symptoms: CSF test abnormal, Multiple sclerosis, Skin ulcer
Clinical narrative: An 18 year old female pt had received an IM, left deltoid, first dose injection of Menactra, lot number U1767AA, on 8/18/2005. Other vaccinations included an IM, right deltoid, second dose injection of Hepatitis A vaccine, lot number AHAVA018AA, on 8/16/05. One hundred and sixty seven days post vaccination of Menactra, the pt developed multiple sclerosis. The pt will require chronic therapy. Per the reporter, the pt had a positive MRI 24 lesions and positive spinal fluid for protein. As of 5/22/06, it was reported that the pt was in remission. There was no report of hospitalization, Recovery status was reported as unknown in remission. Seriousness criteria other medically significant (OMIC).
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, MNQ
Symptoms: Laboratory test abnormal, Multiple sclerosis
Clinical narrative: An 18 year old female pt had received an IM, left deltoid, first dose injection of Menactra, lot number U1767AA, on 8/18/2005. Other vaccinations included an IM, right deltoid, second dose injection of Hepatitis A vaccine, lot number AHAVA018AA, on 8/16/05. One hundred and sixty seven days post vaccination of Menactra, the pt developed multiple sclerosis. The pt will require chronic therapy. Per the reporter, the pt had a positive MRI 24 lesions and positive spinal fluid for protein. As of 5/22/06, it was reported that the pt was in remission. There was no report of hospitalization, Recovery status was reported as unknown in remission. Seriousness criteria other medically significant (OMIC).
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Abnormal behaviour, Aggression, Agitation, Crying, Hypoaesthesia
Clinical narrative: Initial report received on 30/May/2006.  A 17-year-old male patient had received an injection of Menactra, lot number U1783AA, on 08/May/2006.  One day later, he experienced aggressive behavior and tingling in his upper and lower extremities.  Recovery status was not reported.  Additional information was not provided.  Follow-up information received on 07/Aug/2006.  Per the pediatric neurology consultation, one day post-vaccination, the patient experienced muscle ache, neck pain, and numbness and tingling of both his upper and lower extremities.  The numbness and tingling resolved after 15 minutes in the lower extremities and 48 hours in the upper extremities.  Two days post-vaccination he began experiencing a bi-temporal, throbbing headache.  Three days post-vaccination, the patient was with friends when he experienced an episode of aggressive behavior and was "acting out".  When the patient arrived, the patient was stating at the ground, crying and his whole body was shaking.  The parent took him home when he began felling better.  He had no recollection of the aggressive behavior event.  He can only remember that "he was trying to call his teacher".  Upon examination, the patient was alert and oriented.  He continued to have a headache.  Recent and remote memory were intact.  Speech and language were clear.  Motor exam showed no atrophy or fasciculations.  There was no weakness.  Deep tendon reflexes were 2+/2+.  Gait and coordination showed no tremors and no ataxia.  Finger to nose and rapid alternating movements and tarden gait were all intact.  Sensory exam was intact to tactile stimulation.  Neck was supple with tenderness when he flexed and extended his neck.  At the time of exam, his muscle ache and neck pain had become less.  Kerning's sign and straight leg raising were negative.  There was no tenderness in the lumbosacral region although, when he turned laterally, he had some pain in the paraspinal region.  Neurologist assessment was "symptoms most likely all reaction to the vaccine". "  He is already getting better".  The patient was prescribed ALEVE for aches and muscle pains.  He was scheduled for an EEG and neurology follow-up following the test.  At the time of this report, the patient was not fully recovered.
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Meningitis, Paraesthesia
Clinical narrative: Initial report received on 30/May/2006.  A 17-year-old male patient had received an injection of Menactra, lot number U1783AA, on 08/May/2006.  One day later, he experienced aggressive behavior and tingling in his upper and lower extremities.  Recovery status was not reported.  Additional information was not provided.  Follow-up information received on 07/Aug/2006.  Per the pediatric neurology consultation, one day post-vaccination, the patient experienced muscle ache, neck pain, and numbness and tingling of both his upper and lower extremities.  The numbness and tingling resolved after 15 minutes in the lower extremities and 48 hours in the upper extremities.  Two days post-vaccination he began experiencing a bi-temporal, throbbing headache.  Three days post-vaccination, the patient was with friends when he experienced an episode of aggressive behavior and was "acting out".  When the patient arrived, the patient was stating at the ground, crying and his whole body was shaking.  The parent took him home when he began felling better.  He had no recollection of the aggressive behavior event.  He can only remember that "he was trying to call his teacher".  Upon examination, the patient was alert and oriented.  He continued to have a headache.  Recent and remote memory were intact.  Speech and language were clear.  Motor exam showed no atrophy or fasciculations.  There was no weakness.  Deep tendon reflexes were 2+/2+.  Gait and coordination showed no tremors and no ataxia.  Finger to nose and rapid alternating movements and tarden gait were all intact.  Sensory exam was intact to tactile stimulation.  Neck was supple with tenderness when he flexed and extended his neck.  At the time of exam, his muscle ache and neck pain had become less.  Kerning's sign and straight leg raising were negative.  There was no tenderness in the lumbosacral region although, when he turned laterally, he had some pain in the paraspinal region.  Neurologist assessment was "symptoms most likely all reaction to the vaccine". "  He is already getting better".  The patient was prescribed ALEVE for aches and muscle pains.  He was scheduled for an EEG and neurology follow-up following the test.  At the time of this report, the patient was not fully recovered.
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Abnormal behaviour, Paraesthesia
Clinical narrative: Initial report received on 30/May/2006.  A 17-year-old male patient had received an injection of Menactra, lot number U1783AA, on 08/May/2006.  One day later, he experienced aggressive behavior and tingling in his upper and lower extremities.  Recovery status was not reported.  Additional information was not provided.  Follow-up information received on 07/Aug/2006.  Per the pediatric neurology consultation, one day post-vaccination, the patient experienced muscle ache, neck pain, and numbness and tingling of both his upper and lower extremities.  The numbness and tingling resolved after 15 minutes in the lower extremities and 48 hours in the upper extremities.  Two days post-vaccination he began experiencing a bi-temporal, throbbing headache.  Three days post-vaccination, the patient was with friends when he experienced an episode of aggressive behavior and was "acting out".  When the patient arrived, the patient was stating at the ground, crying and his whole body was shaking.  The parent took him home when he began felling better.  He had no recollection of the aggressive behavior event.  He can only remember that "he was trying to call his teacher".  Upon examination, the patient was alert and oriented.  He continued to have a headache.  Recent and remote memory were intact.  Speech and language were clear.  Motor exam showed no atrophy or fasciculations.  There was no weakness.  Deep tendon reflexes were 2+/2+.  Gait and coordination showed no tremors and no ataxia.  Finger to nose and rapid alternating movements and tarden gait were all intact.  Sensory exam was intact to tactile stimulation.  Neck was supple with tenderness when he flexed and extended his neck.  At the time of exam, his muscle ache and neck pain had become less.  Kerning's sign and straight leg raising were negative.  There was no tenderness in the lumbosacral region although, when he turned laterally, he had some pain in the paraspinal region.  Neurologist assessment was "symptoms most likely all reaction to the vaccine". "  He is already getting better".  The patient was prescribed ALEVE for aches and muscle pains.  He was scheduled for an EEG and neurology follow-up following the test.  At the time of this report, the patient was not fully recovered.
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Abnormal behaviour, Amnesia, Crying, Headache, Hypoaesthesia
Clinical narrative: Initial report received on 30/May/2006.  A 17-year-old male patient had received an injection of Menactra, lot number U1783AA, on 08/May/2006.  One day later, he experienced aggressive behavior and tingling in his upper and lower extremities.  Recovery status was not reported.  Additional information was not provided.  Follow-up information received on 07/Aug/2006.  Per the pediatric neurology consultation, one day post-vaccination, the patient experienced muscle ache, neck pain, and numbness and tingling of both his upper and lower extremities.  The numbness and tingling resolved after 15 minutes in the lower extremities and 48 hours in the upper extremities.  Two days post-vaccination he began experiencing a bi-temporal, throbbing headache.  Three days post-vaccination, the patient was with friends when he experienced an episode of aggressive behavior and was "acting out".  When the patient arrived, the patient was stating at the ground, crying and his whole body was shaking.  The parent took him home when he began felling better.  He had no recollection of the aggressive behavior event.  He can only remember that "he was trying to call his teacher".  Upon examination, the patient was alert and oriented.  He continued to have a headache.  Recent and remote memory were intact.  Speech and language were clear.  Motor exam showed no atrophy or fasciculations.  There was no weakness.  Deep tendon reflexes were 2+/2+.  Gait and coordination showed no tremors and no ataxia.  Finger to nose and rapid alternating movements and tarden gait were all intact.  Sensory exam was intact to tactile stimulation.  Neck was supple with tenderness when he flexed and extended his neck.  At the time of exam, his muscle ache and neck pain had become less.  Kerning's sign and straight leg raising were negative.  There was no tenderness in the lumbosacral region although, when he turned laterally, he had some pain in the paraspinal region.  Neurologist assessment was "symptoms most likely all reaction to the vaccine". "  He is already getting better".  The patient was prescribed ALEVE for aches and muscle pains.  He was scheduled for an EEG and neurology follow-up following the test.  At the time of this report, the patient was not fully recovered.
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Myalgia, Neck pain, Paraesthesia
Clinical narrative: Initial report received on 30/May/2006.  A 17-year-old male patient had received an injection of Menactra, lot number U1783AA, on 08/May/2006.  One day later, he experienced aggressive behavior and tingling in his upper and lower extremities.  Recovery status was not reported.  Additional information was not provided.  Follow-up information received on 07/Aug/2006.  Per the pediatric neurology consultation, one day post-vaccination, the patient experienced muscle ache, neck pain, and numbness and tingling of both his upper and lower extremities.  The numbness and tingling resolved after 15 minutes in the lower extremities and 48 hours in the upper extremities.  Two days post-vaccination he began experiencing a bi-temporal, throbbing headache.  Three days post-vaccination, the patient was with friends when he experienced an episode of aggressive behavior and was "acting out".  When the patient arrived, the patient was stating at the ground, crying and his whole body was shaking.  The parent took him home when he began felling better.  He had no recollection of the aggressive behavior event.  He can only remember that "he was trying to call his teacher".  Upon examination, the patient was alert and oriented.  He continued to have a headache.  Recent and remote memory were intact.  Speech and language were clear.  Motor exam showed no atrophy or fasciculations.  There was no weakness.  Deep tendon reflexes were 2+/2+.  Gait and coordination showed no tremors and no ataxia.  Finger to nose and rapid alternating movements and tarden gait were all intact.  Sensory exam was intact to tactile stimulation.  Neck was supple with tenderness when he flexed and extended his neck.  At the time of exam, his muscle ache and neck pain had become less.  Kerning's sign and straight leg raising were negative.  There was no tenderness in the lumbosacral region although, when he turned laterally, he had some pain in the paraspinal region.  Neurologist assessment was "symptoms most likely all reaction to the vaccine". "  He is already getting better".  The patient was prescribed ALEVE for aches and muscle pains.  He was scheduled for an EEG and neurology follow-up following the test.  At the time of this report, the patient was not fully recovered.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Erythema, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Initial report received on 15/Jun/2006 from a health care professional.  A 14-year-old male patient with no significant medical history had received a dose of Adacel, lot number C2456AA, in the left arm,a nd a dose of Menactra, lot number U2008AA, in the left arm on 13/Jun/2006 at 16:00 pm.  The route of administration was not reported for either vaccine.  Sometime during the morning hours the next day, the patient experienced swelling, edema, and slight redness under the left arm to the chest muscle.  He had one swollen gland with slight tenderness under the left arm.  Reportedly, the patient had no infection or fever.  No relevant diagnostic/labortaory data were collected.  Per the reporter, the patient was not medically evaluated.  The patient's recovery status was not reported.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Erythema, Lymphadenopathy, Oedema, Swelling, Tenderness
Clinical narrative: Initial report received on 15/Jun/2006 from a health care professional.  A 14-year-old male patient with no significant medical history had received a dose of Adacel, lot number C2456AA, in the left arm,a nd a dose of Menactra, lot number U2008AA, in the left arm on 13/Jun/2006 at 16:00 pm.  The route of administration was not reported for either vaccine.  Sometime during the morning hours the next day, the patient experienced swelling, edema, and slight redness under the left arm to the chest muscle.  He had one swollen gland with slight tenderness under the left arm.  Reportedly, the patient had no infection or fever.  No relevant diagnostic/labortaory data were collected.  Per the reporter, the patient was not medically evaluated.  The patient's recovery status was not reported.
Age: 82.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site pain, Injection site warmth, Swelling
Clinical narrative: Patient came in 1 week after receiving Td booster, complain of  swelling locally, left deltoid, heat, pain at site, also had a patch of redness, left upper arm, approximately 4 inches below injection site.  Redness, one spot on lateral neck (anterior) and left area above lips.
Age: 0.23
Sex: M
Vaccine: HIBV
Symptoms: Erythema, Irritability, Oedema peripheral
Clinical narrative: Hib#1 given to left thigh without difficulty at 0930.  Patient very fussy at 1000.  Redness with swelling of feet at 1230.  Placed in cooling bath and massaged better at 1300.  Here in clinic at 1400, no redness or swelling.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Myalgia, Pyrexia
Clinical narrative: Follow-up information received on 12/May/2006.  New information received does not change the nature, seriousness or listedness of case.  No further information is expected.  A corrective version was created on 13/Jul/2006 (with a LRD of 12/May/2006) in order to document a narrative for this case.  Initial version received on 18/Apr/2006 from a health care professional.  An 18-year-old male patient had received an intramuscular, left arm injection on Menactra, lot number U197BAA on 17/Apr/2006.  The following day, the patient had experienced muscles aches and a fever of 100.6 degrees Fahrenheit.  It had been initially reported that the patient had experienced stiffness in his neck and legs but, when the reporter was subsequently contacted, it was indicated that the patient had not experienced stiffness.  He was examined by a physician and had no neurological symptoms.  The reporter indicated that "blood test so far were normal", but the reporter did not know what tests had been ordered.  The patient was treated with Ibuprofen.  At the time of this report, the patient was doing "okay", but the reporter was uncertain whether the patient had made a full recovery.  Follow-up information received on 12/May/2006 from a health care professional.  The blood work that the patient had received was a complete blood count. There was no illness at time of vaccination.  At the time of this report, the patient had recovered from the events.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Abdominal pain, Back pain, Dehydration, Dysphagia, Lymphadenopathy
Clinical narrative: Initial report received on 08/May/2006 from an investigator participating in the above mentioned trial.  An 18-year-old female subject developed dehydration one day after she had received an injection of Menactra, lot number not reported, and Hepatitis A vaccine, manufacturer not reported, lot number not reported.  Routes and sites of administration were not reported.  One day post-immunization, the subject was examined by a  physician and was complaining of a sore throat, difficulty swallowing, not drinking fluids, and back and abdominal pain.  She had bilateral swollen and tender lymph nodes in the neck and a temperature of 100.1 degrees Fahrenheit.  A strep culture was obtained, and the subject was sent to the emergency room for treatment of dehydration.  During re-exam in the emergency room, she additionally complained of crusty eyes and a severe headache.  Her temperature, at the time, was 101.1 degrees Fahrenheit.  Oropharynx was red and slightly swollen.  WBC was 16.1 with 93% neutrophils and 3% lymphocytes.  Urinalysis was negative.  She was treated with two liters of normal saline after which time she felt much better, and her headache had resolved.  Impression was a febrile illness, suspect viral etiology with pharyngitis being a strong component of the illness.  The following day, none screen was negative, and WBC was 16.8 with 89% neutrophils and 6% lymphocytes.  Treating for strep A was negative by DNA probe.  Recovery status was not provided.  The investigator did not consider this event to be a serious adverse event.  However, the event was considered to be related to vaccination.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Initial report received on 08/May/2006 from an investigator participating in the above mentioned trial.  An 18-year-old female subject developed dehydration one day after she had received an injection of Menactra, lot number not reported, and Hepatitis A vaccine, manufacturer not reported, lot number not reported.  Routes and sites of administration were not reported.  One day post-immunization, the subject was examined by a  physician and was complaining of a sore throat, difficulty swallowing, not drinking fluids, and back and abdominal pain.  She had bilateral swollen and tender lymph nodes in the neck and a temperature of 100.1 degrees Fahrenheit.  A strep culture was obtained, and the subject was sent to the emergency room for treatment of dehydration.  During re-exam in the emergency room, she additionally complained of crusty eyes and a severe headache.  Her temperature, at the time, was 101.1 degrees Fahrenheit.  Oropharynx was red and slightly swollen.  WBC was 16.1 with 93% neutrophils and 3% lymphocytes.  Urinalysis was negative.  She was treated with two liters of normal saline after which time she felt much better, and her headache had resolved.  Impression was a febrile illness, suspect viral etiology with pharyngitis being a strong component of the illness.  The following day, none screen was negative, and WBC was 16.8 with 89% neutrophils and 6% lymphocytes.  Treating for strep A was negative by DNA probe.  Recovery status was not provided.  The investigator did not consider this event to be a serious adverse event.  However, the event was considered to be related to vaccination.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia, Shoulder pain, Tenderness
Clinical narrative: A 12 year old male pt with a history of asthma and GERD had received a dose of the study vaccine, Menactra, on an unspecified date. The lot number, route and site of administration were not provided. On 3/28/06 at 3:00am the subject developed a fever of 103.0 degrees Fahrenheit. He was treated at home with Advil around 4:15 am. The subject was subsequently seen in the ER at 5:15 am with complaints of bilateral shoulder pain. His temperature at that time was 99.0 degrees Fahrenheit. On examination, no redness or swelling was noted to the painful area, only mild tenderness. The subject was discharged from the emergency the emergency room and his recovery status was not reported. Per the investigator, the events were considered non serious, but related to the study product.
Age: 19.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: A 19 year old female pt, with a history of depressions, had received an injection on Menactra, lot number U2050AA, and an injection of Adacel, lot number C2384AA, on 6/6/2006. Routes and sites of administration were reported as unknown. Twenty four hour later, the pt experienced a fever of 99.8 degrees F, nausea, and generalized body aches. No reaction was reported at the injection site. A Dr office visit did not occur. Relevant diagnostic tests were none. At the time of this report, the pt had not recovered. Follow up information received 7/3/06. Per the reporter, the pt had flu like symptoms at the time of the vaccination on 6/6/2006. No further information is expected for this case.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Paraesthesia, Skin nodule
Clinical narrative: A 19 year old male pt had received an IM, left deltoid, first dose injection of Menactra, lot number U2057AA, on 6/12/06. The following day, the pt developed a small pea sized lump in his left collarbone area and a twinge pinch felling. At the time of this report, the pt had not recovered.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Headache, Vision blurred
Clinical narrative: An 18 year old male pt, with no past medical history, had received an IM, left deltoid injection of Menactra, lot number U2069AA, on 6/19/06. The next day, he experienced a severe headache, dizziness and difficulty focusing. At the time of this report, the pt had not recovered. Follow up information received on 6/26/06 from the pts parent. Per the reporter, the pt had been out drinking all night following vaccination. He was medicated for his symptoms the following morning with Tylenol. He did not require medical intervention and he recovered completely from all symptoms.
Age: 11.0
Sex: F
Vaccine: MNQ, TTOX
Symptoms: Asthenia, Headache, Malaise, Pyrexia
Clinical narrative: An 11 year old female pt with no significant medical history had received a dose of Menactra, lot number U1893AA, and a dose of Tetanus Toxoid vaccine, lot number AC52B006BA, on 6/26/06. The routes and sites of administration were not reported for either vaccine. The pts parent contacted the physicians office by phone and reported that the pt had developed a headache, malaise, low grade fever, lower extremity weakness and one day post immunization. The recovery status of the pt was not reported.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: A 15 year old female pt with on past medical history, had received an IM, arm injection of Menactra, lot number U1822AA, on 6/26/06. On the same day, post vaccination, the pt developed a fever of 103.7 degrees F, body aches and headache. The following day, the pt was examined by a physician, and her temperature was 99.2 deg F. The pt was prescribed Tylenol to reduce body aches and headaches. At the time of this report, the pt had not recovered.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: A 17 year old female pt had received in IM, left deltoid, first dose injection of Menactra, lot number U2004AA, on 6/5/06. One day later, the pt developed a fever of 101.5 deg F, achiness, fatigue and soreness at the site. The event did not require examination, and no diagnostic test were performed. At the time of this report, recovery status was unknown.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Muscle spasms, Nausea
Clinical narrative: Initial report received on 11/Aug/2006 from a health care professional.  AN 18-year-old male patient with no current illness had received a subcutaneous dose of Menactra, lot number U2138AA, in the left deltoid, on 02/Aug/2006.  A subcutaneous injection of Menactra is not a recommended route of administration by the manufacturer.  Three days post-immunization, the patient experiences nausea, headache, stomach pains, cramping, and diarrhea.  The patient was seen in the emergency room three days later and was given fluids.  A stool culture was performed, but the results were not reported.  The patient was subsequently discharged from the emergency room with instructions to go home and rest.  The recovery status of the patient was reported as not recovered.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypokinesia, Lymphadenopathy, Skin nodule
Clinical narrative: Information had been received from a healthcare worker concerning a 17 year old female pt with a sulfonamide allergy who on 8/23/06 was vaccinated IM in left upper arm with a dose of HPV rL1 6 11 16 18 VLP vaccine yeast, lot 653736/089F. There was no concomitant medication. it was reported that 5 days after vaccination, on 8/27/06, the pt developed lymph node swelling in the clavicle area, described as grape size. The pt complained of interference of upper arm movement and felt something was present in the clavicle area. Unspecified blood work was done. On 8/29/06 a CAT scan was performed and lump was described as having 2 smaller and 1 larger lymph nodes involved. On 8/30/06 the pt was scheduled for surgery to have the lymph nodes removed and biopsied. As of the report date, the pt had not recovered. The reporter felt that the lymph node swelling and interference with upper arm movement were other important medical events (OMIC). Additional information has been requested.  10/13/06 Received medical records from hospital which reeal patient seen in ER 8/29/06 for enlarged lymph node left supraclavicular area which was tender to palpation.  Final Dx: lymphadenopathy.  8/31/06 surgical biopsy done of left node & several other lymph nodes were palpated & sent to lab.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information had been received from a healthcare worker concerning a 17 year old female pt with a sulfonamide allergy who on 8/23/06 was vaccinated IM in left upper arm with a dose of HPV rL1 6 11 16 18 VLP vaccine yeast, lot 653736/089F. There was no concomitant medication. it was reported that 5 days after vaccination, on 8/27/06, the pt developed lymph node swelling in the clavicle area, described as grape size. The pt complained of interference of upper arm movement and felt something was present in the clavicle area. Unspecified blood work was done. On 8/29/06 a CAT scan was performed and lump was described as having 2 smaller and 1 larger lymph nodes involved. On 8/30/06 the pt was scheduled for surgery to have the lymph nodes removed and biopsied. As of the report date, the pt had not recovered. The reporter felt that the lymph node swelling and interference with upper arm movement were other important medical events (OMIC). Additional information has been requested.  10/13/06 Received medical records from hospital which reeal patient seen in ER 8/29/06 for enlarged lymph node left supraclavicular area which was tender to palpation.  Final Dx: lymphadenopathy.  8/31/06 surgical biopsy done of left node & several other lymph nodes were palpated & sent to lab.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Arthritis, Cellulitis, Dizziness, Gastritis, Injection site erythema
Clinical narrative: Arm swelling, pain, redness. Diagnosis cellulitis, leukocytosis. Treatment Morphine, Zosyn IV, Zyrtec, Solumedrol IV, Benadryl. Ice to arm. DOS 8/18/06-8/22/06. DC DX multi-level cervical and lumbar spinal arthritis as well as thoracic spine. T-12 compression fracture, probably old, of 50%. Mild disc disease in cervical area with background of Parkinson's disease, hypertension, gastritis, insomnia. Complaints: admitted with generalized joint pain. Fallen approximately 4 times, blacked out. Multiple bruises and abrasions over right hip and both forearm. Back pain.  PE: WNL other than noted above.  Neurology Consult: Impression: chronic dizziness, history of Parkinson's disease, hypertension, arthritis, GERD, anxiety, depression. Cardiology Consult: Impression: chronic dizziness of uncertain etiology, recent loss of consciousness sounds orthostatic in origin, hypertension, GERD, parkinsonism, history of low back pain with herniated discs. Telemetry strips shows sinus rhythm with dysrhythmias. DC DX for DOS8/24-8/27/06 Drug reaction to pneumococcal vaccine, possible cellulitis, Parkinson's disease, degenerative disease of back. Received pneumonia shot during most recent hospitalization. Developed redness in posterial aspect of right arm, worsened seen in ER for possible cellulitis. Started on IV antibiotics. Symptoms did not change much however, with 2 doses of IV steroids they improved significantly.  Current medications: Metoprolol, Lyrica, omeprazole, Sinemet, Ambien. Allergic to Codeine and Hydrocodone.    DC DX multi-level cervical and lumbar spinal arthritis as well as thoracic spine. T-12 compression fracture, probably old, of 50%. Mild disc disease in cervical area with background of Parkinson's disease, hypertension, gastritis, insomnia. Complaints: admitted with generalized joint pain. Fallen approximately 4 times, blacked out. Multiple bruises and abrasions over right hip and both forearm. Back pain.  PE: WNL other than noted above.  Neurology Consult: Impression: chronic dizziness, history of Parkinson's disease, hypertension, arthritis, GERD, anxiety, depression. Cardiology Consult: Impression: chronic dizziness of uncertain etiology, recent loss of consciousness sounds orthostatic in origin, hypertension, GERD, parkinsonism, history of low back pain with herniated discs. Telemetry strips shows sinus rhythm with dysrhythmias. DC DX for DOS8/24-8/27/06 Drug reaction to pneumococcal vaccine, possible cellulitis, Parkinson's disease, degenerative disease of back. Received pneumonia shot during most recent hospitalization. Developed redness in posterial aspect of right arm, worsened seen in ER for possible cellulitis. Started on IV antibiotics. Symptoms did not change much however, with 2 doses of IV steroids they improved significantly.  Current medications: Metoprolol, Lyrica, omeprazole, Sinemet, Ambien.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Injection site reaction, Insomnia, Laboratory test abnormal
Clinical narrative: Arm swelling, pain, redness. Diagnosis cellulitis, leukocytosis. Treatment Morphine, Zosyn IV, Zyrtec, Solumedrol IV, Benadryl. Ice to arm. DOS 8/18/06-8/22/06. DC DX multi-level cervical and lumbar spinal arthritis as well as thoracic spine. T-12 compression fracture, probably old, of 50%. Mild disc disease in cervical area with background of Parkinson's disease, hypertension, gastritis, insomnia. Complaints: admitted with generalized joint pain. Fallen approximately 4 times, blacked out. Multiple bruises and abrasions over right hip and both forearm. Back pain.  PE: WNL other than noted above.  Neurology Consult: Impression: chronic dizziness, history of Parkinson's disease, hypertension, arthritis, GERD, anxiety, depression. Cardiology Consult: Impression: chronic dizziness of uncertain etiology, recent loss of consciousness sounds orthostatic in origin, hypertension, GERD, parkinsonism, history of low back pain with herniated discs. Telemetry strips shows sinus rhythm with dysrhythmias. DC DX for DOS8/24-8/27/06 Drug reaction to pneumococcal vaccine, possible cellulitis, Parkinson's disease, degenerative disease of back. Received pneumonia shot during most recent hospitalization. Developed redness in posterial aspect of right arm, worsened seen in ER for possible cellulitis. Started on IV antibiotics. Symptoms did not change much however, with 2 doses of IV steroids they improved significantly.  Current medications: Metoprolol, Lyrica, omeprazole, Sinemet, Ambien. Allergic to Codeine and Hydrocodone.    DC DX multi-level cervical and lumbar spinal arthritis as well as thoracic spine. T-12 compression fracture, probably old, of 50%. Mild disc disease in cervical area with background of Parkinson's disease, hypertension, gastritis, insomnia. Complaints: admitted with generalized joint pain. Fallen approximately 4 times, blacked out. Multiple bruises and abrasions over right hip and both forearm. Back pain.  PE: WNL other than noted above.  Neurology Consult: Impression: chronic dizziness, history of Parkinson's disease, hypertension, arthritis, GERD, anxiety, depression. Cardiology Consult: Impression: chronic dizziness of uncertain etiology, recent loss of consciousness sounds orthostatic in origin, hypertension, GERD, parkinsonism, history of low back pain with herniated discs. Telemetry strips shows sinus rhythm with dysrhythmias. DC DX for DOS8/24-8/27/06 Drug reaction to pneumococcal vaccine, possible cellulitis, Parkinson's disease, degenerative disease of back. Received pneumonia shot during most recent hospitalization. Developed redness in posterial aspect of right arm, worsened seen in ER for possible cellulitis. Started on IV antibiotics. Symptoms did not change much however, with 2 doses of IV steroids they improved significantly.  Current medications: Metoprolol, Lyrica, omeprazole, Sinemet, Ambien.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Leukocytosis
Clinical narrative: Arm swelling, pain, redness. Diagnosis cellulitis, leukocytosis. Treatment Morphine, Zosyn IV, Zyrtec, Solumedrol IV, Benadryl. Ice to arm. DOS 8/18/06-8/22/06. DC DX multi-level cervical and lumbar spinal arthritis as well as thoracic spine. T-12 compression fracture, probably old, of 50%. Mild disc disease in cervical area with background of Parkinson's disease, hypertension, gastritis, insomnia. Complaints: admitted with generalized joint pain. Fallen approximately 4 times, blacked out. Multiple bruises and abrasions over right hip and both forearm. Back pain.  PE: WNL other than noted above.  Neurology Consult: Impression: chronic dizziness, history of Parkinson's disease, hypertension, arthritis, GERD, anxiety, depression. Cardiology Consult: Impression: chronic dizziness of uncertain etiology, recent loss of consciousness sounds orthostatic in origin, hypertension, GERD, parkinsonism, history of low back pain with herniated discs. Telemetry strips shows sinus rhythm with dysrhythmias. DC DX for DOS8/24-8/27/06 Drug reaction to pneumococcal vaccine, possible cellulitis, Parkinson's disease, degenerative disease of back. Received pneumonia shot during most recent hospitalization. Developed redness in posterial aspect of right arm, worsened seen in ER for possible cellulitis. Started on IV antibiotics. Symptoms did not change much however, with 2 doses of IV steroids they improved significantly.  Current medications: Metoprolol, Lyrica, omeprazole, Sinemet, Ambien. Allergic to Codeine and Hydrocodone.    DC DX multi-level cervical and lumbar spinal arthritis as well as thoracic spine. T-12 compression fracture, probably old, of 50%. Mild disc disease in cervical area with background of Parkinson's disease, hypertension, gastritis, insomnia. Complaints: admitted with generalized joint pain. Fallen approximately 4 times, blacked out. Multiple bruises and abrasions over right hip and both forearm. Back pain.  PE: WNL other than noted above.  Neurology Consult: Impression: chronic dizziness, history of Parkinson's disease, hypertension, arthritis, GERD, anxiety, depression. Cardiology Consult: Impression: chronic dizziness of uncertain etiology, recent loss of consciousness sounds orthostatic in origin, hypertension, GERD, parkinsonism, history of low back pain with herniated discs. Telemetry strips shows sinus rhythm with dysrhythmias. DC DX for DOS8/24-8/27/06 Drug reaction to pneumococcal vaccine, possible cellulitis, Parkinson's disease, degenerative disease of back. Received pneumonia shot during most recent hospitalization. Developed redness in posterial aspect of right arm, worsened seen in ER for possible cellulitis. Started on IV antibiotics. Symptoms did not change much however, with 2 doses of IV steroids they improved significantly.  Current medications: Metoprolol, Lyrica, omeprazole, Sinemet, Ambien.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Woke up next morning with 11 red spots on right thigh. August 25. On Aug 27 3 more red spots appeared on the same area on right thigh. No other symptoms. Referred to her Dr.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Amnesia, Erectile dysfunction, Headache, Malaise, Muscle spasms
Clinical narrative: Headaches, Pruritus general malaise, generalized pain, rash, sexual impotence, no treatment received, memory loss and cramps.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Headaches, Pruritus general malaise, generalized pain, rash, sexual impotence, no treatment received, memory loss and cramps.
Age: 1.41
Sex: F
Vaccine: IPV, MMRV
Symptoms: Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: Thrombocytopenic purpura
Age: 42.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site vesicles, Myalgia
Clinical narrative: Pts right arm blistered at the site where the MMR vaccine was given in. Arm formed a nodule 10mm in size. Area 50mm around site became erythematic. No respiratory problems or blood pressure problems. Gave pt ice to apply to site. When pt stable and no nodule present sent pt to health center to Dr. called Dr before sending pt. Pt at clinic for 20 minutes. Pt went to Dr, but Dr did not do long visit. Dr prescribed an Epi Pen. Pt reported 9/1/06 that her arm muscle was still hardened and sore.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Swelling in left arm, warm to touch 2x1 inch and red.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Abdominal pain upper, Migraine, Pain
Clinical narrative: Complained of migraine and stomach ache 3 days duration, body aches and sore arms x 5 days.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Pt had TDaP administered on 8/29/06, pt called my office the morning of 9/1/06 reporting concerns about a vaccine reaction. Administered in left deltoid area and pt only had mild soreness in the arm then the next day had. Soreness, redness and swelling at site of administration.