chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: F
Vaccine: HEP, HEP
Symptoms: Asphyxia, Autopsy, Brain oedema, Hypersomnia, Hypoxia
Clinical narrative: Information has been received from a case in litigation via a literature article concerning a 7 week old female, who on 21-DEC-1994, was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). Subsequently, on the same day of vaccination, the child died of sudden infant death syndrome or accidental suffocation by sleeping adult and not from a "cytokine storm" triggered by RECOMBIVAX HB (manufacturer unknown). "Although petitioners' expert, offered an opinion that three or four hours was a reasonable period of time for the manifestation of the clinical symptoms of a cytokine storm to appear, Child Doe/11 did not manifest any of the anticipated symptoms within that time frame." A Special Master said "the lack of clinical symptoms within the expected time frame does not support a finding in petitioners' favor regarding the causal relationship between Child Doe/11 vaccination and her death. In the absence of clinical and pathological evidence that a cytokine storm had occurred or that an encephalopathy had resulted, the undersigned is not persuaded by petitioners' theory that Child Doe/11 sleepiness during several hours after her vaccination was indicative of an abnormal vaccination reaction that ultimately led to her death." It was noted that "many of the classic findings in a post mortem examination of a SIDS case were present in Child Doe/11 at autopsy," said a Special Master. "She was a long, weighty baby with a large brain. Although there was evidence of some edema in her brain, because edema of the degree present in Child Doe/11 is accompanied generally by clinical symptoms of a severity and type that were not present in this case... the undersigned is not persuaded that the edema was as severe as the physician described... Even thought the physician admitted that he saw no evidence of edema in those organs, he yet asserted that edema must have been present to account for the heaviness of Child Doe/11's organs and to support petitioners' causation theory of a cytokin-induced encephalopathy." A Special Master said,  a post-mortem of Child Doe/11's body found her organs to be heavy, which is consistent with death by asphyxiation. The special master said, a physician explained that a child's organs become heavy during asphyxiation because in hypoxia, the blood vessels become dilated and the organ become congested with blood. The cause of death was ruled SIDS, by a forensic pathologist, who noted signs associated with SIDS, such as "rare epicardial petechiae," pulmonary congestion and edema. The special master said, the child's age was within the accepted temporal window for SIDS.
Age: 0.2
Sex: F
Vaccine: HEP, HEP
Symptoms: Petechiae, Pulmonary congestion, Pulmonary oedema, Somnolence, Sudden infant death syndrome
Clinical narrative: Information has been received from a case in litigation via a literature article concerning a 7 week old female, who on 21-DEC-1994, was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). Subsequently, on the same day of vaccination, the child died of sudden infant death syndrome or accidental suffocation by sleeping adult and not from a "cytokine storm" triggered by RECOMBIVAX HB (manufacturer unknown). "Although petitioners' expert, offered an opinion that three or four hours was a reasonable period of time for the manifestation of the clinical symptoms of a cytokine storm to appear, Child Doe/11 did not manifest any of the anticipated symptoms within that time frame." A Special Master said "the lack of clinical symptoms within the expected time frame does not support a finding in petitioners' favor regarding the causal relationship between Child Doe/11 vaccination and her death. In the absence of clinical and pathological evidence that a cytokine storm had occurred or that an encephalopathy had resulted, the undersigned is not persuaded by petitioners' theory that Child Doe/11 sleepiness during several hours after her vaccination was indicative of an abnormal vaccination reaction that ultimately led to her death." It was noted that "many of the classic findings in a post mortem examination of a SIDS case were present in Child Doe/11 at autopsy," said a Special Master. "She was a long, weighty baby with a large brain. Although there was evidence of some edema in her brain, because edema of the degree present in Child Doe/11 is accompanied generally by clinical symptoms of a severity and type that were not present in this case... the undersigned is not persuaded that the edema was as severe as the physician described... Even thought the physician admitted that he saw no evidence of edema in those organs, he yet asserted that edema must have been present to account for the heaviness of Child Doe/11's organs and to support petitioners' causation theory of a cytokin-induced encephalopathy." A Special Master said,  a post-mortem of Child Doe/11's body found her organs to be heavy, which is consistent with death by asphyxiation. The special master said, a physician explained that a child's organs become heavy during asphyxiation because in hypoxia, the blood vessels become dilated and the organ become congested with blood. The cause of death was ruled SIDS, by a forensic pathologist, who noted signs associated with SIDS, such as "rare epicardial petechiae," pulmonary congestion and edema. The special master said, the child's age was within the accepted temporal window for SIDS.
Age: 19.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, HPV4, MEN, HPV4, MEN
Symptoms: Autopsy, Death, Headache, Malaise
Clinical narrative: Initial and follow-up information has been received for a direct report from the government(VAERS#334611) concerning a previously healthy 19 year old female happy achieving college freshman with no history of substance abuse, alcohol intake, or depression, or other mental health issues, who was vaccinated on approximately 28-NOV-2008 with a dose of GARDASIL, lot number not reported. Concomitant therapy included: meningococcal vaccine (unspecified). It was reported that on 08-DEC-2008, the student died suddenly, approximately 10 days after receiving GARDASIL and meningococcal vaccine (unspecified). The vaccines were administered by a medical provider in her hometown, while she was home for the Thanksgiving holiday. The student emailed campus health services on Sunday night (07-DEC-2008) complaining of dizziness, headache, and nausea. Student Health Services at her University indicated that it might be a seizure, and arranged an appointment for her to be seen in the health services clinic that Monday (08-DEC-2008) (the day of her death). The medical clerk had entered "possible seizure" as the reason for making the appointment. There was no referral to an Emergency Room (ER). She had no history of epilepsy. She complained of a headache and not feeling well in the 24 hours prior to her death. She went to be at 10:30 PM on 07-DEC-2008, in her dorm room with a roommate. She appeared to still be sleeping the next morning when her roommate left for class. Her body was discovered still in bed around 5:00 PM that day (08-DEC-2008) with rigor mortis. Follow-up information reported that the county medical examiner reported that "examinations performed Dec. 9 were inconclusive, but said there were no signs of foul play and no signs of meningitis or other life threatening infectious diseases. Further tests would be performed and it may take up to six weeks for a final determination." This was originally reported by a physician. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, HPV4, MEN, HPV4, MEN
Symptoms: Death, Dizziness, Headache, Malaise, Nausea
Clinical narrative: Initial and follow-up information has been received for a direct report from the government(VAERS#334611) concerning a previously healthy 19 year old female happy achieving college freshman with no history of substance abuse, alcohol intake, or depression, or other mental health issues, who was vaccinated on approximately 28-NOV-2008 with a dose of GARDASIL, lot number not reported. Concomitant therapy included: meningococcal vaccine (unspecified). It was reported that on 08-DEC-2008, the student died suddenly, approximately 10 days after receiving GARDASIL and meningococcal vaccine (unspecified). The vaccines were administered by a medical provider in her hometown, while she was home for the Thanksgiving holiday. The student emailed campus health services on Sunday night (07-DEC-2008) complaining of dizziness, headache, and nausea. Student Health Services at her University indicated that it might be a seizure, and arranged an appointment for her to be seen in the health services clinic that Monday (08-DEC-2008) (the day of her death). The medical clerk had entered "possible seizure" as the reason for making the appointment. There was no referral to an Emergency Room (ER). She had no history of epilepsy. She complained of a headache and not feeling well in the 24 hours prior to her death. She went to be at 10:30 PM on 07-DEC-2008, in her dorm room with a roommate. She appeared to still be sleeping the next morning when her roommate left for class. Her body was discovered still in bed around 5:00 PM that day (08-DEC-2008) with rigor mortis. Follow-up information reported that the county medical examiner reported that "examinations performed Dec. 9 were inconclusive, but said there were no signs of foul play and no signs of meningitis or other life threatening infectious diseases. Further tests would be performed and it may take up to six weeks for a final determination." This was originally reported by a physician. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema, Rash papular
Clinical narrative: Papular rash on bridge of nose and around upper lip. Entire chin is red in circular pattern. No swelling of lips, no symptoms related to mouth or airway. No swelling of tongue or throat.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Imm administered 12-15-08.  12-19-08 presented to ACHD.  c/o itching rash at site of both PEDIARIX and PREVNAR last pm.  12-19 no itching present.  No treatment.
Age: 20.0
Sex: M
Vaccine: FLUN3, HEPAB, MMR, TDAP
Clinical narrative: See attached progress notes. 12/29/2009 MR received for 2 office visits.  Pt presented 11/6/08 with c/o bilateral extremity weakness, weakness of the hands and feet and ataxia, difficulty walking and numbness to the abdomen. Recently tx for Community Acquired Pneumonia 11/2/08. PE (+) for rhonchi, decreased strength in arms, legs and hips, weakness both ankles, ataxic gait and diminished or absent reflexes. Assessment:  Muscle weakness-hands and feet x 2 days with truncal numbness.  No resp issues.  Sent to Er to r/o GBS.  Community acquired pneumonia. Labs and Diagnostics: CXR WNL. CBC with Hgb 36.6.  Hct 12.6.  Platelets 445. F/U visit for DX: Guillain-Barre Syndrome 11/25/08.  Pt reports still feeling weak, having trouble walking, paresthesias in legs, facial numbness. Unable to open mouth or close R eye. PE (+) for mild R peripheral VII paresis. DX:  Bell's Palsy. F/U 12/2/08 Sx improving but not completely resolved. 2/11/09 MR received for DOS 10/29-11/2/2008, 11/7-12/2008 and 11/12-20/2008 with initial DX of Pneumonia then Guillain Barre Syndrome. Pt initially presented with 5 day hx of worsening cough with yellow sputum, nasal congestion, vomiting and chills. DX with pneumonia and treated with abx.  Also reported knee and ankle pain. Infiltrates improved with abx and d/c on 11/2/08.  Returned 11/7 with c/o numbness/tingling  in his fingers and feet progressing to the thighs and difficulty walking.  Admitted and tx with IVIG with improvement. Able to walk with cane. Transferred for further rehab 11/12/08.
Age: 18.0
Sex: M
Vaccine: BCG, FLUN3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Mechanical ventilation, Pneumonia aspiration
Clinical narrative: See attached progress notes patient is still hospitalized as of see 3/2008.  He is on a ventilation recently complicated by aspiration pneumonia. 12/29/08-records received-C/O fever, chills, congestion, runny nose, sore throat, nausea and productive cough, febrile on 10/6/08-DX:upper respiratory infection. fever. 10/15/08-C/O numbness of feet and numbness of hands and mouth. Assessment:polyneuropathy idiopathic progressive. 10/16/08-developed progressive neurologic symptoms consistent with GBS. Stable. 10/20/08-In rehabilitation center neuro symptoms not progressing. GBS not confirmed. 2/9/09-records received for DOS 10/15-11/13/08-DC DX:Guillain Barre syndrome with respiratory failure requiring ventilator support. HCAP. Presented with C/O tingling in feet bilaterally and in both hands and roof of mouth, weakness in lower extremities while trying to go upstairs. Aphonia, dysphagia. Acute sensory motor neuro deficit, respiratory ventilator and subsequent tracheostomy. IVIG and plasmapheresis. Developed orchitis. Tachycardia and hypertesion.
Age: 24.0
Sex: F
Vaccine: FLU3, HPV4, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving vaccines
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Complains of wheezing advised to go to ER
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Asthenia, Blood test, Chills, Decreased appetite, Malaise
Clinical narrative: On 10-02-2008 the patients mother was in the health department for services and reported that patient became very ill 3 days after getting vaccine here 1/2008. She began with rash and itching on 1 leg that spread in patches all over her body. She did not have a fever. She chilled, had nausea , and was unable to eat. she had no energy. Over the course of her illness (3mo) she lost 20lbs. Shortly after onset of illness, she saw a doctor and was sent to a Dermatologist. According to the patients mother diagnosis was pseudomonas. After 3 months the patient began to have relief from symptoms and is now feeling recovered. Any treatment/ Medications is unknown to me.  12/31/08 Reviewed PCP medical records of 4/08. FINAL DX: erythema multiforme Records reveal patient experienced papular red itchy rash all over x 1 week, decreased appetite, fever & chills x 2 days. Seen in ER on 4/12 & dx w/cellulitis.  Tx w/antibiotics.  PCP dx w/EM & tx w/steroids.  RTC 4/29 w/o improvement, now w/left ear pain & 9# wt loss.  Dx w/otitis externa, treated w/ear drops & referred to Derm.  No other records available.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Nausea, Pseudomonas infection, Weight decreased
Clinical narrative: On 10-02-2008 the patients mother was in the health department for services and reported that patient became very ill 3 days after getting vaccine here 1/2008. She began with rash and itching on 1 leg that spread in patches all over her body. She did not have a fever. She chilled, had nausea , and was unable to eat. she had no energy. Over the course of her illness (3mo) she lost 20lbs. Shortly after onset of illness, she saw a doctor and was sent to a Dermatologist. According to the patients mother diagnosis was pseudomonas. After 3 months the patient began to have relief from symptoms and is now feeling recovered. Any treatment/ Medications is unknown to me.  12/31/08 Reviewed PCP medical records of 4/08. FINAL DX: erythema multiforme Records reveal patient experienced papular red itchy rash all over x 1 week, decreased appetite, fever & chills x 2 days. Seen in ER on 4/12 & dx w/cellulitis.  Tx w/antibiotics.  PCP dx w/EM & tx w/steroids.  RTC 4/29 w/o improvement, now w/left ear pain & 9# wt loss.  Dx w/otitis externa, treated w/ear drops & referred to Derm.  No other records available.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Culture throat negative, Decreased appetite, Gastrooesophageal reflux disease, Irritability, Pharyngitis
Clinical narrative: 12-9-08 Vaccines given.  12/11/08 Fussy since vaccines.  Fever off and on T 101.6 decrease appetite.  Seen by Doctor - Pharyngitis, GE reflux.  TYLENOL after 4 hrs.  12-12-08 Temp down.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: 12-9-08 Vaccines given.  12/11/08 Fussy since vaccines.  Fever off and on T 101.6 decrease appetite.  Seen by Doctor - Pharyngitis, GE reflux.  TYLENOL after 4 hrs.  12-12-08 Temp down.
Age: 0.2
Sex: M
Vaccine: PNC
Symptoms: Crying
Clinical narrative: Excessive crying 12-9-2008 after PREVNAR vaccine 12/10/2008 Phone call-  cried himself to sleep.  No fever. Settled dwon 45minutes.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Rash vesicular, Skin lesion
Clinical narrative: Developed lassie varicella rash with lesions in various stage. Scattered lesion, most prominent on trunk, also on face and limbs. Active infection
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Dysphagia, No reaction on previous exposure to drug, Swelling face
Clinical narrative: Initial report received on 15 December 2008 from a health care professional. A 4-month-old female patient who had concurrent gastroesophagel reflux disease (GERD) and pre-existing medical condition of edema, had received a second dose of the following vaccines on 20 October 2008 at 09:00 am: ACTHIB (lot number UF529AA Sanofi Pasteur SA lot number Z1185-2) intramuscular in the left thigh; DAPTACEL (lot number C2999AA) intramuscular in the right thigh; IPOL (lot number A1109-2) subcutaneous in the left thigh; PREVNAR (manufacturer Wyeth, lot number C97892) intramuscular in the right thigh and oral "rotavirus" vaccine (manufacturer Merck, lot number 1033X). Around 13:45 pm approximately four hours after receiving the vaccinations on 20 October 2008, the patient began to experience facial swelling and had difficulty swallowing. She was taken to the emergency room where she was treated with BENADRYL and the symptoms resolved. The patient is to be evaluated by an allergist (date not provided). The patient had received the first dose of ACTHIB, DAPTACEL, IPOL, PREVNAR and rotavirus vaccine in August 2008 without any adverse events. At the time of this report, the patient had recovered. Documents held by sender: None
Age: 1.9
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, Aphasia, Cognitive disorder, Diet refusal, Dyskinesia
Clinical narrative: A serious spontaneous report of accidental exposure, possible encephalitis, and runny nose has been received from a Registered Nurse (the patient's mother) concerning a 23-month-old female. Medical history and concomitant medications were not reported. On 12-Nov-2008, the patient's father received FLUMIST. The patient did not receive FLUMIST. On 24-Nov-2008, the patient developed a runny nose that was "off and on" and lasted until 01-Dec-2008. On 04-Dec-2008, the patient began experiencing "neurological difficulties." She developed ticks described as blinking, facial movements, shoulder movements down to her fingers, and toes twitching. She had sensitivity as light and "bad" fevers which were 101-102 degrees F with treatment with TYLENOL. She had cognitive and speech loss for 4-5 days where she was not able not able to speak like she normally did, she could not say "apple" which she could easily say previously and she would say "what's that?" to things that she previously knew. She was not eating, only wanted to nurse, was not sleeping and was irritable. She was not lethargic. The patient went to the pediatrician on 05-Dec-2008 and 10-Dec-2008. She was prescribed amoxicillin and the patient's mother was told only to give it to her if she got worse. The patient started getting better so she never received amoxicillin. On 17-Dec-2008, the patient was seen by a neurologist. The neurologist indicated it was possibly encephalitis but there was no way to know because the patient's symptoms were resolving. A brain magnetic resonance imaging (MRI) on 18-Dec-2008 was normal. There was no spinal tap or electroencephalography (EEG) done. As of 22-Dec-2008, the patient's symptoms resolved although she was still experiencing headaches and tiring easily. The patient's mother indicated that the neurologist reviewed the chronology of the events and indicated that it could have been from exposure to the father after receiving FLUMIST. The sponsor considered the event of possible encephalitis to be serious (important medical event). Follow-up: (1) Data not updated. (2) Called mother of patient and left voicemail requesting data. (3) Subject was accidentally exposed to vaccine.
Age: 1.9
Sex: F
Vaccine: FLUN3
Symptoms: Excessive eye blinking, Fatigue, Headache, Inappropriate schedule of drug administration, Insomnia
Clinical narrative: A serious spontaneous report of accidental exposure, possible encephalitis, and runny nose has been received from a Registered Nurse (the patient's mother) concerning a 23-month-old female. Medical history and concomitant medications were not reported. On 12-Nov-2008, the patient's father received FLUMIST. The patient did not receive FLUMIST. On 24-Nov-2008, the patient developed a runny nose that was "off and on" and lasted until 01-Dec-2008. On 04-Dec-2008, the patient began experiencing "neurological difficulties." She developed ticks described as blinking, facial movements, shoulder movements down to her fingers, and toes twitching. She had sensitivity as light and "bad" fevers which were 101-102 degrees F with treatment with TYLENOL. She had cognitive and speech loss for 4-5 days where she was not able not able to speak like she normally did, she could not say "apple" which she could easily say previously and she would say "what's that?" to things that she previously knew. She was not eating, only wanted to nurse, was not sleeping and was irritable. She was not lethargic. The patient went to the pediatrician on 05-Dec-2008 and 10-Dec-2008. She was prescribed amoxicillin and the patient's mother was told only to give it to her if she got worse. The patient started getting better so she never received amoxicillin. On 17-Dec-2008, the patient was seen by a neurologist. The neurologist indicated it was possibly encephalitis but there was no way to know because the patient's symptoms were resolving. A brain magnetic resonance imaging (MRI) on 18-Dec-2008 was normal. There was no spinal tap or electroencephalography (EEG) done. As of 22-Dec-2008, the patient's symptoms resolved although she was still experiencing headaches and tiring easily. The patient's mother indicated that the neurologist reviewed the chronology of the events and indicated that it could have been from exposure to the father after receiving FLUMIST. The sponsor considered the event of possible encephalitis to be serious (important medical event). Follow-up: (1) Data not updated. (2) Called mother of patient and left voicemail requesting data. (3) Subject was accidentally exposed to vaccine.
Age: 1.9
Sex: F
Vaccine: FLUN3
Symptoms: Irritability, Movement disorder, Muscle twitching, Nervous system disorder, Nuclear magnetic resonance imaging brain normal
Clinical narrative: A serious spontaneous report of accidental exposure, possible encephalitis, and runny nose has been received from a Registered Nurse (the patient's mother) concerning a 23-month-old female. Medical history and concomitant medications were not reported. On 12-Nov-2008, the patient's father received FLUMIST. The patient did not receive FLUMIST. On 24-Nov-2008, the patient developed a runny nose that was "off and on" and lasted until 01-Dec-2008. On 04-Dec-2008, the patient began experiencing "neurological difficulties." She developed ticks described as blinking, facial movements, shoulder movements down to her fingers, and toes twitching. She had sensitivity as light and "bad" fevers which were 101-102 degrees F with treatment with TYLENOL. She had cognitive and speech loss for 4-5 days where she was not able not able to speak like she normally did, she could not say "apple" which she could easily say previously and she would say "what's that?" to things that she previously knew. She was not eating, only wanted to nurse, was not sleeping and was irritable. She was not lethargic. The patient went to the pediatrician on 05-Dec-2008 and 10-Dec-2008. She was prescribed amoxicillin and the patient's mother was told only to give it to her if she got worse. The patient started getting better so she never received amoxicillin. On 17-Dec-2008, the patient was seen by a neurologist. The neurologist indicated it was possibly encephalitis but there was no way to know because the patient's symptoms were resolving. A brain magnetic resonance imaging (MRI) on 18-Dec-2008 was normal. There was no spinal tap or electroencephalography (EEG) done. As of 22-Dec-2008, the patient's symptoms resolved although she was still experiencing headaches and tiring easily. The patient's mother indicated that the neurologist reviewed the chronology of the events and indicated that it could have been from exposure to the father after receiving FLUMIST. The sponsor considered the event of possible encephalitis to be serious (important medical event). Follow-up: (1) Data not updated. (2) Called mother of patient and left voicemail requesting data. (3) Subject was accidentally exposed to vaccine.
Age: 1.9
Sex: F
Vaccine: FLUN3
Symptoms: Nuclear magnetic resonance imaging normal, Photophobia, Pyrexia, Rhinorrhoea, Secondary transmission
Clinical narrative: A serious spontaneous report of accidental exposure, possible encephalitis, and runny nose has been received from a Registered Nurse (the patient's mother) concerning a 23-month-old female. Medical history and concomitant medications were not reported. On 12-Nov-2008, the patient's father received FLUMIST. The patient did not receive FLUMIST. On 24-Nov-2008, the patient developed a runny nose that was "off and on" and lasted until 01-Dec-2008. On 04-Dec-2008, the patient began experiencing "neurological difficulties." She developed ticks described as blinking, facial movements, shoulder movements down to her fingers, and toes twitching. She had sensitivity as light and "bad" fevers which were 101-102 degrees F with treatment with TYLENOL. She had cognitive and speech loss for 4-5 days where she was not able not able to speak like she normally did, she could not say "apple" which she could easily say previously and she would say "what's that?" to things that she previously knew. She was not eating, only wanted to nurse, was not sleeping and was irritable. She was not lethargic. The patient went to the pediatrician on 05-Dec-2008 and 10-Dec-2008. She was prescribed amoxicillin and the patient's mother was told only to give it to her if she got worse. The patient started getting better so she never received amoxicillin. On 17-Dec-2008, the patient was seen by a neurologist. The neurologist indicated it was possibly encephalitis but there was no way to know because the patient's symptoms were resolving. A brain magnetic resonance imaging (MRI) on 18-Dec-2008 was normal. There was no spinal tap or electroencephalography (EEG) done. As of 22-Dec-2008, the patient's symptoms resolved although she was still experiencing headaches and tiring easily. The patient's mother indicated that the neurologist reviewed the chronology of the events and indicated that it could have been from exposure to the father after receiving FLUMIST. The sponsor considered the event of possible encephalitis to be serious (important medical event). Follow-up: (1) Data not updated. (2) Called mother of patient and left voicemail requesting data. (3) Subject was accidentally exposed to vaccine.
Age: 1.9
Sex: F
Vaccine: FLUN3
Symptoms: Tic
Clinical narrative: A serious spontaneous report of accidental exposure, possible encephalitis, and runny nose has been received from a Registered Nurse (the patient's mother) concerning a 23-month-old female. Medical history and concomitant medications were not reported. On 12-Nov-2008, the patient's father received FLUMIST. The patient did not receive FLUMIST. On 24-Nov-2008, the patient developed a runny nose that was "off and on" and lasted until 01-Dec-2008. On 04-Dec-2008, the patient began experiencing "neurological difficulties." She developed ticks described as blinking, facial movements, shoulder movements down to her fingers, and toes twitching. She had sensitivity as light and "bad" fevers which were 101-102 degrees F with treatment with TYLENOL. She had cognitive and speech loss for 4-5 days where she was not able not able to speak like she normally did, she could not say "apple" which she could easily say previously and she would say "what's that?" to things that she previously knew. She was not eating, only wanted to nurse, was not sleeping and was irritable. She was not lethargic. The patient went to the pediatrician on 05-Dec-2008 and 10-Dec-2008. She was prescribed amoxicillin and the patient's mother was told only to give it to her if she got worse. The patient started getting better so she never received amoxicillin. On 17-Dec-2008, the patient was seen by a neurologist. The neurologist indicated it was possibly encephalitis but there was no way to know because the patient's symptoms were resolving. A brain magnetic resonance imaging (MRI) on 18-Dec-2008 was normal. There was no spinal tap or electroencephalography (EEG) done. As of 22-Dec-2008, the patient's symptoms resolved although she was still experiencing headaches and tiring easily. The patient's mother indicated that the neurologist reviewed the chronology of the events and indicated that it could have been from exposure to the father after receiving FLUMIST. The sponsor considered the event of possible encephalitis to be serious (important medical event). Follow-up: (1) Data not updated. (2) Called mother of patient and left voicemail requesting data. (3) Subject was accidentally exposed to vaccine.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature, Diarrhoea, Headache, Injection site erythema, Injection site induration
Clinical narrative: Pain at injection site redness, swelling, area hard temp 98. Nausea, Diarrhea headache
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Nausea
Clinical narrative: Pain at injection site redness, swelling, area hard temp 98. Nausea, Diarrhea headache
Age: 52.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Arthralgia, Lymphadenopathy, Pain, Rash
Clinical narrative: Patient developed rash,swollen lymph nodes of the neck,body aches and joint pain on 12/22, 14 days after administration.
Age: 8.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Conjunctival hyperaemia, Dizziness, Eye pain, Fall, Head injury
Clinical narrative: AFTER RECEIEVING THE VACC FOR HEP A,FLU AND PPD ,PT SAYS SHE FELT PAIN IN HER EYES AND ALSO FELT DIZZY ,FELL STRAIGHT BACK  AND HIT HER HEAD AGAINST THE WALL,SAYS SHE REMEMBERS THE INCIDENCE,NO ITCHING,OR PROBLEM BREATHING,,WHEN EXAMINED ,SHE IS LYING ON THE BED STILL C/O PAIN THE EYES,PT NOTICED TO HAVE OBVIOUS CONJUNTIVAL INJECTIO,PT GIVEN BENEDRYL AND OXYGEN,SEND TO ER
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood culture negative, Erythema, Full blood count normal, Joint contracture, Local reaction
Clinical narrative: Large local reaction - 4 x 4.5 inches 2 days after vaccine.  Progressed to include elbow so became concerned about septic joint vs cellulitis vs local reaction.  MRI negative for septic joint. Treated with Keflex. No fever.  Contracture of elbow developed as erythema/swelling resolved.  Contracture resolved without intervention over next few weeks.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Nuclear magnetic resonance imaging normal, Swelling
Clinical narrative: Large local reaction - 4 x 4.5 inches 2 days after vaccine.  Progressed to include elbow so became concerned about septic joint vs cellulitis vs local reaction.  MRI negative for septic joint. Treated with Keflex. No fever.  Contracture of elbow developed as erythema/swelling resolved.  Contracture resolved without intervention over next few weeks.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Blood pressure increased, Blood thyroid stimulating hormone, Chest X-ray normal, Computerised tomogram normal, Confusional state
Clinical narrative: Dizzyness, muddled thinking, somewhat confused.  Began when I woke up the day after around 6AM Wed,Dec 3th.  Called doctor, told me to wait it out, called the next day and went in to see him.  He did an EKG, my blood pressure was elevated (about 145 over 90), did a blood test, sent me downstairs for a chest X-Ray and a head CT. Each day after it got a bit better and I felt like my old self by Sunday, Dec. 7th.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Electrocardiogram normal, Full blood count normal
Clinical narrative: Dizzyness, muddled thinking, somewhat confused.  Began when I woke up the day after around 6AM Wed,Dec 3th.  Called doctor, told me to wait it out, called the next day and went in to see him.  He did an EKG, my blood pressure was elevated (about 145 over 90), did a blood test, sent me downstairs for a chest X-Ray and a head CT. Each day after it got a bit better and I felt like my old self by Sunday, Dec. 7th.
Age: 1.58
Sex: M
Vaccine: DTAP, FLU3, MMR, VARCEL
Symptoms: Asthenia, Decreased appetite, Irritability, Rash, Rhinorrhoea
Clinical narrative: LAST NIGHT RASH APPEARED CHEEKS AND EYELIDS FIRST THEN SPREAD TO CHEST AND BELLY.  iNCREASED FUSSINESS, DECREASED APPETITE NO FEVER, LAST WEEK RHINORRHEA, CLEARED UP AFTER 2 DAYS, NO VOMITING OR DIARRHEA, DECREASED ENERGY BUT NOT LETHARGIC, RUBBING EYES NO KNOWN EXPOSURE OTHER THAN IMMUNIZATION. NO CHANGE IN PERSONAL CARE PRODUCTS.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling, Tenderness
Clinical narrative: 12/18/2008 Patient went to doctor's office w/a reaction of redness, swelling and mild warmth (according to nurse) on 12/19/2008 returned to doctor's office with out itching tenderness. MD gave an antibiotic cream and Benadryl. Patients ok
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Barium swallow normal, Biopsy intestine normal, Blood arsenic normal, Blood folate normal, Blood test normal
Clinical narrative: Experienced viral type syndrome (sore throat, swollen cervical lymph nodes, fever, fatigue) within 48 hours of receiving DRYVAX (x2, no take). SM's symptoms lingered into development (July through Sep/Oct 2006)- headache, neck pain, decreased appetite, muscle weakness and decreased attention span. Around Sept/Oct 06, developed essential hand tremors. Also notes chronic fatigue and headaches. In Nov 2006 developed progressive dysphasia for 3 weeks which spontaneously resolved. Later diagnosed with periodic leg movement of sleep and restless leg syndrome.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: C-reactive protein normal, Computerised tomogram normal, Decreased appetite, Disturbance in attention, Dysphasia
Clinical narrative: Experienced viral type syndrome (sore throat, swollen cervical lymph nodes, fever, fatigue) within 48 hours of receiving DRYVAX (x2, no take). SM's symptoms lingered into development (July through Sep/Oct 2006)- headache, neck pain, decreased appetite, muscle weakness and decreased attention span. Around Sept/Oct 06, developed essential hand tremors. Also notes chronic fatigue and headaches. In Nov 2006 developed progressive dysphasia for 3 weeks which spontaneously resolved. Later diagnosed with periodic leg movement of sleep and restless leg syndrome.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Encephalopathy, Epstein-Barr virus antibody negative, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Experienced viral type syndrome (sore throat, swollen cervical lymph nodes, fever, fatigue) within 48 hours of receiving DRYVAX (x2, no take). SM's symptoms lingered into development (July through Sep/Oct 2006)- headache, neck pain, decreased appetite, muscle weakness and decreased attention span. Around Sept/Oct 06, developed essential hand tremors. Also notes chronic fatigue and headaches. In Nov 2006 developed progressive dysphasia for 3 weeks which spontaneously resolved. Later diagnosed with periodic leg movement of sleep and restless leg syndrome.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Mastoid disorder, Memory impairment, Muscular weakness, Neck pain, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Experienced viral type syndrome (sore throat, swollen cervical lymph nodes, fever, fatigue) within 48 hours of receiving DRYVAX (x2, no take). SM's symptoms lingered into development (July through Sep/Oct 2006)- headache, neck pain, decreased appetite, muscle weakness and decreased attention span. Around Sept/Oct 06, developed essential hand tremors. Also notes chronic fatigue and headaches. In Nov 2006 developed progressive dysphasia for 3 weeks which spontaneously resolved. Later diagnosed with periodic leg movement of sleep and restless leg syndrome.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Nuclear magnetic resonance imaging normal, Oesophagogastroduodenoscopy, Oropharyngeal pain, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: Experienced viral type syndrome (sore throat, swollen cervical lymph nodes, fever, fatigue) within 48 hours of receiving DRYVAX (x2, no take). SM's symptoms lingered into development (July through Sep/Oct 2006)- headache, neck pain, decreased appetite, muscle weakness and decreased attention span. Around Sept/Oct 06, developed essential hand tremors. Also notes chronic fatigue and headaches. In Nov 2006 developed progressive dysphasia for 3 weeks which spontaneously resolved. Later diagnosed with periodic leg movement of sleep and restless leg syndrome.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Restless legs syndrome, Rheumatoid factor negative, Serology negative, Sinusitis, Thyroid neoplasm
Clinical narrative: Experienced viral type syndrome (sore throat, swollen cervical lymph nodes, fever, fatigue) within 48 hours of receiving DRYVAX (x2, no take). SM's symptoms lingered into development (July through Sep/Oct 2006)- headache, neck pain, decreased appetite, muscle weakness and decreased attention span. Around Sept/Oct 06, developed essential hand tremors. Also notes chronic fatigue and headaches. In Nov 2006 developed progressive dysphasia for 3 weeks which spontaneously resolved. Later diagnosed with periodic leg movement of sleep and restless leg syndrome.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Tremor, Urine analysis normal, Viral infection, Vitamin B12 normal
Clinical narrative: Experienced viral type syndrome (sore throat, swollen cervical lymph nodes, fever, fatigue) within 48 hours of receiving DRYVAX (x2, no take). SM's symptoms lingered into development (July through Sep/Oct 2006)- headache, neck pain, decreased appetite, muscle weakness and decreased attention span. Around Sept/Oct 06, developed essential hand tremors. Also notes chronic fatigue and headaches. In Nov 2006 developed progressive dysphasia for 3 weeks which spontaneously resolved. Later diagnosed with periodic leg movement of sleep and restless leg syndrome.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling, Local reaction
Clinical narrative: Local injection site reaction. raised, red, swollen, bruised skin at injection site.
Age: 12.0
Sex: M
Vaccine: DTAPH, MMR
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Vesicular, red papules - scalp, forehead, extremities, back
Age: 1.1
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Blister, Headache, Oropharyngeal pain, Rash papular, Rash pruritic
Clinical narrative: Papular rash on face, trunk, extremeties a few with vesicles;  c/o h/a, itchy rash and sore throat; ACYCLOVIR 200/5, 3 1/2 top QID X 5d and Amox.  400/5, 1 1/2 top BID X 10d
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Patient developed a mild rash all over his body exactly 10 days after his MMR shot.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Pt pruented in office 2 days post VARIVAX vaccine with swelling and itching around injection site, starting 1 day prior.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Blood pressure increased, Flushing, Heart rate normal, Palpitations
Clinical narrative: Pt c/o being flushed and anxious.  BP 160/110 with pulse rate of 70.  Pt c/o heart palpitations.  Reasssessed by staff in 10 minutes, pt stated feeling better and returned to work`
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: On the afternoon of 11/18/08 patient was fussy and whiny.  The next morning she was c/o her arm itching but her dad dressed her in the dark and did not see any rash. In the afternoon her teacher reported that she had been very quiet. By 3pm (after school) she felt warm (temp not taken) and her R arm  itched and was reddened, swollen and hot to touch. Mom telephoned an urgent care facility and they advised her to keep an eye on her fever and level of consciousness and to give benadryl for the itching. On 11/20/08 she was seen at Clinic.  Mom reported that the swelling was down.  Notes report that her right deltoid was firm and warm to touch, non-tender; large area of redness from elbow to shoulder.T 96.8, P102, R 22, BO 88/44. Ice and benadryl prn for age were prescribed and told to return to clinic if temp above 100.5 degrees or increase in swelling/redness occured.   On 11/25/08 Mom was contacted by phone and reported the swelling was down to about the size of a quarter coin, still itchy and red. on 12/8/08 Mom reported all swelling and itching gone.  Patient "fine".
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, VARCEL
Symptoms: Irritability, Pyrexia
Clinical narrative: On the afternoon of 11/18/08 patient was fussy and whiny.  The next morning she was c/o her arm itching but her dad dressed her in the dark and did not see any rash. In the afternoon her teacher reported that she had been very quiet. By 3pm (after school) she felt warm (temp not taken) and her R arm  itched and was reddened, swollen and hot to touch. Mom telephoned an urgent care facility and they advised her to keep an eye on her fever and level of consciousness and to give benadryl for the itching. On 11/20/08 she was seen at Clinic.  Mom reported that the swelling was down.  Notes report that her right deltoid was firm and warm to touch, non-tender; large area of redness from elbow to shoulder.T 96.8, P102, R 22, BO 88/44. Ice and benadryl prn for age were prescribed and told to return to clinic if temp above 100.5 degrees or increase in swelling/redness occured.   On 11/25/08 Mom was contacted by phone and reported the swelling was down to about the size of a quarter coin, still itchy and red. on 12/8/08 Mom reported all swelling and itching gone.  Patient "fine".
Age: 1.83
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC
Symptoms: Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: An itchy rash (around 150 spots) all over the body occured ten days after the vaccine was administered and lasted for four days. Preceding the rash was a mild fever that lasted two days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient complains of redness and pain at injection site.  The pain was reported to be gone after a week with the redness decreasing in size one week after injection.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Rash papular
Clinical narrative: papular rash on face, trunks, and extremities.
Age: 42.0
Sex: F
Vaccine: DTAP
Symptoms: Asthenia, Headache, Mobility decreased, Muscle atrophy, Neck pain
Clinical narrative: by 24 hours post injection I had such muscle loss I could not lift my arm more than four inches away from my body.  I could not lift any weight whatsoever.  I also had arm ache, neckache and headache all on the left side(injection side)  I had severe pain in my arm and could not sleep due to pain.  Motrin and Tylenol did not help.  four days later I regained range of motion. Now three weeks to the day of my injection I still have severe pain and have not gained my strength back past about 70%.  I am effected by this every minute of everyday.
Age: 42.0
Sex: F
Vaccine: DTAP
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: by 24 hours post injection I had such muscle loss I could not lift my arm more than four inches away from my body.  I could not lift any weight whatsoever.  I also had arm ache, neckache and headache all on the left side(injection side)  I had severe pain in my arm and could not sleep due to pain.  Motrin and Tylenol did not help.  four days later I regained range of motion. Now three weeks to the day of my injection I still have severe pain and have not gained my strength back past about 70%.  I am effected by this every minute of everyday.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Blood culture positive, Lethargy, Malaise, Pyrexia, Serratia infection
Clinical narrative: Became sick on 12/14 with fever and poor eating, lethargy. Blood culture from that day grew Serratia Marcescens. 1/29/09-records received for DOS 12/16-12/25/08DC DX: R/O sepsis. Serratia bacteremia resolved. Presented with fever 101-102 increased sleeping and decreased appetite began on day of presentation to ER.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Unsure if this is reportable. Received ROTATEQ 12-17-08. Vomiting and diarrhea began on 12-20-08. To hosp. 12-20-21-08. 1/7/09-records received for DOS 12/19/-12/20/08-DX: acute gastroenteritis. Dehydration. Acidosis. prematurity. Gastroesophageal reflux. presented with C/O vomiting, diarrhea, began 3 days ago.
Age: 7.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Induration, Oedema peripheral, Tenderness
Clinical narrative: Next morning arm swollen, red and hard. Very tender.
Age: 14.0
Sex: F
Vaccine: HEP, HPV4, MNQ, VARCEL
Symptoms: Local reaction
Clinical narrative: Local injection reaction -  treatment ice, NSAIDS
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying
Clinical narrative: excessive crying x 5 days.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Patient received shot on 12/23/08 at 9:30am (left arm), he had swelling and heat at injection site the morning of 12/25/08. On 12/26/08 (in the morning) developed swelling in left hand, and injection site was red and really swollen. By 6pm on 12/26/08 the hand was normal, site  still pink and swollenness has decreased slowly recovering.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Parents noted swelling and redness to left upper arm 24hours after vaccine given used cool cloth
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Dyspnoea, Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Within minutes after immunization coughing, c/o difficulty breathing, audible wheezing, red rash over entire body, welts on entire body. Hospital ER IV-gave BENADRYL and steroids IVP-released after 1 1/2 hour
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: Within minutes after immunization coughing, c/o difficulty breathing, audible wheezing, red rash over entire body, welts on entire body. Hospital ER IV-gave BENADRYL and steroids IVP-released after 1 1/2 hour
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Pt received DTaP and Polio in RT/IM on 12-10-08 at 4 yr WCC. Mom called answering service stating pt developed swelling and rash around the injection site. Mom is to use 150mg IBU Q6 hrs x 24 hrs for swelling and RTO if worse or concerned.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Syncope
Clinical narrative: Patient was at check out with mom, told mom stomach hurt then had syncopal episode-aroused after 3-5 seconds then got up. No incontinence, no disorientation.
Age: 26.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Cough, Ocular hyperaemia
Clinical narrative: Pt called health unit to report eyes red, cough/stopped up approximately starting one hour after vaccine administered. Instructed to report to E.R. now for evaluation
Age: 26.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Cough, Ocular hyperaemia, Respiratory tract congestion
Clinical narrative: Pt called health unit to report eyes red, cough/stopped up approximately starting one hour after vaccine administered. Instructed to report to E.R. now for evaluation