chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: White blood cell count
Clinical narrative: Information has been received from a physician concerning a 75 year old male with no known history who on 02-MAR-2007 was vaccinated SC in the left deltoid with a 0.65 ml first dose of Zostavax (lot # 652925/0621F). There was no concomitant medication or illness at the time of vaccination. Two hours after vaccination on 02-MAR-2007, the patient started developing pain in his neck as well as some achiness. He developed some disorientation and erratic driving over the weekend and was seen by the physician on 05-MAR-2007. The physician recommended work-up for possible Zostavax related meningoencephalitis or viral encephalitis. He was admitted to the hospital observation unit and under went neurological consultation. A MRA of the brain showed no acute infarct, no MRA evidence of encephalitis or meningitis. A 13 mm right medical posterior inferior cerebellar cystic lesion represents a small arachnoid cyst versus the etiology of doubtful clinical significance. He underwent a spinal tap under fluoroscopic guidance which revealed the following findings: fluid protein 80 mg/dl, glucose 68 and white blood count was 23 white cells per microliter, 100% of mononuclear. The patient had PCR for herpes simples virus which was negative. The patient's basic metabolic panel was normal and his white count was 10,800 with 68% neutrophils, 17% lymphocytes, 8.4% monocytes and 5% eosinophils. The patient was discharged to home on 08-MAR-2007. His mental status did not change and he still had the same symptomatology of some disorientation and loss of higher cortical function. The discharge diagnosis was viral meningitis of undetermined etiology possibly post vaccination with Zostavax. The patient's discharge medications included PROTONIX "quarter" mg QD, naprosyn 300 mg PO BID and MIDRIN one capsule PO q 6h for severe headaches. The plan was for the patient to follow-up as an outpatient. As of 30-MAR-2007 the patient was at home and "doing much better". A lot check has been requested. It was reported that CSF fluid was available for PCR testing and the patient was enrolled in the Varicella Zoster virus identification program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the manufacturer vaccine VZV strain. The patient's viral meningitis was considered to be immediately life-threatening. Additional information has been requested. 04/24/07-records received from facility for DOS 03/05-03/08/07-DC DX: viral meningitis of undetermined etiology possible post vaccination with Zostavax. 3/2/07-Two hours after receiving vaccine C/O pain in neck as well as some achiness, developed disorientation and erratic driving.
Age: 0.3
Sex: F
Vaccine: DTAP, IPV, RV5, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Intussusception - surgery.  5/18/07 Received medical records from hospital which reveal patient experienced nausea, bilious vomiting & decreased oral intake for 2 days & 1 episode of blood stool   Admitted 2/13/07-2/14/07.   Taken to OR for exp laparotomy, mechanical reduction of IS.  Progressed well postoperatively & d/c to home w/PCP & clinic f/u. FINAL DX: Intussusception, surgically reduced.
Age: 0.16
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Abnormal faeces, Blood electrolytes normal, Dehydration, Diet refusal, Full blood count normal
Clinical narrative: Received 2 mo vaccines on 3/27/07. More fussy + sleepy that night but OK. Next day screamed all day and refused to eat. Admitted to hospital that night with irritability and dehydration. No fever, no other symptoms otherwise - normal exam. mom ill 3/31 - had diarrhea. Infant also devel. fever and foul stools. Normal exam 4/2/07.  4/24/07 Records received from hospital which reveal patient experienced initially lethargy then irritability & refusal to eat since vaccines.  Seen by PCP on 3/27 & sent home but returned to ER on 3/30 due to ongoing fussiness, being unable to console & decreased oral intake.  Given IVF & admitted 3/28/07-3/30/07 for observation.   FINAL DX: atypical reaction to immunizations.
Age: 0.16
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Irritability, Pyrexia, Screaming, Sick relative, Somnolence
Clinical narrative: Received 2 mo vaccines on 3/27/07. More fussy + sleepy that night but OK. Next day screamed all day and refused to eat. Admitted to hospital that night with irritability and dehydration. No fever, no other symptoms otherwise - normal exam. mom ill 3/31 - had diarrhea. Infant also devel. fever and foul stools. Normal exam 4/2/07.  4/24/07 Records received from hospital which reveal patient experienced initially lethargy then irritability & refusal to eat since vaccines.  Seen by PCP on 3/27 & sent home but returned to ER on 3/30 due to ongoing fussiness, being unable to console & decreased oral intake.  Given IVF & admitted 3/28/07-3/30/07 for observation.   FINAL DX: atypical reaction to immunizations.
Age: 0.16
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Urine analysis normal
Clinical narrative: Received 2 mo vaccines on 3/27/07. More fussy + sleepy that night but OK. Next day screamed all day and refused to eat. Admitted to hospital that night with irritability and dehydration. No fever, no other symptoms otherwise - normal exam. mom ill 3/31 - had diarrhea. Infant also devel. fever and foul stools. Normal exam 4/2/07.  4/24/07 Records received from hospital which reveal patient experienced initially lethargy then irritability & refusal to eat since vaccines.  Seen by PCP on 3/27 & sent home but returned to ER on 3/30 due to ongoing fussiness, being unable to console & decreased oral intake.  Given IVF & admitted 3/28/07-3/30/07 for observation.   FINAL DX: atypical reaction to immunizations.
Age: 0.76
Sex: M
Vaccine: HEP, HEP
Symptoms: Biopsy skin, Pyrexia, Rash, Vasculitis
Clinical narrative: After vaccination, patient developed low grade fever and a rash, which on biopsy was idiosyncratic lymphocytic vasculitis 04/18/07-records received from facility. DOS 3/21-3/21/07- DC DX: fever. Low grade lymphocytic vasculitis.Fever 101 prior to admission, reddish bumps on extremities and face. Rash itchy. PMH:bronchiolitis, rhinorrhea and cough continue
Age: 0.76
Sex: M
Vaccine: HEP, HEP
Symptoms: Biopsy skin, Vasculitis
Clinical narrative: After vaccination, patient developed low grade fever and a rash, which on biopsy was idiosyncratic lymphocytic vasculitis 04/18/07-records received from facility. DOS 3/21-3/21/07- DC DX: fever. Low grade lymphocytic vasculitis.Fever 101 prior to admission, reddish bumps on extremities and face. Rash itchy. PMH:bronchiolitis, rhinorrhea and cough continue
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blood electrolytes normal, Blood glucose normal, Blood urea normal, CSF test normal, Electroencephalogram normal
Clinical narrative: Prolonged Status Epilepticus of approx 2 hrs. Required Helicopter transport to Hospital. Associated with fever, but was afebrile until 1 hr. into seizure. Occurred on 2/17/07, 5 days after vaccination. Had simple febrile seizure on 3/7/07. 04/17/07-records received from facility for DOS 2/17-2/19/07-DC DX:Febrile Seizure. Left Otitis Media. Admitted with febrile status epilepticus lasted over 2 hours. Temperature in ER 38.6 prior to admission 103.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Nuclear magnetic resonance imaging brain normal, Pyrexia, Status epilepticus
Clinical narrative: Prolonged Status Epilepticus of approx 2 hrs. Required Helicopter transport to Hospital. Associated with fever, but was afebrile until 1 hr. into seizure. Occurred on 2/17/07, 5 days after vaccination. Had simple febrile seizure on 3/7/07. 04/17/07-records received from facility for DOS 2/17-2/19/07-DC DX:Febrile Seizure. Left Otitis Media. Admitted with febrile status epilepticus lasted over 2 hours. Temperature in ER 38.6 prior to admission 103.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Bone pain, Myalgia, Tendonitis
Clinical narrative: myalgias, bone pain, tendonitis
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Chest X-ray, Crying, Feeling hot, Full blood count normal, Grand mal convulsion
Clinical narrative: 1130 pm day of vaccines. Child put to bed at 8 pm. Odd cry at 11:30pm-found to be very hot, took from bed and undressed, within 30 seconds had tonic/clonic sz 60-90 sec. 30 min postseizure
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Laboratory test normal
Clinical narrative: 1130 pm day of vaccines. Child put to bed at 8 pm. Odd cry at 11:30pm-found to be very hot, took from bed and undressed, within 30 seconds had tonic/clonic sz 60-90 sec. 30 min postseizure
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Pain, Pyrexia
Clinical narrative: Patients other contacted school nurse the morning after shot. Child had "fever 101 deg and body aches". "Lasted into next day". Mother took patient to PCP doctor, no treatment.
Age: 17.0
Sex: M
Vaccine: BCG, HEP, MNQ
Symptoms: Urticaria
Clinical narrative: urticaria
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Vaccine given 3/22/07, 3/23/07 developed redness at site and itching, seen in office 3/25/07 for redness, tender to touch, warmth R thigh. Treated with Benadryl and Keflex 250 tid X 1 week
Age: 0.42
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Irritability, Vomiting
Clinical narrative: Vomiting, irritability
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site anaesthesia, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Significant pain at injection site and throughout upper arm (6/10) subjection numbness some distribution slight swelling at site.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Only warm red, raised local reaction, some myalgia, fatigue day after - some.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: Only warm red, raised local reaction, some myalgia, fatigue day after - some.
Sex: F
Vaccine: TDAP
Symptoms: Injection site movement impairment, Pain in extremity, Skin burning sensation, Skin discomfort, Skin tightness
Clinical narrative: Approximately 5 days after 2/22/07 developed skin soreness progressing to painful movement with abduction of L upper arm and hyper extension. There is a tightness and burning sensation to entire upper L arm. Advil and Heat do not help movement
Age: 1.29
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Body temperature increased, Full blood count, Rash papular
Clinical narrative: Patient developed papular rash on lower and upper body and a temp of 101.9. Pt received Tylenol and a CBC was taken. Rash appeared 7 days after vaccination.
Age: 13.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Infection transmission via personal contact, No adverse effect
Clinical narrative: Was given Varicella vaccine on 3/12/07. Brother 01/26/1995 DX with chickenpox.
Age: 1.09
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Erythema, Rash generalised, Rash papular
Clinical narrative: Rash over body, red papules, noticed 2 days after immunization.
Age: 0.37
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Blood culture negative, Crying, Culture urine positive, Escherichia infection, Haematocrit increased
Clinical narrative: Acute onset of fever 103.4 rectal and intractable crying 2 AM 3-29-07. Labs done. 350 mg rocephin given IM
Age: 0.37
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Haemoglobin increased, Lymphocyte count increased, Pyrexia, White blood cell count increased
Clinical narrative: Acute onset of fever 103.4 rectal and intractable crying 2 AM 3-29-07. Labs done. 350 mg rocephin given IM
Age: 1.65
Sex: F
Vaccine: DTAPH, IPV
Symptoms: Decreased appetite, Erythema, Irritability, Pruritus, Skin warm
Clinical narrative: Redness, swelling, warm to touch, itching, irritability, decrease appetite, Swelling continued to increase.
Age: 1.65
Sex: F
Vaccine: DTAPH, IPV
Symptoms: Swelling
Clinical narrative: Redness, swelling, warm to touch, itching, irritability, decrease appetite, Swelling continued to increase.
Age: 34.0
Sex: F
Vaccine: TD, UNK, VARCEL
Symptoms: Induration, Injection site erythema, Injection site swelling
Clinical narrative: 3-28-07 Rec'd Varicella immunization.  3-29-07 Redness/Swelling of left upper arm - induration 2" x 3". 3-30-07 States swelling down from yesterday.
Age: 22.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Patient received pneumonia vaccine in LUE on 3/26/07. Has had pain and redness over triceps area x 2 days. Denies numbness and tingling of LUE. No pruritis. Denies hx of previous AEFI. Reports receiving previous pneumonia vaccine since coming on in Oct 2005, but no entry on form. NKDA. Patient examined at bedside by doctor, (limited exam due to pt discomfort)- Erythema, increased warmth and tenderness extending from upper triceps area to just below posterior left elbow. Extremely TTP. No clavicular, cervical or axillary adenopathy. Neurovasc check of LUE intact. Contacted patient on 4/2/07. He said redness, warmth and tenderness surrounding vaccine site have all completely resolved. (This was all incidental to a hospitalization for left shoulder pain (possible left pectoralis tear) and bacteremia with infectious source likely dental procedure).
Age: 1.49
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: Localized redness and swelling, heat with Atarax 10mg TOD and Keflex 20 - BID x 10 days.
Age: 0.31
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Inappropriate schedule of drug administration, Medication error, Skin nodule, Skin warm
Clinical narrative: 5-12-2006 Friday Child's grandmother called and stated that the child's right arm began with redness, swelling, and warmth around 7:30 pm on 5-11-2006 and had received vaccinations on 5-10-2006. Instructed grandmother she would need to have it evaluated by doctor and to obtain copy of follow up notes for our records. 5-15-2006 Monday Spoke with child's grandmother about follow up with MD and she stated she has appointment tomorrow afternoon. 5-17-2006 Wednesday Spoke with grandmother and she stated MD had no further recommendations for treatment and she also stated that all symptoms had resolved except for a small knot on right arm. Reminded to get follow up from MD if able.
Age: 0.31
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Swelling
Clinical narrative: 5-12-2006 Friday Child's grandmother called and stated that the child's right arm began with redness, swelling, and warmth around 7:30 pm on 5-11-2006 and had received vaccinations on 5-10-2006. Instructed grandmother she would need to have it evaluated by doctor and to obtain copy of follow up notes for our records. 5-15-2006 Monday Spoke with child's grandmother about follow up with MD and she stated she has appointment tomorrow afternoon. 5-17-2006 Wednesday Spoke with grandmother and she stated MD had no further recommendations for treatment and she also stated that all symptoms had resolved except for a small knot on right arm. Reminded to get follow up from MD if able.
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site warmth, Muscle strain, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Anthrax injection given 3-26-07 into L deltoid. 2 days later site with large area of erythema, warmth. Mild fever, L shoulder joint soreness and stiffness and L trapezius strain/tension by evening of 3-27-07.
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Pyrexia, Tension
Clinical narrative: Anthrax injection given 3-26-07 into L deltoid. 2 days later site with large area of erythema, warmth. Mild fever, L shoulder joint soreness and stiffness and L trapezius strain/tension by evening of 3-27-07.
Age: 1.62
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, PNC, VARCEL
Symptoms: Rash, Rash maculo-papular, Skin lesion
Clinical narrative: Rash - only left side of body including face, chest, inner arm and thigh. Salmon color macular and small sand paper like lesions coalasced and advance red papules.
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Soreness, redness, warmth at injection site. Area of erythema 11 x 9 cm, chills at 24 hours, temp 98.6.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash erythematous
Clinical narrative: Patient received Pediarix, PedvaxHib, Prevnar and Rotateq on 10/30/06 and 12/28/06. She received all except PedvaxHib on 2/28/07 with each set of immunization she has had an erythematous rash starting the day after immunization on both legs which lasted 10 days.
Age: 37.0
Sex: M
Vaccine: RAB
Symptoms: Dysphagia, Dyspnoea, Lymphadenopathy
Clinical narrative: About 40 minutes after receiving rabies vaccines, he noticed that his anterior cervical lymph nodes were palpable and tender and he began having difficulty swallowing and difficulty breathing. States the difficulty breathing/swallowing subsided after about 2 hours. Patient lives with me and told me this yesterday evening at home. Cervical lymph nodes were still enlarged and tender at this time.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Erythema
Clinical narrative: Extensive erythema involving LLE. Redness extended from groin to knee within 48 hours. Patient given oral antibiotics. Redness resolved within 36-48 hours.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Convulsion, Ear infection, Pyrexia
Clinical narrative: generalized seizure with fever 102, lasting 7-10 minutes, brought to er at st vincent's hospital. was diagnosed with otitis and sent home on amoxicillin.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Electrocardiogram, Gastrointestinal disorder, Night sweats, Non-cardiac chest pain
Clinical narrative: SEVERE JOINT PAIN MOSTLY IN LEGS AND ARMS AND SEVERE NIGHT SWEATS AFTER DAY 1 AND HAS CONTINUED TO PRESENT. UPPER DIGESTIVE PROBLEMS DEVELOPED AFTER 9 MONTHS AND CONTINUE TO PRESENT. CHEST PAIN RELATED TO DIGESTIVE ISSUES.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: One day post administration redness (approx 40mm) and swelling and extreme pain (rated 10 out of 10) at injection site accompanied by flu-like symptoms. Patient returned to doctors office and was given Vicodin.  Day 2 post injection redness and induration had increased to size of grapefruit and pain and flu-like symptoms worsened.  Patient seen in doctors office was given Dilaudid and Celebrex x1 week.  Flu-like symptoms gone by day 3 and redness and induration slowly receeded.  8 days post injection redness and induration at injection site 20 mm. This event seemed like a severe local reaction -- not an allergic reaction but since it required 2 additional doctors visits I thought I would report it.  Also advised by my doctor not to get another PPV23 injection in the future.  I am an RN as well as the patient and I work in an immunization clinic.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: One day post administration redness (approx 40mm) and swelling and extreme pain (rated 10 out of 10) at injection site accompanied by flu-like symptoms. Patient returned to doctors office and was given Vicodin.  Day 2 post injection redness and induration had increased to size of grapefruit and pain and flu-like symptoms worsened.  Patient seen in doctors office was given Dilaudid and Celebrex x1 week.  Flu-like symptoms gone by day 3 and redness and induration slowly receeded.  8 days post injection redness and induration at injection site 20 mm. This event seemed like a severe local reaction -- not an allergic reaction but since it required 2 additional doctors visits I thought I would report it.  Also advised by my doctor not to get another PPV23 injection in the future.  I am an RN as well as the patient and I work in an immunization clinic.
Age: 26.0
Sex: F
Vaccine: JEV, TYP
Symptoms: Blood pressure fluctuation, Blood test, Chest X-ray, Chest discomfort, Dehydration
Clinical narrative: Pt. with history of fainting with blood draws, but not shots was in office for pre-travel vaccines.  Vaccines were administered around 4 pm.  Typhoid administered first without problems, pt. fainted immediately after administration of SQ Japanese Encephalitis.  Pt. lied down with feet up recovered fairly quickly.  Initial BP, just after faining 72/50 w/ pulse of 60.  When stated felt better (about 5-10 minutes) BP 110/62 w/ reg pulse.  Sat up, given  coke to drink and some trail mix.  Stated improvement, returned to desk at 4:40pm.  Received email from patient stated she felt better and was back at her desk.  Returned home for evening at unknown time.  Went out for dinner with roommate around 8pm (dinner was 2 tacos and water).  Did note excessive thirst with dinner drank multiple (around 6 large) glasses of H2O.  At 9pm (still at restaurant, pt began feeling tightness in chest, SOB, and lightheadedness.  Rested for few minutes and then headed home with roommate d/t feeling bad.  Shortly after returned home (~9:30pm), pt states she fainted, and room mate then called 911.  States that was brief LOC and was not told of any seizure movements or urination, or anything unusual.  She just felt chest tightness, tachy HR (per pt report), saw white and went out.  This happened a 2nd time before ambulance arrived again brief.  After transport to Georgetown ER, pt again with similar episodes another 3 times.  Was treated in ER (see #12) and sent home around 3:30am with no diagnosis other than dehydration.  Pt continued to feel tightness in her chest over next day, around 2:30pm experienced similar episode with SOB, increased HR, feeling hot, and lightheaded.  Sat on floor with head between legs and recovered.  No LOC.  At 7:30pm had witnessed LOC at work with brief warning.  Was talking to co-workers, and fell off chair.  She remembers similar feelings as previous, but didn't have time to react.  Wednesday (4/4/07) pt states she still feels off, tightness in chest and subtle lightheadedness, but no further syncope episodes.  Saw consulting MD in employee walk-in clinic who did full assessment without any positive findings.  Encouraged pt. to see neurologist for w/u if has further syncopal episodes. Spoke with pt today (4/5/07) and states she is feeling better, mild tightness in her chest, but no further lightheadedness.
Age: 26.0
Sex: F
Vaccine: JEV, TYP
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Feeling abnormal, Feeling hot
Clinical narrative: Pt. with history of fainting with blood draws, but not shots was in office for pre-travel vaccines.  Vaccines were administered around 4 pm.  Typhoid administered first without problems, pt. fainted immediately after administration of SQ Japanese Encephalitis.  Pt. lied down with feet up recovered fairly quickly.  Initial BP, just after faining 72/50 w/ pulse of 60.  When stated felt better (about 5-10 minutes) BP 110/62 w/ reg pulse.  Sat up, given  coke to drink and some trail mix.  Stated improvement, returned to desk at 4:40pm.  Received email from patient stated she felt better and was back at her desk.  Returned home for evening at unknown time.  Went out for dinner with roommate around 8pm (dinner was 2 tacos and water).  Did note excessive thirst with dinner drank multiple (around 6 large) glasses of H2O.  At 9pm (still at restaurant, pt began feeling tightness in chest, SOB, and lightheadedness.  Rested for few minutes and then headed home with roommate d/t feeling bad.  Shortly after returned home (~9:30pm), pt states she fainted, and room mate then called 911.  States that was brief LOC and was not told of any seizure movements or urination, or anything unusual.  She just felt chest tightness, tachy HR (per pt report), saw white and went out.  This happened a 2nd time before ambulance arrived again brief.  After transport to Georgetown ER, pt again with similar episodes another 3 times.  Was treated in ER (see #12) and sent home around 3:30am with no diagnosis other than dehydration.  Pt continued to feel tightness in her chest over next day, around 2:30pm experienced similar episode with SOB, increased HR, feeling hot, and lightheaded.  Sat on floor with head between legs and recovered.  No LOC.  At 7:30pm had witnessed LOC at work with brief warning.  Was talking to co-workers, and fell off chair.  She remembers similar feelings as previous, but didn't have time to react.  Wednesday (4/4/07) pt states she still feels off, tightness in chest and subtle lightheadedness, but no further syncope episodes.  Saw consulting MD in employee walk-in clinic who did full assessment without any positive findings.  Encouraged pt. to see neurologist for w/u if has further syncopal episodes. Spoke with pt today (4/5/07) and states she is feeling better, mild tightness in her chest, but no further lightheadedness.
Age: 26.0
Sex: F
Vaccine: JEV, TYP
Symptoms: Heart rate increased, Loss of consciousness, Syncope, Tachycardia, Thirst
Clinical narrative: Pt. with history of fainting with blood draws, but not shots was in office for pre-travel vaccines.  Vaccines were administered around 4 pm.  Typhoid administered first without problems, pt. fainted immediately after administration of SQ Japanese Encephalitis.  Pt. lied down with feet up recovered fairly quickly.  Initial BP, just after faining 72/50 w/ pulse of 60.  When stated felt better (about 5-10 minutes) BP 110/62 w/ reg pulse.  Sat up, given  coke to drink and some trail mix.  Stated improvement, returned to desk at 4:40pm.  Received email from patient stated she felt better and was back at her desk.  Returned home for evening at unknown time.  Went out for dinner with roommate around 8pm (dinner was 2 tacos and water).  Did note excessive thirst with dinner drank multiple (around 6 large) glasses of H2O.  At 9pm (still at restaurant, pt began feeling tightness in chest, SOB, and lightheadedness.  Rested for few minutes and then headed home with roommate d/t feeling bad.  Shortly after returned home (~9:30pm), pt states she fainted, and room mate then called 911.  States that was brief LOC and was not told of any seizure movements or urination, or anything unusual.  She just felt chest tightness, tachy HR (per pt report), saw white and went out.  This happened a 2nd time before ambulance arrived again brief.  After transport to Georgetown ER, pt again with similar episodes another 3 times.  Was treated in ER (see #12) and sent home around 3:30am with no diagnosis other than dehydration.  Pt continued to feel tightness in her chest over next day, around 2:30pm experienced similar episode with SOB, increased HR, feeling hot, and lightheaded.  Sat on floor with head between legs and recovered.  No LOC.  At 7:30pm had witnessed LOC at work with brief warning.  Was talking to co-workers, and fell off chair.  She remembers similar feelings as previous, but didn't have time to react.  Wednesday (4/4/07) pt states she still feels off, tightness in chest and subtle lightheadedness, but no further syncope episodes.  Saw consulting MD in employee walk-in clinic who did full assessment without any positive findings.  Encouraged pt. to see neurologist for w/u if has further syncopal episodes. Spoke with pt today (4/5/07) and states she is feeling better, mild tightness in her chest, but no further lightheadedness.
Age: 26.0
Sex: F
Vaccine: JEV, TYP
Symptoms: Urine analysis
Clinical narrative: Pt. with history of fainting with blood draws, but not shots was in office for pre-travel vaccines.  Vaccines were administered around 4 pm.  Typhoid administered first without problems, pt. fainted immediately after administration of SQ Japanese Encephalitis.  Pt. lied down with feet up recovered fairly quickly.  Initial BP, just after faining 72/50 w/ pulse of 60.  When stated felt better (about 5-10 minutes) BP 110/62 w/ reg pulse.  Sat up, given  coke to drink and some trail mix.  Stated improvement, returned to desk at 4:40pm.  Received email from patient stated she felt better and was back at her desk.  Returned home for evening at unknown time.  Went out for dinner with roommate around 8pm (dinner was 2 tacos and water).  Did note excessive thirst with dinner drank multiple (around 6 large) glasses of H2O.  At 9pm (still at restaurant, pt began feeling tightness in chest, SOB, and lightheadedness.  Rested for few minutes and then headed home with roommate d/t feeling bad.  Shortly after returned home (~9:30pm), pt states she fainted, and room mate then called 911.  States that was brief LOC and was not told of any seizure movements or urination, or anything unusual.  She just felt chest tightness, tachy HR (per pt report), saw white and went out.  This happened a 2nd time before ambulance arrived again brief.  After transport to Georgetown ER, pt again with similar episodes another 3 times.  Was treated in ER (see #12) and sent home around 3:30am with no diagnosis other than dehydration.  Pt continued to feel tightness in her chest over next day, around 2:30pm experienced similar episode with SOB, increased HR, feeling hot, and lightheaded.  Sat on floor with head between legs and recovered.  No LOC.  At 7:30pm had witnessed LOC at work with brief warning.  Was talking to co-workers, and fell off chair.  She remembers similar feelings as previous, but didn't have time to react.  Wednesday (4/4/07) pt states she still feels off, tightness in chest and subtle lightheadedness, but no further syncope episodes.  Saw consulting MD in employee walk-in clinic who did full assessment without any positive findings.  Encouraged pt. to see neurologist for w/u if has further syncopal episodes. Spoke with pt today (4/5/07) and states she is feeling better, mild tightness in her chest, but no further lightheadedness.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Diarrhoea, Nasal congestion, Vomiting, Wheezing
Clinical narrative: APPROXIMATELY 40 HOURS AFTER RECEIVING VACCINE,I EXPERIENCED VIOLENT DIARREA AND VOMITING. 1 MONTH LATER, I EXPERIENCED LOW-FREQUENCY EXPIRATORY WHEEZES, COUGHING, FURTHER CONGESTION IN NOSE AND CHEST. PREDNISONE TAPERED DOSAGE ADMINISTERD. AFTER FOUR DAYS, I AM BETTER.
Age: 19.0
Sex: F
Vaccine: ANTH
Symptoms: Abdominal pain upper, Dizziness, Pregnancy test negative, Vomiting
Clinical narrative: Episodic vomitting, dizziness, racing heart beat, over heating, pain in stomach
Age: 4.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Medication error, No adverse effect, Wrong drug administered
Clinical narrative: MMRV (Proquad) was inadvertently administered with Varivax during the same office visit this morning. So far, the mother reports of no side effects on the child.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Anorexia, Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: Headache, pain in legs and abdomen, loss of appetite, moderate to high fever, severe tiredness/weakness, some dizziness
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Headache, pain in legs and abdomen, loss of appetite, moderate to high fever, severe tiredness/weakness, some dizziness
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Influenza serology negative, Nasal congestion, Nausea, Pain
Clinical narrative: FEVER 104, NAUSEA, FATIGUE, BODY ACHES NASAL CONGESTION
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: FEVER 104, NAUSEA, FATIGUE, BODY ACHES NASAL CONGESTION
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Vaccination failure, Varicella
Clinical narrative: developed chicken pox disease 4/1/2007
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Cellulitis, Erythema, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: received immunizations listed below on 04/02/07. On 04/04/07 the child returned to the clinic with "red swollen right upper arm". +pain, +edema,+erythemia. Diagnosed:" cellulitis vs. delayed IGE hypersensitivity reaction"Treated with Keflex(250mg/5ml) 1 3/4 tsp. po bid X 5 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Pain
Clinical narrative: received immunizations listed below on 04/02/07. On 04/04/07 the child returned to the clinic with "red swollen right upper arm". +pain, +edema,+erythemia. Diagnosed:" cellulitis vs. delayed IGE hypersensitivity reaction"Treated with Keflex(250mg/5ml) 1 3/4 tsp. po bid X 5 days.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Vaccination failure, Varicella
Clinical narrative: Developed chicken pox disease after being immunized
Age: 1.25
Sex: F
Vaccine: DTAPH
Symptoms: Abasia, Erythema, Injection site pain, Rash
Clinical narrative: Severe leg pain around injection site and throughout leg (could not walk without pain for approximately 12 hours).  Red, raised rash on abdomen lasting for approximately 10 days.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: L arm redness, swelling with hard center of redness.
Age: 32.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within several hours pt. developed redness/pain/swelling affected arm and spread down to wrist. Afebrile
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Blood culture negative, CSF culture negative, Culture urine negative, Full blood count, Lethargy
Clinical narrative: My daughter became very lethargic on 8/26. She was not nursing well, and we went to the ER that evening. She seemed better there, so we went home. Several hours later (2:30 am 8/27) she had a fever of 100.7. We took her back to the ER, where they took blood, urine, and a spinal fluid sample. She was treated with IV fluids and antibiotics over the course of 3 days. 04/10/07-records received from facility-ER Visits for congestion decreased feedings. Temp 38.5. No vomiting nor diarrhea. Admitted for IVAB. DX:febrile neonate
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: My daughter became very lethargic on 8/26. She was not nursing well, and we went to the ER that evening. She seemed better there, so we went home. Several hours later (2:30 am 8/27) she had a fever of 100.7. We took her back to the ER, where they took blood, urine, and a spinal fluid sample. She was treated with IV fluids and antibiotics over the course of 3 days. 04/10/07-records received from facility-ER Visits for congestion decreased feedings. Temp 38.5. No vomiting nor diarrhea. Admitted for IVAB. DX:febrile neonate
Age: 47.0
Sex: F
Vaccine: HEPA, TD, HEPA, TD
Symptoms: Hemiparesis, Hypoaesthesia, Multiple sclerosis
Clinical narrative: This case was reported by a physician and described the occurrence of weakness in a 47-year-old female subject who was vaccinated with Havrix and Td for prophylaxis. On 28 June 2006 the subject received 1st dose of Havrix at 0.5 ml in the left arm and a booster dose of Td. Within weeks of vaccination with Havrix and Td, the subject experienced weakness and numbness primarily on the left side in both the upper and lower extremities. At the time, no other cause could be identified for the events other than possible multiple sclerosis. The physician considered the events were disabling. No treatment was required and the events resolved 7 to 8 months later.
Age: 47.0
Sex: F
Vaccine: HEPA, TD, HEPA, TD
Symptoms: Hypoaesthesia, Multiple sclerosis, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This case was reported by a physician and described the occurrence of weakness in a 47-year-old female subject who was vaccinated with Havrix and Td for prophylaxis. On 28 June 2006 the subject received 1st dose of Havrix at 0.5 ml in the left arm and a booster dose of Td. Within weeks of vaccination with Havrix and Td, the subject experienced weakness and numbness primarily on the left side in both the upper and lower extremities. At the time, no other cause could be identified for the events other than possible multiple sclerosis. The physician considered the events were disabling. No treatment was required and the events resolved 7 to 8 months later.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt inadvertently given smallpox vaccine despite medical exemption. Auto-inoculation into upper buttock region near wound site of pilonidal cyst excision. No systemic inadvertent or other end-organ involvement.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Limb discomfort, Pain
Clinical narrative: c/c-pain-odd sensation in legs-first dose-adm by Gyn (MD) November 2006. 2nd dose-adm by PMD-Feb 2007- Symptoms-started Feb2-have increased since 8/1/07- records received C/O constant leg pain and back discomfort. Episode of cramping and diarrhea. Treated with Prednisone. Notes from 5/11/07-no futher dicomfort.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Pallor, Pyrexia
Clinical narrative: Mother explained when child woke up 4-3-07 a day after immunization she noticed her skin was pale, weak and has fever.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Physical examination, Screaming
Clinical narrative: Crying and screaming for 3 hrs or more after 1st set of vaccinations starting 3 1/2 hrs after administration. Mom called me. She was advised to give 0.4cc of acetaminophen and continue every 6 hr, patient was fine thereafter
Age: 71.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: right deltoid and arm swelling very painful.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: itchiness, redness, swelling, pain at injection site
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: immediate 2 cm diameter wheal at injection site within minutes of injection; tenderness; redness at site of injection
Age: 11.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling at injection site and fever of 102 deg several hours after injection; given acetaminophen and Keflex in ER
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema
Clinical narrative: 3 inch red spot over injection site, no systemic complaints or fever tx: Bactrim 40/200 per 5 ML, 2 tsp PO every 8 hour x 10 D eval 4-2-07, sooner if problems.
Age: 0.54
Sex: M
Vaccine: RV5, DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Haematochezia, Rotavirus test positive
Clinical narrative: Initial information received on 28 March 2007 from another manufacturer, report number WAES0702USA03484. The initial reporter to this manufacturer has been a health care professional. Information has been received from a pediatrician concerning a 6 month old white male, with a possible history of reflux, who on the morning of 12-FEB-2007 was vaccinated PO with the third 2.0 mL dose of Rotateq (Lot # 656105/1232F). Concomitant vaccines administered on the same day included a third dose in the right anterior thigh of PEDIARIX (Lot# AC21B097AB), a third dose in the left anterior thigh of PREVNAR (B036258B) and a first dose in the right anterior thigh of FLUZONE (Lot# U2285AA). There was no illness at the time of vaccination and no adverse events following prior vaccination. The physician reported that on the night of 15-FEB-2007, the patient developed hematochezia and was taken to the Emergency Room (ER). The patient's stool tested positive for rotavirus (type not known). The patient was subsequently released from the ER. On 16-FEB-2007, the patient was seen by the pediatrician. No further sequelae was noted as the patient was considered to be fully recovered. Follow-up information from a pediatrician via medical records indicated that on 15-FEB-2007 the patient reported to the emergency room via a private vehicle. There, the patient's mother stated that the child had three episodes of diarrhea which all contained a slight bit of which looked to be blood. The patient's mother contacted her pediatrician's office and the answering service directed her to come to the emergency room stating that it could have possibly been a reaction to the immunizations that she just received, which was Rotateq, which she just had her third dose on 12-FEB-2007. The patient had been fine all week, however on that day she had a little bit of mucous and blood in her stool, a low grade fever, and was also acting quite fussy. The patient started with a small cough and started with a rash since she had been there. During the course in the emergency room, a positive heme occult from the patient's diaper was obtained that was presented to the mother that did show some tiny specks of blood. The patient was positive rotavirus via a rectal swab, and had mild diarrhea. The patient was well after this. There was no severe belly pain or intussusception. The patient was seen in the pediatrician's office for follow up on 16-FEB-2007, and had recovered.  Upon internal review, hematochezia was determined to be an other important medical event. Additional information is not expected.
Age: 0.54
Sex: M
Vaccine: RV5, DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Clostridium difficile toxin test, Cough, Diarrhoea, Diarrhoea haemorrhagic, Haematochezia
Clinical narrative: Initial information received on 28 March 2007 from another manufacturer, report number WAES0702USA03484. The initial reporter to this manufacturer has been a health care professional. Information has been received from a pediatrician concerning a 6 month old white male, with a possible history of reflux, who on the morning of 12-FEB-2007 was vaccinated PO with the third 2.0 mL dose of Rotateq (Lot # 656105/1232F). Concomitant vaccines administered on the same day included a third dose in the right anterior thigh of PEDIARIX (Lot# AC21B097AB), a third dose in the left anterior thigh of PREVNAR (B036258B) and a first dose in the right anterior thigh of FLUZONE (Lot# U2285AA). There was no illness at the time of vaccination and no adverse events following prior vaccination. The physician reported that on the night of 15-FEB-2007, the patient developed hematochezia and was taken to the Emergency Room (ER). The patient's stool tested positive for rotavirus (type not known). The patient was subsequently released from the ER. On 16-FEB-2007, the patient was seen by the pediatrician. No further sequelae was noted as the patient was considered to be fully recovered. Follow-up information from a pediatrician via medical records indicated that on 15-FEB-2007 the patient reported to the emergency room via a private vehicle. There, the patient's mother stated that the child had three episodes of diarrhea which all contained a slight bit of which looked to be blood. The patient's mother contacted her pediatrician's office and the answering service directed her to come to the emergency room stating that it could have possibly been a reaction to the immunizations that she just received, which was Rotateq, which she just had her third dose on 12-FEB-2007. The patient had been fine all week, however on that day she had a little bit of mucous and blood in her stool, a low grade fever, and was also acting quite fussy. The patient started with a small cough and started with a rash since she had been there. During the course in the emergency room, a positive heme occult from the patient's diaper was obtained that was presented to the mother that did show some tiny specks of blood. The patient was positive rotavirus via a rectal swab, and had mild diarrhea. The patient was well after this. There was no severe belly pain or intussusception. The patient was seen in the pediatrician's office for follow up on 16-FEB-2007, and had recovered.  Upon internal review, hematochezia was determined to be an other important medical event. Additional information is not expected.
Age: 0.54
Sex: M
Vaccine: RV5, DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Irritability, Mucous stools, Occult blood positive, Pyrexia, Rash
Clinical narrative: Initial information received on 28 March 2007 from another manufacturer, report number WAES0702USA03484. The initial reporter to this manufacturer has been a health care professional. Information has been received from a pediatrician concerning a 6 month old white male, with a possible history of reflux, who on the morning of 12-FEB-2007 was vaccinated PO with the third 2.0 mL dose of Rotateq (Lot # 656105/1232F). Concomitant vaccines administered on the same day included a third dose in the right anterior thigh of PEDIARIX (Lot# AC21B097AB), a third dose in the left anterior thigh of PREVNAR (B036258B) and a first dose in the right anterior thigh of FLUZONE (Lot# U2285AA). There was no illness at the time of vaccination and no adverse events following prior vaccination. The physician reported that on the night of 15-FEB-2007, the patient developed hematochezia and was taken to the Emergency Room (ER). The patient's stool tested positive for rotavirus (type not known). The patient was subsequently released from the ER. On 16-FEB-2007, the patient was seen by the pediatrician. No further sequelae was noted as the patient was considered to be fully recovered. Follow-up information from a pediatrician via medical records indicated that on 15-FEB-2007 the patient reported to the emergency room via a private vehicle. There, the patient's mother stated that the child had three episodes of diarrhea which all contained a slight bit of which looked to be blood. The patient's mother contacted her pediatrician's office and the answering service directed her to come to the emergency room stating that it could have possibly been a reaction to the immunizations that she just received, which was Rotateq, which she just had her third dose on 12-FEB-2007. The patient had been fine all week, however on that day she had a little bit of mucous and blood in her stool, a low grade fever, and was also acting quite fussy. The patient started with a small cough and started with a rash since she had been there. During the course in the emergency room, a positive heme occult from the patient's diaper was obtained that was presented to the mother that did show some tiny specks of blood. The patient was positive rotavirus via a rectal swab, and had mild diarrhea. The patient was well after this. There was no severe belly pain or intussusception. The patient was seen in the pediatrician's office for follow up on 16-FEB-2007, and had recovered.  Upon internal review, hematochezia was determined to be an other important medical event. Additional information is not expected.