chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Drug ineffective, Influenza like illness, Pain, Pharyngolaryngeal pain
Clinical narrative: In study a 45 yr old female subject born on 18Mar1960 was vaccinated IM with 0.5ml of investigational drug on 08Nov05. The subject was seen at the investigative site clinic on 03Mar06 for influenza like illness including aching all over, sore throat, fever, cough. Temp taken at the clinic was 100.5F. Onset of symptoms was on 01Mar06, 113 days after immunization. Subject took ibuprofen starting on day of onset (1 March). Rapid influenza test was positive for influenza A. And the subject was given Tamiflu. Viral culture was positive for influenza A/H3N2. Resolution was on 06Mar06 was complete recovery. The investigator considered the event as not related to vaccination. Seriousness criterion: Medically significant (OMIC). Possible for vaccination failure. The reported events, except for vaccination failure, are not expected. On a case level, the case is considered expected due to vaccination failure. Follow up 23Mar06: We just received the completed documentation. No further relevant new information reported. The reported events, except for vaccination failure, are not expected. On a case level, the case is considered expected due to vaccination failure. Follow up 27Jun06: Today we received the information that the study has been unblinded on 26Jun06. Subject received Fluvirin (lot 61122). The reported events, except for vaccination failure, are not expected. On a case level, the case is considered expected due to vaccination failure.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Viral infection
Clinical narrative: In study a 45 yr old female subject born on 18Mar1960 was vaccinated IM with 0.5ml of investigational drug on 08Nov05. The subject was seen at the investigative site clinic on 03Mar06 for influenza like illness including aching all over, sore throat, fever, cough. Temp taken at the clinic was 100.5F. Onset of symptoms was on 01Mar06, 113 days after immunization. Subject took ibuprofen starting on day of onset (1 March). Rapid influenza test was positive for influenza A. And the subject was given Tamiflu. Viral culture was positive for influenza A/H3N2. Resolution was on 06Mar06 was complete recovery. The investigator considered the event as not related to vaccination. Seriousness criterion: Medically significant (OMIC). Possible for vaccination failure. The reported events, except for vaccination failure, are not expected. On a case level, the case is considered expected due to vaccination failure. Follow up 23Mar06: We just received the completed documentation. No further relevant new information reported. The reported events, except for vaccination failure, are not expected. On a case level, the case is considered expected due to vaccination failure. Follow up 27Jun06: Today we received the information that the study has been unblinded on 26Jun06. Subject received Fluvirin (lot 61122). The reported events, except for vaccination failure, are not expected. On a case level, the case is considered expected due to vaccination failure.
Age: 1.07
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Febrile convulsion, Laboratory test abnormal, Meningitis, Otitis media, Viral infection
Clinical narrative: Pt received Dtap 4 and HAV 1 on 07/05/2006. Febrile seizure on 07/08/2006, then admitted on 7/11/06 for viral meningitis seizure. In hospital from 7/11/06 to present. 7/21/06-records received from TriCity Med Ctr. DC report not included. Seen in ED for seizure activity. PE revealed temp 37.5, heart rate 140, respt 36. Appeared well hydrated. No physical or neurological findings noted. No seizures observed in the ED. Admitted for observation. First seizure occurred on July 7, 2006 2 days after Hepatitis A vaccine. Seen in ED on 7/8/06 with DX of febrile seizures secondary to vaccines, DC to home. Afebrile beginning 7/10/06 but continues to be fussy with 3 day HX of diarrhea, stopped 2 days prior to ED visit of 7/11/06, decreased urine output and intake.  PMH: febrile seizures and small bilateral pneumothoraces. Admitting DX: seizure Viral meningitis right otitis media 8/10/06-Duplicate records received, no DC Summary available for review nor will DC summary be forthcoming.
Age: 5.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Pruritus, Sneezing, Urticaria, Vomiting
Clinical narrative: Within minutes - sneezing, hives, itching. Protracted vomiting. No respiratory problems or swelling. Received steroids, Benadryl, Tagamet in ER. No Epi needed.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Syncope
Clinical narrative: 5-10 min after receiving vaccines, pt felt faint, dizziness. Pt sitting in hallway near office sweating. Pt escorted back to office. Vital signs stable. Pt was observed in office 30-45 min and released home with parent. Instructed to go to ER if symptoms return.
Age: 1.49
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Edema of entire thigh and mild erythema on opposite side of thigh to shot. Apparent tenderness but mild pain when patient ambulates and edema extending beyond knee or hip.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Significant pain, erythema and induration in area (anterior and medial) around left deltoid. Significant streaking of tissue with well demarcated erythema, but no axillary node involvement. Fevers with temperature of 101 F. Symptoms began at 12 hours post administration and were still present on days. Treated with Ibuprofen (600 mg, QID) and antibiotics for possible cellulitis (Cefpodudine 400, BID x 7 OMS)
Age: 46.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Hyperhidrosis, Injection site pain, Nausea, Swelling
Clinical narrative: Received rabies immunization on 06/27/2006 at 18:40.  He states about 1 hr after shot he started diaphoresis that lasted 1 week.  He states he also had joint pain and swelling, intermittent nausea and vomiting, and soreness at injection site starting 06/23/2006 and lasting 3-4 days.
Age: 46.0
Sex: M
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: Received rabies immunization on 06/27/2006 at 18:40.  He states about 1 hr after shot he started diaphoresis that lasted 1 week.  He states he also had joint pain and swelling, intermittent nausea and vomiting, and soreness at injection site starting 06/23/2006 and lasting 3-4 days.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Loss of consciousness, Tremor
Clinical narrative: Trouble breathing, shaking all over, loss of consciousness, redness, swelling at site
Age: 0.99
Sex: M
Vaccine: HEP, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria rash developed 24 hours after vaccines given
Age: 43.0
Sex: F
Vaccine: HEPA, TD, TYP
Symptoms: Erythema, Pruritus
Clinical narrative: Patient complain of redness and itching left upper arm, measuring 5-6 inches in length. No swelling, no deep pain as reported by patient 07/12/2006.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Oedema peripheral
Clinical narrative: Immunization given to a 5 year old on 07/12/2006. Seen in office 07/12/2006 with significant swelling, edema of left leg and large effusion of      . no fever and respiratory symptoms.
Age: 1.31
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Irritability, Pyrexia, Tenderness
Clinical narrative: Tenderness at injection site and fever (100.6F), child irritable.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Abnormal behaviour, Blood urine, Crying, Emphysema, Flatulence
Clinical narrative: approx 90 minutes after injection, pt began to scream, grabbing his head, crying uncontrollably, couldn't sit still, constantly moving, flailing arms and legs, wide eyed, and continued for 3 hours, non stop, appeared to be gagging, soft tissue x-ray neck showed subcutaneous emphysema posterior to airway, CT Neck without contrast was read as negative, never had resp. distress, WBC slightly elevated otherwise unremarkable, urine cath + small amt of blood thought to be from traumatic catheterization, U/S abd negative, eyes stained to r/o corneal abrasions, pt was passing a lot of flatus as well, finally fully recovered after 7 hours in ED.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Psychomotor hyperactivity, Retching, Screaming, White blood cell count increased
Clinical narrative: approx 90 minutes after injection, pt began to scream, grabbing his head, crying uncontrollably, couldn't sit still, constantly moving, flailing arms and legs, wide eyed, and continued for 3 hours, non stop, appeared to be gagging, soft tissue x-ray neck showed subcutaneous emphysema posterior to airway, CT Neck without contrast was read as negative, never had resp. distress, WBC slightly elevated otherwise unremarkable, urine cath + small amt of blood thought to be from traumatic catheterization, U/S abd negative, eyes stained to r/o corneal abrasions, pt was passing a lot of flatus as well, finally fully recovered after 7 hours in ED.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Convulsion
Clinical narrative: Initial report received on 6/2/06 from VAERS, report #257357. The initial reporter was a health care professional who reported the case to another manufacturer who in turn reported the case to VAERS. An 11 year old female patient, with no history of seizure disorder, had received an injection of Menactra, lot number U1741AB; and a right arm injection of Boostrix, lot number ACSZB001AA; on 5/26/06. Route and site of administration of Menactra were unknown. Illness at the time of vaccination was unknown. At an unspecified time post-vaccination, on 5/26/06, the patient experienced a generalized tonic clonic seizure after going to sleep. The event required an overnight hospitalization. The patient recovered from the event. Follow up information received on 6/14/06 from a physician. The reporter confirmed that the patient experienced a tonic clonic seizure on 5/26/06 after going to sleep. It is also confirmed that the patient had received Menactra and Boostrix vaccination earlier that day. Per the reporter, she is reportedly fine after spending the night in the hospital. No additional relevant medical information was obtained for the reported adverse event. This follow up report is not submitted as a 15 day followup report. Follow up information received on 7/5/06. Per the reporter, the patient had no illnesses at the time of the vaccination on 5/26/06. The patient was discharged from the hospital on 5/27/06. Per the hospital discharge summary, the patient had only experienced a single episode of seizure that was likely due to a reaction to immunization on 5/26/06. The patient was to follow up with a neurologist.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: Initial report received on 6/2/06 from VAERS, report #257357. The initial reporter was a health care professional who reported the case to another manufacturer who in turn reported the case to VAERS. An 11 year old female patient, with no history of seizure disorder, had received an injection of Menactra, lot number U1741AB; and a right arm injection of Boostrix, lot number ACSZB001AA; on 5/26/06. Route and site of administration of Menactra were unknown. Illness at the time of vaccination was unknown. At an unspecified time post-vaccination, on 5/26/06, the patient experienced a generalized tonic clonic seizure after going to sleep. The event required an overnight hospitalization. The patient recovered from the event. Follow up information received on 6/14/06 from a physician. The reporter confirmed that the patient experienced a tonic clonic seizure on 5/26/06 after going to sleep. It is also confirmed that the patient had received Menactra and Boostrix vaccination earlier that day. Per the reporter, she is reportedly fine after spending the night in the hospital. No additional relevant medical information was obtained for the reported adverse event. This follow up report is not submitted as a 15 day followup report. Follow up information received on 7/5/06. Per the reporter, the patient had no illnesses at the time of the vaccination on 5/26/06. The patient was discharged from the hospital on 5/27/06. Per the hospital discharge summary, the patient had only experienced a single episode of seizure that was likely due to a reaction to immunization on 5/26/06. The patient was to follow up with a neurologist.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Convulsion
Clinical narrative: An 18 yr old male pt with no significant past medical history, and no history of seizures, and who had no concurrent illnesses had received an IM injection of Menactra, lot number U2107AA, in the left arm on 05Jul06. Approx 20 mins post immunization, the pt experienced an apparent seizure. He was transported to the ER via ambulance and was admitted to the hospital. An EKG, Tilt Table Test, and Caroid Ultrasound were completed but results were not reported. Treatment received and lab testing were not reported. The recovery status of the pt was reported as recovered.
Age: 41.0
Sex: M
Vaccine: TD
Symptoms: Body temperature increased, Chills, Heart rate increased, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Pt reports previous reaction to tetanus developed fever after receiving booster. Given Tylenol. Chart labeled for reaction. Pt transferred to in pt facility for fever/chills. Given diphenhydramine. Follow up Information received 12/13/2006: Pt was in a residential treatment program for psychiatry. He received tetanus-diphtheria vaccine. Developed high fever and tachycardia. Transferred to inpatient facility. Given TYLENOL and BENADRYL. Reports similar reaction in the past.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Dermatitis, Disturbance in attention, Dizziness, Headache
Clinical narrative: Severe headaches followed by high blood pressure, achy joints, dizziness, high cholesterol, loss of concentration, muscle aches, dermatitis (severe). Also blood pressure tends to spike and drop.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Hypercholesterolaemia, Hypertension, Hypotension, Myalgia
Clinical narrative: Severe headaches followed by high blood pressure, achy joints, dizziness, high cholesterol, loss of concentration, muscle aches, dermatitis (severe). Also blood pressure tends to spike and drop.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Hypoaesthesia, Laboratory test abnormal, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Started having numbness in left little finger, up forearm to elbow on 06/10/2006. On 06/11/2006, numbness spread to index finger and palm. On 06/12/2006, numbness now includes left shoulder, half of the back, left side of the chest including half of the left breast. Seen by P.A. on 06/14/2006. Had MRI and X-ray on 06/21/2006. Seen by neurologist on 07/05/2006.  7/25/06 Received medical records from 2nd hospital which included D/C summary, H&P  & labs which reveal patient hospitalized from 7/6/06 to 7/10/06 w/final diagnosis of probable multiple sclerosis & s/p LP headache, markedly improved.  Patient's s/s began mid June 2006 16 days s/p MMR w/left arm numbness & migrated into the shoulder & chest.  Left leg numbness also developed.  PMH: neg.  Family hx: sister has transverse myelitis & possibly MS. Recent MRI of c-spine was WNL but interpreted by this hospital radiology chief as showing posterior column demyelinating plaque on left coinciding w/C5-6 area.  MRI of brain showed single area of abnormality.  LP done, report not included in records. Left side numbness cleared w/course of steroids.  Labs were essentially WNL. MS profile pending at time of d/c.  Continued on tapering steroids at d/c to home and was to f/u w/PCP./ss   7/25/06 Received v/m from reporter that they do not have any medical records beyond the vax record.  No further requests will be made to them/ss 8/1/06 Received medical records from 1st hospital which consisted only of 2 x-ray reports: c-spine series & MRI of c-spine, both of which were WNL./ss Follow-up: I am not sure which to MMR - the MS was not an adverse event from the MMR just correlated with timing. 10-19-2007 pt was diagnosed with MS June 2006 the MMR was given 5.25.06. A VAERS was filled out 7-13-06. The pt. still has MS and is symptomatic with no change to her medical condition.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Post lumbar puncture syndrome, X-ray normal
Clinical narrative: Started having numbness in left little finger, up forearm to elbow on 06/10/2006. On 06/11/2006, numbness spread to index finger and palm. On 06/12/2006, numbness now includes left shoulder, half of the back, left side of the chest including half of the left breast. Seen by P.A. on 06/14/2006. Had MRI and X-ray on 06/21/2006. Seen by neurologist on 07/05/2006.  7/25/06 Received medical records from 2nd hospital which included D/C summary, H&P  & labs which reveal patient hospitalized from 7/6/06 to 7/10/06 w/final diagnosis of probable multiple sclerosis & s/p LP headache, markedly improved.  Patient's s/s began mid June 2006 16 days s/p MMR w/left arm numbness & migrated into the shoulder & chest.  Left leg numbness also developed.  PMH: neg.  Family hx: sister has transverse myelitis & possibly MS. Recent MRI of c-spine was WNL but interpreted by this hospital radiology chief as showing posterior column demyelinating plaque on left coinciding w/C5-6 area.  MRI of brain showed single area of abnormality.  LP done, report not included in records. Left side numbness cleared w/course of steroids.  Labs were essentially WNL. MS profile pending at time of d/c.  Continued on tapering steroids at d/c to home and was to f/u w/PCP./ss   7/25/06 Received v/m from reporter that they do not have any medical records beyond the vax record.  No further requests will be made to them/ss 8/1/06 Received medical records from 1st hospital which consisted only of 2 x-ray reports: c-spine series & MRI of c-spine, both of which were WNL./ss Follow-up: I am not sure which to MMR - the MS was not an adverse event from the MMR just correlated with timing. 10-19-2007 pt was diagnosed with MS June 2006 the MMR was given 5.25.06. A VAERS was filled out 7-13-06. The pt. still has MS and is symptomatic with no change to her medical condition.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Diarrhoea, Headache, Vomiting
Clinical narrative: Began with H/A, vomited 3x, diarrhea, treated with Tylenol, 100.5 10AM today. Symptoms began 3-4 hrs post injection
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Glossitis
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old female with no known allergies and a history of shingles who on 16-JUN-2006 was vaccinated SC with a dose of varicella-zoster virus vaccine live.  There was no concomitant medication.  On 18-JUN-2006, two days after vaccination, the patient developed a swollen tongue.  The patient reported that when she woke up in the morning her tongue was swollen and she even had teeth impression on her tongue.  The patient was scheduled to see her doctor on 28-JUN-2006 since she was still experiencing the problem.  She had no problems breathing and eating.  As of 28-JUN-2006, it was reported that the patient was recovering.  No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/10/2006. Additional information from the pharmacist indicated that the patient's condition has resolved and the patient is fine. The physician's office called the pharmacist to report that the patient's swollen tongue was not due to ZOSTAVAX (Oka/Merck) but due to the patient's new toothpaste. No further information is available.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who was vaccinated with a first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live/  It was noted that the patient was not experiencing any symptoms. No product quality complaint was involved. No other information was provided.  Additional has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning an 8 week old patient who was vaccinated with an oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  On the same day as vaccination the patient experienced intractable vomiting.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/10/2006; 9/1/2006. Information has been received from a physician concerning an 9 week old female, with no medical history and no allergies, who on 26-MAY-2006, in the am, was vaccinated with a first oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (Lot# 653661/0146F). Concomitant vaccines administered at the same time included a first intramuscular dose of PEDIARIX (Lot# AC21B0B3AA) and a first intramuscular dose of PREVNAR (Lot# 808641E). On 27-MAY-2006 the patient developed diarrhea.  At the time of the report the patient was fine, frequency was normal, but still had watery stools.  There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a physician indicated that one day after receiving ROTATEQ, on 27-MAY-2006, the patient had loose stools, 2-3 times per day with the consistency of water until 10-JUN-2006. It was reported that from 11-JUN-2006 to 21-JUN-2006 the stools were watery once per day, and on 23-JUN-2006 the stools were watery twice per day. Follow-up information from a physician indicated that the patient's loose stools ended on approximately 26-JUN-2006. Additional informational is not expected.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning an 8 week old patient who was vaccinated with an oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  On the same day as vaccination the patient experienced intractable vomiting.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning an 4 month old patient who on 12-JUN-2006 was vaccinated with a first  oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live.  No symptoms were noted.  It was not specified if medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who in June 2006, was vaccinated by mouth with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live.  Concomitant vaccinations included a dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsag (yeast) (+) pertussis acellular 3 component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid. The physician reported that in June 2006, a half hour after being vaccinated, the patient began vomiting.  Unspecified medical attention was sought.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 14-week-old female who on 14-JUN-2006 was vaccinated by mouth with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live.  The patient had no complaints and no adverse event was involved.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTP, HBHEPB, IPV, PNC, RV5
Symptoms: Gastrointestinal disorder, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning an 8-week-old female with reflux problems and vomiting (often) who on 14-JUN-2006 was vaccinated by mouth with a 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live.  Concomitant vaccinations administered on that day included a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, hepatitis B virus vaccine rHBsag (yeast) (+) Hib conj vaccine, pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine and poliovirus vaccine inactivated (unspecified). The LPN reported that on 14-JUN-2006, immediately after being vaccinated with rotavirus G1 G2 G3 G4 P1 reassortant vaccine live, the patient vomited it back up.  Unspecified medical attention was sought and the dose was not repeated.  At the time of this report, the patient was noted to be fine.  The LPN felt that the patient's vomiting was not related to therapy with rotavirus G1 G2 G3 G4 P1 reassortant vaccine G1 G2 G3 G4 P1 vaccine live since the patient had reflux issues.  No further information is available.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a medical assistant concerning a 4-month-old male who on 20-JUN-2006 was vaccinated by mouth with a dose rotavirus G1 G2 G3 G4 P1 reassortant vaccine live.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 4-month-old patient who was vaccinated with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live.  It was unknown if medical attention was sought and no symptoms were involved.  Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician's office concerning a 12-month-old patient who was vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine virus.  It was unknown if medical attention was sought.  No further information is available.
Age: 0.67
Sex: F
Vaccine: DTAP, HEP, IPV, RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning an 8 week old female, with no medial history and no allergies, who was vaccinated with a first 0.5 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live by injection.  Concomitant vaccines administered on the same day included a dose of poliovirus vaccine, a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and a dose of hepatitis B vaccine, recombivax (manufacturer unknown).  It was reported that the patient had recovered. It was noted that the physician would complete other doses.  There were no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: Pt had inj right deltoid on 6/8, on 6/10 broke out in hives around inj site. Did have hives on chest but was itchy days before inj given. Mother used Benadryl cream and PO med for hives which relieved symptoms. On June 16 broke out in hives again at inj site used Benadryl PO and resolved.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: 20cm around arm, width, 21 1/2 cm in length. Red, hot, swollen left arm.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Bruxism, Chills, Dyspnoea, Loss of consciousness, Tinnitus
Clinical narrative: On 07/06/2006 Per mother, son blacked out for 30 seconds immediately after Tdap, he told her he had blurry vision and ringing in ears. Went to ER for shortness of breath, tremors, and teeth chattering. Went to cardiologist on 07/10/06 normal tests, mom's concern is he wakes up at night with shortness of breath. Concerned vaccine causing reactions.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Tremor, Visual disturbance
Clinical narrative: On 07/06/2006 Per mother, son blacked out for 30 seconds immediately after Tdap, he told her he had blurry vision and ringing in ears. Went to ER for shortness of breath, tremors, and teeth chattering. Went to cardiologist on 07/10/06 normal tests, mom's concern is he wakes up at night with shortness of breath. Concerned vaccine causing reactions.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Fever 101(in the office) ibuprofen, elevated WBC 23600 65% gram. No fussiness, no local swelling/erythema.
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Bacterial infection, Pyrexia, White blood cell disorder
Clinical narrative: Fever 103.2 (Rectal), WBC 19.9. Treated for possible bacteremia/fever without source. B Cx negative.
Age: 1.67
Sex: F
Vaccine: DTAP, MMR, PNC
Symptoms: Erythema, Urticaria
Clinical narrative: MMR given right lower thigh, within 30 seconds pt presents local reaction where MMR was given. Pt presents 1 1/2-2" red patchy hives. MA administered 1 tsp Benadryl pt was monitored for 20 min. No further reaction seen. Pt to follow up with allergist.
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Erythema, Hypersensitivity, Swelling
Clinical narrative: Swelling, redness down to the calf.  No fever, no streaking up the leg, no SOB per phone with mom.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Hypotonia, Tremor, Vaccine positive rechallenge
Clinical narrative: 5/11/06 at 9:06 Mother states child started shaking, went limp, sent to ER. Diagnosed with seizures possibly due to Dtap immunization.
Age: 20.0
Sex: M
Vaccine: TYP
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Recurrent episodes of hives and SOB occurring 2-3 times per week since 2 days after receiving typhoid vaccine. Symptoms: Hives Dyspnea (shortness of breath)
Age: 12.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Convulsion, Dyspnoea, Gaze palsy
Clinical narrative: Child was Administered TD, IPV, MMRI Hep B at around 12:05 pm was giving mom instructions for care of child after immunization. Tylenol for fever cool cloths etc. When child became unresponsive and with convulsive seizure activity. Baby was listless and convulsing eyes rolled back and breathing was labored through pursed lips. Seizure activity lasted 2-3 minutes child was groggy and sleepy when child finally came around. Child was transported to ER per ambulance as per mom's request
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Noted mild redness and swelling to left upper deltoid area, warm to touch. Patient taking Tylenol for pain able to use arm. No serious injury noted. Healed
Age: 49.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Joint stiffness, Muscular weakness, Pyrexia, Swelling
Clinical narrative: Approximately 5 minutes following vaccine, jaw/teeth felt tight almost clenched. Had fever x 3 days, uncertain, now high, weakness both arms, right had side of nose started swelling 3 days later after few days that went down. Gums swollen @ same time. Head felt "weird" x 3 days. Patient went back to MD's office, sat and waited x 3 hours to see MD and left, went home  and took Benadryl when unable to see MD.
Sex: U
Vaccine: PPV
Symptoms: Medication error
Clinical narrative: Pneumococcal vaccine polyvalent Pneumovax 23, 0.5ml single dose vials. The expiration date is ambiguous. Lot number 0751P. It is depicted on the vial as 07Jun06. Interpreted as expiring June 6 2007 and June 7 2006.
Age: 1.13
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Pyrexia
Clinical narrative: The patient experienced fever, blisters (multiple vesicular lesions) on his hand, trunk and scalp.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dehydration, Diarrhoea, Diarrhoea haemorrhagic, Face oedema, Hypokalaemia
Clinical narrative: Received vaccine on a thursday, on Sunday had a reaction after eating (all foods had been previously eaten with no adverse effects). Had severe diarrhea, cramping, facial and throat swelling and passed out. Was eventually transported to hospital via ambulance and diarrhea progressed to bloody diarrhea. Discharge summary states dehydration, hypokalemia. msv
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Muscle spasms, Pharyngeal oedema, White blood cell count increased
Clinical narrative: Received vaccine on a thursday, on Sunday had a reaction after eating (all foods had been previously eaten with no adverse effects). Had severe diarrhea, cramping, facial and throat swelling and passed out. Was eventually transported to hospital via ambulance and diarrhea progressed to bloody diarrhea. Discharge summary states dehydration, hypokalemia. msv
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 12 x 14 cm reddened area left deltoid, firm to touch.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right leg red, swollen, warm to the touch at site of DTaP.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Dermatitis, Dry skin, Eczema, Folliculitis, Rash
Clinical narrative: The Patient is a 34 year old male. Primary smallpox vaccine adminstered 3/7/2003 with reported normal take/reaction/recovery. 4/11/03 He received PPD and Typhoid VI. Approx 4/15/03 he c/o rash to legs/waist with diagnosis of folliculitis. His rash continued to spread, f/u tx w Dr. Diagnosed him with dermatitis. Referred to Dermatology with presc for creams, wraps and skin care instructins, Rx Atarax.  His itch persisted worse at night.  By Oct 2003 the rash was in both palms L>R.  Rash was dried, scaly, flaky, located to palms, knees. By 2006 he was diagnosed with ECZEMA.  He was referred to Vaccine Healthcare Center for report  filing and questions if SMPX vaccine gave him eczema/folliculitis° No systemic symptoms  o  General overall feeling  °  Feeling fine  °  No lethargy °  No fever °  No chills °  No recent weight changeo  Chronic dryness of the skin o  Localized to both hands anterior L>R knee o  With cracking o  Pruritus localized to area of exposure o  Of the ears had in the past but it's gone now o  Skin cracking to palms of both hands and dry scaley skin to anterior knee. Have some periodically under left axilla but not active now°  No cardiovascular symptoms  °  No pulmonary symptoms  °  No gastrointestinal symptoms  °  No endocrine symptoms  °  No musculoskeletal symptoms  °  No psychological symptoms
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Skin exfoliation
Clinical narrative: The Patient is a 34 year old male. Primary smallpox vaccine adminstered 3/7/2003 with reported normal take/reaction/recovery. 4/11/03 He received PPD and Typhoid VI. Approx 4/15/03 he c/o rash to legs/waist with diagnosis of folliculitis. His rash continued to spread, f/u tx w Dr. Diagnosed him with dermatitis. Referred to Dermatology with presc for creams, wraps and skin care instructins, Rx Atarax.  His itch persisted worse at night.  By Oct 2003 the rash was in both palms L>R.  Rash was dried, scaly, flaky, located to palms, knees. By 2006 he was diagnosed with ECZEMA.  He was referred to Vaccine Healthcare Center for report  filing and questions if SMPX vaccine gave him eczema/folliculitis° No systemic symptoms  o  General overall feeling  °  Feeling fine  °  No lethargy °  No fever °  No chills °  No recent weight changeo  Chronic dryness of the skin o  Localized to both hands anterior L>R knee o  With cracking o  Pruritus localized to area of exposure o  Of the ears had in the past but it's gone now o  Skin cracking to palms of both hands and dry scaley skin to anterior knee. Have some periodically under left axilla but not active now°  No cardiovascular symptoms  °  No pulmonary symptoms  °  No gastrointestinal symptoms  °  No endocrine symptoms  °  No musculoskeletal symptoms  °  No psychological symptoms
Age: 80.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: Patient received Td on July 13, 2006, returned today and stated that her left deltoid is sore. Noted slightly reddened area and skin slightly swollen at the site of injection. Denies any pain, but stated "it itches." Note: Our tetanus is a "purchased vaccine - not from State."
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy, Rash erythematous
Clinical narrative: Pt. was seen in urgent care for a laceration to her knee on 7/8/06. She received a DTaP on 7/10/06 as she had not gotten her kindergarten immunizations. She presented to the clinic for an appointment with Dr. on 7/12/06 at 9:37 A.M. with a reddened, swollen, warm area on her right thigh surrounding the injection site area. There was no complaints of itching at the site. The MD observed a 3.0 cm erythematous, warm, raised area that was slightly tender. She did have adenopathy in the right groin area according to the MD. The symptoms were notice the previous evening by the patient's mother. She had inked a circle around the area and the MD noted the erythema was extending out beyond the circle when she saw her in the clinic. Temperature was normal. She was treated with Augmentin 400 mg bid for 10 days.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Tenderness
Clinical narrative: Pt. was seen in urgent care for a laceration to her knee on 7/8/06. She received a DTaP on 7/10/06 as she had not gotten her kindergarten immunizations. She presented to the clinic for an appointment with Dr. on 7/12/06 at 9:37 A.M. with a reddened, swollen, warm area on her right thigh surrounding the injection site area. There was no complaints of itching at the site. The MD observed a 3.0 cm erythematous, warm, raised area that was slightly tender. She did have adenopathy in the right groin area according to the MD. The symptoms were notice the previous evening by the patient's mother. She had inked a circle around the area and the MD noted the erythema was extending out beyond the circle when she saw her in the clinic. Temperature was normal. She was treated with Augmentin 400 mg bid for 10 days.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chills, Fatigue, Heart rate increased, Injection site rash, Pain
Clinical narrative: Vomiting, fever (100.9), chills, aches, racing heart, fatigue, and restlessness.  These occurred 22-26 hours after vaccination.  A rash approximately 3" in diameter developed 48 hours afer vaccination below the vaccination site on the right arm.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Restlessness, Vomiting
Clinical narrative: Vomiting, fever (100.9), chills, aches, racing heart, fatigue, and restlessness.  These occurred 22-26 hours after vaccination.  A rash approximately 3" in diameter developed 48 hours afer vaccination below the vaccination site on the right arm.
Age: 7.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Loss of consciousness, Pyrexia, Syncope
Clinical narrative: Had fever beginning 8 days after DTaP/IPV/MMR vaccination.  A day later, she fainted and was unconscious less than 1 minute.  I saw her in the office a few hours later, at which time she was asymptomatic.  Her exam was normal.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Developed hives/urticarial rash approximately 3 hours after vaccine.  No other know precipitants for urticaral rash.  Patient continued to have symptoms for 2 days.  Today still with few hives but not as prominent as on the first 2 days.  Patient has been using Bendaryl 25 mg q 4 hrs scheduled since the hives began.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Swelling, Tenderness
Clinical narrative: RIGHT ARM SWELLING AND TENDERNESS.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: A 35-year-old female patient received an injection of pneumococcal vaccine on 06/27/06. On 06/28/06, at 0300 in the morning, 13 hours after the pneumococcal vaccine was administered, the patient complained of severe muscular pain in the right shoulder at the site of injection. The patient had not previously complained of any pain. Tylenol was administered to the patient as a rescue medication for the pain. No laboratory or diagnostic testing was done.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Rash pustular
Clinical narrative: Generalized papular and pustular rash.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Discomfort, Hypoaesthesia, Joint swelling, Pain, Paraesthesia
Clinical narrative: 7/6/06: R knee pain and swelling (relief with ibuprofen and ice after 2 days) 7/11/06: R 3rd finger pain, joint swelling and numbness (relief with ibuprofen & ice after 3 days) 7/15/06: L wrist pain, swelling and tingling 7/16/06: visit to clinic due to discomfort and referral to PCP (scheduled for 7/18/06)
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Swelling
Clinical narrative: 7/6/06: R knee pain and swelling (relief with ibuprofen and ice after 2 days) 7/11/06: R 3rd finger pain, joint swelling and numbness (relief with ibuprofen & ice after 3 days) 7/15/06: L wrist pain, swelling and tingling 7/16/06: visit to clinic due to discomfort and referral to PCP (scheduled for 7/18/06)
Age: 1.99
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure after temperature spike to 104F. Seizure did not respond to Ativan or Versed.  Rapid sequence intubation done & pt started on Cerebryx. Admitted to PICU. Rapidly weaned & extubated after sizure stopped. CT of head & EEG WNL.  Discharged on Diastat 2 days later. DC Summary for DOS 7/11/06-7/13/06: DC DX: Complex febrile seizure. HX of present illness and hospital course: On 7/11/06 had generalized tonic-clonic seizures associated with fever 12 hours prior to seizure received DTAP and hepatitis A. Seen in ED seizing and had temperature of 104.1. Given Versed and Ativan and intubated. He was loaded with Cerebyx. Extubated following morning. Continued with fevers, treated with Tylenol. Afebrile for greater than 12 hours and discharged home. PE: normal DC with Diastat as needed for seizures.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: redness/pain/swelling at injection site 2 d after; fever/myalgia/arthralgia night of shot admin;
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: redness/pain/swelling at injection site 2 d after; fever/myalgia/arthralgia night of shot admin;
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Unevaluable event
Clinical narrative: Child reported died 2 days after vaccine given.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Agitation, Crying, Pyrexia, Screaming, Urine analysis abnormal
Clinical narrative: Inconsolable crying x 72hrs started 4 hrs after vaccination. 07/19/06-records received from hospital. Chief Complaint: per mother "we are here because of crying: Prior to admission, medicated with Tylenol for bit of fever. Cried throughout night and on into the next day after immunization. Mother indicated child appeared constipated. PMH: 34 week gestational age,11 day hospitalization after birth for prematurity, NG feedings for a time.  Physical Exam: Temp 99 (R), pulse 160, inconsolable crying during entire exam. Impression: fever by palpation per history, continuous crying per parents' history. Plan: admit treat with Ampicillin and Ceftriaxone for 48 hours. No DC summary available or dictated.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Respiratory disorder
Clinical narrative: Patient experienced pruritus on the face and neck anterior chest, scratchy throat. she was treated with Benadryl, Pepcid and observed in the emergency department and discharged. She has similar reaction if exposed to cats and penicillin.
Age: 1.37
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Erythema, Rash, Rash macular
Clinical narrative: Grandmother comes in clinic without child. States child has rash all over and red blotches on his face. Grandmother was counseled on potential side effects from vaccinations. Vaccine information statements were reviewed and provided. She denies other medications or changes. Advised grandmother to see physician for evaluation. She stated she understood and left to get child and take him to see physician.
Age: 5.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A 5 x 7 cm red swollen area on thigh just adjacent to a mosquito bite.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Chest discomfort, Injection site pain, Pruritus, Rash, Throat tightness
Clinical narrative: Patient developed a constellation of generalized itching, mild skin rash, injection site soreness, throat and chest tightness. Episodes 24 to 48 hours after a Td injection at her primary care clinic. Pruritus started 07/08/2006 and ended 07/13/2006, it was generalized and started about 24 hours after shot. Rash, focal, started 07/08/2006 and ended 07/13/2006, it was a few itchy papules on the forearm. Chest tightness started 07/09/2006 and ended 07/09/2006, episodes staring 48 hours after shot and resolved by the following day.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Fontanelle bulging, Pyrexia
Clinical narrative: Bulging fontanel:  First noticed 6/24/06 approximately 8:00 AM.  Bulging gone 6/25/06 AM.  No treatment.  High Fever:  101.7 temporal artery method first noted 6/24/06 approximately 2:00 AM.  Fever gone by 8:00 PM 6/24/06.  Four doses of infants Tylenol given approximately 5 hours apart.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm swelling, red and hot from site of vaccine to elbow.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Encephalopathy, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a RN concerning a 5 yr old male who in Nov 2001, was vaccinated with a dose of varicella virus vaccine live. In Feb 2005, the pt developed a full blown case of chickenpox that resulted in encephalopathy. Medical attention was sought. He was hospitalized, treated (unk measures) and recovered completely. There was no product quality complaint involved. The pt's varicella that resulted in encephalopathy was considered to be an other important medical event (OMIC). Additional information has been requested.
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Convulsion
Clinical narrative: One and half weeks after vaccination he had a seizure, then 2 weeks later he had another seizure.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Anaemia, Chest pain, Myocarditis, Pericarditis, Pleurisy
Clinical narrative: Vaccine administered by nurse to myself in office pending foreign travel. No immediate or local reaction. Several days later, onset chest pain, pericarditis, pleuritis (mimicking inferior MI). Recovery in progress. Medical records state myocarditis, pericarditis. msv
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: Reaction not stated.
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Fatigue, Headache, Rash, Respiratory disorder
Clinical narrative: Fatigue, weakness, sleep disturbances, persistent headaches, skin rashes, respiratory issues.
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Sleep disorder
Clinical narrative: Fatigue, weakness, sleep disturbances, persistent headaches, skin rashes, respiratory issues.
Sex: U
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: Reaction not stated.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: Reaction not stated.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Mother called and left message that son had been vomiting since after vaccine administered. Vomited approximately 10 to 12 times the day after. Called patient on Monday and he stated "I'm fine."
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient has area that is red, hard to touch, warm to touch and raised.