chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dizziness, Dizziness postural, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female who, on 05-SEP-2007 was vaccinated with GARDASIL (Lot # not reported). It was reported that the patient fainted about ten minutes after (also reported as "immediately after injection") receiving her first dose of GARDASIL. She continued to feel light headed 40 minutes later but went home. As of 06-SEP-2007, the outcome of the patient's fainting and light-headedness was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/8/2007. Initial and follow-up information has been redeived from two physicians concerning a female with gastrooesophageal reflux disease who, on 05-SEP-2007, at 16:00 was vaccinated IM, into left arm, with a first 0.5 ml dose of GARDASIL (Lot # 658558/1061U). Concomitant therapy included PREVACID. On 05-SEP-2007, at 16:12, (previously reported as "immediately after injection") the patient complained to her mother about feeling "very dizzy." The patient fainted and went unconscious. The patient was laid on the floor with legs elevated. In less than a minute the patient began to rouse. It was reported that she was "in and out" for a few minute. She was given sips of coke. After 40 minutes she was still too dizzy to stand. She was sent to the emergency room. The outcome of dizziness was unknown. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who, on 05-SEP-2007 was vaccinated with GARDASIL (Lot # not reported). It was reported that the patient fainted about ten minutes after (also reported as "immediately after injection") receiving her first dose of GARDASIL. She continued to feel light headed 40 minutes later but went home. As of 06-SEP-2007, the outcome of the patient's fainting and light-headedness was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/8/2007. Initial and follow-up information has been redeived from two physicians concerning a female with gastrooesophageal reflux disease who, on 05-SEP-2007, at 16:00 was vaccinated IM, into left arm, with a first 0.5 ml dose of GARDASIL (Lot # 658558/1061U). Concomitant therapy included PREVACID. On 05-SEP-2007, at 16:12, (previously reported as "immediately after injection") the patient complained to her mother about feeling "very dizzy." The patient fainted and went unconscious. The patient was laid on the floor with legs elevated. In less than a minute the patient began to rouse. It was reported that she was "in and out" for a few minute. She was given sips of coke. After 40 minutes she was still too dizzy to stand. She was sent to the emergency room. The outcome of dizziness was unknown. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Full blood count normal, HIV antibody negative, Lymphadenopathy, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female with no pertinent medical history who on 07-AUG-2007 was vaccinated with a of GARDASIL. Concomitant therapy included LOESTRIN, and PROZAC. On approximately 12-AUG-2007 the patient developed symptoms of lymphadenopathy. The patient visited the office due to swollen inguinal lymph nodes. She was placed on antibiotics doxycycline. Laboratory data revealed complete blood cell count a normal, screening for chlamydia, gonorrhea and sexually transmitted disease (STD's) were negative. A pelvic ultrasound revealed multiple enlarged lymph nodes. At the time of this report the patient was recovering. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female with no pertinent medical history who on 07-AUG-2007 was vaccinated with a of GARDASIL. Concomitant therapy included LOESTRIN, and PROZAC. On approximately 12-AUG-2007 the patient developed symptoms of lymphadenopathy. The patient visited the office due to swollen inguinal lymph nodes. She was placed on antibiotics doxycycline. Laboratory data revealed complete blood cell count a normal, screening for chlamydia, gonorrhea and sexually transmitted disease (STD's) were negative. A pelvic ultrasound revealed multiple enlarged lymph nodes. At the time of this report the patient was recovering. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chlamydia serology negative, Full blood count normal, Laboratory test normal, Lymphadenopathy, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female with no pertinent medical history who on 07-AUG-2007 was vaccinated with a of GARDASIL. Concomitant therapy included LOESTRIN, and PROZAC. On approximately 12-AUG-2007 the patient developed symptoms of lymphadenopathy. The patient visited the office due to swollen inguinal lymph nodes. She was placed on antibiotics doxycycline. Laboratory data revealed complete blood cell count a normal, screening for chlamydia, gonorrhea and sexually transmitted disease (STD's) were negative. A pelvic ultrasound revealed multiple enlarged lymph nodes. At the time of this report the patient was recovering. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Abdominal X-ray, Barium enema, Chest X-ray, Intussusception, Surgery
Clinical narrative: Information has been received from a registered nurse concerning a 24 week old male who on 23-FEB-2007 was vaccinated orally with 2.0 ml first and second doses of Rotateq respectively. On 13-JUN-2007, after the second dose was administered the patient was diagnosed with intussusception. The patient was hospitalized and he had surgery on 13-JUN-2007. The patient remained hospitalized for an unspecified amount of time. The patient recovered on an unspecified day in June 2007. Despite this event the patient went on to receive a third dose of Rotateq on 29-JUN-2007. There was no product quality complaint involved. Additional information has been requested. The patient's intussusception was considered serious for hospitalization. The reporter also considered the patient's intussusception an other important medical event.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Urinary system X-ray, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 24 week old male who on 23-FEB-2007 was vaccinated orally with 2.0 ml first and second doses of Rotateq respectively. On 13-JUN-2007, after the second dose was administered the patient was diagnosed with intussusception. The patient was hospitalized and he had surgery on 13-JUN-2007. The patient remained hospitalized for an unspecified amount of time. The patient recovered on an unspecified day in June 2007. Despite this event the patient went on to receive a third dose of Rotateq on 29-JUN-2007. There was no product quality complaint involved. Additional information has been requested. The patient's intussusception was considered serious for hospitalization. The reporter also considered the patient's intussusception an other important medical event.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Inappropriate schedule of drug administration, Intussusception, Surgery
Clinical narrative: Information has been received from a registered nurse concerning a 24 week old male who on 23-FEB-2007 was vaccinated orally with 2.0 ml first and second doses of Rotateq respectively. On 13-JUN-2007, after the second dose was administered the patient was diagnosed with intussusception. The patient was hospitalized and he had surgery on 13-JUN-2007. The patient remained hospitalized for an unspecified amount of time. The patient recovered on an unspecified day in June 2007. Despite this event the patient went on to receive a third dose of Rotateq on 29-JUN-2007. There was no product quality complaint involved. Additional information has been requested. The patient's intussusception was considered serious for hospitalization. The reporter also considered the patient's intussusception an other important medical event.
Age: 1.6
Sex: M
Vaccine: DTAP, FLU3, MMR, VARCEL, MMR, VARCEL
Symptoms: Death
Clinical narrative: Information has been received from a police officer who heard about a report through a fellow officer of a 14 month old male child with a history of "at least one seizure" who on 24-SEP-2007, was vaccinated with ProQuad or MMR II alone. The patient was put to bed on the night of 24-SEP-2007, and in the morning of 25-SEP-2007, the "child passed away and was found face down on the bed. It was indicated that there was no reported suspicion of foul play, but per police department protocol, the case and case file had been transferred to a local detective for investigation. An autopsy is to be performed per police report. The reporter was not involved in the case, but did review the case file out of interest because he has a child of his own the same age as the child involved in this report." A product quality complaint was not reported. No further information was available. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pallor, Rash papular
Clinical narrative: (Rash) blanching papular rash on face and trunk.
Age: 80.0
Sex: F
Vaccine: TTOX
Symptoms: Dyspnoea
Clinical narrative: An 80-year-old female patient had received a Tetanus vaccination and had difficulty breathing. The manufacturer and date of vaccination were unknown at the time of the report. No further information was provided.
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: We received on 05 OCT 2007 from a nurse the following information: A female patient (birthday unknown) was vaccinated with Fluvirin, batch no. 78480 on an unknown date. She developed an anaphylactic reaction on 03 OCT 2007. The outcome is unknown. Company assessment: Seriousness criterion: medically significant. Causality: possible. Expectedness assessment according to SPC: Anaphylactic reaction is expected after vaccination with Fluvirin. No change in benefit risk-ratio. No measures necessary.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Pain to immunization site immediately with duration 7 days swelling to immunization site 8-10 hours to vaccine" no erythema or warmthness to touch, no other symptoms.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Convulsion
Clinical narrative: Mom called 10/10/07 to report seizure at 3pm 10/10/07. Had received vaccine at approximately 1030 AM same day. Had history of seizure, none in past 2 years.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pain in extremity, Skin warm, Tremor
Clinical narrative: 10/12/07 Reports left upper arm and armpit 'sore' upon exam, 2 red, slightly raised, warm areas, temp 37.2, ice pack applied. Patient took Ibuprofen, c/o shaky and ache. LUA area "15" x "3 1/2" "23 1/2" x 2".
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Oedema peripheral, Tenderness
Clinical narrative: Right upper arm red, swollen, tender afebrile T= 36.6 - 37.2 (10.9.07) joint ache.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Convulsion, Crying, Disturbance in attention, Electroencephalogram abnormal, Hypokinesia
Clinical narrative: Initially, patient was fussy and less interactive for about 1 week after her shots. She cried more and had poor eye contact. Then she developed seizures by 9/21. She was hospitalized on 10/1 for infantile spasms. 10/19/07 Reviewed vax record which confirms RO dose & lot # as reported.  11/16/07 Reviewed hospital ER medical records of 9/29/07 which reveal patient experienced continued myoclonus activity after being on antiseizure meds x few days.  D/C to home to f/u w/pcp & neuro.  11/27/07 Reviewed hospital medical records which reveal patient had initial seizure on 9/22/07 after being irritable x 1 day.  Seen at outlying ER where she was diagnosed w/mycoplasma pneumonia & tx w/antibiotics x 5 days.  Seen by pcp after that & referred to neurologist who read EEG as hypsarrhythmia & MRI as WNL.  Started antiseizure meds.  Continued to have bursts of seizure activity & pcp referred to hospital for ped neuro consult.  Admitted 10/1-10/9/2007.  Tx w/IVIG, antiseizure meds. FINAL DX: no d/c summary available, admit & d/c dates obtained verbally.  Admit dx: new onset encephalopathy & possible infantile spasm; recent mycoplasma pneumonia. Per 60 day follow up: Patient suffered infantile spasms from this event. Not sure if it was directly linked to vaccines, but the pediatric neurlogist fit it was.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Infantile spasms, Irritability, Social avoidant behaviour
Clinical narrative: Initially, patient was fussy and less interactive for about 1 week after her shots. She cried more and had poor eye contact. Then she developed seizures by 9/21. She was hospitalized on 10/1 for infantile spasms. 10/19/07 Reviewed vax record which confirms RO dose & lot # as reported.  11/16/07 Reviewed hospital ER medical records of 9/29/07 which reveal patient experienced continued myoclonus activity after being on antiseizure meds x few days.  D/C to home to f/u w/pcp & neuro.  11/27/07 Reviewed hospital medical records which reveal patient had initial seizure on 9/22/07 after being irritable x 1 day.  Seen at outlying ER where she was diagnosed w/mycoplasma pneumonia & tx w/antibiotics x 5 days.  Seen by pcp after that & referred to neurologist who read EEG as hypsarrhythmia & MRI as WNL.  Started antiseizure meds.  Continued to have bursts of seizure activity & pcp referred to hospital for ped neuro consult.  Admitted 10/1-10/9/2007.  Tx w/IVIG, antiseizure meds. FINAL DX: no d/c summary available, admit & d/c dates obtained verbally.  Admit dx: new onset encephalopathy & possible infantile spasm; recent mycoplasma pneumonia. Per 60 day follow up: Patient suffered infantile spasms from this event. Not sure if it was directly linked to vaccines, but the pediatric neurlogist fit it was.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram, Full blood count normal, Laboratory test normal
Clinical narrative: Non-febrile seizure, only post ictum witnessed.  10/19/07 Reviewed ER medical records which reveal patient experienced diarrhea, sleepiness, slurred speech, difficulty walking, diaphosesis & seizure like activity.  Seen in ER 10/12/2007.  Exam & labs all WNL.  PCP to see next day. ER Diagnosis:  possible seizures.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Nuclear magnetic resonance imaging, Postictal state, Scan brain
Clinical narrative: Non-febrile seizure, only post ictum witnessed.  10/19/07 Reviewed ER medical records which reveal patient experienced diarrhea, sleepiness, slurred speech, difficulty walking, diaphosesis & seizure like activity.  Seen in ER 10/12/2007.  Exam & labs all WNL.  PCP to see next day. ER Diagnosis:  possible seizures.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Hyperhidrosis, Lethargy, Nausea
Clinical narrative: Non-febrile seizure, only post ictum witnessed.  10/19/07 Reviewed ER medical records which reveal patient experienced diarrhea, sleepiness, slurred speech, difficulty walking, diaphosesis & seizure like activity.  Seen in ER 10/12/2007.  Exam & labs all WNL.  PCP to see next day. ER Diagnosis:  possible seizures.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Scan brain, Vomiting
Clinical narrative: Non-febrile seizure, only post ictum witnessed.  10/19/07 Reviewed ER medical records which reveal patient experienced diarrhea, sleepiness, slurred speech, difficulty walking, diaphosesis & seizure like activity.  Seen in ER 10/12/2007.  Exam & labs all WNL.  PCP to see next day. ER Diagnosis:  possible seizures.
Age: 63.0
Sex: F
Vaccine: HEPAB, IPV, MNQ, TDAP, TYP, YF
Symptoms: CSF glucose normal, CSF lymphocyte count increased, CSF protein increased, CSF test abnormal, CSF white blood cell count increased
Clinical narrative: Malaise, fever for 2 weeks after vaccination, resolved, then had HA, stiff neck, decreased mentation beginning 25 days after vaccination.   Per documents from CDC: Pt developed flu-like sx including fever, myalgias and H/A 2 days s/p vax.  These sx resolved over the following 2 weeks.  On 9/29/2007 (20 days s/p vax) pt developed  acute onset of nausea and H/A.  Sx worsened and pt developed confusion.  Pt admitted to local hospital with fever and confusion.  During admission mental status continued to decline and pt became unresponsive. Txd with abx, antivirals, and eventually corticosteroids from which pt had a good response, but not return to baseline mental status.  Transfered to another facility for further eval and tx.  11/5/2007 MR received from transfer facility for DOS 10/08-16/2007 with D/C DX: Meningoencephalitis. Chronic Lymphocytic Leukemia. Pt presented as above. Per D/c Summary "it is most likely that pt did have yellow fever reactivation meningoencephalitis". No evidence of encephalitis upon d/c.
Age: 63.0
Sex: F
Vaccine: HEPAB, IPV, MNQ, TDAP, TYP, YF
Symptoms: Cytomegalovirus test negative, Enterovirus serology test negative, Epstein-Barr virus antibody negative, Headache, Herpes simplex serology negative
Clinical narrative: Malaise, fever for 2 weeks after vaccination, resolved, then had HA, stiff neck, decreased mentation beginning 25 days after vaccination.   Per documents from CDC: Pt developed flu-like sx including fever, myalgias and H/A 2 days s/p vax.  These sx resolved over the following 2 weeks.  On 9/29/2007 (20 days s/p vax) pt developed  acute onset of nausea and H/A.  Sx worsened and pt developed confusion.  Pt admitted to local hospital with fever and confusion.  During admission mental status continued to decline and pt became unresponsive. Txd with abx, antivirals, and eventually corticosteroids from which pt had a good response, but not return to baseline mental status.  Transfered to another facility for further eval and tx.  11/5/2007 MR received from transfer facility for DOS 10/08-16/2007 with D/C DX: Meningoencephalitis. Chronic Lymphocytic Leukemia. Pt presented as above. Per D/c Summary "it is most likely that pt did have yellow fever reactivation meningoencephalitis". No evidence of encephalitis upon d/c.
Age: 63.0
Sex: F
Vaccine: HEPAB, IPV, MNQ, TDAP, TYP, YF
Symptoms: Malaise, Musculoskeletal stiffness, Polymerase chain reaction, Pyrexia, White blood cell count increased
Clinical narrative: Malaise, fever for 2 weeks after vaccination, resolved, then had HA, stiff neck, decreased mentation beginning 25 days after vaccination.   Per documents from CDC: Pt developed flu-like sx including fever, myalgias and H/A 2 days s/p vax.  These sx resolved over the following 2 weeks.  On 9/29/2007 (20 days s/p vax) pt developed  acute onset of nausea and H/A.  Sx worsened and pt developed confusion.  Pt admitted to local hospital with fever and confusion.  During admission mental status continued to decline and pt became unresponsive. Txd with abx, antivirals, and eventually corticosteroids from which pt had a good response, but not return to baseline mental status.  Transfered to another facility for further eval and tx.  11/5/2007 MR received from transfer facility for DOS 10/08-16/2007 with D/C DX: Meningoencephalitis. Chronic Lymphocytic Leukemia. Pt presented as above. Per D/c Summary "it is most likely that pt did have yellow fever reactivation meningoencephalitis". No evidence of encephalitis upon d/c.
Age: 30.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood pressure, Feeling abnormal, Tachycardia
Clinical narrative: Tachycardia HR 100-92 bpm, blood pressure 148/96, Impending feelings of doom.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site swelling, Pain, Pyrexia, Urticaria
Clinical narrative: Swelling at injection site - firm at the size of a baseball. Pain, welts, and low grade fever. Approximately 6-8 hours after injection. Prednisone 40 mg x 5d q 6 and Ranitidine 150mg BID, Benadryl 25-50 mg q 6, Hydromorphine 2mg PRN prescribed by ER doctor.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: Patient left pharmacy and went to an assisted living complex to see someone. He then experienced dizziness, sweating and fatigue. Nurses took his vitals and glucose levels. All were normal. Symptoms resolved 30 minutes after with no treatment. Patient returned to pharmacy to inform me of event. Patient was of even temperament.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Body temperature increased, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: Lethargy, fatigue, "flu-like" symptoms headache, temperature > 102 F, rash over upper body, swelling and pain at injection site of Pneumovax.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site swelling, Lethargy, Rash
Clinical narrative: Lethargy, fatigue, "flu-like" symptoms headache, temperature > 102 F, rash over upper body, swelling and pain at injection site of Pneumovax.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Headache, Injection site pain, Injection site swelling, Laboratory test normal
Clinical narrative: Lethargy, fatigue, "flu-like" symptoms headache, temperature > 102 F, rash over upper body, swelling and pain at injection site of Pneumovax.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Myalgia, Pyrexia, Rash, Red blood cell sedimentation rate increased, Skin warm
Clinical narrative: Lethargy, fatigue, "flu-like" symptoms headache, temperature > 102 F, rash over upper body, swelling and pain at injection site of Pneumovax.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Urticaria, White blood cell count increased
Clinical narrative: Lethargy, fatigue, "flu-like" symptoms headache, temperature > 102 F, rash over upper body, swelling and pain at injection site of Pneumovax.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: On 10/9 patient received Tdap, Hep A, HPV, MCV4, and Varivax after the Varivax patient's arm swelled slightly and turned red. Ice was applied, swelling went down. Patient was discharged on 10/12 patients mother called arm still swollen and hot to touch patient was sent to ER.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Patient received vaccination on 10/10/07 had redness and swelling on 10/11/07 and saw her ENT. Her ENT told her that if it got worse she would need to call doctor on 10/12/07 we referred her to ER.
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Eye discharge, Eye pain, Eye swelling, Ocular hyperaemia
Clinical narrative: Painful conjucta, eye swollen, red, and + discharge.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Increase red, swell, pain left arm erythema left lateral axillary node rx with antibiotics.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Swelling
Clinical narrative: Vaccinated on 10/9/07. One day after patient had soreness at the site and down into armpit area with swelling in front of armpit area. Patient taking IBU, is better, patient notified us this date, 10/12/07.
Age: 0.55
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC, RV5
Symptoms: Incorrect dose administered
Clinical narrative: The flu vaccine given on 10-12-07 at 10am was 0.5ml and should have been 0.25 ml. No signs or symptoms - no treatment required.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eyelid oedema, Pruritus
Clinical narrative: Coughing, itching, eye lids swollen
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Right deltoid, swelling, itching, redness and heat seen by provider; counseled re s/s infection/ s/s escalating Benadryl, Benadryl and ice.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm erythema/ swelling ~ 24 hours after vaccine administration.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Emotional distress, Injection site erythema
Clinical narrative: Two hours after received vaccine child became inconsolable and resisting weight bearing for approximately two hours. Improved after Tylenol. Completely resolved by next morning. afebrile, slight redness at site of DTaP.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Erythema
Clinical narrative: 8 x 13cm area of erythema anterior thigh given Keflex and Benadryl.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Urticaria
Clinical narrative: Severe edema and erythema at injection site of left upper arm within 12 hours of injection. Hives developed on left upper arm within 24 hours. Evaluated at Urgent Care. Treated with Benadryl.
Age: 1.26
Sex: M
Vaccine: DTAPH, PNC
Symptoms: Chills, Injection site erythema, Pyrexia, Vomiting
Clinical narrative: Patient has a fever, chills, and emesis. Patient also has a red spot on left thigh where vaccine was administered. Patient was given Amoxil 400/5 1 tsp BID x 10 10 days.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Electroencephalogram abnormal
Clinical narrative: Began having seizures ~ 3 month old per mom. She didn't know what they were so didn't say anything re: them until his 9 month visit.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness swelling of arm Prednisone in ER.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness and nausea on arising the moving after receiving vaccine lasted less than 30 minutes. Patient seemed off after lying down for 30 minutes after event.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: 2.5cm lump at injection site right arm redness 4-5cm wide extending to elbow evaluated by doctor. Diagnosed rule out cellulitis. Treatment: Benadryl, Keflex 250/5cc 1 tsp TID x 10 days.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus, Pain, Swelling
Clinical narrative: large, red, swollen circle appeared 2 days after receiving vaccination. the area throbbed and later in the course started to itch. this cleared up on 10/5/07. the patient took benadryl at bedtime each night until cleared.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia areata
Clinical narrative: Developed alopecia areata. Exact date of on-set is unknown with large patch of missing hair noticed in mid August. So, within 5 weeks of vaccine, serious alopecia areata had developed. Currently, applying Clobetasol propionate cream as prescribed by physician. Additional hair loss continues to occur.  10/16/07 Reviewed pcp medical records.  Received vax record which confirms dose & lot # for HPV.  No medical records beyond 6/20 included.  T/C to pcp to request same. PCP reports no visits in July or August.  11/27/07 Reviewed medical records from specialist which reveals patient exprienced baseball sized area of hair loss w/rash inside it on the occiput.  Noted to have very mild seborrheic dermatitis in other areas of scalp but not enough to produce alopecia.  Tx w/topical cream.   FINAL DX: alopecia areata.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Per pt.'s grandmother, patient developed hives all over her body that required Benadryl every 4 hours around the clock for 24 hours.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Patient was given the influenza virus vaccine.  After administration, a nurse noticed that the patient's parents were not asked about allergies, specifically an egg allergy.  The patient was kept in the exam room for 10 minutes, after which a small welt at the injection site was noted.  The patient was moved to a treatment room for further observation.  Diphenhydramine was administered through the patient's G-tube and ice was applied to the injection site.  Patient rapidly and fully recovered
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Client went to our flu clinic on 10-11-07, was vaccinated with injectable flu vaccine using the Biojectat approx. 5:30 -6:00 pm. She stated that she felt fine and went to bed at 11:00 pm. She stated she woke up at about midnignt with severe itching on  top of her  right thigh and both elbows, she also had "welts".  SHe stated she did take a Benadrl that was expired and used wet cold cloths to soothe the areas. She eventually went back to sleep and woke up this morning and the welts and itching are gone and she feels better.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Oedema peripheral, Urticaria
Clinical narrative: recived pediarix,prevnar, and hib afternoon of 10/11/2007. Broke out in hives at 730 pm.Also had swelling with extreme redness in lt leg. Dr was called and they were instructed to give benadryl and bring daughter in 10/12/ was seen 10/12/07 by pac. was instucted that baby waas fine and to give benadryl prior to next immun.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Oedema peripheral, Pain, Paraesthesia
Clinical narrative: HPV vaccine given at Elementary School clinic. About 10 minutes after HPV adminictered in left deltoid, child began c/o numbness/tingling in the whole arm and hand radiating to that scapula. Complaints worsened for 3 hours. Hand also became visably [but not grossly] swollon. Pulses, perfusion,sensaton, strength were normal in the hand. 200mg ibuprofen was given and we elevated arm. She felt relief but not resolution in 1 hour. The hand was normal 2 hours later. Pain and tingling still present but markedly less. The next morning it was totally resolved per school health aide. We think the hand swelling may be due to her dangling and favoring arm at the time.
Age: 0.42
Sex: F
Vaccine: HIBV, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: erythema 8.5x5 cm on left thigh. Induration the size of olive. Prevnar was the only vaccine administered in the left thigh.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Vomiting
Clinical narrative: About 10 hours after getting the shot, I had a 100.2 deg temp, the chills, and violent vomiting. About 3 hours later, another bout of violent vomiting. The next morning, vomiting returned about 8am after drinking some juice. My wife had the same shot at the same time, our diet was the same, and she had no adverse effects.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Rash
Clinical narrative: Developed a rash about one hour after vaccines, started on face and spread to trunk, lasted about 8 hours. At 4 month  vaccines, did not receive Rotateq and did not  develop a rash.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Urticaria
Clinical narrative: Developed a rash about one hour after vaccines, started on face and spread to trunk, lasted about 8 hours. At 4 month  vaccines, did not receive Rotateq and did not  develop a rash.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool, Diarrhoea, Haematochezia, Occult blood, Rotavirus test
Clinical narrative: Onset of blood-tinged watery stools one day after vaccine administration.  10/19/07 Reviewed vax record which provided RO dose & lot #.  Unable to read other lot numbers.  T/C to pcp to clarify.  v/m left for return call. 10/23/07 Received t/c from pcp office.  Will mail vax records.  Patient has recovered completely. 10/26/07 Received vax record w/readable info.  VAERS database updated w/same.
Age: 25.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: "swelling and redness around vaccine site, approx 3" above and below injection site."
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: 45 minutes after second anthrax immunization the patient developed a bilateral raised erythematous pruritic rash that persisted six hours later although it had improved.  No treatment instituted.  Temporary medical exemption (MT) issued.  Will see allergist after return CONUS before third immunization.
Age: 21.0
Sex: F
Vaccine: ANTH, FLU3
Symptoms: Headache, Injection site induration, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: ON 2 OCT 2007, PT RECEIVED DOSE #1 OF ANTHRAX VACCINE (SUB q) IN THE RIGHT UPPER DELTOID REGION. STATES SHE HAD A HEADACHE THAT AFTERNOON. PT STATES THAT THE INJECTION SITE HURT (LEVEL 5 ON THE PAIN SCALE) FOR 5 DAYS. THERE WAS A SMALL HARD LUMP, IT BACAME ITCHY (PT RUBBED, DID NOT SCRATCH THE SITE). SITE STARTED TO LOOK LIKE A RASH. SHE APPEARS TODAY WITH A 50mm X 40mm swollen, reddened raised welt region on her arm. SHE WAS SEEN TODAY BY NP, PRESCRIBED CLARITIN. PT DENIES BREATHING, WEAKNESS, PALENESS, OR SWELLING DIFFICULTIES.
Age: 21.0
Sex: F
Vaccine: ANTH, FLU3
Symptoms: Swelling, Urticaria
Clinical narrative: ON 2 OCT 2007, PT RECEIVED DOSE #1 OF ANTHRAX VACCINE (SUB q) IN THE RIGHT UPPER DELTOID REGION. STATES SHE HAD A HEADACHE THAT AFTERNOON. PT STATES THAT THE INJECTION SITE HURT (LEVEL 5 ON THE PAIN SCALE) FOR 5 DAYS. THERE WAS A SMALL HARD LUMP, IT BACAME ITCHY (PT RUBBED, DID NOT SCRATCH THE SITE). SITE STARTED TO LOOK LIKE A RASH. SHE APPEARS TODAY WITH A 50mm X 40mm swollen, reddened raised welt region on her arm. SHE WAS SEEN TODAY BY NP, PRESCRIBED CLARITIN. PT DENIES BREATHING, WEAKNESS, PALENESS, OR SWELLING DIFFICULTIES.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest X-ray normal, Cyanosis neonatal, Death, Dehydration, Infantile apnoeic attack
Clinical narrative: This is a newborn (10/3/07) WF by emergency C-section that received a single dose of Fluarix (lot AFLUA302BA exp 6/30/08) on 10/5 instead of Engerix B (the syringes look alike). The error was discovered on 10/9. The patient was treated with IV genatmicin and ampicillin from days one through three to rule out sepsis. Blood cultures were negative and the patient was discharged on 10/6. The patient was brought in for a baby check on 10/8/07. She appeared lethargic, jaundiced and dehydrated. She had bouts of apnea with cyanosis. She was given fluids and electrolytes and transferred to Children's Medical Center. The patient expired on 10/10/07. The initial impression is enteral viral sepsis without a definitive cause at this point. Cause from the flu vaccine is doubtful but unknown.  10/16/07 T/C to reporter who provided patient demographics.  10/18 Linked w/293414./ss 10/26/07 Hospital medical records including vax record reviewed which reveal lot number correct as reported.  D/C to home 10/6 with f/u scheduled for 10/8.  11/13/07 Received hospital medical records which reveal patient experienced poor feeding & apnea/cyanosis events at home.  Lethargic w/multiple apneic events at pcp office on 10/8/07.  WBC 16.8, platelets 20,000 in pcp poffice.  Pcp placed on O2 & called EMS.  Blood c/s done & IV antibiotics given. Admitted 10/8-10/10/2007.  Admit exam revealed overriding sutures, irritable with minimal suck & response to pain. Had multiple apneic & bradycardic episodes & was intubated.  Unable to convert SVT, blood pressure dropped, expired. 11/13/07 Received autopsy report with hospital records which states COD as myocarditis; massive acute hemorrhage, liver; meningitis; extensive lung hemorrhages, bilateral pneumonia & pleural effusions.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Jaundice neonatal, Lethargy, Sepsis, Wrong drug administered
Clinical narrative: This is a newborn (10/3/07) WF by emergency C-section that received a single dose of Fluarix (lot AFLUA302BA exp 6/30/08) on 10/5 instead of Engerix B (the syringes look alike). The error was discovered on 10/9. The patient was treated with IV genatmicin and ampicillin from days one through three to rule out sepsis. Blood cultures were negative and the patient was discharged on 10/6. The patient was brought in for a baby check on 10/8/07. She appeared lethargic, jaundiced and dehydrated. She had bouts of apnea with cyanosis. She was given fluids and electrolytes and transferred to Children's Medical Center. The patient expired on 10/10/07. The initial impression is enteral viral sepsis without a definitive cause at this point. Cause from the flu vaccine is doubtful but unknown.  10/16/07 T/C to reporter who provided patient demographics.  10/18 Linked w/293414./ss 10/26/07 Hospital medical records including vax record reviewed which reveal lot number correct as reported.  D/C to home 10/6 with f/u scheduled for 10/8.  11/13/07 Received hospital medical records which reveal patient experienced poor feeding & apnea/cyanosis events at home.  Lethargic w/multiple apneic events at pcp office on 10/8/07.  WBC 16.8, platelets 20,000 in pcp poffice.  Pcp placed on O2 & called EMS.  Blood c/s done & IV antibiotics given. Admitted 10/8-10/10/2007.  Admit exam revealed overriding sutures, irritable with minimal suck & response to pain. Had multiple apneic & bradycardic episodes & was intubated.  Unable to convert SVT, blood pressure dropped, expired. 11/13/07 Received autopsy report with hospital records which states COD as myocarditis; massive acute hemorrhage, liver; meningitis; extensive lung hemorrhages, bilateral pneumonia & pleural effusions.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Apnoea, Autopsy, Death, Medication error, Wrong drug administered
Clinical narrative: This is a newborn (10/3/07) WF by emergency C-section that received a single dose of Fluarix (lot AFLUA302BA exp 6/30/08) on 10/5 instead of Engerix B (the syringes look alike). The error was discovered on 10/9. The patient was treated with IV genatmicin and ampicillin from days one through three to rule out sepsis. Blood cultures were negative and the patient was discharged on 10/6. The patient was brought in for a baby check on 10/8/07. She appeared lethargic, jaundiced and dehydrated. She had bouts of apnea with cyanosis. She was given fluids and electrolytes and transferred to Children's Medical Center. The patient expired on 10/10/07. The initial impression is enteral viral sepsis without a definitive cause at this point. Cause from the flu vaccine is doubtful but unknown.  10/16/07 T/C to reporter who provided patient demographics.  10/18 Linked w/293414./ss 10/26/07 Hospital medical records including vax record reviewed which reveal lot number correct as reported.  D/C to home 10/6 with f/u scheduled for 10/8.  11/13/07 Received hospital medical records which reveal patient experienced poor feeding & apnea/cyanosis events at home.  Lethargic w/multiple apneic events at pcp office on 10/8/07.  WBC 16.8, platelets 20,000 in pcp poffice.  Pcp placed on O2 & called EMS.  Blood c/s done & IV antibiotics given. Admitted 10/8-10/10/2007.  Admit exam revealed overriding sutures, irritable with minimal suck & response to pain. Had multiple apneic & bradycardic episodes & was intubated.  Unable to convert SVT, blood pressure dropped, expired. 11/13/07 Received autopsy report with hospital records which states COD as myocarditis; massive acute hemorrhage, liver; meningitis; extensive lung hemorrhages, bilateral pneumonia & pleural effusions.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Loss of consciousness
Clinical narrative: loss of consciousness approx 5 min post vaccination.  pt was standing when consciousness lost.  no seizure activity, no cyanosis, no post ictal confusion
Age: 0.92
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Developed knots in both thighs 3-4 hours after vaccines were given. Has swelling and erythema and tenderness in both thighs.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pruritus, Urticaria
Clinical narrative: Pt. stated her right arm was swollen with an area of redness about 3 inches in diameter. Now has some red areas on her back with itching, which she thinks are hives.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt developed an outbreak of herpes zoster on the the right buttock 11 days after receiving the vaccine.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Erythema, Lip swelling, Rash papular, Rash pruritic
Clinical narrative: Pt was administered the flu vaccine at 1:40 pm on 10/11/07. Pt reported following flu vaccine swollen lips and chest tightness. In addition, a diffuse rash appeared over his body that was itchy, pink and papular.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Incorrect route of drug administration, Tenderness
Clinical narrative: Vaccine administered SQ left triceps area on 10/10/07.  On 10/12/07 patient awakened with tender red area 4" long.  I examined her on 10/12 and felt it was not infected and advised treatement with ice and to call if any worse
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood culture negative, Body temperature increased, Culture urine negative, Cyanosis, Musculoskeletal stiffness
Clinical narrative: Approximately 24 hours after receiving dTap, Hep B, IPV, Hib, PCV, pt had axillary temp of 108 degrees farenheit per mom, then had a an episode of tense extremities, turned purple, had tonic-clonic activity lasting approximately 4 minutes per mom, had tmax od 104 degrees farenheit in the AD at hospital.  He was treated with antibiotics for 48 hours, had negative blood and urine cultures and an eeg.  11/16/07 Received vax record & VAERS database updated w/same.  12/4/07 Received hospital medical records which reveal patient experienced fever, diarrhea & dry cough x 1 day with one episode of  rigidity, cyanosis & tonic-clonic movements for approx 4 min while on the way to outlying ER.  Temp at home reported to be 108.  Transferred to higer level of care after received IV antibiotics in ER. Admittted 10/10-10/12/2007.  Peds neuro consult done.   FINAL DX: complicated febrile seizure and vaccination reaction.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Tonic clonic movements
Clinical narrative: Approximately 24 hours after receiving dTap, Hep B, IPV, Hib, PCV, pt had axillary temp of 108 degrees farenheit per mom, then had a an episode of tense extremities, turned purple, had tonic-clonic activity lasting approximately 4 minutes per mom, had tmax od 104 degrees farenheit in the AD at hospital.  He was treated with antibiotics for 48 hours, had negative blood and urine cultures and an eeg.  11/16/07 Received vax record & VAERS database updated w/same.  12/4/07 Received hospital medical records which reveal patient experienced fever, diarrhea & dry cough x 1 day with one episode of  rigidity, cyanosis & tonic-clonic movements for approx 4 min while on the way to outlying ER.  Temp at home reported to be 108.  Transferred to higer level of care after received IV antibiotics in ER. Admittted 10/10-10/12/2007.  Peds neuro consult done.   FINAL DX: complicated febrile seizure and vaccination reaction.
Age: 1.33
Sex: F
Vaccine: MMRV
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash
Clinical narrative: 10/7/07-10/10/07: Fever (102-103.5), lack of appetite and fussiness.  10/12/07: Rash on neck,back,stomach and diaper area-some on face, still lack of appetite and fussiness.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: MOM CALLED AND STATED CHILDS LT WAS RED,SWOLLEN, AND HOT TO THE TOUCH ON TUESDAY EVENING. SHE GAVE MOTRIN AND A BATH. CHILD DOING FINE TODAY. AGH.
Age: 75.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dyspnoea, Swollen tongue
Clinical narrative: Tongue swelling, shortness of breath began about 1-2 hours after administration of Zostavax and Fluvirin. Patient took Benadryl and was told to call 911 and go to ER.  In ER was given Benadryl and steroids.
Age: 36.0
Sex: F
Vaccine: ANTH
Symptoms: Cellulitis, Erythema, Pyrexia
Clinical narrative: Member had a 150 mm erythemic area with cellulitic response and fever 101, treated with antibiotics.
Age: 1.51
Sex: F
Vaccine: DTAP, PNC
Symptoms: Autism, Constipation, Ear infection, Eczema, Irritable bowel syndrome
Clinical narrative: The thimerosal in this vaccination caused mercury toxicity, eczema, chronic constipation, persistant ear infections, irritable bowel syndrome and autistic like behaviors. Vaccine data updated in VAERS per vax record.  Prevnar given on 5/16/03, not IPV.  10/23/2007 MR received for WCC on 2/14/2003 to 3/29/2005.  WCC on 2/14/03 with normal growth & dev however still walking with assistance at age 15 mon.  Child had seen opthomologist for eval of stabismus/pseudostrabismus. 18 mon WCC 5/16/03 shows only saying 4 words otherwise doing well.  Hearing eval 5/03 and myringotomy tubes placed 6/03.  TC with MD 8/27/03 re: autism.  MD advised to watch progression of speech and reassessment of skills now that pt is hearing well 2' to ear tubes.  Speech delay noted at 2yr WCC.  Speaks 3-5 words, no phrases. Receiving speech tx and early intervention. Multiple visits for ear issues-bleeding, drainage, OM. 3 yr check with developmental delay noted.  DX: Autistic Disorder. PDD. Refered to GI for constipation and stool withholding. See also 292955. Per 60 day follow up: Mercury toxicity, constant eczema, chronic constipation, irritable bowel syndrome, lack of speech, autism. 1/12/2010 Patient still has chronic constipation, constant eczema and exhitbits autistic like behaviors.
Age: 1.51
Sex: F
Vaccine: DTAP, PNC
Symptoms: Myringotomy, Porphyrins urine abnormal, Urine analysis abnormal, Urine mercury abnormal
Clinical narrative: The thimerosal in this vaccination caused mercury toxicity, eczema, chronic constipation, persistant ear infections, irritable bowel syndrome and autistic like behaviors. Vaccine data updated in VAERS per vax record.  Prevnar given on 5/16/03, not IPV.  10/23/2007 MR received for WCC on 2/14/2003 to 3/29/2005.  WCC on 2/14/03 with normal growth & dev however still walking with assistance at age 15 mon.  Child had seen opthomologist for eval of stabismus/pseudostrabismus. 18 mon WCC 5/16/03 shows only saying 4 words otherwise doing well.  Hearing eval 5/03 and myringotomy tubes placed 6/03.  TC with MD 8/27/03 re: autism.  MD advised to watch progression of speech and reassessment of skills now that pt is hearing well 2' to ear tubes.  Speech delay noted at 2yr WCC.  Speaks 3-5 words, no phrases. Receiving speech tx and early intervention. Multiple visits for ear issues-bleeding, drainage, OM. 3 yr check with developmental delay noted.  DX: Autistic Disorder. PDD. Refered to GI for constipation and stool withholding. See also 292955. Per 60 day follow up: Mercury toxicity, constant eczema, chronic constipation, irritable bowel syndrome, lack of speech, autism. 1/12/2010 Patient still has chronic constipation, constant eczema and exhitbits autistic like behaviors.