chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 13-APR-2007 was vaccinated with the first dose of Gardasil (lot #656049/0187U), 0.5 ml, injection. Concomitant therapy included hepatitis A virus vaccine (unspecified). On 13-APR-2007, the patient fainted and had pseudo seizure like symptoms. The patient had dreams about receiving the shot and the physician felt that the reaction was anxiety related. The patient had the following laboratory diagnostic tests performed after the incident: glucose 85, blood pressure 135/75, pulse 85 and one hour later the blood pressure 97/63, pulse 73 and oxygen saturation 99%. No Benadryl was given to the patient. Subsequently the patient recovered from the events that same day. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Chills, Influenza like illness, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 23 year old female who on 02-MAR-2007 was vaccinated with Gardasil. Two or three days later, on approximately 04-MAR-2007, the patient experienced flu like symptoms and fever. Subsequently, the patient recovered from flu like symptoms and fever. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 23 year old female who on 02-MAR-2007 was vaccinated with Gardasil. Two or three days later, on approximately 04-MAR-2007, the patient experienced flu like symptoms and fever. Subsequently, the patient recovered from flu like symptoms and fever. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Antinuclear antibody positive, Arthralgia, Headache, Hypoaesthesia, Joint swelling
Clinical narrative: Information has been received from a physician, concerning a 15 year old female patient, who on 22-MAR-2007 was vaccinated with the first dose, 0.5ml, IM, of Gardasil (Lot #655849/0263U). Concomitant therapy administered on 22-MAR-2007, included Menactra. On 08-APR-2007, the patient experienced "generalized weakness, headache, upper and lower extremity joint pain, and upper and lower extremity hives." The physician reported that the generalized weakness, headache and hives resolved on approximately 15-APR-2007 ("after one week"). At the time of this report, the patient's joint pain continued in both her upper and lower extremities, though the physician confirmed that the patient was recovering from this event. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Rash maculo-papular, Red blood cell sedimentation rate increased, Urticaria
Clinical narrative: Information has been received from a physician, concerning a 15 year old female patient, who on 22-MAR-2007 was vaccinated with the first dose, 0.5ml, IM, of Gardasil (Lot #655849/0263U). Concomitant therapy administered on 22-MAR-2007, included Menactra. On 08-APR-2007, the patient experienced "generalized weakness, headache, upper and lower extremity joint pain, and upper and lower extremity hives." The physician reported that the generalized weakness, headache and hives resolved on approximately 15-APR-2007 ("after one week"). At the time of this report, the patient's joint pain continued in both her upper and lower extremities, though the physician confirmed that the patient was recovering from this event. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Arthralgia, Asthenia, Headache, Urticaria
Clinical narrative: Information has been received from a physician, concerning a 15 year old female patient, who on 22-MAR-2007 was vaccinated with the first dose, 0.5ml, IM, of Gardasil (Lot #655849/0263U). Concomitant therapy administered on 22-MAR-2007, included Menactra. On 08-APR-2007, the patient experienced "generalized weakness, headache, upper and lower extremity joint pain, and upper and lower extremity hives." The physician reported that the generalized weakness, headache and hives resolved on approximately 15-APR-2007 ("after one week"). At the time of this report, the patient's joint pain continued in both her upper and lower extremities, though the physician confirmed that the patient was recovering from this event. The patient sought unspecified medical attention. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site swelling, Swelling
Clinical narrative: After baby received Dtap/IPV/Hep B, Hib, PCV and Rotavirus vaccines yesterday AM (5/15/07) in the afternoon baby started to swell up in her thighs, shoulders and then generalized "looking like a marshmallow".
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Neutrophil count decreased, Rash, Varicella, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning a 14 month old female with congenital neutropenia and no known allergies who at "12 months old", in March 2006, was vaccinated with Varivax. The patient had two episodes of chickenpox after receiving Varivax. The first episode of chickenpox with vesicles occurred in April 2007, "one month" after she was vaccinated with Varivax. The vesicles were sent to the lab and tested positive for varicella zoster virus. She was hospitalized for 10 days due to the rash spreading and her neutrophil count went down. The patient was treated with intravenous acyclovir for 10 days and then discharged after the rash was resolved. Earlier this month the rash reappeared on her arm. At the time of this report, the  patient was considered recovering from the events. No product quality complaint was involved.  Upon internal review, chickenpox and neutrophil count went down were determined to be other important medical events. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow up information has been received from a nurse and manufacturer pregnancy registry concerning a 23 year old black female patient with one previous pregnancy who on 08-DEC-2006 was vaccinated with a dose of Gardasil. On 14-DEC-2006 a pregnancy test was positive. The patient's LMP was late November 2006. On 07-MAY-2007 the nurse reported that the patient had not been to the office since the original prenatal appointment on 12-FEB-2007. She had cancelled 3 appointments on 05-March-2007, 12-MAR-2007 and 19-MAR-2007. Follow up information from the nurse indicated that on 16-NOV-2006 patient had her last menstrual period and her estimated delivery date 20-AUG-2007. She called back on 07-MAY-2007 but did not give any information about the miscarriage. On 24-APR-2007 patient reported that she had miscarried. No date was identified when the patient miscarried. Unspecified medical attention was sought. The outcome was unknown. Upon internal review, miscarriage was considered an other important medical event. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Antepartum haemorrhage, Blood human chorionic gonadotropin abnormal, Foetal heart rate abnormal, Ultrasound scan, Urinary tract infection
Clinical narrative: Initial and follow up information has been received, via the manufacturer pregnancy registry, from a registered nurse, and a 25 year old female with a history of one previous full term delivery with no complications (date unspecified), who on 09-FEB-2007, was vaccinated with a first dose of Gardasil (Lot #654741/0013U). There was no concomitant medication. On 16-APR-2007, the patient reported that she was "four or five weeks pregnant." The date of the LMP and estimated date of delivery were not provided. Follow up information received from a registered nurse, indicated that the patient was taking prenatal vitamins (PRENATAL ELITE), and had experienced bleeding during her pregnancy. On 26-APR-2007, an ultrasound confirmed the presence of a yolk sac, but a fetal heart sound or fetal motion was not detected. On 29-APR-2007, the patient was diagnosed with a urinary tract infection and was treated with MACROBID 100mg, twice daily, from 29-APR-2007 through 03-MAY-2007. During this time, an human chorionic gonadotroin test (HCG) test result confirmed an "abnormal rise" in the value (date not specified). On 04-MAY-2007, a repeat ultrasound confirmed the previous finding of yolk sac, but no detection of a fetal heart sound or fetal motion. a dilatation and curettage (D&C) was performed, and the products of conception was examined (results not specified). At the time of this report, it was unknown if the patient had recovered. Upon internal review, no fetal heart rate (resulting in a D&C) was determined to be an other important medical event. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Uterine dilation and curettage
Clinical narrative: Initial and follow up information has been received, via the manufacturer pregnancy registry, from a registered nurse, and a 25 year old female with a history of one previous full term delivery with no complications (date unspecified), who on 09-FEB-2007, was vaccinated with a first dose of Gardasil (Lot #654741/0013U). There was no concomitant medication. On 16-APR-2007, the patient reported that she was "four or five weeks pregnant." The date of the LMP and estimated date of delivery were not provided. Follow up information received from a registered nurse, indicated that the patient was taking prenatal vitamins (PRENATAL ELITE), and had experienced bleeding during her pregnancy. On 26-APR-2007, an ultrasound confirmed the presence of a yolk sac, but a fetal heart sound or fetal motion was not detected. On 29-APR-2007, the patient was diagnosed with a urinary tract infection and was treated with MACROBID 100mg, twice daily, from 29-APR-2007 through 03-MAY-2007. During this time, an human chorionic gonadotroin test (HCG) test result confirmed an "abnormal rise" in the value (date not specified). On 04-MAY-2007, a repeat ultrasound confirmed the previous finding of yolk sac, but no detection of a fetal heart sound or fetal motion. a dilatation and curettage (D&C) was performed, and the products of conception was examined (results not specified). At the time of this report, it was unknown if the patient had recovered. Upon internal review, no fetal heart rate (resulting in a D&C) was determined to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Monoplegia, Pain, Paraesthesia
Clinical narrative: Initial and follow-up information has been received from a licensed practical head nurse, concerning a mentally challenged female who in March 2007, was vaccinated with Gardasil. Almost immediately after the vaccination, the patient experienced pain, tingling, and slight paralysis going down the arm. The licensed practical head nurse thought the complaint of "paralysis" was a result of having to hold the patient down. Subsequently, the patient recovered from the pain, tingling and slight paralysis going down the arm before she left the office. Upon internal review, slight paralysis going down the arm was considered to be an important medical event. This is one of two reports from the same source. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Blood bilirubin increased, Dysstasia, Full blood count, Hypoventilation
Clinical narrative: Information has been received from a mother concerning her 12 year old daughter with hypersensitivity to red dye who in February 2007, was vaccinated with a first dose of Gardasil. In April 2007, the patient was vaccinated with her second dose of Gardasil there were no concomitant medications. On approximately 06-APR-2007 the patient experienced stomach pain, difficulty standing, and shallow breathing. The patient went to the emergency room where laboratory data revealed bilirubin was elevated. At the time of the report, the patient was recovering from the stomach pain, difficulty standing, shallow breathing, and elevated bilirubin. The consumer considered stomach pain, difficulty standing, shallow breathing, and elevated bilirubin to be disabling. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphagia, Dyspnoea, Incorrect route of drug administration, Throat tightness
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female with gastrooesophageal reflux disease and a history of anaphylactic reaction while on therapy with VICODIN who on 04-MAR-2007 was vaccinated subcutaneously with a 0.5 mL dose of Gardasil (lot 657622/0388U). Concomitant therapy included NUVARING, PRILOSEC, cholestyramine resin, vitamins (unspecified) and probiotics "PB8". The patient left the office after receiving the dose of Gardasil. Within 15 minutes, the patient started to have shortness of breath, difficulty swallowing, and a feeling of her throat tightening. The patient was never unconscious and had no other symptoms. The patient went to the emergency room where she received possibly prednisone, BENADRYL, and TAGAMET IV. The patient was discharged to home after 4 hours. Subsequently, the patient recovered and was not receiving further treatment for the event. Shortness of breath, difficulty swallowing and throat tightness were considered to be immediately life-threatening by the reporter. Additional information has been requested.
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with Gardasil concomitantly with hepatitis A virus vaccine (manufacturer unspecified). Subsequently the patient experienced a seizure. Upon internal review, seizure was determined to be an Other Important Medical Event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated with Gardasil. Subsequently the patient experienced seizures. Upon internal review, seizure was determined to be an Other Important Medical Event. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Gait disturbance, Oedema peripheral, Pruritus, Skin tightness, Skin warm
Clinical narrative: 4:40pm On 5/11/07 parent brought in child - Left thigh swollen, skin tight, warm to the touch, child was limping, child states leg was itchy. No Peds Physician on site  to examine child. Instructed mother to take child to Peds Urgent Care for evaluation. Mom ended up taking.  6/12/07 Received hospital medical rcords which reveal patient seen in ER on 5/11/07 for erythema, swelling, tenderness  & itching of left thigh where received DTaP & IPV vax on 5/10. Tx w/Benadryl & d/c to home.  Returned to ER later same day w/fever 102.3 & increased edema from waist to patella on left.  Labs done (no reports).  Admitted & started on IV antibiotics.  Erythema & pain markedly improved by next day & was d/c to home.  Vax record accompanied hospital records & VAERS database updated w/corrected vax info. FINAL DX: local reaction to immunization (likely DTaP).
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Extreme pain around torso  about 12 hours after vaccination. Described as "nerve" pain.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: 930am after vaccines administered, patient began screaming and wouldn't stop screaming unconsolable 1545pm - left thigh red and tender to touch, ? fever, not sure had Tylenol at 900 and 1400 patient responded well to Benadryl.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Barium enema, Intussusception, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Pt received Rotateq vaccine 4/4/07 Pt had intussusception dx'd 5/15/07 05/23/07-records received for DOS 5/15/07-DX: Intussusception. Surgical repair. HX nausea vomiting no bowel movement for past 48 hours Temp 100.4. PE abdomen soft mild distention with decreased bowel sounds, non tender. no masses.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Pt received Rotateq vaccine 4/4/07 Pt had intussusception dx'd 5/15/07 05/23/07-records received for DOS 5/15/07-DX: Intussusception. Surgical repair. HX nausea vomiting no bowel movement for past 48 hours Temp 100.4. PE abdomen soft mild distention with decreased bowel sounds, non tender. no masses.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV, MMRV, PNC
Symptoms: Rash morbilliform
Clinical narrative: Morbilliform rash 7 days after vaccination 3 MMR Rxn
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain
Clinical narrative: Information has been received from a 64 year old female consumer with no known allergies and a history of shingles which started "four years ago" who on 19-DEC-2006 was vaccinated SC with a dose of Zostavax. There was no concomitant medication. On 19-JAN-2007 the patient brokeout with blisters between L2 and L3 on her back. After the blisters popped she was in extreme pain. The patient reported that she had been getting these blisters for a about a year once a month. However, previously the outbreaks were very mild and did not cause her great discomfort. Since vaccination, the "outbreaks are significant and painful". At the time of the report, the patient had not recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 67 year old female who on 17-APR-2007 was vaccinated with a dose of Zostavax. On 17-APR-2007 the patient experienced "injection site reaction" which included redness, lump, warmness and itching at injection site. Patient was treated with Keflex. The patient recovered on the same day. A product quality complaint was not involved. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: FLUX
Symptoms: Acute respiratory failure, Asthenia, Blood test, Dyspnoea, Echocardiogram
Clinical narrative: Patient reported being in his relatively normal state of health until he received a flu vaccination at a "roadside stand".  He alleged that approximately 2-3 days after this vaccination he developed worsening weakness, altered mental status and trouble breathing.  The patient was taken to hospital via EMS on 11/21/06 where he was found to be in acute respiratory failure.  The patient was admitted and during the patient's 14-day stay, he underwent multiple treatments & tests.  The patient's condition was treated medically and his condition progressively improved to the point of discharge to a rehab facility on 12/04/06.  Upon chart review and discussions with the patient's physicians, it was believed that the patient's condition might have been caused by the flu vaccination he allegedly received in mid-November.  No information is known as to where the patient received the alleged flu vaccination or the exact administration date.  While hospitalized the patient described the location of the vaccination as a "roadside stand".   5/25/07 Received hospital medical records which reveal patient experienced altered mental status & not feeling well for approx 5 days, body aches & malaise w/decreased oral intake & problems walking, difficulty breathing & increasing confusion.  In ER patient was hypoxic on RA, O2 applied, was lethargic & extremely dry, wheezing & tight lungs, distended abdomen & was disoriented.  A presumptive dx of infectious delirium & acute renal failure was made & started on IV antibiotics after cultures.  Admitted to ICU, 11/21/06-12/4/06.  Treated w/continued IV antibiotics, IV steroids & inhalers.  Neuro consult felt bilat LE weakness c/w GBS s/p flu vax.  Heme, GI & Pulm consults done.  Progressed & was transferred to rehab facility on continued nasal O2 with PT/OT.  FINAL DX: COPD, oxygen dependent; pneumonia, distal weakness, possible GBS; HTN; BPH; mild acute renal failure, resolving; abnormal LFTs, resolved; thrombocytopenia, resolving; essential tremor.
Age: 76.0
Sex: M
Vaccine: FLUX
Symptoms: Mental status changes
Clinical narrative: Patient reported being in his relatively normal state of health until he received a flu vaccination at a "roadside stand".  He alleged that approximately 2-3 days after this vaccination he developed worsening weakness, altered mental status and trouble breathing.  The patient was taken to hospital via EMS on 11/21/06 where he was found to be in acute respiratory failure.  The patient was admitted and during the patient's 14-day stay, he underwent multiple treatments & tests.  The patient's condition was treated medically and his condition progressively improved to the point of discharge to a rehab facility on 12/04/06.  Upon chart review and discussions with the patient's physicians, it was believed that the patient's condition might have been caused by the flu vaccination he allegedly received in mid-November.  No information is known as to where the patient received the alleged flu vaccination or the exact administration date.  While hospitalized the patient described the location of the vaccination as a "roadside stand".   5/25/07 Received hospital medical records which reveal patient experienced altered mental status & not feeling well for approx 5 days, body aches & malaise w/decreased oral intake & problems walking, difficulty breathing & increasing confusion.  In ER patient was hypoxic on RA, O2 applied, was lethargic & extremely dry, wheezing & tight lungs, distended abdomen & was disoriented.  A presumptive dx of infectious delirium & acute renal failure was made & started on IV antibiotics after cultures.  Admitted to ICU, 11/21/06-12/4/06.  Treated w/continued IV antibiotics, IV steroids & inhalers.  Neuro consult felt bilat LE weakness c/w GBS s/p flu vax.  Heme, GI & Pulm consults done.  Progressed & was transferred to rehab facility on continued nasal O2 with PT/OT.  FINAL DX: COPD, oxygen dependent; pneumonia, distal weakness, possible GBS; HTN; BPH; mild acute renal failure, resolving; abnormal LFTs, resolved; thrombocytopenia, resolving; essential tremor.
Age: 51.0
Sex: M
Vaccine: FLUX, HEPA
Symptoms: Electromyogram, Nerve conduction studies, Paraesthesia
Clinical narrative: Tingling in feet that progressed to hands. This began sometime in December of 2007 (cannot remember exact date).  Did NOT require hospitalization. Saw Dr. (neurologist) at hospital who diagnosed GBS based on EMG, nerve conduction study. Is recovering, still has some tingling in feet. Neurology note dted 2/207-Impression clinical and electrodiagnostic studies document the presence of mainly sensory polyneuropathy. Involving both motor and sensory fibers coming on relatively abruptly and reaching a plateau after just 1-2 wekks and then stabilizing is strongly suggestive of mild form of Guillain-Barre syndrome. C/O paresthesia in left foot and migrating to right foot and then into the hands.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Body temperature increased, Headache, Injection site erythema, Injection site pain
Clinical narrative: Day after administration, tenderness and redness at site noted. Symptoms increased by end of day to include edema, warmth, and soreness at site.  Also, body aches, weakness and headache.  Slight elevation of temperature.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: Day after administration, tenderness and redness at site noted. Symptoms increased by end of day to include edema, warmth, and soreness at site.  Also, body aches, weakness and headache.  Slight elevation of temperature.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis
Clinical narrative: Patient received a DTaP and IPV vaccines in left thigh and developed cellulitis of left thigh
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain
Clinical narrative: PAIN IN ARM WHERE VACCINATION WAS ADMINISTERED, LASTED 72 HOURS
Age: 28.0
Sex: M
Vaccine: HEPAB
Symptoms: Asthma, Fatigue, Pharyngeal oedema
Clinical narrative: Patient reports received Twinrix #3 dos e on 05/16/2007 around 3:30 Noted that evening Very tired.  Had experienced some allergy type symptoms prior to the vaccination consisting of clogged sinus, runny nose.   awakened this am and noticed continued fatigue, swelling in throat, need to use asthma inhaler.  Was sent home from work. Called Public HEalth.  Recomending contact PCP and report to Public HEalth findings.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Oedema peripheral, Pain, Pyrexia
Clinical narrative: FEVER OVER 100 DEGREE; ARM SWOLLEN TO ELBOW AND RED; CHILLS AND ACHY
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Cough, Influenza, Myalgia, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Onset of symptoms on 3/1/07: fever, sore throat, cough, and myalgia.  Respiratory failure on 3/6/07.  6/1/07 Received Death Certificate from epidemiologist which reveals COD asmultiorgan system failure and influenza B viral sepsis with contributing cause of staphyloccoccal secondary infection.  Medical records included w/death certificate indicate patient was transferred to higher level of care on 3/6, was intubated & in PICU w/pneumonia & ARDS.  Reportedly had been in good health until 3/1/07 when she developed sore throat, nasal congestion, rhinnorhea & low grade fever.  COntinued to worsen & developed myalgias, chest pain & nonproductive cough w/higher fever.  Seen by PCP on 3/5 & rapid strep was neg & dx was probable influenza.  Sent home & developed nausea, vomiting & diarrhea as well as petechial rash over abdomen.  Taken to outlying ER on 3/6 & found to be in respiratory failure, intubated & transferred to higher level of care.  Respiratory status declined further & was placed on oscillator & ECMO.  Peds ID consult done.  Consult states had HPV vax at PCP on 3/2 & no other recent vaccines. 6/1/07 Received fax medical & vaccine records from CDC who had contacted provider.  Reveals that on 1/2/07, patient received TDaP & HPV.  On 3/2/07 received HPV #2.  VAERS database updated w/same.  On day of vax patient also dx w/right CTS, migraine HA, scoliosis.  She was referred to Neuro & PT for the CTS & HA.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Respiratory failure
Clinical narrative: Onset of symptoms on 3/1/07: fever, sore throat, cough, and myalgia.  Respiratory failure on 3/6/07.  6/1/07 Received Death Certificate from epidemiologist which reveals COD asmultiorgan system failure and influenza B viral sepsis with contributing cause of staphyloccoccal secondary infection.  Medical records included w/death certificate indicate patient was transferred to higher level of care on 3/6, was intubated & in PICU w/pneumonia & ARDS.  Reportedly had been in good health until 3/1/07 when she developed sore throat, nasal congestion, rhinnorhea & low grade fever.  COntinued to worsen & developed myalgias, chest pain & nonproductive cough w/higher fever.  Seen by PCP on 3/5 & rapid strep was neg & dx was probable influenza.  Sent home & developed nausea, vomiting & diarrhea as well as petechial rash over abdomen.  Taken to outlying ER on 3/6 & found to be in respiratory failure, intubated & transferred to higher level of care.  Respiratory status declined further & was placed on oscillator & ECMO.  Peds ID consult done.  Consult states had HPV vax at PCP on 3/2 & no other recent vaccines. 6/1/07 Received fax medical & vaccine records from CDC who had contacted provider.  Reveals that on 1/2/07, patient received TDaP & HPV.  On 3/2/07 received HPV #2.  VAERS database updated w/same.  On day of vax patient also dx w/right CTS, migraine HA, scoliosis.  She was referred to Neuro & PT for the CTS & HA.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Acute respiratory distress syndrome, Biopsy lymph gland, Blood culture positive, Carpal tunnel syndrome, Chest pain
Clinical narrative: Onset of symptoms on 3/1/07: fever, sore throat, cough, and myalgia.  Respiratory failure on 3/6/07.  6/1/07 Received Death Certificate from epidemiologist which reveals COD asmultiorgan system failure and influenza B viral sepsis with contributing cause of staphyloccoccal secondary infection.  Medical records included w/death certificate indicate patient was transferred to higher level of care on 3/6, was intubated & in PICU w/pneumonia & ARDS.  Reportedly had been in good health until 3/1/07 when she developed sore throat, nasal congestion, rhinnorhea & low grade fever.  COntinued to worsen & developed myalgias, chest pain & nonproductive cough w/higher fever.  Seen by PCP on 3/5 & rapid strep was neg & dx was probable influenza.  Sent home & developed nausea, vomiting & diarrhea as well as petechial rash over abdomen.  Taken to outlying ER on 3/6 & found to be in respiratory failure, intubated & transferred to higher level of care.  Respiratory status declined further & was placed on oscillator & ECMO.  Peds ID consult done.  Consult states had HPV vax at PCP on 3/2 & no other recent vaccines. 6/1/07 Received fax medical & vaccine records from CDC who had contacted provider.  Reveals that on 1/2/07, patient received TDaP & HPV.  On 3/2/07 received HPV #2.  VAERS database updated w/same.  On day of vax patient also dx w/right CTS, migraine HA, scoliosis.  She was referred to Neuro & PT for the CTS & HA.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Cough, Culture positive, Culture throat negative, Culture urine negative, Death
Clinical narrative: Onset of symptoms on 3/1/07: fever, sore throat, cough, and myalgia.  Respiratory failure on 3/6/07.  6/1/07 Received Death Certificate from epidemiologist which reveals COD asmultiorgan system failure and influenza B viral sepsis with contributing cause of staphyloccoccal secondary infection.  Medical records included w/death certificate indicate patient was transferred to higher level of care on 3/6, was intubated & in PICU w/pneumonia & ARDS.  Reportedly had been in good health until 3/1/07 when she developed sore throat, nasal congestion, rhinnorhea & low grade fever.  COntinued to worsen & developed myalgias, chest pain & nonproductive cough w/higher fever.  Seen by PCP on 3/5 & rapid strep was neg & dx was probable influenza.  Sent home & developed nausea, vomiting & diarrhea as well as petechial rash over abdomen.  Taken to outlying ER on 3/6 & found to be in respiratory failure, intubated & transferred to higher level of care.  Respiratory status declined further & was placed on oscillator & ECMO.  Peds ID consult done.  Consult states had HPV vax at PCP on 3/2 & no other recent vaccines. 6/1/07 Received fax medical & vaccine records from CDC who had contacted provider.  Reveals that on 1/2/07, patient received TDaP & HPV.  On 3/2/07 received HPV #2.  VAERS database updated w/same.  On day of vax patient also dx w/right CTS, migraine HA, scoliosis.  She was referred to Neuro & PT for the CTS & HA.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Diarrhoea, Influenza, Intensive care, Intubation, Mechanical ventilation
Clinical narrative: Onset of symptoms on 3/1/07: fever, sore throat, cough, and myalgia.  Respiratory failure on 3/6/07.  6/1/07 Received Death Certificate from epidemiologist which reveals COD asmultiorgan system failure and influenza B viral sepsis with contributing cause of staphyloccoccal secondary infection.  Medical records included w/death certificate indicate patient was transferred to higher level of care on 3/6, was intubated & in PICU w/pneumonia & ARDS.  Reportedly had been in good health until 3/1/07 when she developed sore throat, nasal congestion, rhinnorhea & low grade fever.  COntinued to worsen & developed myalgias, chest pain & nonproductive cough w/higher fever.  Seen by PCP on 3/5 & rapid strep was neg & dx was probable influenza.  Sent home & developed nausea, vomiting & diarrhea as well as petechial rash over abdomen.  Taken to outlying ER on 3/6 & found to be in respiratory failure, intubated & transferred to higher level of care.  Respiratory status declined further & was placed on oscillator & ECMO.  Peds ID consult done.  Consult states had HPV vax at PCP on 3/2 & no other recent vaccines. 6/1/07 Received fax medical & vaccine records from CDC who had contacted provider.  Reveals that on 1/2/07, patient received TDaP & HPV.  On 3/2/07 received HPV #2.  VAERS database updated w/same.  On day of vax patient also dx w/right CTS, migraine HA, scoliosis.  She was referred to Neuro & PT for the CTS & HA.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Methicillin-resistant staphylococcal aureus test positive, Migraine, Multi-organ failure, Myalgia, Nasal congestion
Clinical narrative: Onset of symptoms on 3/1/07: fever, sore throat, cough, and myalgia.  Respiratory failure on 3/6/07.  6/1/07 Received Death Certificate from epidemiologist which reveals COD asmultiorgan system failure and influenza B viral sepsis with contributing cause of staphyloccoccal secondary infection.  Medical records included w/death certificate indicate patient was transferred to higher level of care on 3/6, was intubated & in PICU w/pneumonia & ARDS.  Reportedly had been in good health until 3/1/07 when she developed sore throat, nasal congestion, rhinnorhea & low grade fever.  COntinued to worsen & developed myalgias, chest pain & nonproductive cough w/higher fever.  Seen by PCP on 3/5 & rapid strep was neg & dx was probable influenza.  Sent home & developed nausea, vomiting & diarrhea as well as petechial rash over abdomen.  Taken to outlying ER on 3/6 & found to be in respiratory failure, intubated & transferred to higher level of care.  Respiratory status declined further & was placed on oscillator & ECMO.  Peds ID consult done.  Consult states had HPV vax at PCP on 3/2 & no other recent vaccines. 6/1/07 Received fax medical & vaccine records from CDC who had contacted provider.  Reveals that on 1/2/07, patient received TDaP & HPV.  On 3/2/07 received HPV #2.  VAERS database updated w/same.  On day of vax patient also dx w/right CTS, migraine HA, scoliosis.  She was referred to Neuro & PT for the CTS & HA.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Nausea, Oxygen supplementation, Petechiae, Pharyngolaryngeal pain, Pneumonia
Clinical narrative: Onset of symptoms on 3/1/07: fever, sore throat, cough, and myalgia.  Respiratory failure on 3/6/07.  6/1/07 Received Death Certificate from epidemiologist which reveals COD asmultiorgan system failure and influenza B viral sepsis with contributing cause of staphyloccoccal secondary infection.  Medical records included w/death certificate indicate patient was transferred to higher level of care on 3/6, was intubated & in PICU w/pneumonia & ARDS.  Reportedly had been in good health until 3/1/07 when she developed sore throat, nasal congestion, rhinnorhea & low grade fever.  COntinued to worsen & developed myalgias, chest pain & nonproductive cough w/higher fever.  Seen by PCP on 3/5 & rapid strep was neg & dx was probable influenza.  Sent home & developed nausea, vomiting & diarrhea as well as petechial rash over abdomen.  Taken to outlying ER on 3/6 & found to be in respiratory failure, intubated & transferred to higher level of care.  Respiratory status declined further & was placed on oscillator & ECMO.  Peds ID consult done.  Consult states had HPV vax at PCP on 3/2 & no other recent vaccines. 6/1/07 Received fax medical & vaccine records from CDC who had contacted provider.  Reveals that on 1/2/07, patient received TDaP & HPV.  On 3/2/07 received HPV #2.  VAERS database updated w/same.  On day of vax patient also dx w/right CTS, migraine HA, scoliosis.  She was referred to Neuro & PT for the CTS & HA.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Pneumonia staphylococcal, Pyrexia, Respiratory failure, Rhinorrhoea, Scoliosis
Clinical narrative: Onset of symptoms on 3/1/07: fever, sore throat, cough, and myalgia.  Respiratory failure on 3/6/07.  6/1/07 Received Death Certificate from epidemiologist which reveals COD asmultiorgan system failure and influenza B viral sepsis with contributing cause of staphyloccoccal secondary infection.  Medical records included w/death certificate indicate patient was transferred to higher level of care on 3/6, was intubated & in PICU w/pneumonia & ARDS.  Reportedly had been in good health until 3/1/07 when she developed sore throat, nasal congestion, rhinnorhea & low grade fever.  COntinued to worsen & developed myalgias, chest pain & nonproductive cough w/higher fever.  Seen by PCP on 3/5 & rapid strep was neg & dx was probable influenza.  Sent home & developed nausea, vomiting & diarrhea as well as petechial rash over abdomen.  Taken to outlying ER on 3/6 & found to be in respiratory failure, intubated & transferred to higher level of care.  Respiratory status declined further & was placed on oscillator & ECMO.  Peds ID consult done.  Consult states had HPV vax at PCP on 3/2 & no other recent vaccines. 6/1/07 Received fax medical & vaccine records from CDC who had contacted provider.  Reveals that on 1/2/07, patient received TDaP & HPV.  On 3/2/07 received HPV #2.  VAERS database updated w/same.  On day of vax patient also dx w/right CTS, migraine HA, scoliosis.  She was referred to Neuro & PT for the CTS & HA.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Sepsis, Sputum culture positive, Staphylococcal infection, Streptococcal identification test, Viral test
Clinical narrative: Onset of symptoms on 3/1/07: fever, sore throat, cough, and myalgia.  Respiratory failure on 3/6/07.  6/1/07 Received Death Certificate from epidemiologist which reveals COD asmultiorgan system failure and influenza B viral sepsis with contributing cause of staphyloccoccal secondary infection.  Medical records included w/death certificate indicate patient was transferred to higher level of care on 3/6, was intubated & in PICU w/pneumonia & ARDS.  Reportedly had been in good health until 3/1/07 when she developed sore throat, nasal congestion, rhinnorhea & low grade fever.  COntinued to worsen & developed myalgias, chest pain & nonproductive cough w/higher fever.  Seen by PCP on 3/5 & rapid strep was neg & dx was probable influenza.  Sent home & developed nausea, vomiting & diarrhea as well as petechial rash over abdomen.  Taken to outlying ER on 3/6 & found to be in respiratory failure, intubated & transferred to higher level of care.  Respiratory status declined further & was placed on oscillator & ECMO.  Peds ID consult done.  Consult states had HPV vax at PCP on 3/2 & no other recent vaccines. 6/1/07 Received fax medical & vaccine records from CDC who had contacted provider.  Reveals that on 1/2/07, patient received TDaP & HPV.  On 3/2/07 received HPV #2.  VAERS database updated w/same.  On day of vax patient also dx w/right CTS, migraine HA, scoliosis.  She was referred to Neuro & PT for the CTS & HA.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, TDAP
Symptoms: Vomiting
Clinical narrative: Onset of symptoms on 3/1/07: fever, sore throat, cough, and myalgia.  Respiratory failure on 3/6/07.  6/1/07 Received Death Certificate from epidemiologist which reveals COD asmultiorgan system failure and influenza B viral sepsis with contributing cause of staphyloccoccal secondary infection.  Medical records included w/death certificate indicate patient was transferred to higher level of care on 3/6, was intubated & in PICU w/pneumonia & ARDS.  Reportedly had been in good health until 3/1/07 when she developed sore throat, nasal congestion, rhinnorhea & low grade fever.  COntinued to worsen & developed myalgias, chest pain & nonproductive cough w/higher fever.  Seen by PCP on 3/5 & rapid strep was neg & dx was probable influenza.  Sent home & developed nausea, vomiting & diarrhea as well as petechial rash over abdomen.  Taken to outlying ER on 3/6 & found to be in respiratory failure, intubated & transferred to higher level of care.  Respiratory status declined further & was placed on oscillator & ECMO.  Peds ID consult done.  Consult states had HPV vax at PCP on 3/2 & no other recent vaccines. 6/1/07 Received fax medical & vaccine records from CDC who had contacted provider.  Reveals that on 1/2/07, patient received TDaP & HPV.  On 3/2/07 received HPV #2.  VAERS database updated w/same.  On day of vax patient also dx w/right CTS, migraine HA, scoliosis.  She was referred to Neuro & PT for the CTS & HA.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: PATIENTS DAUGHTER CALLED STATING "MY MOTHER DEVELOPED CELLULITIS AT VACCINE ADMINISTRATION SITE AND WAS SEEN IN THE EMERGANCY ROOM FOR THIS PROBLEM".  "MY MOTHER WAS TREATED WITH KEFLEX 500 MGM BID X 10 DAYS FOR THIS".
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: BREAK THROUGH CHICKEN POX
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: LeftArm is red and swollen, itchy and painful. more than the typical reaction. Came to see Doctor two days after vaccines given
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Injection site erythema
Clinical narrative: PATIENT REPORTED EXPLOSIVE DIARRHEA FOR 1ST 24 HRS & FEELING VERY EXHAUSTED. ALSO HAD LARGE RED CIRCLE AT INJECTION SITE THAT WAS NOT PAINFUL OR WARM & SMOOTH,NOT RAISED.  STOPPED IN PHARMACY ABOUT 1 WEEK AFTER RECEIVING THE SHOT TO REPORT THIS REACTION.  RED CIRCLE ON ARM WAS ABOUT THE WIDTH OF A GOLF BALL, BUT AGAIN NOT SWOLLEN, NOT PAINFUL OR RAISED.  SHE WAS FEELING FINE SHE SAID AFTER THE 24 HOURS.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Malaise, Pyrexia, Tremor
Clinical narrative: RECEIVED SHOT APPROXIMATELY 1145, WENT TO BED EARLY ~2100 NOT FEELING WELL, WOKE WITH "FEVER 102 F, 'EXTREME H/A,DIZZINESS,SHAKING'"; WAS FEELING BETTER BY ~1030.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Anorexia, Diarrhoea, Pyrexia
Clinical narrative: Diarhhea and anorexia beginning the day after the vaccines and lasting for 6 days; tactile fever on first day of sx; no other family memebers were sick or became sick.
Age: 0.16
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Diarrhoea, Laboratory test, Lumbar puncture, Pyrexia, Vomiting
Clinical narrative: FEVER UP TO 102.0 ON 5-5-07. SEVERE VOMITING AND DIARRHEA PER MOTHER AT TIME OF VISIT ON 5-7-07. PATIENT SENT TO HOSPITAL ER. SHE WAS THEN ADMITTED. 06/07/07-records received from facility for DOS 5/7/07-DC DX febrile illness. History of feverl to 102 (R) for 4 days. Increased sleep and fussiness when awake. Vomiting. Decreased oral intake.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death
Clinical narrative: Unsure of adverse events. Patient died on 5/5/07.  11/16/07 Received autopsy report which states COD as sudden infant death while co-sleeping and hippocampal dysplasia.  Sleeping on parent's chest in prone position and found unresponsive.  Had been seen in ER 4/13/07 for apneic episodes.  Autopsy also revealed mild laryngopharyngitis & recent history of cold symptoms. 5/29/08 Received vax record which confirms as reported.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site swelling, Local reaction, Lymphadenopathy, Pain
Clinical narrative: Patient had local symptoms to the area where the shot was given.  He had swelling at the site and in lymph nodes under the arm vaccinated.  He also had body aches as the second synptom.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Vomiting, severe headache, fever,
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Axillary pain, Injection site extravasation, Injection site pain, Injection site swelling
Clinical narrative: Patient had swelling and draining from the site of vaccination and axillary area tender.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Complained of very sore vaccine location (slightly red) and spiked a fever of 103.6 (oral) approximately 12 hours after the vaccination (3rd HPV vaccine in set). Fever treated with Motrin, came down fairly quickly. No fever as of noon today, and fever has not recurred as of yet.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm cellulitis in a 4-year-old male subject who was vaccinated with Infanrix and ProQuad for prophylaxis. The subject's medical history included extrinsic asthma, respiratory infections and an unspecified reaction to oxybenzoyl described as a rash from baby oil. Concurrent medications included Albuterol and Pulmicort Nebulised. On 3 May 2007 the subject received 5th dose of Infanrix (.5 ml, unknown, left arm), and the 2nd dose of ProQuad (unknown, left arm). On 4 May 2007, within 24 hours of receiving the vaccinations, the subject's left arm became swollen and red, and he developed a fever of 104 degrees Fahrenheit. The subject was treated with ibuprofen (Motrin) and Benadryl with no improvement in symptoms. On 5 May 2007 at 3:43 p.m., the subject presented at the physician's office and was diagnosed with cellulitis. The subject's left arm was swollen from the deltoid to the elbow, his skin was taut, warm to the touch, and red. This case was assessed as medically serious by manufacturer. The subject was prescribed Augmentin for 10 days. At the time of reporting the arm cellulitis, swelling, redness, and warmness to the touch were improved, but the outcome of the fever and skin tautness was not specified. The healthcare professional considered the events were possibly related to vaccination with Infanrix and ProQuad. Per the source document, the healthcare professional in uncertain if cellulitis was due to Infanrix or ProQuad. Per the source document, the healthcare professional in uncertain if cellulitis was due to Infanrix or ProQuad since both vaccines were received on the same day.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Skin tightness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm cellulitis in a 4-year-old male subject who was vaccinated with Infanrix and ProQuad for prophylaxis. The subject's medical history included extrinsic asthma, respiratory infections and an unspecified reaction to oxybenzoyl described as a rash from baby oil. Concurrent medications included Albuterol and Pulmicort Nebulised. On 3 May 2007 the subject received 5th dose of Infanrix (.5 ml, unknown, left arm), and the 2nd dose of ProQuad (unknown, left arm). On 4 May 2007, within 24 hours of receiving the vaccinations, the subject's left arm became swollen and red, and he developed a fever of 104 degrees Fahrenheit. The subject was treated with ibuprofen (Motrin) and Benadryl with no improvement in symptoms. On 5 May 2007 at 3:43 p.m., the subject presented at the physician's office and was diagnosed with cellulitis. The subject's left arm was swollen from the deltoid to the elbow, his skin was taut, warm to the touch, and red. This case was assessed as medically serious by manufacturer. The subject was prescribed Augmentin for 10 days. At the time of reporting the arm cellulitis, swelling, redness, and warmness to the touch were improved, but the outcome of the fever and skin tautness was not specified. The healthcare professional considered the events were possibly related to vaccination with Infanrix and ProQuad. Per the source document, the healthcare professional in uncertain if cellulitis was due to Infanrix or ProQuad. Per the source document, the healthcare professional in uncertain if cellulitis was due to Infanrix or ProQuad since both vaccines were received on the same day.