chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Upper arm hot, red and swollen size of baseball-increase in size since this am. No fever, not painful when touched, arm hurts when pt moves his arm in circle.
Age: 49.0
Sex: F
Vaccine: UNK, FLU3
Symptoms: Back pain, Injection site pain
Clinical narrative: Pain at inj site-radiating to back and down to elbow, continuing 27 days after inj. Tx-ice area, shower massage.
Age: 49.0
Sex: F
Vaccine: UNK, FLU3
Symptoms: Injection site pain, Shoulder pain, Tendonitis
Clinical narrative: Pain at inj site-radiating to back and down to elbow, continuing 27 days after inj. Tx-ice area, shower massage.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site infection, Injection site oedema, Urticaria
Clinical narrative: Hives all around arm and red. MD prescribed levquin tables-500mg for swollen and infected area.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: L leg (+) warmth, erythema slightly raised, 6x5cm area of L thigh.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Rash erythematous, Rash maculo-papular, Urticaria
Clinical narrative: Rash maculo-papular erythematous and certain area urticaria all over body incl. palms, soles, face, head-rash blanching on pressure, no fever, no vomiting, no diarrhea, no wheezing. Recheck 11/19/02, 70% rash resolved.
Age: 34.0
Sex: M
Vaccine: FLU3, YF
Symptoms: Diarrhoea, Hypoxia, Jaundice, Liver function test abnormal, Pyrexia
Clinical narrative: 11/16/02 seen in clinic for diarrhea, vomiting, jaundice, elevation of liver enzymes. 11/17/02 hospitalized for severe hypoxia, tachycardia, fever 104, rash, diarrhea. On ventilator for respiratory failure.
Age: 34.0
Sex: M
Vaccine: FLU3, YF
Symptoms: Rash, Respiratory failure, Tachycardia, Vomiting
Clinical narrative: 11/16/02 seen in clinic for diarrhea, vomiting, jaundice, elevation of liver enzymes. 11/17/02 hospitalized for severe hypoxia, tachycardia, fever 104, rash, diarrhea. On ventilator for respiratory failure.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Cyanosis
Clinical narrative: Cyanotic/apneic spell occupied the night after receiving 2 month vaccine.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema, Pyrexia, Rash papular
Clinical narrative: Left arm red swollen from shoulder to elbow. Area had multiple scattered raised papular rash. Low grade fever.
Age: 1.1
Sex: M
Vaccine: HEP, HIBV, MMR, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Shingles, left L2 distribution. Week of 11/15/2002. No history of wild vericella disease.
Age: 0.9
Sex: M
Vaccine: PNC, PNC
Symptoms: Erythema, Injection site induration
Clinical narrative: RT THIGH RED BUMP 2CM X 5CM, INDURATION AREA ABOUT 5CM X 4CM.
Age: 0.9
Sex: M
Vaccine: PNC, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: RT THIGH RED BUMP 2CM X 5CM, INDURATION AREA ABOUT 5CM X 4CM.
Age: 68.0
Sex: M
Vaccine: DTPHIB
Symptoms: Arteritis, Myalgia, Pain, Vasculitis
Clinical narrative: Had shot on Tues  Nov 5, 2002.  By Sat Nov 9 I was experiancing considerable pain at the back left side of my head.  Note that the pain was located on the outside of my head, not inside. The pain continued to increase and spread to my left ear and into my left neck muscle. Went on a trip. As the trip progressed the pain intensity increased to the point where I  to start taking the pain killer HYDROCODN/APAP Tabs to sleep or contnue. On Fri Nov 22 the pain progressed to my left thigh muscles and I coudn't stand the situation any longer and went to the ER.  After a CAT Scan and blood checks the only thing they could determine was that the blood check indicated a possible VIRAL infection, for which there was nothing they could do. The pain is now over my entire body, particularly the large muscle groups.  The outer head pain has seemed to decrease from its origional intensity.  I went to my personal physian,Wed nov2.  He couldn't determine a cause either but said there may have benn an interaction of the Flu ahot and the Coumaden I take.  He didn't think it was likely.  My question to you is have you received similar complaint's from others?  If so, can you provide a remidy or at least an explanation so I can obtain an effective treatment.  I am 68 years old and have NEVER, to my knowledge experienced pain of this magnitude.  At present it is very painful to just walk around the house at a very slow pace. Before, I was running 10-14 miles/wk and  walking another 6-8 miles.  Thanking you in advance for your consideration of my proble.  Hope to hear from you next week . In the section below it asks what type immunization I received?  I don't know!  All I know is that it was a flu shot.  The entry in 13 is not correct because I have been unsble to eliminate it.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Pain, Paraesthesia
Clinical narrative: 8 days post-injection, developed shooting pains down left arm with tinglin sensation to fingers. Injection site soreness for 3 days.Induration but no erythema noted at injection site 11 days post-injection.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia, Restlessness
Clinical narrative: Experienced bilateral lower extremity weakness, mid-thigh down to feet, with numbness. No chills, no fever, no other bodyache. Restless and could not sleep that night.Symptoms resolved in 1 day. No injection site reaction
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Feeling hot, Influenza like illness, Injection site mass, Pyrexia
Clinical narrative: Burning in the arm (shot was sub derma) at first.  Next day there was a lump at injection area.  very tired for two days and felt feverish/flu like.  Second shot was two weeks later (in the mussel) and felt very tired the next day could not run more than 7 minutes at a time usually run for 30 minutes
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, IPV, LYME
Symptoms: Irritability, Oral intake reduced, Pyrexia, Rash macular
Clinical narrative: From correspondence received from manufacturer report number 2000017961 describes Coxsackie virus infection in a 16 month old male who inadvertently received an injection of Lyme disease vaccine recombinant OspA (LYMErix). Medical history, concurrent conditions, and concurrent medications were not specified. The child was well at the time of immunization. ON 9/13/00, the child received an injection of LYMErix (lot # LY144B9), instead of an injection of 7-valent pneumococcal conjugate vaccine. On that date, he also received injections of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed, Haemophilus influenzae type B conjugate vaccine, and inactivated poliomyelitis virus vaccine. Number of previous doses of these vaccines was not reported. On 9/18/00, five days post-immunization, the child developed fever to 103 degrees F. He was seen by the physician, who noted a non-specific macular rash and a red pharynx. On 9/20/00, seven days post-immunization the child had a fever of 101 degrees F., decreased eating and fussiness. He was again seen by the physician, who noted multiple small vesicles and ulcers in the oropharynx. The physician stated that the events were consistent with Coxsackie virus. Doubt vaccine reaction. All symptoms resolved in two to three with no sequelae.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Rash
Clinical narrative: A report from Lederle Labs (HQ7246614FEB2001) regarding events in Texas. "A nurse practitioner reported that a 4 month old child received the first dose of Prevnar (Lederle) and second doses of IPV (Aventis Pasteur SA), Tripedia (Aventis Pasteur Inc.) and ActHIB (Aventis Pasteur SA) vaccines on 02/12/01. Later that day, the child developed a red rash on the face, buttocks and extremities." From additional correspondence received on 05/15/01, it was reported that the patient  was a male. The lot number for the Prevnar product and the responsible nurse practitioner's information were provided. From mailed correspondence received on 06/21/01, it was reported that the patient recovered from this experience. This case is closed.
Age: 0.6
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site reaction, Viral infection
Clinical narrative: From mailed correspondence received from Lederle LABS (HQ7744127FEB2001) regarding events. "A mother reported that her 7 month old sdaughter received Prevnar (Ledrle) and DPT (manufacturer unknown) vaccines on 01/05/01. The following day, the infant developed wheezing, diarrhea, vomiting, a rash, and was  irritable. The mother considered these events to be an allergic reaction. She recovered by 01/08/01. Follow up information received from the physician on 05/22/01 indicated that the infant received Prevnar (Lederle), ActHib (Averntis Pasteur SA) and Tripedia (Aventis Pasteur,Inc. The following day, the infant developed  nasal congestion, an 'occassional' cough, runny nose, vomiting X 2 and 'mild' diarrhea. She was diagnosed with a viral syndrome.Sshe also developed an injection site reaction characterized by redness and swelling. The reporter indicated that the mother could not recall which leg was affected.  The viral syndrome resolved the following day without treatment." From mailed correspondence received on 08/27/01, it was reported, "Reviewed, no additional information at this time time." This case is closed.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site oedema, Vasodilation procedure
Clinical narrative: A nurse reported that an 18-month-old female received Prevnar, TriHIBit (combination of ActHIB & Tripedia), hepatitis b an IPV vaccines on April 30, 2001. The following day, the child developed an injection site reaction characterized by redness, warmth and swelling. The specific sites of vaccine administration were not reported. She was also fussy. The child was seen in an emergency room where they 'marked the area of reaction'. On May 2, 2001, she was seen by the physician 'because the redness had spread outside the markings'. No further information was provided from correspondence returned on August 27, 2001. This case closed.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: From mailed correspondence received from manufacturer regarding events in CA. A health care professional reported that an 18 month old male received Prevnar, Tripedia, and ActHIB vaccines on 2/16/01. The following day, the child developed a welt like rash all over body and was itchy. He was treated with Benadryl. The child recovered by 2/20/01.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: A nurse reported that a 15 month old female received her first dose of Prevnar along with DTaP, and Comvax vaccines on 1/24/01. That same day, the child developed a fever of 102 degrees F and experienced a febrile seizure. She was seen in an emergency room and recovered. Febrile seizure is considered medically important. Information regarding this event has been forwarded to manufacturer of Comvax.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Blister, Injection site induration, Injection site rash, Pyrexia
Clinical narrative: It was reported that a 6 month old female patient received an ActHIB vaccination administered in the right thigh on 9/12/01 at 10:30am. Reportedly on 9/13/01 at 09:00am the patient developed red blisters on her right thigh and an elevated temperature (T 100.2 rectal and axillary) 24 hours after injection. Currently the patient's right thigh has 40mmx45mm induration and rash at injection site. Reportedly the site is healing.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: From telephone conversation with reporting physician, it was stated that a 6 month old female patien received an ActHIB, a Tripedia, a hepatiis B (Merck) and a Prevnar vaccination on 03/12/01. Within 15 minutes, the patient developed generalized urticaria. Patient was given Benadryl per oral and the symptoms completely resolved. From additional correspondence received on 09/18/01, additional patient, vaccine and responsible physician information was provided. Upon receipt of additional correspondence from Merck (WAES 01062501) on 11/26/01, this report has been upgraded to serious, labeled. "Information has been received from a physician concerning a 6 month old white female, with atopic dermatitis and known illness at the time of vaccination, who on 03/12/01 was vaccinated with a second dose of Hepatitis B vaccine recombiant (yeast), administered IM in the right thigh (lot 637372/1324K).  Concomitant therapy that day included the third dose of haemophilus b conjugate vaccine (ActHib) (lot # UA3578AA), administered IM in the left thigh; streptococcal pneumonia vaccine (Prevnar) (Lot # 4721049), administered IM in the right thigh and DTaP (Tripedia) ( lot# UO356BA), administered in the left thigh. There were no additional concomitant medications reported. The patient presented to the physician's office with a 'few fine minimally raised red patches 1-3mm in diameter on her face and trunk.' It was reported that on 03/12/01, she developed urticaria within 15 minutes of the immunization and was treated with diphenhydramine (Benadryl). The patient was sent to an allergy specialist for skin testing. It was reported that she had tested positive for thimerosol allergy. Subsequent follow-up indicated that the skin testing revealed an allergy to hepatitis B recombinant (yeast) and diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia), but results were negative for allergy to haemophilus b conjugsate vaccine (ACTHib) and streptococcus pneumonia  vaccine (Prevnar).  On 03/12/02, the patient recovered from her experience. Urticaria, testing positive for thimerosol allergy, and 'allergy to DTaP and HBV' were determined to be other important medical events. No further information is available. This case is closed.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Crying
Clinical narrative: From correspondence received from manufacturer it was reported that a 2 month old male patient received an ActHIB, and IPOL and a Tripedia vaccination on 9/27/01. That same day the patient began crying and became fussy. Further information is requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Agitation, Irritability
Clinical narrative: From correspondence received from manufacturer it was reported that a 2 month old male patient received an ActHIB, and IPOL and a Tripedia vaccination on 9/27/01. That same day the patient began crying and became fussy. Further information is requested.
Age: 0.75
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: From correspondence received from manufacturer it was reported that a 9 month old male patient received ActHIB, an IPOL and a Tripedia vaccination on 9/25/01. The next day the patient experienced fever, vomiting and injection site redness and swelling. The patient recovery status is unknown at this time.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: This report was received from manufacturer research concerning a 10 week old white female with no known past medical history who on 8/21/01 was vaccinated with the first dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) IM in the right thigh (lot # 1759E - invalid). Concomitant vaccinations that same day included the first dose of diphtheria toxoid/pertussis vaccine/teta (INFANRIX) IM in the left thigh (lot #U05144), the first dose of poliovirus vaccine (IPOL) SC in the left thigh (lot # T0285) and the first dose of Streptococcus pneumoniae vaccine (PREVNAR) IM in the right thigh (lot # 480567). The patient was being seen for a well baby visit at the time of vaccination. On 8/21/01, 2 to 3 hours post vaccination, the patient developed a fever of 106 degrees F which persisted for 18 hours and then a fever of 102 degrees F for 18 hours. There was no serious criteria. An ER/doctor visit was required. Subsequently, the patient recovered. This report was originally reported by a physician, with follow up information received from a licensed practical nurse. No further information is available.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Convulsion
Clinical narrative: From mailed correspondence received at manufact on 25 Feb. 2002 from manufact (HQ0466804FEB2002) regarding an event occurring in the US. It was reported that a 6 month old female pt received an ACT-HIB, a Prevnar (Lederle) , an Infanrix (GSK) , and an Engerix B (GSK) vaccination on 24 Jan 2002. Reportedly on 25 Jan 2002 the pt experienced a seizure and was hospitalized. further information is requested. From additional correspondence received at manufact. on 26 Feb 2002 from manufact it was reported: "A sales representative reported that a 6 month old infant received Prevnar vaccine (pneumococcal 7-valent conjugate vaccine) and subsequently developed a "high" fever. The infant was brought to the hospital and was admitted. No additional information was available as of the date of this report. Additional information received 05 Feb2002 from a sales representative (VAERS form). A health care professional reported that a 6 month old female received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine), 2nd dose of Infanrix (GSK) (diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed), 2nd dose of Act- Hib (Aventis Pastuer) (haemophilus b conjugate vaccine) and 2nd dose of Engerix B (GSK) (hepatitis B vaccine) on 24 Jan 2002. On 25 Jan 2002, pt developed a "high" fever and seizures. The infant was brought to the hospital and was admitted. She was discharged from the hospital and she recovered. No additional information was available as of the date of this report.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Aspartate aminotransferase increased, Convulsion, Heart rate increased, Musculoskeletal stiffness, Nasal congestion
Clinical narrative: From mailed correspondence received at manufact on 25 Feb. 2002 from manufact (HQ0466804FEB2002) regarding an event occurring in the US. It was reported that a 6 month old female pt received an ACT-HIB, a Prevnar (Lederle) , an Infanrix (GSK) , and an Engerix B (GSK) vaccination on 24 Jan 2002. Reportedly on 25 Jan 2002 the pt experienced a seizure and was hospitalized. further information is requested. From additional correspondence received at manufact. on 26 Feb 2002 from manufact it was reported: "A sales representative reported that a 6 month old infant received Prevnar vaccine (pneumococcal 7-valent conjugate vaccine) and subsequently developed a "high" fever. The infant was brought to the hospital and was admitted. No additional information was available as of the date of this report. Additional information received 05 Feb2002 from a sales representative (VAERS form). A health care professional reported that a 6 month old female received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine), 2nd dose of Infanrix (GSK) (diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed), 2nd dose of Act- Hib (Aventis Pastuer) (haemophilus b conjugate vaccine) and 2nd dose of Engerix B (GSK) (hepatitis B vaccine) on 24 Jan 2002. On 25 Jan 2002, pt developed a "high" fever and seizures. The infant was brought to the hospital and was admitted. She was discharged from the hospital and she recovered. No additional information was available as of the date of this report.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Pyrexia, Somnolence, Tremor
Clinical narrative: From mailed correspondence received at manufact on 25 Feb. 2002 from manufact (HQ0466804FEB2002) regarding an event occurring in the US. It was reported that a 6 month old female pt received an ACT-HIB, a Prevnar (Lederle) , an Infanrix (GSK) , and an Engerix B (GSK) vaccination on 24 Jan 2002. Reportedly on 25 Jan 2002 the pt experienced a seizure and was hospitalized. further information is requested. From additional correspondence received at manufact. on 26 Feb 2002 from manufact it was reported: "A sales representative reported that a 6 month old infant received Prevnar vaccine (pneumococcal 7-valent conjugate vaccine) and subsequently developed a "high" fever. The infant was brought to the hospital and was admitted. No additional information was available as of the date of this report. Additional information received 05 Feb2002 from a sales representative (VAERS form). A health care professional reported that a 6 month old female received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine), 2nd dose of Infanrix (GSK) (diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed), 2nd dose of Act- Hib (Aventis Pastuer) (haemophilus b conjugate vaccine) and 2nd dose of Engerix B (GSK) (hepatitis B vaccine) on 24 Jan 2002. On 25 Jan 2002, pt developed a "high" fever and seizures. The infant was brought to the hospital and was admitted. She was discharged from the hospital and she recovered. No additional information was available as of the date of this report.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: From mailed correspondence received at manufact on 25 Feb. 2002 from manufact (HQ0466804FEB2002) regarding an event occurring in the US. It was reported that a 6 month old female pt received an ACT-HIB, a Prevnar (Lederle) , an Infanrix (GSK) , and an Engerix B (GSK) vaccination on 24 Jan 2002. Reportedly on 25 Jan 2002 the pt experienced a seizure and was hospitalized. further information is requested. From additional correspondence received at manufact. on 26 Feb 2002 from manufact it was reported: "A sales representative reported that a 6 month old infant received Prevnar vaccine (pneumococcal 7-valent conjugate vaccine) and subsequently developed a "high" fever. The infant was brought to the hospital and was admitted. No additional information was available as of the date of this report. Additional information received 05 Feb2002 from a sales representative (VAERS form). A health care professional reported that a 6 month old female received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine), 2nd dose of Infanrix (GSK) (diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed), 2nd dose of Act- Hib (Aventis Pastuer) (haemophilus b conjugate vaccine) and 2nd dose of Engerix B (GSK) (hepatitis B vaccine) on 24 Jan 2002. On 25 Jan 2002, pt developed a "high" fever and seizures. The infant was brought to the hospital and was admitted. She was discharged from the hospital and she recovered. No additional information was available as of the date of this report.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: From mailed correspondence received at manufact on 25 Feb. 2002 from manufact (HQ0466804FEB2002) regarding an event occurring in the US. It was reported that a 6 month old female pt received an ACT-HIB, a Prevnar (Lederle) , an Infanrix (GSK) , and an Engerix B (GSK) vaccination on 24 Jan 2002. Reportedly on 25 Jan 2002 the pt experienced a seizure and was hospitalized. further information is requested. From additional correspondence received at manufact. on 26 Feb 2002 from manufact it was reported: "A sales representative reported that a 6 month old infant received Prevnar vaccine (pneumococcal 7-valent conjugate vaccine) and subsequently developed a "high" fever. The infant was brought to the hospital and was admitted. No additional information was available as of the date of this report. Additional information received 05 Feb2002 from a sales representative (VAERS form). A health care professional reported that a 6 month old female received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine), 2nd dose of Infanrix (GSK) (diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed), 2nd dose of Act- Hib (Aventis Pastuer) (haemophilus b conjugate vaccine) and 2nd dose of Engerix B (GSK) (hepatitis B vaccine) on 24 Jan 2002. On 25 Jan 2002, pt developed a "high" fever and seizures. The infant was brought to the hospital and was admitted. She was discharged from the hospital and she recovered. No additional information was available as of the date of this report.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: From faxed correspondence received at manufacturer on 3/18/02 from a pediatric group and from a telephone conversation with the reporting nurse on 3/20/02. The patient, a 5 year old male, was vaccinated with Tripedia, IPOL and MMR II on 2/5/02. On 2/6/02, the patient developed a 2x4 warm, hard, swelling area on the left upper arm at the injection site of the Tripedia. The event has resolved, date unknown.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site induration, Injection site swelling
Clinical narrative: From faxed correspondence received at manufacturer on 3/18/02 from a pediatric group and from a telephone conversation with the reporting nurse on 3/20/02. The patient, a 5 year old male, was vaccinated with Tripedia, IPOL and MMR II on 2/5/02. On 2/6/02, the patient developed a 2x4 warm, hard, swelling area on the left upper arm at the injection site of the Tripedia. The event has resolved, date unknown.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site induration
Clinical narrative: From corresponding received at Aventis Pasteur Inc. on 03/20/02 from the reporting physician. It was reported that a 5 year old male patient received his fifth dose of Tripedia vaccination administered IM in his left deltoid, an IPOl vaccination administered SC in his  right arm on 02/26/02. Forty-eight hours after vaccination the patient developed a 6cm X 7 cm of redness and warmth on his left deltoid. The patient is able to move his arm. The symptoms resolved and the patient recovered.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site reaction
Clinical narrative: From corresponding received at Aventis Pasteur Inc. on 03/20/02 from the reporting physician. It was reported that a 5 year old male patient received his fifth dose of Tripedia vaccination administered IM in his left deltoid, an IPOl vaccination administered SC in his  right arm on 02/26/02. Forty-eight hours after vaccination the patient developed a 6cm X 7 cm of redness and warmth on his left deltoid. The patient is able to move his arm. The symptoms resolved and the patient recovered.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP, DTAP, HEP, DTAP, HEP
Symptoms: Erythema
Clinical narrative: From faxed correspondence received at Aventis Pasteur Inc on 02/20/02. The patient, an 18 month old male,was vaccinated with Tripedia and hepatitis  b (Merck) on 03/11/02 at 3;45 pm. On 03/12/02 at 3:00 pm, the patient developed a 10 cm X 8 cm area of redness on his left upper arm at the site of the Tripedia injection, with no duration and no pus.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP, DTAP, HEP, DTAP, HEP
Symptoms: Injection site erythema
Clinical narrative: From faxed correspondence received at Aventis Pasteur Inc on 02/20/02. The patient, an 18 month old male,was vaccinated with Tripedia and hepatitis  b (Merck) on 03/11/02 at 3;45 pm. On 03/12/02 at 3:00 pm, the patient developed a 10 cm X 8 cm area of redness on his left upper arm at the site of the Tripedia injection, with no duration and no pus.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP, DTAP, HEP, DTAP, HEP
Symptoms: Erythema
Clinical narrative: From faxed correspondence received on 03/18/02 at Aventis Pasteur Inc., it was reported than an 18 month old male received a DTAP (Tripedia) vaccination and a Hepatitis b (Merck) vaccination on 03/11/02. Patient developed a 10 cm X 8 cm red area area to the left upper arm on 03/12/02. No induration and no pus noted.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP, DTAP, HEP, DTAP, HEP
Symptoms: Injection site erythema
Clinical narrative: From faxed correspondence received on 03/18/02 at Aventis Pasteur Inc., it was reported than an 18 month old male received a DTAP (Tripedia) vaccination and a Hepatitis b (Merck) vaccination on 03/11/02. Patient developed a 10 cm X 8 cm red area area to the left upper arm on 03/12/02. No induration and no pus noted.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: It was reported that a 5 year old female patient was vaccinated on 04/10/02 with Tripedia, IPOL, and MMR. On 04/12/02, the patient developed a softball sized swelling at the injection site. The area was red and hot to the touch. On 04/15/02, the area was tan colored. This case is linked with cases: U2002-00298, U2002-00299, U2002-00300, U2002-00302. From additional info received on 11/26/02, it was reported that the pt had no pre-existing illnesses or allergie at time of vaccination. No other vaccines were given within 4 weeks. Pt was diagnosed with cellulitis and took Amoxicillin for seven days. The adverse event coding was updated to include cellulitis. It was not reported whether the pt recovered.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site warmth, Skin discolouration
Clinical narrative: It was reported that a 5 year old female patient was vaccinated on 04/10/02 with Tripedia, IPOL, and MMR. On 04/12/02, the patient developed a softball sized swelling at the injection site. The area was red and hot to the touch. On 04/15/02, the area was tan colored. This case is linked with cases: U2002-00298, U2002-00299, U2002-00300, U2002-00302. From additional info received on 11/26/02, it was reported that the pt had no pre-existing illnesses or allergie at time of vaccination. No other vaccines were given within 4 weeks. Pt was diagnosed with cellulitis and took Amoxicillin for seven days. The adverse event coding was updated to include cellulitis. It was not reported whether the pt recovered.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: From faxed correspondence received 04/16/02 at Aventis Pasteur Inc. It was reported that a 4 year old male patient was vaccinated on 04/18/02 with Tripedia, IPOl, and MMR. On 04/12/02, the patient displayed a tennis ball sized area of swelling and redness at the injection site. This area was hot to the touch and itchy. This case is linked with cases: U2002-00298, U2002-00300, U2002-00301, and U2002-00302. From additional info received on 11/26/02, it was reported that no lab work or diagnostic testing was needed. Birth weight is unknown. The vaccine was purchased with public funds, not private. It is unknown if there were any adverse events following prior vaccination. The adverse event coding was updated (injection site reaction was changed to injection site inflammation). Reportedly, the pt recovered.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: From faxed correspondence received 04/16/02 at Aventis Pasteur Inc. It was reported that a 4 year old male patient was vaccinated on 04/18/02 with Tripedia, IPOl, and MMR. On 04/12/02, the patient displayed a tennis ball sized area of swelling and redness at the injection site. This area was hot to the touch and itchy. This case is linked with cases: U2002-00298, U2002-00300, U2002-00301, and U2002-00302. From additional info received on 11/26/02, it was reported that no lab work or diagnostic testing was needed. Birth weight is unknown. The vaccine was purchased with public funds, not private. It is unknown if there were any adverse events following prior vaccination. The adverse event coding was updated (injection site reaction was changed to injection site inflammation). Reportedly, the pt recovered.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Pruritus
Clinical narrative: From faxed correspondence received 04/16/02 at Aventis Pasteur Inc. It was reported that a 4 year old male patient was vaccinated on 04/18/02 with Tripedia, IPOl, and MMR. On 04/12/02, the patient displayed a tennis ball sized area of swelling and redness at the injection site. This area was hot to the touch and itchy. This case is linked with cases: U2002-00298, U2002-00300, U2002-00301, and U2002-00302. From additional info received on 11/26/02, it was reported that no lab work or diagnostic testing was needed. Birth weight is unknown. The vaccine was purchased with public funds, not private. It is unknown if there were any adverse events following prior vaccination. The adverse event coding was updated (injection site reaction was changed to injection site inflammation). Reportedly, the pt recovered.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: From faxed correspondence received 4/16/02 at manufacturer it was reported that a 6 year old male patient was vaccinated on 4/3/02 with Tripedia, IPOL< and MMR. On 4/12/02 the patient developed a swollen right arm, which spread with time (shoulder to elbow). This area was red, hot to the touch, and painful. This case is linked with cases: U200200298, U200200299, U200200300, and U200200301. From additional info received on 11/26/02, it was reported that th ept was not on any other medications at the time of vaccination. The adverse event coding was updated (peripheral edema and injection site reaction were changed to injection site inflammation and injection site pain was added). The pt was treated with Keflex for seven days, Benadryl and cool compresses. The pt recovered from these adverse events.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site inflammation, Injection site pain, Oedema peripheral
Clinical narrative: From faxed correspondence received 4/16/02 at manufacturer it was reported that a 6 year old male patient was vaccinated on 4/3/02 with Tripedia, IPOL< and MMR. On 4/12/02 the patient developed a swollen right arm, which spread with time (shoulder to elbow). This area was red, hot to the touch, and painful. This case is linked with cases: U200200298, U200200299, U200200300, and U200200301. From additional info received on 11/26/02, it was reported that th ept was not on any other medications at the time of vaccination. The adverse event coding was updated (peripheral edema and injection site reaction were changed to injection site inflammation and injection site pain was added). The pt was treated with Keflex for seven days, Benadryl and cool compresses. The pt recovered from these adverse events.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Pain
Clinical narrative: From faxed correspondence received 4/16/02 at manufacturer it was reported that a 6 year old male patient was vaccinated on 4/3/02 with Tripedia, IPOL< and MMR. On 4/12/02 the patient developed a swollen right arm, which spread with time (shoulder to elbow). This area was red, hot to the touch, and painful. This case is linked with cases: U200200298, U200200299, U200200300, and U200200301. From additional info received on 11/26/02, it was reported that th ept was not on any other medications at the time of vaccination. The adverse event coding was updated (peripheral edema and injection site reaction were changed to injection site inflammation and injection site pain was added). The pt was treated with Keflex for seven days, Benadryl and cool compresses. The pt recovered from these adverse events.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: From faxed correspondence received 04/16/02at Aventis Pasteur Inc. it was reported that a 4 year old patient was vaccinated on 04/10/02 with Tripedia, IPOL , and MMR. The patient developed a 3cm X 3cm site circular area on her right upper arm surrounding the injection site. This area was slightly erythematous and warm. This case is linked with cases : U2002-00299, U2002-00300, u2002-00301 and U2002-00302.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Erythema induratum, Oedema peripheral
Clinical narrative: From fax correspondence received 4/16/02 at manufacturer, it was reported that a 5 year old female patient was vaccinated on 4/10/02 with Tripedia, IPOL, and MMR. The patient developed a reaction on her right arm. The entire circumference of her upper right arm became swollen, erythematous and slightly indurated. The patient was treated with 250mg of Keflex three times a day for 7 days. This case is linked with cases: U200200298, U200200299, U200200301, and U200200302.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: From fax correspondence received 4/16/02 at manufacturer, it was reported that a 5 year old female patient was vaccinated on 4/10/02 with Tripedia, IPOL, and MMR. The patient developed a reaction on her right arm. The entire circumference of her upper right arm became swollen, erythematous and slightly indurated. The patient was treated with 250mg of Keflex three times a day for 7 days. This case is linked with cases: U200200298, U200200299, U200200301, and U200200302.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blindness transient
Clinical narrative: Lost vision right eye, treated with 8 day course of tapering prednisone.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blindness
Clinical narrative: Lost vision right eye, treated with 8 day course of tapering prednisone.
Age: 0.25
Sex: M
Vaccine: HBHEPB, HBHEPB
Symptoms: Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Information has been received from a registered nurse concerning her 14-week-old white son with no known allergies who on June 5, 2002, at 10:30 was vaccinated with the first does of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (641324/1392L)(exp. August 9,2004) IM in the right thigh. There was no concomitant medication. At 15:00 on June 5, 2002, the patient started crying uncontrollably and did not stop until 16:15. His leg became swollen and a rasided lump appeared measuring 6cm. It was noted that the lump was "beet red." One dose of acetaminophen (Tylenol) was administered. The reporter took the patient to the emergency room. He had a low grade fever (99.8). She reported on June 17, 2002, that the lump was still present, was 1cm in diameter, and palpable. She noted that the nurse at the doctor's office told her to ice and massage the leg, and that this was a normal reaction. Additional information has been received from the physician. The physician reported that the child developed localized redness and swelling at the injection site. The physician reported that the child was fussy but had no fever or respiratory distress. It was reported that the child recovered on June 5, 2002. No additional information is expected.
Age: 0.25
Sex: M
Vaccine: HBHEPB, HBHEPB
Symptoms: Agitation, Erythema, Pyrexia, Swelling
Clinical narrative: Information has been received from a registered nurse concerning her 14-week-old white son with no known allergies who on June 5, 2002, at 10:30 was vaccinated with the first does of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (641324/1392L)(exp. August 9,2004) IM in the right thigh. There was no concomitant medication. At 15:00 on June 5, 2002, the patient started crying uncontrollably and did not stop until 16:15. His leg became swollen and a rasided lump appeared measuring 6cm. It was noted that the lump was "beet red." One dose of acetaminophen (Tylenol) was administered. The reporter took the patient to the emergency room. He had a low grade fever (99.8). She reported on June 17, 2002, that the lump was still present, was 1cm in diameter, and palpable. She noted that the nurse at the doctor's office told her to ice and massage the leg, and that this was a normal reaction. Additional information has been received from the physician. The physician reported that the child developed localized redness and swelling at the injection site. The physician reported that the child was fussy but had no fever or respiratory distress. It was reported that the child recovered on June 5, 2002. No additional information is expected.
Sex: M
Vaccine: OPV, IPV
Symptoms: Dyspnoea, Lung disorder, Neoplasm malignant, Pleural mesothelioma
Clinical narrative: A legal complaint was received from an attorney alleging that a male received Orimune vaccine sometime after 1960. As an adult, he was diagnosed with mesothelioma on or about July 1998 and died on 5/3/00. "The decedent has mesothelioma in which SV40 was a substantial factor and therefore one of the causes of his mesothelioma." It is alleged that the "decedent's exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the decedent, included but not limited to breathing difficulties, asbetosis, lung and/or other cancer, mesothelioma, and/or lung damage. The reporter stated that the "Decedent retired from his last place of employment at regular retirement age. He had therefore suffered no disability from his asbestos-related disease as "disability" is defined in Code of Civil Procedure 340.2."
Sex: M
Vaccine: OPV, IPV
Symptoms: Lung disorder
Clinical narrative: A legal complaint was received from an attorney alleging that a male received Orimune vaccine sometime after 1960. As an adult, he was diagnosed with mesothelioma on or about July 1998 and died on 5/3/00. "The decedent has mesothelioma in which SV40 was a substantial factor and therefore one of the causes of his mesothelioma." It is alleged that the "decedent's exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the decedent, included but not limited to breathing difficulties, asbetosis, lung and/or other cancer, mesothelioma, and/or lung damage. The reporter stated that the "Decedent retired from his last place of employment at regular retirement age. He had therefore suffered no disability from his asbestos-related disease as "disability" is defined in Code of Civil Procedure 340.2."
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Eczema, Lymphocytosis, Pyrexia, Viral infection
Clinical narrative: Information has been received from a pharmacist concerning a 12 month old female pt with past medical history of food allergies, rashes and eczema, who on 10/10/02 was vaccinated with a dose of varicella virus vaccine live. On 10/14/02 (also reported as around the time of vaccination) the pt developed unexplained "on and off" fevers every couple of days, and "rashes" for one month following vaccination with varicella virus vaccine live. The fevers were described as low grade "about 101 deg F." It was noted that the pt was treated with Augmentin (unknown dates, unknown dosage). On approximately 11/9/02 the pt was hospitalized for a temperature of 103 deg F, and rash which was described as "eczematous with broken blood vessels, but crusting over like chickenpox." The pt was diagnosed with Epstein-Barr infection. The reporter indicated the labs were normal except for elevated lymphocytes; an immunologic work-up was negative, and the child did not have any immunosupression. The reporter indicated that a recent there was a virus where the pt attends daycare. Additional info has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 67 year old male pt, who on 11/5/02 was vaccinated IM with a dose of pneumococcal vaccine 23 polyvalent (lot 643503-0541M). On 11/6/02 the pt developed SXs of cellulitis in the upper arm that included swelling, redness and pain. An ER/doctor visit was required and the pt was treated with Tylenol, Motrin, and Keflex. The reporter indicated that the pt's experience was an other important medical event (OMIC). Additional info has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Inflammation, Oedema peripheral, Pain, Rash
Clinical narrative: Information has been received from a physician concerning a retired 63 year old white male who on 11/5/02 was vaccinated with a 0.5ml dose of pneumococcal vaccine 23 polyvalent (lot 642750/0210M). Concomitant therapy with oral medications included Claritin 10mg, Prozac 20mg, Wellbutrin Sr 150mg, Lipitor 20mg and viagra 50mg. On 11/5/02 the pt's left arm became swollen, and he developed a rash. On 11/6/02 the pt's left arm was red, had marked inflammation/edema, and was tender. The pt was treated with Clarinex 1 by mouth daily and Keflex 500mg TID. As of the report on 11/19/02, the pt had not recovered and was still being treated. It was reported that the pt had no prior exposure to this or a related drug. Left arm swelling, left arm redness, left arm with marked inflammation/edema and left arm tenderness were considered to be disabling. Additional info has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a physician concerning a retired 63 year old white male who on 11/5/02 was vaccinated with a 0.5ml dose of pneumococcal vaccine 23 polyvalent (lot 642750/0210M). Concomitant therapy with oral medications included Claritin 10mg, Prozac 20mg, Wellbutrin Sr 150mg, Lipitor 20mg and viagra 50mg. On 11/5/02 the pt's left arm became swollen, and he developed a rash. On 11/6/02 the pt's left arm was red, had marked inflammation/edema, and was tender. The pt was treated with Clarinex 1 by mouth daily and Keflex 500mg TID. As of the report on 11/19/02, the pt had not recovered and was still being treated. It was reported that the pt had no prior exposure to this or a related drug. Left arm swelling, left arm redness, left arm with marked inflammation/edema and left arm tenderness were considered to be disabling. Additional info has been requested.
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Cognitive disorder, Drug toxicity, Drug withdrawal syndrome, Mental retardation severity unspecified, Nervous system disorder
Clinical narrative: A legal complaint was received from an attorney alleging that a male child received series of Tripedia, ActHIB, Engerix B, and Acel-Imune vaccines as well as Hib-TITER vaccine from 8/4/98 through 5/2/00 and subsequently "sustained severe, devastating, and permanent, neurological injuries through mercury toxicity and associated neurological injuries through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure, via IM injections of mercury" in the "thimerosal-containing vaccinations." According to the legal complaint, the child "was born a perfectly normal, healthy boy whose APGAR scores at birth were well within the normal range." It is alleged that at approximately between 24 and 36 months of age, the child "was neurologically devastated by the accumulations of mercury in his body, having been exposed via IM vaccinations, and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to inability to speak, unresponsive to his environment, and initial loss of language skills, motor skills and affect." According to the legal complaint, the child "suffered severe and permanent injuries" and "sustained and will sustain in the future a mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders and impairments."