chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.52
Sex: M
Vaccine: DTAP, IPV
Symptoms: Skin ulcer, Urticaria
Clinical narrative: From initial information received on 29Sep03 from manufacturer, which was reported to them by a physician regarding an adverse event. It was reported that an 18 month old male pt received IPOL, lot number, route and site not reported, and Infanrix (lot number DTPA590A9) administered in the upper left thigh on 13Sep2003.  This report was received from a physician and described the occurrence of erythema multiforme in an 18 month old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt had no known allergies, no concurrent medications, and no adverse experiences following receipt of the first three doses of diphtheria and tetanus toxoids and enhanced pertussis vaccine (Daptacel). The pt was described by the physician as otherwise healthy. The pt received Infanrix on 13Sep03 for the fourth dose in the immunization series. On 17Sep03, four days post immunization, the pt developed a fever of less than 100 degrees, an itchy maculopapular rash that was confluent on the thigh where Infanrix had been administered, and a lot of other urticarial, target-like lesions on the whole  body. The target-like lesions ranged in size from greater than 3mm to 1.5 inches in diameter. The pt was seen by the physician, who made a diagnosis of typical erythema multiforme. She also stated that his whole set of symptoms were like a serum-sickness type reaction. The physician prescribed diphenhydramine, which helps with the itchy rash. The pt continued to have a fever and to get new lesions as of 18Sep03. The recovery status of the pt is UNK. (OMIC)
Age: 0.39
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, IPV, HBHEPB, PNC
Symptoms: Pallor, Pyrexia, Retching, Similar reaction on previous exposure to drug, Wheezing
Clinical narrative: From initial information received on 02/13/04 from another manufacturer (reference # HQWYE824405FEB04) regarding an adverse event occurring in the USA, it was initially reported by the pt's relative and a physician that a 4 month old female pt received an IPOL vaccination on 11/07/03.  The lot #, route and site of administration were not reported. That same day, the pt developed a "rhythmic grunt or sighing noise when exhaling", gagged a couple of times, became pale and had an axillary temperature of 102 degrees F.  No other information was provided. The recovery status of the pt was reported as unknown.
Age: 0.39
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, IPV, HBHEPB, PNC
Symptoms: Grunting, Pallor, Pyrexia, Retching
Clinical narrative: From initial information received on 02/13/04 from another manufacturer (reference # HQWYE824405FEB04) regarding an adverse event occurring in the USA, it was initially reported by the pt's relative and a physician that a 4 month old female pt received an IPOL vaccination on 11/07/03.  The lot #, route and site of administration were not reported. That same day, the pt developed a "rhythmic grunt or sighing noise when exhaling", gagged a couple of times, became pale and had an axillary temperature of 102 degrees F.  No other information was provided. The recovery status of the pt was reported as unknown.
Age: 0.39
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, IPV, HBHEPB, PNC
Symptoms: Dyspnoea, Pallor, Pyrexia, Respiratory disorder, Retching
Clinical narrative: From initial information received on 02/13/04 from another manufacturer (reference # HQWYE824405FEB04) regarding an adverse event occurring in the USA, it was initially reported by the pt's relative and a physician that a 4 month old female pt received an IPOL vaccination on 11/07/03.  The lot #, route and site of administration were not reported. That same day, the pt developed a "rhythmic grunt or sighing noise when exhaling", gagged a couple of times, became pale and had an axillary temperature of 102 degrees F.  No other information was provided. The recovery status of the pt was reported as unknown.
Age: 0.23
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, DTAP, IPV, PNC
Symptoms: Laboratory test abnormal, Pyrexia, Viral infection
Clinical narrative: Initial report received on 08Oct03. The subject is a 16 week old male, who was admitted to the hospital due to viral syndrome while enrolled in a Immunogenicity assessment of Daptacel. Co-administered with a pneumococcal conjugate vaccine. The subject received the study vaccine on 01Aug03. The subject developed a high fever of 103.5 degrees Fahrenheit 33 days post immunization and was admitted to the hospital on the same day. Treatment included 500 mg of Rocephin given IM. The subject was discharged from the hospital on the following day. The subject recovered and continued the trial. The event of viral syndrome was reported by the investigator as unrelated to the study vaccine.
Age: 0.23
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, DTAP, IPV, PNC
Symptoms: Pyrexia, Viral infection
Clinical narrative: Initial report received on 08Oct03. The subject is a 16 week old male, who was admitted to the hospital due to viral syndrome while enrolled in a Immunogenicity assessment of Daptacel. Co-administered with a pneumococcal conjugate vaccine. The subject received the study vaccine on 01Aug03. The subject developed a high fever of 103.5 degrees Fahrenheit 33 days post immunization and was admitted to the hospital on the same day. Treatment included 500 mg of Rocephin given IM. The subject was discharged from the hospital on the following day. The subject recovered and continued the trial. The event of viral syndrome was reported by the investigator as unrelated to the study vaccine.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV, DTAPHEPBIP, HIBV, IPV
Symptoms: Crying, Medication error
Clinical narrative: From initial information received on 12/11/03 from another manufacturer (case # A0430918A) regarding an adverse event occurring in the USA, it was initially reported by a physician that a 2 month old female pt received a first dose of PEDIARIX (Lot # 21895A2) a dose of HIB-TITER (Lot # not reported) as well as an inadvertent dose of IPOL (Lot # not reported) on 10/13/03.  The routes and sites of administration were not reported. Later that same day, the pt experienced crying. The pt's recovery status was not reported.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Feeling hot, Lacrimation increased, Rash, Rash erythematous, Vomiting
Clinical narrative: From initial information received on 23MAR2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a four year old male patient received a dose of DAPTACEL, lot no C1679AA, administered in the left thigh; a dose of IPOL, lot number X0707, administered in the left outer thigh; and a dose of MMR, lot no 0822N,Merk, administered in the right outer thigh on 15MAR2004 at 12:00 PM. The routes of administration were not reported for any of the products. Within five minutes of receiving the vaccines, the patient developed generalized hives, vomiting, watering eyes, wheezing and became faint. It was not reported whether the patient lost consciousness. The symptoms were treated with epinephrine, oral Benadryl and Xopenex and have resolved. Reportedly, the patient recovered from these events. The reporter of this case is the same reporter of case 2004-01259. From additional information received on 14APR2004 from MERK WAES 0403USA02121, it was reported that the DAPTACEL vaccination was given IM, the IPOL vaccination SC and the MMR vaccination SC. The pt also experienced a rash. On follow up it was reported that on 15MAR2004 the patient began with watering eyes and faint rash at 12:20 PM and after five minutes the rash was more intense and had spread with warmth to touch 97.5AX, vomiting and wheezing. The patient was not hospitalized, but was seen by the doctor and treated. The patient recovered on 15MAR2004. It was also reported on follow up that the patient's reaction was considered to be an anaphylactic reaction with an onset of about twenty minutes after vaccination. Follow up information indicated that the MMR vaccination was considered to be the primary suspect because the rash started at the MMR injection site and spread from there. It was reported that the MMR was the only vaccination given in the child's thigh where the rash started. The other two vaccinations were given in the child's other thigh.. It was also reported that another male patient experienced an anaphylactic reaction following vaccination with the MMR vaccine. No other information was provided. (OMIC)
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Wheezing
Clinical narrative: From initial information received on 23MAR2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a four year old male patient received a dose of DAPTACEL, lot no C1679AA, administered in the left thigh; a dose of IPOL, lot number X0707, administered in the left outer thigh; and a dose of MMR, lot no 0822N,Merk, administered in the right outer thigh on 15MAR2004 at 12:00 PM. The routes of administration were not reported for any of the products. Within five minutes of receiving the vaccines, the patient developed generalized hives, vomiting, watering eyes, wheezing and became faint. It was not reported whether the patient lost consciousness. The symptoms were treated with epinephrine, oral Benadryl and Xopenex and have resolved. Reportedly, the patient recovered from these events. The reporter of this case is the same reporter of case 2004-01259. From additional information received on 14APR2004 from MERK WAES 0403USA02121, it was reported that the DAPTACEL vaccination was given IM, the IPOL vaccination SC and the MMR vaccination SC. The pt also experienced a rash. On follow up it was reported that on 15MAR2004 the patient began with watering eyes and faint rash at 12:20 PM and after five minutes the rash was more intense and had spread with warmth to touch 97.5AX, vomiting and wheezing. The patient was not hospitalized, but was seen by the doctor and treated. The patient recovered on 15MAR2004. It was also reported on follow up that the patient's reaction was considered to be an anaphylactic reaction with an onset of about twenty minutes after vaccination. Follow up information indicated that the MMR vaccination was considered to be the primary suspect because the rash started at the MMR injection site and spread from there. It was reported that the MMR was the only vaccination given in the child's thigh where the rash started. The other two vaccinations were given in the child's other thigh.. It was also reported that another male patient experienced an anaphylactic reaction following vaccination with the MMR vaccine. No other information was provided. (OMIC)
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Feeling hot, Injection site rash, Lacrimation increased, Rash
Clinical narrative: From initial information received on 23MAR2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a four year old male patient received a dose of DAPTACEL, lot no C1679AA, administered in the left thigh; a dose of IPOL, lot number X0707, administered in the left outer thigh; and a dose of MMR, lot no 0822N,Merk, administered in the right outer thigh on 15MAR2004 at 12:00 PM. The routes of administration were not reported for any of the products. Within five minutes of receiving the vaccines, the patient developed generalized hives, vomiting, watering eyes, wheezing and became faint. It was not reported whether the patient lost consciousness. The symptoms were treated with epinephrine, oral Benadryl and Xopenex and have resolved. Reportedly, the patient recovered from these events. The reporter of this case is the same reporter of case 2004-01259. From additional information received on 14APR2004 from MERK WAES 0403USA02121, it was reported that the DAPTACEL vaccination was given IM, the IPOL vaccination SC and the MMR vaccination SC. The pt also experienced a rash. On follow up it was reported that on 15MAR2004 the patient began with watering eyes and faint rash at 12:20 PM and after five minutes the rash was more intense and had spread with warmth to touch 97.5AX, vomiting and wheezing. The patient was not hospitalized, but was seen by the doctor and treated. The patient recovered on 15MAR2004. It was also reported on follow up that the patient's reaction was considered to be an anaphylactic reaction with an onset of about twenty minutes after vaccination. Follow up information indicated that the MMR vaccination was considered to be the primary suspect because the rash started at the MMR injection site and spread from there. It was reported that the MMR was the only vaccination given in the child's thigh where the rash started. The other two vaccinations were given in the child's other thigh.. It was also reported that another male patient experienced an anaphylactic reaction following vaccination with the MMR vaccine. No other information was provided. (OMIC)
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Syncope, Urticaria, Vomiting, Wheezing
Clinical narrative: From initial information received on 23MAR2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a four year old male patient received a dose of DAPTACEL, lot no C1679AA, administered in the left thigh; a dose of IPOL, lot number X0707, administered in the left outer thigh; and a dose of MMR, lot no 0822N,Merk, administered in the right outer thigh on 15MAR2004 at 12:00 PM. The routes of administration were not reported for any of the products. Within five minutes of receiving the vaccines, the patient developed generalized hives, vomiting, watering eyes, wheezing and became faint. It was not reported whether the patient lost consciousness. The symptoms were treated with epinephrine, oral Benadryl and Xopenex and have resolved. Reportedly, the patient recovered from these events. The reporter of this case is the same reporter of case 2004-01259. From additional information received on 14APR2004 from MERK WAES 0403USA02121, it was reported that the DAPTACEL vaccination was given IM, the IPOL vaccination SC and the MMR vaccination SC. The pt also experienced a rash. On follow up it was reported that on 15MAR2004 the patient began with watering eyes and faint rash at 12:20 PM and after five minutes the rash was more intense and had spread with warmth to touch 97.5AX, vomiting and wheezing. The patient was not hospitalized, but was seen by the doctor and treated. The patient recovered on 15MAR2004. It was also reported on follow up that the patient's reaction was considered to be an anaphylactic reaction with an onset of about twenty minutes after vaccination. Follow up information indicated that the MMR vaccination was considered to be the primary suspect because the rash started at the MMR injection site and spread from there. It was reported that the MMR was the only vaccination given in the child's thigh where the rash started. The other two vaccinations were given in the child's other thigh.. It was also reported that another male patient experienced an anaphylactic reaction following vaccination with the MMR vaccine. No other information was provided. (OMIC)
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Feeling hot, Lacrimation increased, Rash, Syncope
Clinical narrative: From initial information received on 23MAR2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a four year old male patient received a dose of DAPTACEL, lot no C1679AA, administered in the left thigh; a dose of IPOL, lot number X0707, administered in the left outer thigh; and a dose of MMR, lot no 0822N,Merk, administered in the right outer thigh on 15MAR2004 at 12:00 PM. The routes of administration were not reported for any of the products. Within five minutes of receiving the vaccines, the patient developed generalized hives, vomiting, watering eyes, wheezing and became faint. It was not reported whether the patient lost consciousness. The symptoms were treated with epinephrine, oral Benadryl and Xopenex and have resolved. Reportedly, the patient recovered from these events. The reporter of this case is the same reporter of case 2004-01259. From additional information received on 14APR2004 from MERK WAES 0403USA02121, it was reported that the DAPTACEL vaccination was given IM, the IPOL vaccination SC and the MMR vaccination SC. The pt also experienced a rash. On follow up it was reported that on 15MAR2004 the patient began with watering eyes and faint rash at 12:20 PM and after five minutes the rash was more intense and had spread with warmth to touch 97.5AX, vomiting and wheezing. The patient was not hospitalized, but was seen by the doctor and treated. The patient recovered on 15MAR2004. It was also reported on follow up that the patient's reaction was considered to be an anaphylactic reaction with an onset of about twenty minutes after vaccination. Follow up information indicated that the MMR vaccination was considered to be the primary suspect because the rash started at the MMR injection site and spread from there. It was reported that the MMR was the only vaccination given in the child's thigh where the rash started. The other two vaccinations were given in the child's other thigh.. It was also reported that another male patient experienced an anaphylactic reaction following vaccination with the MMR vaccine. No other information was provided. (OMIC)
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Urticaria, Vomiting, Wheezing
Clinical narrative: From initial information received on 23MAR2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a four year old male patient received a dose of DAPTACEL, lot no C1679AA, administered in the left thigh; a dose of IPOL, lot number X0707, administered in the left outer thigh; and a dose of MMR, lot no 0822N,Merk, administered in the right outer thigh on 15MAR2004 at 12:00 PM. The routes of administration were not reported for any of the products. Within five minutes of receiving the vaccines, the patient developed generalized hives, vomiting, watering eyes, wheezing and became faint. It was not reported whether the patient lost consciousness. The symptoms were treated with epinephrine, oral Benadryl and Xopenex and have resolved. Reportedly, the patient recovered from these events. The reporter of this case is the same reporter of case 2004-01259. From additional information received on 14APR2004 from MERK WAES 0403USA02121, it was reported that the DAPTACEL vaccination was given IM, the IPOL vaccination SC and the MMR vaccination SC. The pt also experienced a rash. On follow up it was reported that on 15MAR2004 the patient began with watering eyes and faint rash at 12:20 PM and after five minutes the rash was more intense and had spread with warmth to touch 97.5AX, vomiting and wheezing. The patient was not hospitalized, but was seen by the doctor and treated. The patient recovered on 15MAR2004. It was also reported on follow up that the patient's reaction was considered to be an anaphylactic reaction with an onset of about twenty minutes after vaccination. Follow up information indicated that the MMR vaccination was considered to be the primary suspect because the rash started at the MMR injection site and spread from there. It was reported that the MMR was the only vaccination given in the child's thigh where the rash started. The other two vaccinations were given in the child's other thigh.. It was also reported that another male patient experienced an anaphylactic reaction following vaccination with the MMR vaccine. No other information was provided. (OMIC)
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Feeling hot, Lacrimation increased, Rash, Vomiting
Clinical narrative: From initial information received on 23MAR2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a four year old male patient received a dose of DAPTACEL, lot no C1679AA, administered in the left thigh; a dose of IPOL, lot number X0707, administered in the left outer thigh; and a dose of MMR, lot no 0822N,Merk, administered in the right outer thigh on 15MAR2004 at 12:00 PM. The routes of administration were not reported for any of the products. Within five minutes of receiving the vaccines, the patient developed generalized hives, vomiting, watering eyes, wheezing and became faint. It was not reported whether the patient lost consciousness. The symptoms were treated with epinephrine, oral Benadryl and Xopenex and have resolved. Reportedly, the patient recovered from these events. The reporter of this case is the same reporter of case 2004-01259. From additional information received on 14APR2004 from MERK WAES 0403USA02121, it was reported that the DAPTACEL vaccination was given IM, the IPOL vaccination SC and the MMR vaccination SC. The pt also experienced a rash. On follow up it was reported that on 15MAR2004 the patient began with watering eyes and faint rash at 12:20 PM and after five minutes the rash was more intense and had spread with warmth to touch 97.5AX, vomiting and wheezing. The patient was not hospitalized, but was seen by the doctor and treated. The patient recovered on 15MAR2004. It was also reported on follow up that the patient's reaction was considered to be an anaphylactic reaction with an onset of about twenty minutes after vaccination. Follow up information indicated that the MMR vaccination was considered to be the primary suspect because the rash started at the MMR injection site and spread from there. It was reported that the MMR was the only vaccination given in the child's thigh where the rash started. The other two vaccinations were given in the child's other thigh.. It was also reported that another male patient experienced an anaphylactic reaction following vaccination with the MMR vaccine. No other information was provided. (OMIC)
Age: 1.56
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Autism
Clinical narrative: From initial information received on 5/17/04 from another manufacturer, regarding a case in litigation concerning an adverse event occurring in the USA, a male patient, (born on 1/4/00) received, at the age of 18 months, a third dose of IPOL, a dose of MMR, and a fourth dose of DTaP on 7/25/01. On 10/2/02, the patient was diagnosed with severe autism when aged of 32 months. It was rpeorted that Thimerosal used in the vaccines and the MMR vaccine, individually and/or jointly combined caused the child's autism spectrum disorder. Additional information is expected. It was not reported whether the patient recovered from this event. Upon medical review, this case was assessed as serious/other medical event (OMIC).
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Unevaluable event
Clinical narrative: From initial information received on 11/MAY/2004 from a HCP regarding an AE occurring in the USA, it was reported that a 2 month old female pt received her first dose of ActHIB, administered in the left thigh, her first dose of Daptacel, administered in the left thigh and her first dose of IPOL, administered in the right thigh on 10/FEB/2004. At approximately 5:00 AM the next morning the pt was found dead. An autopsy was performed, the physician's office is sending a certified letter requesting results. The physician's office will forward a copy to the manufacturer once it is received. reportedly the local sheriff's office quarantined the sharps container and the vaccine lots involved. From additional information received on 01/Nov/2004 from the initial reporter, the information has reportedly been reviewed on 04/Nov/2004 and no additional information is available at this time. From additional information received on 03/Feb/2005 from a health care professional, the information has reportedly been review on 11/Jan/2005 and no additional information is available at this time.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR
Symptoms: Antisocial behaviour, Apathy, Aphasia, Autism, Drug toxicity
Clinical narrative: (OMIC) From initial information received regarding a case in litigation on 17May04 from the manufacturer concerning an adverse event occurring, it was reported that an 18 month old male pt received an MMR vaccination, lot number and route of administration unknown, on 15Feb00 and developed autism spectrum disorder and pervasive developmental disorder NOS (PPD/NOS). At the age of 18 months, the boy was withdrawn, unable to speak and was unresponsive to his environment. His injuries included the loss of language skills, motor skills, and affect. The child could no longer maintain eye contact with those around him, could no longer point his finger to recognize items and could no longer interact with his mother and father and others in his social environment. It was reported that the child had received numerous injections containing toxic mercury in the form of thimerosal in at least 14 doses administered between 04Dec98 and 09Nov2001. It was also reported that thimerosal used in vaccines and the MMR vaccine individually and/or jointly combined to cause the child's autism spectrum disorder. A summary of the child's vaccinations are as follows: On 04Dec98 the child was vaccinated with Hep B, (lot numbers and route of administration unknown), On 29Dec98 at approximately 2 months of age, the child received three vaccine injections including Ipol, Acthib, and Tripedia (lot numbers and route of administration unknown), On 26Feb99 at approx 4 months of age, the child received three more vaccine injections including Ipol, Acthib, and Tripedia (lot numbers and route of administration unknown), On 27Apr99 at approx 6 months of age, the child received two more vaccine injections including Tripedia and Acthib (lot numbers and route of administration unknown), On 29Jul99 at approx 9 months of age, the child received vaccination with Hep B (lot number and route of administration unknown), On 15Feb00 at approx 16 months of age, the child received vaccination with MMR vaccine  (lot number and route of administration unknown), On 12May00 at approx 18 months of age, the child received two more vaccine injections including Ipol and Acthib (lot numbers and route of administration unknown), On 07Nov00 at two years of age, the child received Fluzone  (lot number and route of administration unknown) and Prevnar (lot number and route of administration unknown), On 07Dec00 at 25 months of age, the child received Fluzone (lot numbers and route of administration unknown), On 25Jun01 the child was diagnosed as having an autism spectrum disorder/pervasive developmental disorders. On 09Nov01 at 3 years of age, the child was vaccinated again with his final Fluzone dose (lot number and route of administration unknown). The pt did not recover from these events.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR
Symptoms: Hypokinesia, Speech disorder
Clinical narrative: (OMIC) From initial information received regarding a case in litigation on 17May04 from the manufacturer concerning an adverse event occurring, it was reported that an 18 month old male pt received an MMR vaccination, lot number and route of administration unknown, on 15Feb00 and developed autism spectrum disorder and pervasive developmental disorder NOS (PPD/NOS). At the age of 18 months, the boy was withdrawn, unable to speak and was unresponsive to his environment. His injuries included the loss of language skills, motor skills, and affect. The child could no longer maintain eye contact with those around him, could no longer point his finger to recognize items and could no longer interact with his mother and father and others in his social environment. It was reported that the child had received numerous injections containing toxic mercury in the form of thimerosal in at least 14 doses administered between 04Dec98 and 09Nov2001. It was also reported that thimerosal used in vaccines and the MMR vaccine individually and/or jointly combined to cause the child's autism spectrum disorder. A summary of the child's vaccinations are as follows: On 04Dec98 the child was vaccinated with Hep B, (lot numbers and route of administration unknown), On 29Dec98 at approximately 2 months of age, the child received three vaccine injections including Ipol, Acthib, and Tripedia (lot numbers and route of administration unknown), On 26Feb99 at approx 4 months of age, the child received three more vaccine injections including Ipol, Acthib, and Tripedia (lot numbers and route of administration unknown), On 27Apr99 at approx 6 months of age, the child received two more vaccine injections including Tripedia and Acthib (lot numbers and route of administration unknown), On 29Jul99 at approx 9 months of age, the child received vaccination with Hep B (lot number and route of administration unknown), On 15Feb00 at approx 16 months of age, the child received vaccination with MMR vaccine  (lot number and route of administration unknown), On 12May00 at approx 18 months of age, the child received two more vaccine injections including Ipol and Acthib (lot numbers and route of administration unknown), On 07Nov00 at two years of age, the child received Fluzone  (lot number and route of administration unknown) and Prevnar (lot number and route of administration unknown), On 07Dec00 at 25 months of age, the child received Fluzone (lot numbers and route of administration unknown), On 25Jun01 the child was diagnosed as having an autism spectrum disorder/pervasive developmental disorders. On 09Nov01 at 3 years of age, the child was vaccinated again with his final Fluzone dose (lot number and route of administration unknown). The pt did not recover from these events.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR
Symptoms: Aphasia, Autism, Coma, Drug toxicity, Gaze palsy
Clinical narrative: (OMIC) From initial information received regarding a case in litigation on 17May04 from the manufacturer concerning an adverse event occurring, it was reported that an 18 month old male pt received an MMR vaccination, lot number and route of administration unknown, on 15Feb00 and developed autism spectrum disorder and pervasive developmental disorder NOS (PPD/NOS). At the age of 18 months, the boy was withdrawn, unable to speak and was unresponsive to his environment. His injuries included the loss of language skills, motor skills, and affect. The child could no longer maintain eye contact with those around him, could no longer point his finger to recognize items and could no longer interact with his mother and father and others in his social environment. It was reported that the child had received numerous injections containing toxic mercury in the form of thimerosal in at least 14 doses administered between 04Dec98 and 09Nov2001. It was also reported that thimerosal used in vaccines and the MMR vaccine individually and/or jointly combined to cause the child's autism spectrum disorder. A summary of the child's vaccinations are as follows: On 04Dec98 the child was vaccinated with Hep B, (lot numbers and route of administration unknown), On 29Dec98 at approximately 2 months of age, the child received three vaccine injections including Ipol, Acthib, and Tripedia (lot numbers and route of administration unknown), On 26Feb99 at approx 4 months of age, the child received three more vaccine injections including Ipol, Acthib, and Tripedia (lot numbers and route of administration unknown), On 27Apr99 at approx 6 months of age, the child received two more vaccine injections including Tripedia and Acthib (lot numbers and route of administration unknown), On 29Jul99 at approx 9 months of age, the child received vaccination with Hep B (lot number and route of administration unknown), On 15Feb00 at approx 16 months of age, the child received vaccination with MMR vaccine  (lot number and route of administration unknown), On 12May00 at approx 18 months of age, the child received two more vaccine injections including Ipol and Acthib (lot numbers and route of administration unknown), On 07Nov00 at two years of age, the child received Fluzone  (lot number and route of administration unknown) and Prevnar (lot number and route of administration unknown), On 07Dec00 at 25 months of age, the child received Fluzone (lot numbers and route of administration unknown), On 25Jun01 the child was diagnosed as having an autism spectrum disorder/pervasive developmental disorders. On 09Nov01 at 3 years of age, the child was vaccinated again with his final Fluzone dose (lot number and route of administration unknown). The pt did not recover from these events.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR
Symptoms: Autism, Neurodevelopmental disorder, Speech disorder
Clinical narrative: (OMIC) From initial information received regarding a case in litigation on 17May04 from the manufacturer concerning an adverse event occurring, it was reported that an 18 month old male pt received an MMR vaccination, lot number and route of administration unknown, on 15Feb00 and developed autism spectrum disorder and pervasive developmental disorder NOS (PPD/NOS). At the age of 18 months, the boy was withdrawn, unable to speak and was unresponsive to his environment. His injuries included the loss of language skills, motor skills, and affect. The child could no longer maintain eye contact with those around him, could no longer point his finger to recognize items and could no longer interact with his mother and father and others in his social environment. It was reported that the child had received numerous injections containing toxic mercury in the form of thimerosal in at least 14 doses administered between 04Dec98 and 09Nov2001. It was also reported that thimerosal used in vaccines and the MMR vaccine individually and/or jointly combined to cause the child's autism spectrum disorder. A summary of the child's vaccinations are as follows: On 04Dec98 the child was vaccinated with Hep B, (lot numbers and route of administration unknown), On 29Dec98 at approximately 2 months of age, the child received three vaccine injections including Ipol, Acthib, and Tripedia (lot numbers and route of administration unknown), On 26Feb99 at approx 4 months of age, the child received three more vaccine injections including Ipol, Acthib, and Tripedia (lot numbers and route of administration unknown), On 27Apr99 at approx 6 months of age, the child received two more vaccine injections including Tripedia and Acthib (lot numbers and route of administration unknown), On 29Jul99 at approx 9 months of age, the child received vaccination with Hep B (lot number and route of administration unknown), On 15Feb00 at approx 16 months of age, the child received vaccination with MMR vaccine  (lot number and route of administration unknown), On 12May00 at approx 18 months of age, the child received two more vaccine injections including Ipol and Acthib (lot numbers and route of administration unknown), On 07Nov00 at two years of age, the child received Fluzone  (lot number and route of administration unknown) and Prevnar (lot number and route of administration unknown), On 07Dec00 at 25 months of age, the child received Fluzone (lot numbers and route of administration unknown), On 25Jun01 the child was diagnosed as having an autism spectrum disorder/pervasive developmental disorders. On 09Nov01 at 3 years of age, the child was vaccinated again with his final Fluzone dose (lot number and route of administration unknown). The pt did not recover from these events.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Blister, Erythema, Swelling, Tenderness
Clinical narrative: From initial information received on 05/24/04 from a RN regarding an adverse event occurring in the USA, it was reported that a 5 year old female pt received a dose of IPOL, Lot # X0772 with an expiration date of 07/06, administered SC in her left thigh on 05/20/04.  That same day, the pt developed redness, tenderness and swelling on her left thigh. Right leg circumference was 35.5cm and left leg circumference was 38cm (measured in 2 placed). In addition, the child developed vesicles on top of her leg, which were the size of a quarter. The pt did not develop a fever. The pt's recovery status was not reported.  From additional information received on 05/26/04 from a RN, the pt's full name, address and telephone # as well as her date of birth were provided. At the time of the event, the pt was 4 years old.  It was also reported that the pt has one sibling. The reporter provided the names of the vaccine administrator and the responsible physician as well. In addition to IPOL, the pt also received her fifth dose of DAPTACEL, Lot # C1614AA, administered IM in the left thigh and her second dose of MMRII, Lot # 1034N, administered SC in an unspecified site. The pt previously received three doses of IPOL.  She was vaccinated at a private doctor's office/hospital in the county on 05/20/04 at 15:00 and developed a reaction the following day. Her left leg was 5.5cm larger than her right leg and the vesicle on the top of her leg developed specifically on her left thigh. The vaccines were purchased with private funds. The pt did not have any illnesses at the time of vaccination. Reportedly, the pt recovered from these events. The reporter of this case is the same reporter of case 2004-019993.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site vesicles
Clinical narrative: From initial information received on 05/24/04 from a RN regarding an adverse event occurring in the USA, it was reported that a 5 year old female pt received a dose of IPOL, Lot # X0772 with an expiration date of 07/06, administered SC in her left thigh on 05/20/04.  That same day, the pt developed redness, tenderness and swelling on her left thigh. Right leg circumference was 35.5cm and left leg circumference was 38cm (measured in 2 placed). In addition, the child developed vesicles on top of her leg, which were the size of a quarter. The pt did not develop a fever. The pt's recovery status was not reported.  From additional information received on 05/26/04 from a RN, the pt's full name, address and telephone # as well as her date of birth were provided. At the time of the event, the pt was 4 years old.  It was also reported that the pt has one sibling. The reporter provided the names of the vaccine administrator and the responsible physician as well. In addition to IPOL, the pt also received her fifth dose of DAPTACEL, Lot # C1614AA, administered IM in the left thigh and her second dose of MMRII, Lot # 1034N, administered SC in an unspecified site. The pt previously received three doses of IPOL.  She was vaccinated at a private doctor's office/hospital in the county on 05/20/04 at 15:00 and developed a reaction the following day. Her left leg was 5.5cm larger than her right leg and the vesicle on the top of her leg developed specifically on her left thigh. The vaccines were purchased with private funds. The pt did not have any illnesses at the time of vaccination. Reportedly, the pt recovered from these events. The reporter of this case is the same reporter of case 2004-019993.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling, Irritability, Musculoskeletal stiffness
Clinical narrative: From initial information received on 22JUL2003 from another manufacturer, regarding an adverse event occurring in the USA, it was reported that a four year old female patient received IPOL, administered SC in the left deltoid, Infanrix GSK, administered IM in the left deltoid, and MMR II Vaccine, Merck, administered SC in the right deltoid by 17APR2003. 24 hours later, the patient experienced an injection site reaction characterized by pain, swelling and inflammation. The patient's left arm was stiff. The patient also experienced irritability and a low grade fever. The events resolved on 20APR2003. This case was reported to the other manufacturer by a nurse, who considered the events were related to vaccination with Infanrix. The reporter of this case is the same reporter of cases 2003-01441 through 2003-01445.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Pyrexia
Clinical narrative: From initial information received on 22JUL2003 from another manufacturer, regarding an adverse event occurring in the USA, it was reported that a four year old female patient received IPOL, administered SC in the left deltoid, Infanrix GSK, administered IM in the left deltoid, and MMR II Vaccine, Merck, administered SC in the right deltoid by 17APR2003. 24 hours later, the patient experienced an injection site reaction characterized by pain, swelling and inflammation. The patient's left arm was stiff. The patient also experienced irritability and a low grade fever. The events resolved on 20APR2003. This case was reported to the other manufacturer by a nurse, who considered the events were related to vaccination with Infanrix. The reporter of this case is the same reporter of cases 2003-01441 through 2003-01445.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site inflammation, Injection site pain, Injection site reaction, Injection site swelling, Irritability
Clinical narrative: From initial information received on 07/22/03 from another company, regarding an adverse event occurring in the USA, it was reported that a 5 year old male pt received IPOL, Lot # not reported, administered SC in the LA, Infanrix, Lot # DTPA586A9, administered IM in the left deltoid and MMRII vaccine lot # not reported administered SC in the right deltoid on 03/18/03.  24 hours later, the pt experienced an injection site reaction characterized by pain, swelling and inflammation. The pt's left arm was stiff. The pt also experienced irritability and low-grade fever. The events resolved on 03/20/03.  This case was reported to the other manufacturer by a nurse, who considered the events to be related to vaccination with Infanrix. The reporter of this case is the same reporter of cases 2003-01440, 2003-01441, 2003-01443, and 2003-01444.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: From initial information received on 07/22/03 from another company, regarding an adverse event occurring in the USA, it was reported that a 5 year old male pt received IPOL, Lot # not reported, administered SC in the LA, Infanrix, Lot # DTPA586A9, administered IM in the left deltoid and MMRII vaccine lot # not reported administered SC in the right deltoid on 03/18/03.  24 hours later, the pt experienced an injection site reaction characterized by pain, swelling and inflammation. The pt's left arm was stiff. The pt also experienced irritability and low-grade fever. The events resolved on 03/20/03.  This case was reported to the other manufacturer by a nurse, who considered the events to be related to vaccination with Infanrix. The reporter of this case is the same reporter of cases 2003-01440, 2003-01441, 2003-01443, and 2003-01444.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Agitation, Injection site inflammation, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: From initial information received on 07/22/03 from another company, regarding an adverse event occurring in the USA, it was reported that a 5 year old male pt received IPOL, Lot # not reported, administered SC in the LA, Infanrix, Lot # DTPA586A9, administered IM in the left deltoid and MMRII vaccine lot # not reported administered SC in the right deltoid on 03/18/03.  24 hours later, the pt experienced an injection site reaction characterized by pain, swelling and inflammation. The pt's left arm was stiff. The pt also experienced irritability and low-grade fever. The events resolved on 03/20/03.  This case was reported to the other manufacturer by a nurse, who considered the events to be related to vaccination with Infanrix. The reporter of this case is the same reporter of cases 2003-01440, 2003-01441, 2003-01443, and 2003-01444.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site inflammation, Injection site pain, Injection site reaction, Injection site swelling, Irritability
Clinical narrative: From initial information received on 22JUL2003 from another company, regarding an adverse event occurring in the USA, it was reported that a five year old female pt received IPOL, administered SC in the left deltoid, Infanrix, administered IM in the left deltoid and MMR II Vaccine, administered SC in the right deltoid on 17APR2003. 24 hours later, the pat experienced injection site reaction characterized by pain, swelling and inflammation. The patient's left arm was stiff. The patient also experienced irritability and low grade fever. The events resolved on 20APR2003. This case was reported to the other manufacturer by a nurse, who considered the events to be related to vaccination with Infanrix. The reporter of this case is the same reporter of cases 2003-01441 through 2003-01445.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: From initial information received on 22JUL2003 from another company, regarding an adverse event occurring in the USA, it was reported that a five year old female pt received IPOL, administered SC in the left deltoid, Infanrix, administered IM in the left deltoid and MMR II Vaccine, administered SC in the right deltoid on 17APR2003. 24 hours later, the pat experienced injection site reaction characterized by pain, swelling and inflammation. The patient's left arm was stiff. The patient also experienced irritability and low grade fever. The events resolved on 20APR2003. This case was reported to the other manufacturer by a nurse, who considered the events to be related to vaccination with Infanrix. The reporter of this case is the same reporter of cases 2003-01441 through 2003-01445.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling, Irritability, Musculoskeletal stiffness
Clinical narrative: From initial information received on 22JUL2003 from another company, regarding an adverse event occurring in the USA, it was reported that a five year old female pt received IPOL, administered SC in the left deltoid, Infanrix, administered IM in the left deltoid and MMR II Vaccine, administered SC in the right deltoid on 17APR2003. 24 hours later, the pat experienced injection site reaction characterized by pain, swelling and inflammation. The patient's left arm was stiff. The patient also experienced irritability and low grade fever. The events resolved on 20APR2003. This case was reported to the other manufacturer by a nurse, who considered the events to be related to vaccination with Infanrix. The reporter of this case is the same reporter of cases 2003-01441 through 2003-01445.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Pyrexia
Clinical narrative: From initial information received on 22JUL2003 from another company, regarding an adverse event occurring in the USA, it was reported that a five year old female pt received IPOL, administered SC in the left deltoid, Infanrix, administered IM in the left deltoid and MMR II Vaccine, administered SC in the right deltoid on 17APR2003. 24 hours later, the pat experienced injection site reaction characterized by pain, swelling and inflammation. The patient's left arm was stiff. The patient also experienced irritability and low grade fever. The events resolved on 20APR2003. This case was reported to the other manufacturer by a nurse, who considered the events to be related to vaccination with Infanrix. The reporter of this case is the same reporter of cases 2003-01441 through 2003-01445.