chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Diarrhoea, Faeces pale, Haematochezia, Nasal congestion, Pyrexia
Clinical narrative: A nurse reported that a 2 month old male received his 1st injection of Prevnar, Infanrix, PedvaxHib and IPV and a 2nd injection of Engerix-B on 2/16/01. The following day, the child developed congestion, a slight fever, vomited 1 time and was sleeping more frequently. The child was seen by a local pediatrician and noted to have clear lungs, soft abdomen, a soft stool with some mucous and blood. The child's mother was advised to stop drinking milk (child is breast fed). On 2/18/01, the child was noted to have a yellow stool, additional physical examination findings were normal. On 2/22/01, the child's pediatrician noted "mucoid stools, intermittent and blood noted. Child acts fine, 6 to 7 stools/day with blood, appear not as green." The child's mother received "Keflex 2 weeks ago for mastitis." This is 1 of 2 cases received from this reporter concerning adverse events following Prevnar lot 473331. Follow up information was received on 05/01/2001 from the patient's pediatrician. The patient continues to have diarrhea stools with mucous and further blood. Further evaluation is pending with a pediatric gastrointestinal physician. Follow up info has been received on 06/11/2001 from the 2 month old pt's pediatrician. The child has recovered.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Somnolence, Vomiting
Clinical narrative: A nurse reported that a 2 month old male received his 1st injection of Prevnar, Infanrix, PedvaxHib and IPV and a 2nd injection of Engerix-B on 2/16/01. The following day, the child developed congestion, a slight fever, vomited 1 time and was sleeping more frequently. The child was seen by a local pediatrician and noted to have clear lungs, soft abdomen, a soft stool with some mucous and blood. The child's mother was advised to stop drinking milk (child is breast fed). On 2/18/01, the child was noted to have a yellow stool, additional physical examination findings were normal. On 2/22/01, the child's pediatrician noted "mucoid stools, intermittent and blood noted. Child acts fine, 6 to 7 stools/day with blood, appear not as green." The child's mother received "Keflex 2 weeks ago for mastitis." This is 1 of 2 cases received from this reporter concerning adverse events following Prevnar lot 473331. Follow up information was received on 05/01/2001 from the patient's pediatrician. The patient continues to have diarrhea stools with mucous and further blood. Further evaluation is pending with a pediatric gastrointestinal physician. Follow up info has been received on 06/11/2001 from the 2 month old pt's pediatrician. The child has recovered.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Diarrhoea, Gait disturbance, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: A nurse reports post vaccine that same evening  the pt could not walk. The following evening the pt developed injection site reaction characterized as a swollen, red hot left thigh and was seen by dr. The pt was noted to have diarrhea, fever and a generalized rash over entire body. That evening the child was up all night. F/U on 2/18/01 the child was seen by his pediatricianand noted to continue to have a 2-3" in diameter red and swollen injection site, a fever of 100.4F, red throat, and rash. The child was treated with amoxicillin. F/U  info rec'd on 4/20/01 concerning the pt. The physician reported the child recovered from all events. The physician noted the child was a product of a 36 wk pregnancy and spontaneous vaginal delivery. The child has not drug allergies, chronic medical problems, but has had the occasional cold.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Insomnia, Rash
Clinical narrative: A nurse reports post vaccine that same evening  the pt could not walk. The following evening the pt developed injection site reaction characterized as a swollen, red hot left thigh and was seen by dr. The pt was noted to have diarrhea, fever and a generalized rash over entire body. That evening the child was up all night. F/U on 2/18/01 the child was seen by his pediatricianand noted to continue to have a 2-3" in diameter red and swollen injection site, a fever of 100.4F, red throat, and rash. The child was treated with amoxicillin. F/U  info rec'd on 4/20/01 concerning the pt. The physician reported the child recovered from all events. The physician noted the child was a product of a 36 wk pregnancy and spontaneous vaginal delivery. The child has not drug allergies, chronic medical problems, but has had the occasional cold.
Age: 0.6
Sex: M
Vaccine: PNC
Symptoms: Ear disorder, Infection, Sinusitis
Clinical narrative: The mother of a 7 month old male reported that her son received his 3rd Prevnar in 1/01. The pt recently recovered from a "chronic dermatitis around his mouth" that resolved when he was switched to a latex-free bottle. He received his 1st and 2nd doses of Prevnar in 8/00 and 9/00, respectively. In 11/00, the pt (approx. 5 month of age) developed a bilateral ear infection and sinusitis and was prescribed Zithromax (azithromycin); see HQ7407020FEB2001 for this report. In 12/00, the symptoms were not resolving and the pt was prescribed Cefzil (cefprozil). In 1/01, the pt developed bronchiolitis and "a more sever" bilateral ear infection. He was prescribed steroids and Cefzil again.
Sex: U
Vaccine: PNC
Symptoms: Injection site swelling
Clinical narrative: A pharmacist reported that an unidentified pt received an injection of Prevnar and subsequently, developed swelling at the injection site that extended over the entire leg. The reporter indicated that 3 pts experienced this event with Prevnar lot 471212. Additional reports will be generated when identifying information is provided.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: A 15 month old male received his 1st dose of Prevnar, as well as, his 4th doses of Tripedia and ActHIB on 9/12/00 and within 1 t0 7 days, post vax, he developed fever and an injection site reaction characterized by redness and swelling at the Prevnar injection site.
Age: 1.2
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A 14 month old male received his 1st dose of Prevnar in 11/00 and the next day, developed an injection site reaction characterized by a 1 1/2cm area of erythema, swelling and tenderness. As of 12/7/00, no further information was available.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: A territory representative reported that a 3 year old male received an injection of Prevnar on 12/5/00. The next day, the child developed an injection site reaction characterized by swelling and a 6cm X 4cm area of redness and warmth. He recovered. This is 1 of 3 pts from this facility who had an adverse experience following receipt of Prevnar lot 471231.
Age: 0.5
Sex: F
Vaccine: PNC
Symptoms: Injection site swelling, Pyrexia, Somnolence
Clinical narrative: A pharmacy technician reported that her co-worker's 6 month old daughter received her 1st dose of Prevnar and other unspecified vaccines on 12/12/00. Three to four hours, post vax, the pt developed fever of 105F and she was seen in the ER. The pt was treated with ibuprofen and acetaminophen; she was catheterized. Viral infection was ruled out by blood test. The pt slept "a lot" and her fever increased 102F. She was again treated with ibuprofen. She was not admitted to the hospital. On 12/13/00, she developed fever white at daycare and her mother has been administering ibuprofen and acetaminophen. The reporter indicated that the pt's mother stated that her daughter's legs looked swollen at the injection sites. Exact administration site of Prevnar was not specified.
Age: 0.6
Sex: F
Vaccine: DTP, HEP, PNC
Symptoms: Injection site induration
Clinical narrative: A mother who is also a nurse, reported that her 7 month old daughter received her 1st dose of Prevnar, as well as, her 3rd dose of DTAP and Recombivax vaccines on 12/13/00 and the next day, developed induration on both sides of her right leg below the level of the Prevnar injection site. The mother stated that she feels "that the nurses technique was faulty" and the route of administration was either subcutaneous or intradermal.
Age: 0.8
Sex: M
Vaccine: PNC
Symptoms: Injection site induration, Pyrexia, Rash, Viral infection, White blood cell count decreased
Clinical narrative: An MA reported that a 10 month old male received an injection of Prevnar on 12/4/00. The next day, the infant developed a fever of 102.5F and a large area of induration at the injection site. On 12/6/00, he was seen in an ER and treated with Cefzil (cefprozil), Motrin (ibuprofen) and Tylenol (acetaminophen). The next day, the infant was seen by the physician. On 12/8/00, he was again seen by the physician. At that time, the injection site induration was improving but his fever was reportedly 104.5F. He was referred to an ER where a CBC was performed. His white blood cell count was 4.5, differential was 21%, band neutrophils were 16% and lymphocytes were 43%. A blood culture and a chest x-ray were negative. An unspecified urine test was negative. The ER physician felt that the child had an "acute viral syndrome"; however, the pediatrician felt the symptoms were a "vaccine reaction". On 12/9/00, the infant was seen by the physician. The next day, he developed "whole-body rash". On 12/11/00, he was seen again by the physician who changed the infant's treatment to Zithromax (azithromycin) and Atarax (hydroxyzine). He recovered.
Age: 1.0
Sex: F
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: A physician reported that a 12 month old female received her 1st dose of Prevnar, as well as, varicella, measles, mumps and rubella and hepatitis B vaccines on 9/29/00 and within 1 to 5 days, post vax, developed fever of 103F and a rash. The physician indicated that the pt developed a rash from the MMR vaccine.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Rash
Clinical narrative: A territory representative reported that pt rec'd vaccine and immediately developed a rash on back, chest and face. She was treated with diphenydramine. She recovered. The reporter indicated that the child was being treated with an unknown antibiotic and decongestant for an unspecified illness at the time of immunization.
Age: 0.2
Sex: U
Vaccine: PNC
Symptoms: Irritability
Clinical narrative: Irritability post vac. A physician reports post vaccine pt became fussy. The infant recovered after 24 to 30 hours.
Age: 1.8
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: A nurse reports post vaccine, within 12 hrs pt developed fever of 104F measured rectally.
Age: 0.9
Sex: F
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Mother reports post vaccine that evening pt developed hives on her legs, the hives spread over her entire body. She was treated with acetaminophen. She recovered.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Injection site swelling
Clinical narrative: A nurse reports post vaccine in the evening pt developed significant swelling at the injection site. The swelling was approximately 5cm to 7cm across. The reporter indicates the child recovered.
Sex: U
Vaccine: DTAP, IPV, PNC
Symptoms: Irritability
Clinical narrative: A nurse reported post vaccine within 24 hrs pt became irritable. The pt recovered
Age: 1.58
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Pyrexia, Urticaria
Clinical narrative: A physician reports post vaccine, that evening pt developed fever of 102F, 24 hours post vaccine he developed generalized hives.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Diarrhoea, Insomnia, Irritability, Pyrexia, Vomiting
Clinical narrative: A mother reports post vaccine within 24 hours the pt developed fever of 103F, vomiting, diarrhea, difficulty sleeping and irritability. Mother states that the child's physician does not believe symptoms are related to vaccine. Mother states her sister's child had a similar though much worse reaction. Additional information received from the physician on 03/20/2001 stated that the office was not aware of the child's adverse experience post-immunization.
Sex: U
Vaccine: PNC
Symptoms: Injection site reaction, Screaming
Clinical narrative: A physician reports post vaccine pt subsequently developed more immediate type injection site reactions and crying episodes.
Age: 0.6
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: A nurse reported that her 7 month old son post vaccine's developed an injection site reaction described as hot, raised and red.
Sex: U
Vaccine: PNC
Symptoms: Injection site pain
Clinical narrative: A physician reported via a Co representative, that post vaccine pt experienced pain upon administration. Follow up information received from the physician on 03/08/2001 stated that the physician does not know the specific identity of these patients. The nurses administering Prevnar reported the adverse events described to the physician, plus increased immediate crying post-immunization.
Age: 1.7
Sex: M
Vaccine: DTAP, MMR, PNC
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: A mother reports post vaccine pt developed an injection site reaction characterized by redness, swelling, and warmth at  the injection site. He recovered.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: A nurse reports post vaccine, later that evening the pt developed an injection site reaction characterized by swelling, redness, and pain which progressed to include her left leg. Follow up information rec'd from pt's physician indicated 2 wks prior to vaccine's the child experienced gastrointestinal symptoms. At the time of vaccine the pt has a 1-2 day history of cough with sneezing.
Age: 0.7
Sex: F
Vaccine: PNC
Symptoms: Injection site mass, Injection site reaction
Clinical narrative: Injection site reaction. It was reported 2 days post vaccine the pt developed a big, red hard lump at the injection site. Follow up states the event has resolved.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Diarrhoea, Laboratory test abnormal, Pyrexia, Vomiting
Clinical narrative: A mother reports post vaccine pt developed high fever, diarrhea and vomiting for 5 days. The reporter noted that her HCP told her this was not related to Prevnar. An antibody titer was drawn, however results were pending. The child has a history of ear and upper respiratory tract infections since he was 5 months old. Allergies have been ruled out by a blood test. Common variable immune deficiency syndrome was ruled out. IGA antibody tests were negative.
Sex: F
Vaccine: DTAP, OPV, PNC
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: A pediatrician reported post vaccine's pt developed a fever of 103F and swelling at the Prevnar injection site, extending from the thigh down to the knee.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site induration, Injection site inflammation, Injection site reaction, Injection site swelling, Irritability
Clinical narrative: It was reported pt post vaccine's developed fever of 105F along with an injection site reaction described as hard, inflamed and swollen. The child also experienced irritability.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: It was reported pt post vaccine's developed fever of 105F along with an injection site reaction described as hard, inflamed and swollen. The child also experienced irritability.
Age: 1.55
Sex: F
Vaccine: PNC
Symptoms: Irritability, Rash, Vomiting
Clinical narrative: It was reported post vaccine pt developed a rash that extended from her head to her toes. Pt also vomited and became irritable. Additional information received from the physician on 03/14/2001 indicated the patient recovered.
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema
Clinical narrative: Mother of pt reports post vaccine pt experienced injection site redness.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: It was reported post vaccine pt developed an injection site reaction characterized by redness, swelling, and heat at an unspecified site.
Age: 0.8
Sex: U
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: It was reported that 3 hrs post vaccine the pt developed a fever 102.2F, the pt was taken to the emergency room.
Sex: U
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site reaction
Clinical narrative: It was reported post vaccine pt developed injection site reaction characterized by 5cm hard red lump.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: It was reported post vaccine the pt developed a fever of 104.5F. She also developed an injection site reaction characterized by a 6.5" by 3.5" in area of redness and swelling. As of the date of this report the child is not much better. Follow up information received from the physician on 04/17/2001 indicated that the patient received the injection of Prevnar on 02/19/2001 and recovered.
Age: 0.3
Sex: U
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site reaction, Swelling
Clinical narrative: It was reported 2 hrs post vaccine pt developed an injection site reaction characterized by redness, swelling and heat at an unspecified site.
Age: 3.0
Sex: F
Vaccine: DTP, PNC
Symptoms: Cough, Diarrhoea, Injection site reaction, Irritability, Rash
Clinical narrative: A mother reports post vaccine pt developed wheezing, diarrhea, vomiting, rash and was irritable. The mother considered these events to be an allergic reaction. The patient recovered by 01/08/2001. Follow up information received from the physician on 04/22/2001 indicated the patient received Prevnar, Act-Hib, and Tripedia vaccines. The following day the patient developed nasal congestion, an "occasional" cough, runny nose, vomiting X 2 and mild diarrhea. The patient was diagnosed with a viral syndrome which resolved the following day without treatment. The patient also developed an injection site reaction characterized by redness and swelling.
Age: 3.0
Sex: F
Vaccine: DTP, PNC
Symptoms: Rhinorrhoea, Vomiting, Wheezing
Clinical narrative: A mother reports post vaccine pt developed wheezing, diarrhea, vomiting, rash and was irritable. The mother considered these events to be an allergic reaction. The patient recovered by 01/08/2001. Follow up information received from the physician on 04/22/2001 indicated the patient received Prevnar, Act-Hib, and Tripedia vaccines. The following day the patient developed nasal congestion, an "occasional" cough, runny nose, vomiting X 2 and mild diarrhea. The patient was diagnosed with a viral syndrome which resolved the following day without treatment. The patient also developed an injection site reaction characterized by redness and swelling.
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema
Clinical narrative: It was reported by mother of pt, post vaccine the pt experienced injection site redness.
Sex: U
Vaccine: DTAP
Symptoms: Injection site oedema, Injection site rash
Clinical narrative: One week post vax, the pt experienced swelling and a rash at the injection site. The child was seen by a physician and treated at the office. The most recent information received on 2/11/00 reports the condition of the pt as unknown.
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Injection site warmth, Lethargy, Pyrexia
Clinical narrative: One week post vax, the child had definite lethargy and high fever. Additionally, the child had heat and a 2cm induration at the injection site. The pt was seen by a physician and treated at the office. The most recent information received on 4/12/00 reported the condition as completely resolved.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Irritability
Clinical narrative: One day post vax, on 2/14/00 the pt experienced significant local swelling (twice as big), hot to the touch, redness, pain and tenderness at the injection site as well as fussiness and fever. The swelling was localized on the left thigh and persisted 1-2 days. Benadryl and Tylenol were administered and they relieved swelling after a "couple" of doses. He was treated by his mother with cold compresses with a resolution of symptoms in 24 hours. The most recent information received on 3/14/00 reports the outcome of the pt as resolved.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: One day post vax, on 2/14/00 the pt experienced significant local swelling (twice as big), hot to the touch, redness, pain and tenderness at the injection site as well as fussiness and fever. The swelling was localized on the left thigh and persisted 1-2 days. Benadryl and Tylenol were administered and they relieved swelling after a "couple" of doses. He was treated by his mother with cold compresses with a resolution of symptoms in 24 hours. The most recent information received on 3/14/00 reports the outcome of the pt as resolved.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: The pt experienced significant local swelling (twice as big), hot to the touch, redness, pain and tenderness at the injection site. Additionally there was a hard area around the injection site. The pt returned to the office on 2/16/00 and was treated with Keflex for possible cellulitis. The pt recovered on 2/17/00. The most recent information received on 2/18/00 reports the outcome of the pt as resolved.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth
Clinical narrative: The pt experienced significant local swelling (twice as big), hot to the touch, redness, pain and tenderness at the injection site. Additionally there was a hard area around the injection site. The pt returned to the office on 2/16/00 and was treated with Keflex for possible cellulitis. The pt recovered on 2/17/00. The most recent information received on 2/18/00 reports the outcome of the pt as resolved.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Hypokinesia, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: On 2/8/00, the pt experienced significant local swelling (twice as big), hot to the touch, redness, pain, hardness and tenderness at the injection site. He could not walk. Outpatient treatment was required. Physician prescribed Benadryl and a warm towel compress to treat injection site swelling. The most recent information received on 3/14/00 reports the condition of the pt as resolved.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site warmth, Pain
Clinical narrative: On 2/8/00, the pt experienced significant local swelling (twice as big), hot to the touch, redness, pain, hardness and tenderness at the injection site. He could not walk. Outpatient treatment was required. Physician prescribed Benadryl and a warm towel compress to treat injection site swelling. The most recent information received on 3/14/00 reports the condition of the pt as resolved.
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Pyrexia
Clinical narrative: The evening of the vax, the pt experienced a fever of 101 (rectal) which was treated with Tylenol and lasted three days. The most recent information received on 3/27/00 reports the condition of the pt is resolved.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Somnolence
Clinical narrative: Following vax, the pt experienced sleepiness and a red injection site. The pt was treated with Tylenol. The most recent information received on 3/27/00 reports the condition of the pt as resolved.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Hypotonia, Injection site erythema, Pyrexia, Screaming, Somnolence
Clinical narrative: On 2/15/00 the pt received her second dose of Infanrix. Subsequently she was sleepy for 24 hours, screamed for 4 hours and was flaccid, had a fever the next day and had a slightly red injection site. The pt was treated with Tylenol. Outcome resolved. The most recent information received on 3/27/00 reports the condition of the pt as resolved. Following the 1st dose, the pt was lethargic, but recovered.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Pyrexia, Screaming
Clinical narrative: On 12/21/99, the pt received his first dose of Infanrix, subsequently he screamed and was difficult to console. Additionally he had a fever of 100.6 degrees (rectal). Outcome of pt is resolved.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Screaming
Clinical narrative: On 12/23/99, the pt received his first dose of Infanrix. Subsequently on 12/23/99 he screamed for two hours. Outcome: resolved. The most recent information received on 3/27/00 reports the condition of the pt as resolved.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Agitation, Injection site pain, Pyrexia, Screaming
Clinical narrative: In 2/00 the pt received her third dose of Infanrix. Subsequently, the same day as the vax, she screamed and had a fever and soreness at the injection site (leg). No treatment was given. Outcome: resolved. The most recent information received on 3/27/00 reports the condition of the pt as resolved.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: On the same day of vax, the pt experienced redness and heat at the injection site, which was 1/2/ the size of a softball. Outcome: resolved. The most recent information received on 3/27/00 reports the condition of the pt as resolved.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Screaming
Clinical narrative: Following vaccination, the same day the pt cried for 6 hours. No treatment was given. The outcome is resolved. The most recent information received on 3/27/00 reports the condition of the pt as resolved.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Crying, Injection site oedema, Irritability
Clinical narrative: Two hours post vax, the pt was irritable, and screamed for nine hours. The injection site was swollen. The next day she was "out of sorts". The most recent information received on 3/27/00 reported the condition of the pt as resolved.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: One day post vax, it was reported that the pt developed left hip to knee swelling, erythema, heat (injection site), and tenderness to the touch (injection site). MD visits on 3/24/00 and 3/25/00 were required, and the pt was found to have cellulitis. No crepitus was noted, no drainage, no fever, and no cultures were obtained. He was treated with Rocephin on 3/24/00. Decadron on 3/25/00 and then Cephalexin for 10 days. The most recent information received on 4/4/00 reports that the pt is lost to follow-up.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site warmth
Clinical narrative: One day post vax, it was reported that the pt developed left hip to knee swelling, erythema, heat (injection site), and tenderness to the touch (injection site). MD visits on 3/24/00 and 3/25/00 were required, and the pt was found to have cellulitis. No crepitus was noted, no drainage, no fever, and no cultures were obtained. He was treated with Rocephin on 3/24/00. Decadron on 3/25/00 and then Cephalexin for 10 days. The most recent information received on 4/4/00 reports that the pt is lost to follow-up.
Age: 1.6
Sex: M
Vaccine: DTAP
Symptoms: Injection site oedema
Clinical narrative: One day post vax, the pt's father called and reported swelling around the site of the Infanrix injection. He was advised to treat the reaction with ibuprofen and diphenhydramine, and to contact the physician if the reaction worsened or persisted. Two days later (3 days post vax), the father reported that the swelling was almost completely resolved and that the child was generally well and normally active. No sequelae have been reported. The most recent information received on 8/18/00 reports the condition of the pt is resolved.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Within 12 hours of the fourth dose of Infanrix, the pt experienced swelling of the injection site from the hip to the knee, noted by his mother. The swelling was 2cm greater than the other thigh. There was warmth, erythema and tenderness at the injection site. The physician prescribed diphenhydramine (Benadryl), loratadine (Claritin), ibuprofen and cold compresses. The most recent information received on 4/18/00 reported the symptoms resolved within 48-72 hours.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Following vaccination, the pt experienced a hot, red, sore spot at the injection site. Acetaminophen (Tylenol) was given as treatment. The most recent information received on 4/27/00 reported the symptoms resolved on the second day.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, OPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Viral infection
Clinical narrative: 36-48 hours post vax, the pt went to the doctor and presented with swelling of her left arm. It was markedly swollen from her elbow to her shoulder approximately twice the size of the right arm. The pt also had localized erythema and induration at the injection site. Treatment included topical hydrocortisone cream, diphenhydramine, and Amoxicillin. The most recent information received on 5/15/00 reported the symptoms resolved within 5 days. When she went to her doctor, she did not appear to be clinically ill and was afebrile. She was later hospitalized for viral-syndrome which reported as a non-event.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: On 5/2/00, the pt received the fourth dose of Infanrix and approximately 24 hours later he experienced rapid swelling of the left thigh from hip to knee approximately one inch greater than the right thigh. His mother noticed redness "like an insect bite", erythema, induration and warmth at the injection site. 48 hours post vax, the pt experienced a fever of 103 degrees and was taken to the ER. He was treated with oral antipyretics. The ER physician noted the child's fever had improved, he did not appear to be clinically ill and his thigh was only slightly swollen. The most recent information received on 5/5/00 reported the symptoms were resolving.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Pyrexia
Clinical narrative: On 2/24/00 at 2:00 the pt developed a fever of 105. The most recent information received on 7/7/00 reports the outcome of the event as recovered.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site oedema, Injection site reaction, Pruritus
Clinical narrative: On 8/9/00 the pt was seen in the doctor's office with no immunization record. The pt was given Infanrix and IPV. It was later discovered that these vaccinations had already been given to the child. The physician reported that the pt experienced a localized reaction with redness, swelling, itching, and bruising. The physician considered these reactions to be moderate in intensity and related to Infanrix. As of 9/29/00, the outcome of the events is resolved.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Within hours of the vax, the pt experienced generalized body hives. An ER or doctor visit was required and the pt was treated with diphenhydramine hydrochloride (Benadryl) on 8/15/00. As of 8/15/00, the outcome of the event is unresolved.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: 8 days post vax, the pt developed cellulitis at the injection site. A doctors visit was required. Starting on 8/2/00 the pt was treated with ceftriaxone sodium (Rocephin). The cellulitis resolved on 8/12/00. The physician believed it was related to the injection and not to the vaccine. The adverse event was considered to be mild in intensity. As of 11/10/00, the outcome of the event is resolved.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: In 1999, the pt received her 2nd dose of DTPa vaccine. "A few days later", she experienced hives. As of 10/23/00, the outcome of the event is resolved.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: On 11/1/00, the vaccinee received his 1st left lateral thigh dose of Infanrix. "Immediately" upon vaccination, the vaccinee experienced swelling and redness at the injection site. A doctor visit was required on 11/3/00 and the vaccinee was treated on 11/3/00 with acetaminophen (Tylenol) prn. As of 11/7/00, the outcome of the event is resolved.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The vaccinee received her 3rd dose of haemophilus influenza B vaccine on 10/30/00. On 6/27/00, 8/28/00 and 10/30/00, the vaccinee received her 1st, 2nd and 3rd left thigh doses of Infanrix. Three days, post vax, of the 3rd Infanrix, on 11/2/00, the pt was seen in physician's office with redness and swelling below the injection site. There was no fever noted, nor complaint of pain or fussiness. No treatment was given. As of 11/2/00, the outcome of the events is unknown.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin discolouration, Urticaria
Clinical narrative: On 9/29/00, the pt received his 5th, left arm, dose of Infanrix. The pt's mother stated that 2 days later, on 10/01/00, the vaccinee developed a red, hot, purple rash below the injection site. The vaccinee did not complain of pain; the site was swollen. On 10/6/00, the pt experienced multiple hives in various sizes on the left arm only below the injection site which blanched with pressure. No itching or fever was noted. A doctor visit was required and the pt was treated with diphenhydramine hydrochloride 12.5mg every 6 hours. As of 11/2/00, the outcome of the event is unknown.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site warmth, Irritability, Skin discolouration
Clinical narrative: The vaccinee "is a normal, healthy, 18 month old with no known allergies", who received concomitant HIB and IPV on 8/21/00. On 8/21/00, the pt also received her 4th left leg dose of Infanrix. On 8/23/00, the pt returned to the doctor's office presenting with a 6" area below the injection site that was red with a purple tinge and warm. The pt did not have a fever or pain. She was very fussy. She was treated from 8/23/00 to 8/28/00 with hydroxyzine hydrochloride (Atarax) 0.5mg po prn every 8 hours. As of 11/2/00, the outcome of the event is unknown.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Irritability, Pyrexia
Clinical narrative: The vaccinee is healthy and had no known allergies. He received his 1st injections of IPV and HIB on the date of the Infanrix vaccination. There is no family history of vaccine-related events. In late July or early August, 2000, the pt received his 1st dose of Infanrix. Between 30 and 60 minutes, post vax, the pt's mother was contacted by the pt's daycare provider, who reported that he was irritable, crying, and had a temperature of 104F. (The anatomic site of temperature measurement was not known). The pt was treated with ibuprofen and acetaminophen orally and recovered without sequela. As of 11/7/00, the outcome of the events is resolved.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The pt had no concurrent medical conditions; specifically, she had no known allergies. She was taking no concurrent medications. She received an injection of Infanrix on 12/1/00. Within 24 hours, she developed a large, raised area of firmness, redness, swelling and warmth at the injection site. She was seen by the physician, who noted that the injected thigh was 5cm larger in circumference that the contralateral thigh. The injection site swelling did not extend to the hip or knee. The pt was treated with loratadine (Claritin) and warm compresses to the injection site. She recovered by 12/4/00. The reporter indicated that 2 pts experienced injection site reactions following receipt of Infanrix lot DTPA972A2. However, only 1 pt was identified.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: The same day of vax, the pt developed moderate redness and swelling at the Infanrix site. Half of his thigh became inflamed. He recovered without treatment. The reporter considered the thigh inflammation, injection site redness, and injection site swelling to be related to Infanrix administration.
Age: 2.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: On 12/1/00 within hours of vax, he developed severe redness and swelling at the injection site. He also developed a moderate fever and moderate pain. On 12/2/00 he developed moderate swelling of his thigh. He recovered on 12/2/00 without treatment. The reporter considered the fever, pain and swollen thigh to be related to the Infanrix administration.
Age: 1.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Irritability
Clinical narrative: Within 24 hours of vax on 12/8/00, the pt became fussy. Two days post vax on 12/9/00 she developed moderate redness and swelling at the Infanrix site. She was treated with ibuprofen (Motrin) and recovered. The reporter considered the fussiness, injection site redness, and injection site swelling to be related to Infanrix administration.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Within 24 hours of vax, on 12/8/00 he developed severe redness and swelling at the Infanrix injection site. He also developed severe swelling of his right thigh, the swelling was almost circumferential. His thigh was not tender. He was treated with diphenhydramine (Benadryl) and ibuprofen (Motrin). He recovered 12/12/00. The reporter considered the thigh swelling to be related to the vax administration.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, RV, TTOX
Symptoms: Diarrhoea, Pyrexia, Rash
Clinical narrative: The infants mother reported that at a later unspecified date, the infant developed diarrhea. The infant recovered after nine days. The vaccine provider stated "we have no record of a problem". The infants mother reported that the infant subsequently developed a fever and a rash following her second dose of Rota Shield.
Sex: U
Vaccine: DTAP
Symptoms: Abscess
Clinical narrative: On an unspecified date, a child received an injection of DTPa. Some time later (date not provided), the child developed an abscess at an unspecified site. The child was treated with an antibiotic. Outcome of the event was not provided. The reporter indicated that two additional children experienced this event following receipt of DTPa, they did not require antibiotic therapy. These two pt's are not presently identifiable. Additional reports will be generated when identifying information is provided.
Sex: U
Vaccine: DTAP, PNC
Symptoms: Convulsion
Clinical narrative: Seizure; patient visit.
Age: 1.08
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Apnoea, Blood creatinine increased, Blood urea increased, Convulsion, Cyanosis
Clinical narrative: On 06/04/99 an 07/28/99, this child received her first two vaccinations with Infanrix, with no untoward effects. On 03/07/00, she received the third dose of Infanrix and received a Comvax vaccination. The day before the event, 03/10/00, the child had diarrhea and decreased appetite. Four days after the vaccinations, 03/11/00, the child while drinking her bottle experienced a 5-10 second apneic episode with body stiffening and perioral cyanosis. She gasped after back pats. This was followed by several hours of increased sleepiness. The child was brought to the ER where she was diagnosed as having had two non-febrile seizures that morning. She was given Ativan. Neurology admitted her to the hospital on 03/11/00. the info was received on 05/10/00 reported as the symptoms resolved, and the child was discharged from the hospital on 03/13/00 after 2 days.
Age: 1.08
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Decreased appetite, Diarrhoea, Haematochezia, Laboratory test abnormal, Musculoskeletal stiffness
Clinical narrative: On 06/04/99 an 07/28/99, this child received her first two vaccinations with Infanrix, with no untoward effects. On 03/07/00, she received the third dose of Infanrix and received a Comvax vaccination. The day before the event, 03/10/00, the child had diarrhea and decreased appetite. Four days after the vaccinations, 03/11/00, the child while drinking her bottle experienced a 5-10 second apneic episode with body stiffening and perioral cyanosis. She gasped after back pats. This was followed by several hours of increased sleepiness. The child was brought to the ER where she was diagnosed as having had two non-febrile seizures that morning. She was given Ativan. Neurology admitted her to the hospital on 03/11/00. the info was received on 05/10/00 reported as the symptoms resolved, and the child was discharged from the hospital on 03/13/00 after 2 days.
Age: 1.08
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Somnolence
Clinical narrative: On 06/04/99 an 07/28/99, this child received her first two vaccinations with Infanrix, with no untoward effects. On 03/07/00, she received the third dose of Infanrix and received a Comvax vaccination. The day before the event, 03/10/00, the child had diarrhea and decreased appetite. Four days after the vaccinations, 03/11/00, the child while drinking her bottle experienced a 5-10 second apneic episode with body stiffening and perioral cyanosis. She gasped after back pats. This was followed by several hours of increased sleepiness. The child was brought to the ER where she was diagnosed as having had two non-febrile seizures that morning. She was given Ativan. Neurology admitted her to the hospital on 03/11/00. the info was received on 05/10/00 reported as the symptoms resolved, and the child was discharged from the hospital on 03/13/00 after 2 days.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Anaphylactic reaction, Asthenia, Cyanosis, Hyperhidrosis, Hypertension
Clinical narrative: The pt received Infanrix and MMRII on 5/18/00. Ten minutes, post vax, she developed sudden pallor, marked diaphoresis, weakness and perioral cyanosis. She was taken back into an examination room. Her BP was initially 100/70; it dropped to 90/60. Her pulse was approx. 111. She was responsive, but very sleepy. She had no stridor, rales or wheezing. She was administered oxygen. Her BP rose to 116/80 and her pulse was 100. She was markedly lethargic. She was transferred by EMS to the hospital. A dx of vascular anaphylaxis was made by the attending physician. The vaccinee was treated with oxygen and IV fluids. No local reactions developed at either vaccine injection site. The vaccinee recovered completely by the next morning and was discharged from the hospital. The attending physician considered both vaccines to be suspect in this event.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Hypotension, Lethargy, Pallor
Clinical narrative: The pt received Infanrix and MMRII on 5/18/00. Ten minutes, post vax, she developed sudden pallor, marked diaphoresis, weakness and perioral cyanosis. She was taken back into an examination room. Her BP was initially 100/70; it dropped to 90/60. Her pulse was approx. 111. She was responsive, but very sleepy. She had no stridor, rales or wheezing. She was administered oxygen. Her BP rose to 116/80 and her pulse was 100. She was markedly lethargic. She was transferred by EMS to the hospital. A dx of vascular anaphylaxis was made by the attending physician. The vaccinee was treated with oxygen and IV fluids. No local reactions developed at either vaccine injection site. The vaccinee recovered completely by the next morning and was discharged from the hospital. The attending physician considered both vaccines to be suspect in this event.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Information has been received from a physician concerning a 73 year old female pt who on 12/13/00 had vaccines. On 12/16/00 or 12/18/01, the pt experienced "ascending paralysis consistent with Guillain-Barre'. Follow-up information has been received which reports the pt was hospitalized from 12/18/00 to 2/14/01 and had complications of aspiration pneumonia, SIADH and a UTI. It was noted that a LP was done which showed a CSF protein 71 and WBC 1. The pt was in a rehab facility. At the time of the report, 3/20/00, the events were considered to be immediately life threatening, disabling and "Other Significant Medical Event" by the reporter. The outcome was unknown. Follow-up received from a health care provider which states that as of the last doctor visit on 4/9/01, she had recovered from her experience. The pt completed rehabilitation, was functioning well and was able to perform all activities of daily living. It was reported that the only vaccine the health care provider saw reference to, was the flu vaccine. He states he could not definitely state whether or not the pt ever received pneumococcal vaccine 23 polyvalen. He also reported that he did not know if the pt's experieces were even related to her vaccines. The pt's experiences were considered to be immediately life-threatening, disabling and "Other Significant Medical Events" by the reporter. F/U info rec'd on 4/17/01 indicated that the pt recovered.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: CSF test abnormal, Guillain-Barre syndrome, Hypoxia, Laboratory test abnormal, Paralysis
Clinical narrative: Information has been received from a physician concerning a 73 year old female pt who on 12/13/00 had vaccines. On 12/16/00 or 12/18/01, the pt experienced "ascending paralysis consistent with Guillain-Barre'. Follow-up information has been received which reports the pt was hospitalized from 12/18/00 to 2/14/01 and had complications of aspiration pneumonia, SIADH and a UTI. It was noted that a LP was done which showed a CSF protein 71 and WBC 1. The pt was in a rehab facility. At the time of the report, 3/20/00, the events were considered to be immediately life threatening, disabling and "Other Significant Medical Event" by the reporter. The outcome was unknown. Follow-up received from a health care provider which states that as of the last doctor visit on 4/9/01, she had recovered from her experience. The pt completed rehabilitation, was functioning well and was able to perform all activities of daily living. It was reported that the only vaccine the health care provider saw reference to, was the flu vaccine. He states he could not definitely state whether or not the pt ever received pneumococcal vaccine 23 polyvalen. He also reported that he did not know if the pt's experieces were even related to her vaccines. The pt's experiences were considered to be immediately life-threatening, disabling and "Other Significant Medical Events" by the reporter. F/U info rec'd on 4/17/01 indicated that the pt recovered.