chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: DTAP, PNC, VARCEL, DTAP, PNC, VARCEL, DTAP, PNC, VARCEL
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Information has been received from an NP concerning a 15 month old male with no past medical history who on 4/6/01 was vaccinated withhis first dose in the left thigh of varicella virus vaccine (lot # 637669/0088L)live in the physician's office. On the same day, the pt was also vaccinated with DTAP and Prevnar. Subsequently, the pt experienced urticaria, ecchymosis and maculopapular rash which began on his back and spread all over his body. The NP gave the child Benadryl but the pt's experience continued. The pt was taken to ER and was hospitalized. At the time of the report, the pt's outcome was unknown. Additional information has been requested. Per follow-up, there was no reported problems with his 1st DTAP. An unspecified antiviral cream was prescribed that day for his diaper rash. In the evening of 4/6/01, he was bitten by an unspecified insect. Early in the morning of 4/7/01, he developed a maculopapular rash which began on his neck and upper back and by the evening, the rash had spread to his legs and remainder of his body. The rash had a "purplish hue". He also experienced urticaria and ecchymosis. The NP gave the child Benadryl but the pt's experience continued. On 4/8/01, his lips and face were swollen. The pt was taken to ER and was initially dx'd with an allergic reaction. He was treated with Benadryl and sent home. The child's symptoms worsened and he was again taken to ER and given epinephrine. He had not responded to the epinephrine so it was thought that the child had a viral illness rather than an allergic reaction. He was hospitalized overnight and was subsequently discharged. At the time of the report, the pt's outcome was unknown and the NP was not aware of the final dx. Additional information has been requested. Follow-up info has been received from a nurse practitioner who reports the child also had a fever of 103.1 and diarrhea at the time of hospitalization. He was admited to rule out sepsis. CSF cultures and blood cultures were obtained and were negative. His urinalysis was followed during his hospitalization to rule out hemolytic uremic syndrome and did not show nay blodod. In addition, erythema nodosum and henoch-Schonlein purpura were considered in the differential diagnosis of this rash. His vital signs remained stable and his diarrhea resolved without any treatment. At the time of discharge a cocci serology, C1 esterase inhibitor, stool culture, stool for ova and parasites, and a stool for reducing substances were all pending. He was discharged on hydroxine hydrochloride for control of any further symptoms. She reported that the child recovered completely on 04/14/2001 from all his adverse experiences. It was noted that no definitive diagnosis was ever made, but the discharge diagnosis was either an allergic reaction or a viral febrile illness. No further info is expected.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC, VARCEL, DTAP, PNC, VARCEL, DTAP, PNC, VARCEL
Symptoms: Autoimmune disorder, Diarrhoea, Ecchymosis, Erythema, Henoch-Schonlein purpura
Clinical narrative: Information has been received from an NP concerning a 15 month old male with no past medical history who on 4/6/01 was vaccinated withhis first dose in the left thigh of varicella virus vaccine (lot # 637669/0088L)live in the physician's office. On the same day, the pt was also vaccinated with DTAP and Prevnar. Subsequently, the pt experienced urticaria, ecchymosis and maculopapular rash which began on his back and spread all over his body. The NP gave the child Benadryl but the pt's experience continued. The pt was taken to ER and was hospitalized. At the time of the report, the pt's outcome was unknown. Additional information has been requested. Per follow-up, there was no reported problems with his 1st DTAP. An unspecified antiviral cream was prescribed that day for his diaper rash. In the evening of 4/6/01, he was bitten by an unspecified insect. Early in the morning of 4/7/01, he developed a maculopapular rash which began on his neck and upper back and by the evening, the rash had spread to his legs and remainder of his body. The rash had a "purplish hue". He also experienced urticaria and ecchymosis. The NP gave the child Benadryl but the pt's experience continued. On 4/8/01, his lips and face were swollen. The pt was taken to ER and was initially dx'd with an allergic reaction. He was treated with Benadryl and sent home. The child's symptoms worsened and he was again taken to ER and given epinephrine. He had not responded to the epinephrine so it was thought that the child had a viral illness rather than an allergic reaction. He was hospitalized overnight and was subsequently discharged. At the time of the report, the pt's outcome was unknown and the NP was not aware of the final dx. Additional information has been requested. Follow-up info has been received from a nurse practitioner who reports the child also had a fever of 103.1 and diarrhea at the time of hospitalization. He was admited to rule out sepsis. CSF cultures and blood cultures were obtained and were negative. His urinalysis was followed during his hospitalization to rule out hemolytic uremic syndrome and did not show nay blodod. In addition, erythema nodosum and henoch-Schonlein purpura were considered in the differential diagnosis of this rash. His vital signs remained stable and his diarrhea resolved without any treatment. At the time of discharge a cocci serology, C1 esterase inhibitor, stool culture, stool for ova and parasites, and a stool for reducing substances were all pending. He was discharged on hydroxine hydrochloride for control of any further symptoms. She reported that the child recovered completely on 04/14/2001 from all his adverse experiences. It was noted that no definitive diagnosis was ever made, but the discharge diagnosis was either an allergic reaction or a viral febrile illness. No further info is expected.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC, VARCEL, DTAP, PNC, VARCEL, DTAP, PNC, VARCEL
Symptoms: Oedema, Pyrexia, Rash, Thrombocytopenia, Urticaria
Clinical narrative: Information has been received from an NP concerning a 15 month old male with no past medical history who on 4/6/01 was vaccinated withhis first dose in the left thigh of varicella virus vaccine (lot # 637669/0088L)live in the physician's office. On the same day, the pt was also vaccinated with DTAP and Prevnar. Subsequently, the pt experienced urticaria, ecchymosis and maculopapular rash which began on his back and spread all over his body. The NP gave the child Benadryl but the pt's experience continued. The pt was taken to ER and was hospitalized. At the time of the report, the pt's outcome was unknown. Additional information has been requested. Per follow-up, there was no reported problems with his 1st DTAP. An unspecified antiviral cream was prescribed that day for his diaper rash. In the evening of 4/6/01, he was bitten by an unspecified insect. Early in the morning of 4/7/01, he developed a maculopapular rash which began on his neck and upper back and by the evening, the rash had spread to his legs and remainder of his body. The rash had a "purplish hue". He also experienced urticaria and ecchymosis. The NP gave the child Benadryl but the pt's experience continued. On 4/8/01, his lips and face were swollen. The pt was taken to ER and was initially dx'd with an allergic reaction. He was treated with Benadryl and sent home. The child's symptoms worsened and he was again taken to ER and given epinephrine. He had not responded to the epinephrine so it was thought that the child had a viral illness rather than an allergic reaction. He was hospitalized overnight and was subsequently discharged. At the time of the report, the pt's outcome was unknown and the NP was not aware of the final dx. Additional information has been requested. Follow-up info has been received from a nurse practitioner who reports the child also had a fever of 103.1 and diarrhea at the time of hospitalization. He was admited to rule out sepsis. CSF cultures and blood cultures were obtained and were negative. His urinalysis was followed during his hospitalization to rule out hemolytic uremic syndrome and did not show nay blodod. In addition, erythema nodosum and henoch-Schonlein purpura were considered in the differential diagnosis of this rash. His vital signs remained stable and his diarrhea resolved without any treatment. At the time of discharge a cocci serology, C1 esterase inhibitor, stool culture, stool for ova and parasites, and a stool for reducing substances were all pending. He was discharged on hydroxine hydrochloride for control of any further symptoms. She reported that the child recovered completely on 04/14/2001 from all his adverse experiences. It was noted that no definitive diagnosis was ever made, but the discharge diagnosis was either an allergic reaction or a viral febrile illness. No further info is expected.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC, VARCEL, DTAP, PNC, VARCEL, DTAP, PNC, VARCEL
Symptoms: Diarrhoea, Ecchymosis, Face oedema, Hypersensitivity, Pyrexia
Clinical narrative: Information has been received from an NP concerning a 15 month old male with no past medical history who on 4/6/01 was vaccinated withhis first dose in the left thigh of varicella virus vaccine (lot # 637669/0088L)live in the physician's office. On the same day, the pt was also vaccinated with DTAP and Prevnar. Subsequently, the pt experienced urticaria, ecchymosis and maculopapular rash which began on his back and spread all over his body. The NP gave the child Benadryl but the pt's experience continued. The pt was taken to ER and was hospitalized. At the time of the report, the pt's outcome was unknown. Additional information has been requested. Per follow-up, there was no reported problems with his 1st DTAP. An unspecified antiviral cream was prescribed that day for his diaper rash. In the evening of 4/6/01, he was bitten by an unspecified insect. Early in the morning of 4/7/01, he developed a maculopapular rash which began on his neck and upper back and by the evening, the rash had spread to his legs and remainder of his body. The rash had a "purplish hue". He also experienced urticaria and ecchymosis. The NP gave the child Benadryl but the pt's experience continued. On 4/8/01, his lips and face were swollen. The pt was taken to ER and was initially dx'd with an allergic reaction. He was treated with Benadryl and sent home. The child's symptoms worsened and he was again taken to ER and given epinephrine. He had not responded to the epinephrine so it was thought that the child had a viral illness rather than an allergic reaction. He was hospitalized overnight and was subsequently discharged. At the time of the report, the pt's outcome was unknown and the NP was not aware of the final dx. Additional information has been requested. Follow-up info has been received from a nurse practitioner who reports the child also had a fever of 103.1 and diarrhea at the time of hospitalization. He was admited to rule out sepsis. CSF cultures and blood cultures were obtained and were negative. His urinalysis was followed during his hospitalization to rule out hemolytic uremic syndrome and did not show nay blodod. In addition, erythema nodosum and henoch-Schonlein purpura were considered in the differential diagnosis of this rash. His vital signs remained stable and his diarrhea resolved without any treatment. At the time of discharge a cocci serology, C1 esterase inhibitor, stool culture, stool for ova and parasites, and a stool for reducing substances were all pending. He was discharged on hydroxine hydrochloride for control of any further symptoms. She reported that the child recovered completely on 04/14/2001 from all his adverse experiences. It was noted that no definitive diagnosis was ever made, but the discharge diagnosis was either an allergic reaction or a viral febrile illness. No further info is expected.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC, VARCEL, DTAP, PNC, VARCEL, DTAP, PNC, VARCEL
Symptoms: Rash maculo-papular, Urticaria, Viral infection
Clinical narrative: Information has been received from an NP concerning a 15 month old male with no past medical history who on 4/6/01 was vaccinated withhis first dose in the left thigh of varicella virus vaccine (lot # 637669/0088L)live in the physician's office. On the same day, the pt was also vaccinated with DTAP and Prevnar. Subsequently, the pt experienced urticaria, ecchymosis and maculopapular rash which began on his back and spread all over his body. The NP gave the child Benadryl but the pt's experience continued. The pt was taken to ER and was hospitalized. At the time of the report, the pt's outcome was unknown. Additional information has been requested. Per follow-up, there was no reported problems with his 1st DTAP. An unspecified antiviral cream was prescribed that day for his diaper rash. In the evening of 4/6/01, he was bitten by an unspecified insect. Early in the morning of 4/7/01, he developed a maculopapular rash which began on his neck and upper back and by the evening, the rash had spread to his legs and remainder of his body. The rash had a "purplish hue". He also experienced urticaria and ecchymosis. The NP gave the child Benadryl but the pt's experience continued. On 4/8/01, his lips and face were swollen. The pt was taken to ER and was initially dx'd with an allergic reaction. He was treated with Benadryl and sent home. The child's symptoms worsened and he was again taken to ER and given epinephrine. He had not responded to the epinephrine so it was thought that the child had a viral illness rather than an allergic reaction. He was hospitalized overnight and was subsequently discharged. At the time of the report, the pt's outcome was unknown and the NP was not aware of the final dx. Additional information has been requested. Follow-up info has been received from a nurse practitioner who reports the child also had a fever of 103.1 and diarrhea at the time of hospitalization. He was admited to rule out sepsis. CSF cultures and blood cultures were obtained and were negative. His urinalysis was followed during his hospitalization to rule out hemolytic uremic syndrome and did not show nay blodod. In addition, erythema nodosum and henoch-Schonlein purpura were considered in the differential diagnosis of this rash. His vital signs remained stable and his diarrhea resolved without any treatment. At the time of discharge a cocci serology, C1 esterase inhibitor, stool culture, stool for ova and parasites, and a stool for reducing substances were all pending. He was discharged on hydroxine hydrochloride for control of any further symptoms. She reported that the child recovered completely on 04/14/2001 from all his adverse experiences. It was noted that no definitive diagnosis was ever made, but the discharge diagnosis was either an allergic reaction or a viral febrile illness. No further info is expected.
Age: 33.0
Sex: F
Vaccine: RUB
Symptoms: Arthralgia, Arthritis, Rash
Clinical narrative: This patient has an extreme rash within one week. (Ob/Gyn Prescribed Lidex). She had joint pain, started in her fingers, and feet within 2 weeks. Thereafter diagnosed with "seronegative inflammatory arthritis" in the active stage. Currently on Methotrexate, Celebrex, and Arava.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Hypertension, Injection site erythema, Injection site rash, Laboratory test abnormal
Clinical narrative: The pt experienced a rash, erythema, pruritus at the site of injection, hypertension, nausea, vomiting, pallor, weakness. Treated with Allegra, Pepcid, Epinephrine, Medrol Dose Pak, and IV Fluids.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Pallor, Pruritus, Vomiting, White blood cell count increased
Clinical narrative: The pt experienced a rash, erythema, pruritus at the site of injection, hypertension, nausea, vomiting, pallor, weakness. Treated with Allegra, Pepcid, Epinephrine, Medrol Dose Pak, and IV Fluids.
Age: 1.08
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Anaemia, Otitis media, Petechiae, Thrombocytopenic purpura
Clinical narrative: This infant was seen in the clinic on 03/28/01, diagnosed with bilateral  otitis media. He was also given DTaP #4, IPV #3, Hib #4, Varivax, and PCV #1. Seen on 04/13/01 with petechiae, platelet count <1, diagnosed with Idiopathic Thrombocytopenic Purpura, hospitalized for 3 days, IVIG Win-Rho. Also diagnosed with anemia. Mom states on 05/09/2001 that child is recovered from her point of view, scratches are healing okay
Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Cough, Dyspnoea, Hypoxia, Pneumonia
Clinical narrative: Dry cough began on 4/15/01. Pt seen on 4/16/01 and Prevnar given. On 4/16/01 PM, pt had increased difficulty breathing. He was hospitalized on 4/17/01 and required transport to PICU on 4/17/01 for heliox treatment.  Diagnosed with viral pneumonia.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Bacterial infection, Meningitis, Pneumonia
Clinical narrative: A sales representative reported that a 9 month old developed "strep. pneumonia meningitis" approx. 3 months after the 2nd dose of Prevnar. The child had a recent medical history of otitis media. The sales representative stated that he was "pretty" certain that the child was hospitalized. The reporter indicated that a physician specializing in Pediatric Infectious Diseases performed lab, blood, titer and serotyping and the child reportedly was positive for 1 of the 7 serotypes contained in Prevnar. He stated that the healthcare provider indicated that the child was very ill with a poor prognosis. F/U info rec'd 6/11/01 indicated that blood cultures and lumbar puncture were performed both were positive for Strep pneumo. The reporter idicated that the pt had not recovered and was now disabled. Upon review on 9/22/01, this event is reclssified as expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: This patient was exposed to his sibling with the chicken pox on 03/31/01, 30 - 40 lesions on his trunk, extremities and mouth. Afebrile.
Age: 29.0
Sex: F
Vaccine: YF
Symptoms: Dyspnoea, Eye disorder, Flushing, Pruritus, Skin disorder
Clinical narrative: This patient received yellow fever injection at 9:15 AM, symptoms occurred at 9:45 AM. The patient was sent to the ER with flushing, itching, dyspnea, nasal-ocular systems, burning skin.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: This child received Varivax 03/12/97. He had the chicken pox outbreak starting 03/02/01. Approximately 25 lesions.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Gianotti-Crosti syndrome, Rash papular
Clinical narrative: This patient was given Varivax on 03/09/01 in the right thigh. On 03/22/01, the youngster erupted vesicular rash on the right leg. She had multiple small vesicular / papular covered right knee,thigh; patches vesicular papular over the abdomen, right lower leg. Vesicular erupted both hands and feet. Acyclovir on 04/11/01. Lesions began to resolve by 04/15/01. The follow up received on 5/18/01 states rash has since been diagnosed as papular acrodermatitis of childhood (Gianotti-Crosti syndrome).
Age: 5.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: This child developed varicella lesions on 04/10/01.
Age: 6.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: No data.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Laboratory test abnormal, Oedema peripheral, Rash
Clinical narrative: A questionable rash s/p immunization within 24 hours, mild swelling of her toes, fingers, and hands with erythema. No fever, no local site reaction; no vomiting. Questions being stung by an insect on the left 2nd great toes. Meds yesterday, Tylenol.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This infant had erythema and induration (2x1.5 cm).
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Rash papular, Rash vesicular
Clinical narrative: This infant had scattered red papules, some vesicular, some excoriated on the chest, back, face, and ears.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: This patient had local swelling at the injection site on the right arm (DTaP / HIB). He had a fever of 102 for 48 hours.
Age: 1.6
Sex: M
Vaccine: DTAP, HBHEPB, MMR, PNC
Symptoms: Injection site oedema
Clinical narrative: This infant had vaccine administered on 04/09/01. On 04/11/01, he presents with right arm edema at the injection site down to the wrist. The patient was seen by the doctor at the health center.
Age: 1.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Erythema multiforme, Pyrexia, Rash
Clinical narrative: This infant developed a fever and a rash; erythema multiforme.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Face oedema, Hypersensitivity
Clinical narrative: This infant had swelling of the face consistent with allergic reaction approximately 16 hours after receiving her vaccine. She was given Benadryl.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Ear disorder, Pyrexia
Clinical narrative: On 04/19/01 in the PM, this patient's mother called reporting the patient had a 103 temp, no other sicknesses; although pulling at her ears. The patient was seen in the office on 04/20/01 at 10:30 and no otitis media was evident.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Dyspnoea, Pyrexia, Vomiting
Clinical narrative: On 04/17/01 at 8:30 PM, the mother noted a temp of 100.5, at 9:15 PM seizure one, time and vomiting twice. On 04/18/01 at 4:00 AM, patient had a temp of 103.9, difficulty breathing; resolved with nebulizer treatment. T 8:30 AM, the patient was seen in the clinic with a temp of 101. On 04/20/01, the patient had a recheck in the clinic, the temp was elevated to 103 on 04/19; no seizure. The patient was referred for a neuro work up.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Convulsion, Feeling hot, Pyrexia
Clinical narrative: The mother states that this child had a seizure at 1:30 AM, and states the child felt warm to touch. He had a 2nd seizure at 6:30 AM, his temp was 102 (ax). At 7:30 the child was taken to the hospital, the temp was 103 (rect), he was given Motrin, Blood work was done. He had a 3rd seizure at 2 PM some day 04/03/01 none since. The patient was in the clinic on 04/12/01 to inform of the seizure activity with the child.
Age: 0.8
Sex: M
Vaccine: HEP, IPV, PNC
Symptoms: Irritability, Rash erythematous, Restlessness
Clinical narrative: Prevnar 1st dose given on 04/17/01, IPV 3rd dose given on 04/17/01, Hep B 3rd dose given on 04/17/01. On 04/18/01, in the Am, the child had pinpoint erythematous rash, irritable, restless, scratching. No hives, no fever, no wheezing. On 04/19/01, the patient was seen in the office, rash on the neck, torso, arms, legs,and diaper area. On 04/19/01, Benadryl was given.
Age: 1.8
Sex: M
Vaccine: DTAP, HEP, MMR
Symptoms: Agitation, Pyrexia, Screaming
Clinical narrative: This infant had a fever with inconsolability for 5 days after his injection (described by his mother- did not bring the child in during this time).
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash
Clinical narrative: This patient complained of rash (approximately 10 lesions) which developed a blister which scabbed over.
Age: 6.0
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: This child had erythema in the left arm at the site of injection given on 04/16. In 24 hours it developed erythematous tender area, cellulitis versus local reaction.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Erythema, Feeling hot, Rash macular
Clinical narrative: This infant had a 9 x 10 cm erythematous, warm macular area with central clearing to the feet and upper thigh. Recommended treatment of Aveeno bath and Benadryl for 2 days, then as needed.
Age: 18.0
Sex: F
Vaccine: RAB
Symptoms: Hypokinesia, Lymphadenopathy, Pain
Clinical narrative: This patient developed body aches, left arm ache, multiple swollen glands, left clavicular , left anterior cervical. No axillary nodes. The patient incapacitated by arm pain 1 day, slowly improved over 3 days.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: This infant had a fever of 103 in one ear and 105 in the other ear. He had a febrile seizure (star mode) 10-15 minutes. The baby was rushed to the ER. Return to his doctor the next day had a reaction to the shots.
Age: 1.3
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Febrile convulsion, Pyrexia, Rash
Clinical narrative: This infant had a high fever of 103 beginning 9 days after his MMR, lasted 48 hours. Probable febrile seizure x 2. He broke out into a rash 12 days after the vaccine it lasted 24 hours.
Age: 19.0
Sex: M
Vaccine: HEP, TD
Symptoms: Chills, Diarrhoea, Pain, Pyrexia, Vomiting
Clinical narrative: A Tetanus-Diptheria vaccine was administered on 03/27/01. The mother phoned into the office on 03/29/01 stating that the patient had experienced a deep aching pain in the left arm along with diarrhea, vomiting, temp, and chills on 03/27/01. The patient referred to physician.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Headache, Nausea
Clinical narrative: Within 30 minutes after Hep B #2 vaccine, the patient developed frontal headache, epigastric pain, and nausea, no emesis. History of the same symptoms after the flu vaccine 3 years ago.
Age: 2.0
Sex: M
Vaccine: PNC, PNC
Symptoms: Anaphylactic reaction, Dyspnoea, Hypotension, Pulmonary function test decreased, Stridor
Clinical narrative: Several hours following Prevnar administration this infant developed a fever, severe respiratory distress, and hypotension. The patient was seen in the ER, given IV Boluses, and Rocephin. The patient was admitted and observed or night. Now stable.
Age: 2.0
Sex: M
Vaccine: PNC, PNC
Symptoms: Hypotension, Pyrexia, Respiratory distress
Clinical narrative: Several hours following Prevnar administration this infant developed a fever, severe respiratory distress, and hypotension. The patient was seen in the ER, given IV Boluses, and Rocephin. The patient was admitted and observed or night. Now stable.
Age: 13.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Pruritus, Rash, Sleep disorder, Urticaria
Clinical narrative: This child received Hep B # 3 on 02/08 (morning) at school. The mother called PHN on Thurs 02/15. On Wednesday 02/14, the patient came home from school, showered, ate dinner, soon after developed generalized itching, then hives which became gradually worse covering her trunk, neck, shoulders, arms, behind her knees. The patient didn't sleep well due to the itching, but no other symptoms. At the time of the initial conversation, the mother wasn't sure whether the daughter had eaten anything "new" at school valentine's celebration, or had used a new body wash, shampoo or cream rinse. In a hurry to get off the phone to purchase some Benadryl at only local store before closing. Inquiring about any known connection with Hep B vaccine. Friday 02/16, PHN called someone at the State of AK immunization Program. Has never heard of this reaction to Hep B vaccine. Especially unlikely after #3 vaccination and 6 days later. Advised to complete VAERS form. At 9 Am return call to the mother the rash and itching subsiding after the use of Benadryl 02/16. The daughter did attend school today. Did not check with daughter regarding whether shampoo, rinse or body wash, etc were new. Did realize that the daughter ate 'lots of" strawberries, but mom aware that allergic reaction can happen with subsequent ingestion of foods. Plans to get allergy testing for the daughter. NOTE: The local PA was on vacation from the clinic 02/15/01 for 1 month. No other local medical providers. The mother plans to fly with the daughter only if no resolution of sickness. Over the next several days.
Age: 13.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Insomnia, Pruritus, Rash, Urticaria
Clinical narrative: This child received Hep B # 3 on 02/08 (morning) at school. The mother called PHN on Thurs 02/15. On Wednesday 02/14, the patient came home from school, showered, ate dinner, soon after developed generalized itching, then hives which became gradually worse covering her trunk, neck, shoulders, arms, behind her knees. The patient didn't sleep well due to the itching, but no other symptoms. At the time of the initial conversation, the mother wasn't sure whether the daughter had eaten anything "new" at school valentine's celebration, or had used a new body wash, shampoo or cream rinse. In a hurry to get off the phone to purchase some Benadryl at only local store before closing. Inquiring about any known connection with Hep B vaccine. Friday 02/16, PHN called someone at the State of AK immunization Program. Has never heard of this reaction to Hep B vaccine. Especially unlikely after #3 vaccination and 6 days later. Advised to complete VAERS form. At 9 Am return call to the mother the rash and itching subsiding after the use of Benadryl 02/16. The daughter did attend school today. Did not check with daughter regarding whether shampoo, rinse or body wash, etc were new. Did realize that the daughter ate 'lots of" strawberries, but mom aware that allergic reaction can happen with subsequent ingestion of foods. Plans to get allergy testing for the daughter. NOTE: The local PA was on vacation from the clinic 02/15/01 for 1 month. No other local medical providers. The mother plans to fly with the daughter only if no resolution of sickness. Over the next several days.
Age: 13.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Pruritus, Sleep disorder
Clinical narrative: This child received Hep B # 3 on 02/08 (morning) at school. The mother called PHN on Thurs 02/15. On Wednesday 02/14, the patient came home from school, showered, ate dinner, soon after developed generalized itching, then hives which became gradually worse covering her trunk, neck, shoulders, arms, behind her knees. The patient didn't sleep well due to the itching, but no other symptoms. At the time of the initial conversation, the mother wasn't sure whether the daughter had eaten anything "new" at school valentine's celebration, or had used a new body wash, shampoo or cream rinse. In a hurry to get off the phone to purchase some Benadryl at only local store before closing. Inquiring about any known connection with Hep B vaccine. Friday 02/16, PHN called someone at the State of AK immunization Program. Has never heard of this reaction to Hep B vaccine. Especially unlikely after #3 vaccination and 6 days later. Advised to complete VAERS form. At 9 Am return call to the mother the rash and itching subsiding after the use of Benadryl 02/16. The daughter did attend school today. Did not check with daughter regarding whether shampoo, rinse or body wash, etc were new. Did realize that the daughter ate 'lots of" strawberries, but mom aware that allergic reaction can happen with subsequent ingestion of foods. Plans to get allergy testing for the daughter. NOTE: The local PA was on vacation from the clinic 02/15/01 for 1 month. No other local medical providers. The mother plans to fly with the daughter only if no resolution of sickness. Over the next several days.
Age: 0.6
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Apnoea, Sudden infant death syndrome
Clinical narrative: Reportedly two days after vax, the pt expired. The pt was put down for a nap, the pt's mother went to check on him, the pt wasn't breathing. 911 was called.
Age: 0.6
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Apnoea
Clinical narrative: Reportedly two days after vax, the pt expired. The pt was put down for a nap, the pt's mother went to check on him, the pt wasn't breathing. 911 was called.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Bacterial infection, Meningitis, Musculoskeletal stiffness, Pyrexia, Vomiting
Clinical narrative: Pt was hospitalized and dx'd with bacterial meningitis. This occurred 10 days after receiving the new Prevnar vaccine. Symptoms included fever, vomiting and stiff neck. Pt was given various antibiotics for 14 days. Tests conducted on the cultures were unable to determine the exact strain of meningitis.
Age: 0.25
Sex: F
Vaccine: PNC
Symptoms: Apnoea, Dyspnoea, Hypotonia, Hypoventilation, Respiratory syncytial virus infection
Clinical narrative: My daughter received the shot of Prevnar on Tuesday evening. Wednesday she was fine all day until 6:45 PM. She woke up from a nap barely able to cry, when I picked her up she had thick mucus coming from her nose and mouth. As I had her on her side trying to suction it out of her mouth, she went limp and stopped breathing. About a minute later she was gasping for air while we waited for the ambulance to arrive. Her breathing was very shallow and she did vomit mucus. At the hospital she was hooked up to watch her heart and oxygen level, while she was being checked she vomited a lot of mucus again. They took x-rays of her chest to check her lungs which were clear. They sent us to another hospital with a pediatric ward. Once there they drew blood and also watched her heart rate and oxygen level which was at 100%. She had tests done for apnea and acid reflux which were all negative. The only test that came back positive was for RSV. Since her release from the hospital on the 13th, I have found out there were two more incidents identical to my daughters in our home town alone. Both had occurred within 24 hours of receiving Prevnar shot. I have also contacted the hospital in which our daughter and one other baby had gone to let them know of this possible connection and was told there has been numerous cases of RSV lately with infants. They said they are going to contact the doctors of those patient's to see if Prevnar was given prior to them being rushed to the hospital with breathing difficulties. I can only say from my own experience I am glad this happened before we went to bed for the night, my daughter probably would not be here with us right now. If there is a problem with this shot, I can only hope to warn others to monitor their babies closely.
Age: 0.25
Sex: F
Vaccine: PNC
Symptoms: Vomiting
Clinical narrative: My daughter received the shot of Prevnar on Tuesday evening. Wednesday she was fine all day until 6:45 PM. She woke up from a nap barely able to cry, when I picked her up she had thick mucus coming from her nose and mouth. As I had her on her side trying to suction it out of her mouth, she went limp and stopped breathing. About a minute later she was gasping for air while we waited for the ambulance to arrive. Her breathing was very shallow and she did vomit mucus. At the hospital she was hooked up to watch her heart and oxygen level, while she was being checked she vomited a lot of mucus again. They took x-rays of her chest to check her lungs which were clear. They sent us to another hospital with a pediatric ward. Once there they drew blood and also watched her heart rate and oxygen level which was at 100%. She had tests done for apnea and acid reflux which were all negative. The only test that came back positive was for RSV. Since her release from the hospital on the 13th, I have found out there were two more incidents identical to my daughters in our home town alone. Both had occurred within 24 hours of receiving Prevnar shot. I have also contacted the hospital in which our daughter and one other baby had gone to let them know of this possible connection and was told there has been numerous cases of RSV lately with infants. They said they are going to contact the doctors of those patient's to see if Prevnar was given prior to them being rushed to the hospital with breathing difficulties. I can only say from my own experience I am glad this happened before we went to bed for the night, my daughter probably would not be here with us right now. If there is a problem with this shot, I can only hope to warn others to monitor their babies closely.
Age: 1.3
Sex: M
Vaccine: HIBV, MMR, PNC, UNK, VARCEL
Symptoms: Convulsion, Dyspnoea, Pyrexia
Clinical narrative: On 03/29/01 father of child returned with patient for trouble breathing. He reported to a nurse that on 03/28/01 approximately 1:00 AM, the child began with seizures and the EMS was called. Transported to the ER released later. Give Motrin and Tylenol, and see PCP. The PCP was seen later that day with same treatment for the fever. On 03/30/01, child report having fever of 101, treatment being followed. On 04/02/01 the child was afebrile, no other symptoms reported.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Erythema, Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site rash
Clinical narrative: On 4/23/01 the pt experienced 5cm x 3cm wheal at the injection site. On 4/24/01, there were erythematous areas surroudning ears and cheeks the left greater than the right. The injection site had a 6cm round indurated erythematous area. The pt had a temp of 100 axillary, treated with Motrin. On 4/25/01 the injection site was still induratied with redness, Motrin given again. Face and ears had rash. On 4/26/01 the injection had grown to 10cm round, was hot, indurated and had a hematoma.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Injection site reaction, Injection site warmth, Pyrexia, Urticaria
Clinical narrative: On 4/23/01 the pt experienced 5cm x 3cm wheal at the injection site. On 4/24/01, there were erythematous areas surroudning ears and cheeks the left greater than the right. The injection site had a 6cm round indurated erythematous area. The pt had a temp of 100 axillary, treated with Motrin. On 4/25/01 the injection site was still induratied with redness, Motrin given again. Face and ears had rash. On 4/26/01 the injection had grown to 10cm round, was hot, indurated and had a hematoma.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Erythema, Skin nodule
Clinical narrative: This infant had a little knot with redness.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Oedema, Screaming
Clinical narrative: On 04/13/01, this patient's mother called at 12:30 stating the infant hadn't stopped crying since he was given the immunization 04/12/01. No fever or rash, gave the infant Tylenol. She couldn't see what was causing him to cry, no transportation to bring him to the MD. The mother promised to carry him to the PMD. The grandmother noted his left thigh was swollen and the infant's thigh was rubbed with alcohol and he stopped crying. The infant was not carried to the PMD and as of 04/19/01, no other problems.
Age: 0.75
Sex: M
Vaccine: HEP, PNC
Symptoms: Erythema, Feeling hot, Injection site induration
Clinical narrative: Pt developed induration, erythema and warmth about the size of a 50 cent piece.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Contusion, Pain
Clinical narrative: This patient received a vaccine on 04/13/01, he developed a large bruise to the site of injection. Cellulitis extends from the site of the injection to below the elbow. The patient was treated with Augmentin for 10 days, Motrin as needed for the pain, and warm compress to the site.
Age: 40.0
Sex: F
Vaccine: LYME
Symptoms: Arthropathy, Chills, Discomfort, Myalgia, Pyrexia
Clinical narrative: Report 2001010237-1 describes migratory joint discomfort in a 40 year old female who received Lyme disease vaccine recombinant OspA (Lymerix). Medical history included "many somatic complaints". Concurrent medications were not specified. The patient received two injections of Lymerix on unspecified dates. At some later time, she experienced migratory joint discomfort. As of 04/24/01, the joint discomfort had persisted for several months and was ongoing. The reporting physician considered the joint discomfort to be "probably not related" to Lymerix administration. The adverse event of migratory joint discomfort does not meet ICH serious criteria, but is being submitted as an expedited report by report by special FDA request per the June 28, 2000 letter. On 08/02/2001, additional info was received from a different physician within the initial reporter's group. The second physician did not confirm the occurrence of migratory joint discomfort. The second physician reproted that on 04/29/1999, the pt experienced chills, fever and myalgias. These events were of moderate intensity. No laboratory evaluations were performed. The chills, fever, and myalgias resovlved after an unspecified period of time. the second physician considered the chills, fever, and myalgias to be possibly related to LYMErix administration, and the immunization series was discontinued. The follow up states that the additional info was received from another physician within the same medical group. Medical history also included osteoarthritis. The pt had no known drug allergies. There were no concurrent medications. The initial reporter stated that the patient received one injection of LYMErix on 04/28/1999. On 08/02/2001, additional info was received from a different physician within the initial reporter's group. The second physician did not confirm the occurrence of migratory joint discomfort. The second physician reported that, on 04/29/1999, the pt experienced chills, fever and myalgias. These events were of moderate intensity. No laboratory evaluations were performed. The chills, fever, and myalgias resolved after an unspecified period  of time. The second physician considered the chills, fever, and myalgias to be possibly related to LYMErix administration, and te immunization series was discontinued.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Feeling hot, Injection site reaction, Otitis media
Clinical narrative: This infant had a 2 inch diameter reaction around the area of DTaP. Warm to touch. Giving him Motrin and cool compresses to the area, left thigh. On Augmentin for 2 weeks for Serous Otitis Media. Started 04/18/01.
Age: 1.5
Sex: M
Vaccine: HIBV, OPV, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: A child received Varivax at 18 months of age. At 7 yrs and 3 mos, he developed a mild distinct case of chicken pox precisely 14 days post-exposure to a classmate who developed varicella.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: This child had varicella begin on 04/18/01, only 12 lesions. He had Varivax vaccine 08/25/00, failed vaccine.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Convulsion
Clinical narrative: 10 minutes after immunization was given, as the patient was leaving the examining room, she turned around and started seizing and fell down. The seizure lasted less than 30 seconds. The patient recovered completely.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Infection, Laboratory test abnormal, Lymphadenopathy, Muscle spasms
Clinical narrative: This patient received MMR at their primary physicians office on 03/09/01 (after neg mump titer). By 03/28/01, she noted right node by both, right jaw / neck very swollen, she had a low grade temp, intense facial pain with spasms, especially after eating. The symptoms gradually went away in 10 days. Fatigue lasted 10 days. Diagnosed with Mumps disease
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pyrexia
Clinical narrative: This patient received MMR at their primary physicians office on 03/09/01 (after neg mump titer). By 03/28/01, she noted right node by both, right jaw / neck very swollen, she had a low grade temp, intense facial pain with spasms, especially after eating. The symptoms gradually went away in 10 days. Fatigue lasted 10 days. Diagnosed with Mumps disease
Age: 0.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Rash papular
Clinical narrative: This infant had localized erythema, swelling,and a papular rash. Treated with oral Benadryl.
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: This patient had swollen cervical and occipital lymph glands, fever, and myalgias.
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Asthenia, Chills, Sleep disorder
Clinical narrative: After my physical exam last Monday, March 12, she was given Pneumovax injection, a vaccine against bacterial pneumonia, about 3 PM. The person who gave her the shot and I talked jovially about the side effects which were dismissed as basically nil. About 5 PM the same day, only two hours after the shot, I began to experience malarial chills, (These were similar to malaria which I had when I was 11). These became worse as the evening wore on. So I had a warm bath and went to bed a little earlier than usual. But my sleep was extremely disturbed. The next day, Tuesday, was even worse. The chills started again, then petered out and started again. By noon I had to take a noon nap. This is extremely rare for me. My normal energetic self had been changed into a slowly walking exhausted and sick man; just as the same as when I returned from overseas several years ago. I had fish poisoning on the eve of my departure. The flight back took 14 hours flying with diarrhea all the way, waited for the connections to Washington. I walked off the plane looking ghastly sick. That's what my wife said I looked like on Tuesday last. I literally dragged myself around all day. On Wednesday, I had recovered 95%. My reaction to the vaccine was absolutely horrendous for 36 hours. Please include this report in my medical record and, in all fairness to others, the FDA should also be notified of this reaction. I wish I had been told that there may be this kind of reaction to the vaccine. May I hear from you about this matter?
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Lethargy, Pyrexia, Sinusitis, Thrombocytopenic purpura
Clinical narrative: It was reported that a 5 year-old male patient received IPOL and a Tripedia vaccination on 03/29/2001. Reportedly, the next day the patient developed a fever of 102 F and lethargy. One week later, he dedveloped sinusitis and a reccurrence of ITP (Idiopathic thrombocytopenic purpura). From FOLLOW-UP telephone contact on 08/15/2001 with vaccinatin physician it was stated that the patient received a DTP vaccination in 1977 (Tetramune) and developed ITP a couple weeks later. After the resolution of the ITP platelets counts were discontinued "On 03/29/2001, (patient) was given a DAPT vaccine in the left arm He developed bruises and a platelet count on 04/05/2001 was 55,000. He was again followed by Hospital and platelet counts have since returned to normal without treatment.
Age: 3.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Autism, Neurodevelopmental disorder
Clinical narrative: Autism, PDD
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Haemorrhage, Injection site erythema, Injection site oedema, Muscle disorder, Myositis
Clinical narrative: The pt experienced an adverse reaction after receiving the tetanus and diphtheria adsorbed vaccine which included acute swelling, red blotches, internal bleeding and deep pain. It progressed to loss of feeling 90% in pt's arm.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Pain, Paraesthesia, Rash macular
Clinical narrative: The pt experienced an adverse reaction after receiving the tetanus and diphtheria adsorbed vaccine which included acute swelling, red blotches, internal bleeding and deep pain. It progressed to loss of feeling 90% in pt's arm.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Difficulty in walking, Influenza like illness, Lethargy, Nausea, Vomiting
Clinical narrative: A report received from a health professional on 04/09/01 concerning a 7 year old, male patient who experienced flu-like symptoms, severe nausea, vomiting, and lethargy one day after receiving the Fluvirin vaccine, IM on 03/01/01, which led to hospitalization. The patient has a relevant medical history of sickle cell disease. The patient received a dose of Prevnar concomitantly. On 03/02/01, the patient experienced a syndrome of events including flu-like symptoms, sever nausea, vomiting, and lethargy for the duration of one week. The patient was not fully ambulatory and required inpatient hospitalization. The reporter was unsure of the duration of hospitalization. The patient was eventually discharged without further complications. After this adverse experience the physician noticed that his current stock of Fluvirin vaccines had partially crystallized. The reporter noted that the storage temp was 33 degrees F, below the recommended 36-46 degrees F for this product. It was recommended that the remainder of the physician's stock be discarded. There was insufficient info to determine the causality assessment of the reporter.