chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling, Musculoskeletal pain
Clinical narrative: 1-3 d after injection, had 3 cm lump at site with "pimple", redness, tenderness, pain into shoulder.  7d after injection, has 3 cm hard lump, mildly tender, complained of itching. No redness or other surface symptoms.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling 11 cm x 12 cm left upper arm with site of MMRV and moderate heart present.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: On the evening of 2/10/07 she noted swelling of 2 lymph nodes. She saw the doctor on 2/14/07. On 2/16/07 pt notes decreased in size of lymph node.  Tenderness at site resolved. No redness.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Localized reaction from vaccine redden, hard upper deltoid area on right arm.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC
Symptoms: Injection site erythema, Injection site warmth, Pyrexia, Rash generalised
Clinical narrative: Rash 2-10-07 at 3:00-over entire body by 2-12-07. Fever 2-11-07 afternoon 2" reddened area at injection site, warm to touch
Age: 1.08
Sex: F
Vaccine: IPV, MMRV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Appeared at office on 2/7/07 with rash on face, legs, moving to lower trunk, rash red and raised, site of injection red and swollen.
Age: 1.08
Sex: F
Vaccine: IPV, MMRV, MMRV
Symptoms: Injection site erythema, Rash generalised, Rash morbilliform
Clinical narrative: Appeared at office on 2/7/07 with rash on face, legs, moving to lower trunk, rash red and raised, site of injection red and swollen.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Injection site rash, Urticaria
Clinical narrative: Urticarial rash developed immediately at the site of DTaP and IPV injections.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left deltoid at injection site, red, swollen, tender x 2 days-treatment: warm compress, Keflex 250 mg-6 ml po every 6 hr x 7 days, Ibuprofen 100/5 ml 7.5 ml po and 6 hr prn
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain upper, Asthenia, Ear pain, Migraine, Otitis media acute
Clinical narrative: 2 hrs after received Adacel and Menactra developed ear pain, migraine, vomiting, generalized weakness, cold fingers, stomache, fever. Lasted 48 hrs ear pain persisted and had acute otitis media acute exam 2/9/07.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Peripheral coldness, Pyrexia, Virus culture, Vomiting
Clinical narrative: 2 hrs after received Adacel and Menactra developed ear pain, migraine, vomiting, generalized weakness, cold fingers, stomache, fever. Lasted 48 hrs ear pain persisted and had acute otitis media acute exam 2/9/07.
Age: 36.0
Sex: M
Vaccine: IPV, MNQ, TDAP, TYP
Symptoms: Convulsion, Urinary incontinence
Clinical narrative: Immediately following the administration of 4th vaccine, client slumped over in chair, appeared to experience a seizure and was incontinent of urine.  Episode lasted approximately 30-45 seconds.  No apparent LOC. No SOB or respiratory distress noted.  Cold compress applied to neck. EMS arrived and client agreed to transport to local hospital for further evaluation.03/06/07-records received from facility for DOS 02/08/07-DX Syncope. Denies fall or injury-evaluated in ER and discharged. No diagnostics ordered.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Nausea, Tremor
Clinical narrative: Pt received Gardasil on Feb 5 2007 in pm. She went home the next day she woke up 6:00 am with dizziness, legs shaking, nauseated, feeling faint lasting 3 days unable to go to school.  The fourth day she felt better.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Bedridden, Dizziness, Flushing, Muscular weakness, Nausea
Clinical narrative: Pt received Gardasil on Feb 5 2007 in pm. She went home the next day she woke up 6:00 am with dizziness, legs shaking, nauseated, feeling faint lasting 3 days unable to go to school.  The fourth day she felt better.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope, Tremor
Clinical narrative: Pt received Gardasil on Feb 5 2007 in pm. She went home the next day she woke up 6:00 am with dizziness, legs shaking, nauseated, feeling faint lasting 3 days unable to go to school.  The fourth day she felt better.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Induration, Rash pruritic, Skin warm
Clinical narrative: Vaccine administered 2-19-07 in thigh.  Dark red, circular patch 3x5 cm approx.  Lighter red excoriated surrounding patch w/indistinct borders.  Mildly indurated.  Severe puritic, warm to touch. Presented to office 2-20 and 2-21 w/above symptoms. Oral antibiotic-Amoxicillin given and Benadryl to be used PRN. Left thigh
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Eye oedema, Induration, Injection site oedema
Clinical narrative: edema around eyes and face.  redness, induration and edema at site of injection
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Supportive therapy Aveeno bath, Caladryl lotion, Benadryl
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Dry skin, Erythema, Pruritus
Clinical narrative: red spots, dry skin, itching on arms, legs, chest monitor
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Anorexia, Back pain, Disturbance in attention, Joint swelling, Musculoskeletal pain
Clinical narrative: The evening after receiving MMR pt started having hand tremors. She woke up the next morning with a sore back, neck and shoulders. Her jaw was swollen and sore the to point she could not eat.  On the 12th her ankles became swollen.  She is having trouble concentrating.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Neck pain, Osteitis, Pain in jaw, Tremor
Clinical narrative: The evening after receiving MMR pt started having hand tremors. She woke up the next morning with a sore back, neck and shoulders. Her jaw was swollen and sore the to point she could not eat.  On the 12th her ankles became swollen.  She is having trouble concentrating.
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Swelling
Clinical narrative: Pt presents with left upper arm pain and swelling, 1 day after the pneumoccal vaccination
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 1.16
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Unevaluable event
Clinical narrative: Child received immunization on 02/06/2007 per my conversation with mom. Child was transported to emergency room via EMS for possible seizure. Was told by emergency room physician to follow up with primary care provider.
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration, Injection site pain, Skin warm
Clinical narrative: PT presented 3 days after vaccination c/o 1 day l/o redness, swelling, pain surrounding injection site. Warm, indurated. Cellulitis diagnosed and treated with antibiotics.
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: PT presented 3 days after vaccination c/o 1 day l/o redness, swelling, pain surrounding injection site. Warm, indurated. Cellulitis diagnosed and treated with antibiotics.
Sex: M
Vaccine: HEP
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Red bumps like a rash or hives, it lasted about 2 weeks to 2 1/2 weeks vaccine does mention that side effect may be hives. First day he was fine the next day his skin broke out.
Age: 71.0
Sex: M
Vaccine: HEPA, TD, TYP
Symptoms: Erythema, Infection, Pain
Clinical narrative: Son called health dept. stated arm red and sore, took dad to doctor and was told infected given pills.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Joint range of motion decreased, Mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Pt developed pain, swelling redness 9cm x 9cm area R deltoid and decrease ROM of R arm.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature, Burning sensation, Erythema, Local reaction, Pain in extremity
Clinical narrative: Client received vaccine at 10am presented to PMD office at 2pm c/o arm pain, shaking and burning on bottom of feet. Temp 100.6 orally. MD DX with local reaction, tender to palpation with redness or swelling. was given Decadron IM. RTC this am for recheck arm improved, no fever.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Swelling, Tenderness, Tremor
Clinical narrative: Client received vaccine at 10am presented to PMD office at 2pm c/o arm pain, shaking and burning on bottom of feet. Temp 100.6 orally. MD DX with local reaction, tender to palpation with redness or swelling. was given Decadron IM. RTC this am for recheck arm improved, no fever.
Age: 53.0
Sex: M
Vaccine: MMR
Symptoms: Blood creatinine decreased, Fatigue, Full blood count, Oedema peripheral, Rash generalised
Clinical narrative: About 1/27/07 head to toe rash and hives edema in legs. Decreased urine output, tired, seen in ER and referred to personal MD on 1-30-07. Dr placed on Benadryl PO and hydrocortisone cream and and review of lab work as ordered by MD.
Age: 53.0
Sex: M
Vaccine: MMR
Symptoms: Urine output decreased
Clinical narrative: About 1/27/07 head to toe rash and hives edema in legs. Decreased urine output, tired, seen in ER and referred to personal MD on 1-30-07. Dr placed on Benadryl PO and hydrocortisone cream and and review of lab work as ordered by MD.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, VARCEL
Symptoms: Decreased appetite, Pyrexia, Rash
Clinical narrative: 3 days after vaccination woke up with bumpy rash on face, lips, hands, legs and trunk, no itching, decreased appetite because lips hurt, fever x2 days. TX with Tylenol. 1-31/06 still has rash has DR appt today.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Warmth, redness, induration and pain R anterio lateral thigh approx 36 hours after vaccine.
Age: 0.48
Sex: F
Vaccine: HIBV
Symptoms: Agitation, Crying, Injection site nodule, Pyrexia
Clinical narrative: Initial and follow up information has been received from a physician concerning a 5 month old female who on 09-JAN-2006, at "likely 5 PM"(exact time not specified), was vaccinated into the left thigh with the second dose of PedvaxHIB (Lot#652226/0655R). It was reported that the patient had been vaccinated with a prior dose of PedvaxHIB (details of the first vaccination date and lot number number were not reported) and no reaction. There were no illness at the time of vaccination. It was reported that less than 24 hours after receiving the vaccine, the patient presented with "hysterical crying" and was "inconsolable to parents". It was reported that the patient developed a "fever to 10.1 rectally" (previously reported that on an unspecified date, the child developed an "unusually severe reaction" involving "high fever", "inconsolable crying" and "red lumps at the injection site"). The physician reported that she saw the patient on 14-MAR-2006 and she "looked perfect". It was reported that the patient was fully recovered. The physician checked with parents of other children vaccinated with this lot number and they were fine. A lot check of concern has been requested. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. In addition, a review of the Quality control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill. No further information is available.
Age: 0.42
Sex: F
Vaccine: HIBV
Symptoms: Crying, Injection site nodule, Pyrexia
Clinical narrative: Initial and follow up information has been received from a physician concerning a 5 month old female who on an unspecified date, was vaccinated with the first dose of PedvaxHIB  (Lot# 652226/0655R). It was reported that the patient's mother had requested to wait and vaccinate the patient with PedvaxHIB at the 5 month visit. It was reported that the patient was well at the time of vaccination and did not received any other concomitant vaccines on the day of vaccination with PedvaxHIB. On an unspecified date, the child developed an "unusually severe reaction" involving "high fever", "inconsolable crying," "red lumps at the injection site" and " a sore at the injection site". On an unspecified date, the patient recovered from the events. It was noted that a twin sibling had a similar experience following vaccination with PedvaxHIB, (WAES#0601USA01931). The physician checked with parents of the other children vaccinated with this lot number and they were fine. A lot check of concern has been requested. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. In addition, a review of the Quality control Quarantine/Rejection System that there were no open Quarantines registered against this lot/fill. No further information is available.
Age: 0.6
Sex: M
Vaccine: HIBV
Symptoms: Agitation neonatal, Crying, Induration, Injection site nodule, Injection site reaction
Clinical narrative: Initial and follow up information has been received from a physician concerning a 5 month old white with no pre-existing allergies, birth defects, or medical conditions reported. On 03-JAN-2006, at approximately 3 PM, the patient was vaccinated into the right thigh with the first dose of PedvaxHIB (Lot#65226/0655R). It was reported that the patient's mother had requested to wait and vaccinate the patient at his 5 month visit. It was reported that the patient was well at the time of vaccination and did not receive any other concomitant vaccines on the day of the vaccination with PedvaxHIB. On 03-JAN-2006, at approximately 6 or 7 PM, the patient developed "inconsolable crying" and was "not as responsive to mother when crying". It was further noted that the patient had a "thigh hard" and was "sore at injection site" (previously reported that the child developed an "unusually severe reaction" involving "high fevers", "inconsolable crying" and "red lumps at the injection site". On 10-JAN-2006, (also reported as the patient "one week later, was still not sleeping as well'). There were no signs or symptoms of illness and the patient was "still not as responsive". The patient's mother reported that the patient was "not himself" and more fussy" for 2 to 3 weeks after the vaccination. At the time of this report, the patient had recovered from the events (date unknown). It was noted that a twin brother had a similar experience following vaccination with PedvaxHIB (WAES#0601USA01930). The physician checked with parents of other children vaccinated with this lot number and they were fine. A lot check of concern has been requested. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no pen Quarantines registered that there were no open Quarantines registered against this lot/fill. Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia, Sleep disorder, Unresponsive to stimuli
Clinical narrative: Initial and follow up information has been received from a physician concerning a 5 month old white with no pre-existing allergies, birth defects, or medical conditions reported. On 03-JAN-2006, at approximately 3 PM, the patient was vaccinated into the right thigh with the first dose of PedvaxHIB (Lot#65226/0655R). It was reported that the patient's mother had requested to wait and vaccinate the patient at his 5 month visit. It was reported that the patient was well at the time of vaccination and did not receive any other concomitant vaccines on the day of the vaccination with PedvaxHIB. On 03-JAN-2006, at approximately 6 or 7 PM, the patient developed "inconsolable crying" and was "not as responsive to mother when crying". It was further noted that the patient had a "thigh hard" and was "sore at injection site" (previously reported that the child developed an "unusually severe reaction" involving "high fevers", "inconsolable crying" and "red lumps at the injection site". On 10-JAN-2006, (also reported as the patient "one week later, was still not sleeping as well'). There were no signs or symptoms of illness and the patient was "still not as responsive". The patient's mother reported that the patient was "not himself" and more fussy" for 2 to 3 weeks after the vaccination. At the time of this report, the patient had recovered from the events (date unknown). It was noted that a twin brother had a similar experience following vaccination with PedvaxHIB (WAES#0601USA01930). The physician checked with parents of other children vaccinated with this lot number and they were fine. A lot check of concern has been requested. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no pen Quarantines registered that there were no open Quarantines registered against this lot/fill. Additional information has been requested.
Age: 1.7
Sex: M
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male infant at 2 months of age was vaccinated with Comvax. At 8 months of age, approximately 10-SEP-2005, and on 26-JAN-2006 the patient was vaccinated intramuscularly with a 0.5 ml first and a second dose of Hib conj vaccine. There was no concomitant medication. A slight injection site reaction was noted. It was also reported that the patient had received 2 doses of Pediarix, dates unknown and some of the injections were given at another practice. Unspecified medical attention was sought. No product quality complaint was involved. Outcome unknown. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Movement disorder, Myoclonus
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a 6 month old male with no past medical history, who on 03-MAY-2006 at 11:00 AM was vaccinated intramuscularly in the left thigh with the third dose of PedvaxHib (lot #652500/1006R). Concomitant vaccination on 03-MAY-2006 included the third dose of Pediarix (lot #AC21B056AA) given in the right thigh. The patient had no illnesses at the time of vaccination, and had no adverse events following prior vaccinations. On 03-MAY-2006, at 4:00 PM, the patient developed a "drawing of the neck to the left". The movement of the neck was repetitive (10-15 times per minute). The movement was described as being "not seizure like" but was described as myoclonus. The patient was previously vaccinated with the second dose of PedvaxHib (lot #652500/1006R) which was "tolerated fine". Unspecified medical attention was sought. At the time of this report, the myoclonus persisted. The patient was scheduled to undergo an EEG. The patient's physician felt that the event was not related to therapy with PedvaxHib. No further information is expected.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 week old male infant who on approximately 12-MAY-2006 was vaccinated (route unknown) with PedvaxHIB (Lot # unknown). On the same day, the child was given a dose of Prevnar and a dose of Pediarix. On approximately 12-MAY-2006 the patient developed fever and diarrhea. Subsequently, the patient recovered from fever and diarrhea. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Adverse event
Clinical narrative: Information has been received regarding a case in litigation concerning a patient (age and gender unknown) who was vaccinated (route unknown) with 3 doses of PedvaxHIB (lot#627932/0981H, 626622/0427H, and 626413/0215H). Subsequently, on an unknown date the patient experienced an unspecified adverse experience. The outcome of the patient's experience was not reported. No further information is available.
Age: 0.35
Sex: F
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumin, Blood calcium normal, CSF glucose
Clinical narrative: Information has been received from a physician concerning an 16 week old, female, with no pre-existing allergies, birth defects or medical conditions, who reportedly weighted 16 pounds (lbs) and 5 ounces (oz)and whose height was 25 and 3/4 inches (in) who in the "PM" on 15-AUG-2006 was vaccinated intramuscularly in the left thigh with a second dose of Hib conj vaccine (Lot #652867/0084F). On 15-AUG-2006, the patient developed seizure. On 16-AUG-2006, in the "PM" the patient developed seizure and urinary tract infection (UTI). Laboratory evaluation revealed aspartate aminotransferase 40, alanine aminotransferase 28, alkaline phosphatase 206, total bilirubin 0.1, ammonia 41, total protein 5.2, albumin 3.7, cerebral spinal fluid revealed: glucose 62, protein 22, 0 red blood cells, 0 white blood cells and urine culture revealed: E-coli >100,000. The patient had a renal ultrasound. Subsequently, on 17-AUG-2006, the patient recovered from seizure, and UTI. It was reported the patient had one sibling. Upon internal review, it was considered that seizure was an other important medical event.
Age: 0.35
Sex: F
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC
Symptoms: CSF protein, Convulsion, Haemolysis, Laboratory test, Protein total decreased
Clinical narrative: Information has been received from a physician concerning an 16 week old, female, with no pre-existing allergies, birth defects or medical conditions, who reportedly weighted 16 pounds (lbs) and 5 ounces (oz)and whose height was 25 and 3/4 inches (in) who in the "PM" on 15-AUG-2006 was vaccinated intramuscularly in the left thigh with a second dose of Hib conj vaccine (Lot #652867/0084F). On 15-AUG-2006, the patient developed seizure. On 16-AUG-2006, in the "PM" the patient developed seizure and urinary tract infection (UTI). Laboratory evaluation revealed aspartate aminotransferase 40, alanine aminotransferase 28, alkaline phosphatase 206, total bilirubin 0.1, ammonia 41, total protein 5.2, albumin 3.7, cerebral spinal fluid revealed: glucose 62, protein 22, 0 red blood cells, 0 white blood cells and urine culture revealed: E-coli >100,000. The patient had a renal ultrasound. Subsequently, on 17-AUG-2006, the patient recovered from seizure, and UTI. It was reported the patient had one sibling. Upon internal review, it was considered that seizure was an other important medical event.
Age: 0.35
Sex: F
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC
Symptoms: Ultrasound kidney, Urinary tract infection, Urine analysis
Clinical narrative: Information has been received from a physician concerning an 16 week old, female, with no pre-existing allergies, birth defects or medical conditions, who reportedly weighted 16 pounds (lbs) and 5 ounces (oz)and whose height was 25 and 3/4 inches (in) who in the "PM" on 15-AUG-2006 was vaccinated intramuscularly in the left thigh with a second dose of Hib conj vaccine (Lot #652867/0084F). On 15-AUG-2006, the patient developed seizure. On 16-AUG-2006, in the "PM" the patient developed seizure and urinary tract infection (UTI). Laboratory evaluation revealed aspartate aminotransferase 40, alanine aminotransferase 28, alkaline phosphatase 206, total bilirubin 0.1, ammonia 41, total protein 5.2, albumin 3.7, cerebral spinal fluid revealed: glucose 62, protein 22, 0 red blood cells, 0 white blood cells and urine culture revealed: E-coli >100,000. The patient had a renal ultrasound. Subsequently, on 17-AUG-2006, the patient recovered from seizure, and UTI. It was reported the patient had one sibling. Upon internal review, it was considered that seizure was an other important medical event.
Age: 0.35
Sex: F
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC
Symptoms: Alanine aminotransferase normal, Ammonia decreased, Aspartate aminotransferase normal, Band neutrophil count decreased, Blood albumin normal
Clinical narrative: Information has been received from a physician concerning an 16 week old, female, with no pre-existing allergies, birth defects or medical conditions, who reportedly weighted 16 pounds (lbs) and 5 ounces (oz)and whose height was 25 and 3/4 inches (in) who in the "PM" on 15-AUG-2006 was vaccinated intramuscularly in the left thigh with a second dose of Hib conj vaccine (Lot #652867/0084F). On 15-AUG-2006, the patient developed seizure. On 16-AUG-2006, in the "PM" the patient developed seizure and urinary tract infection (UTI). Laboratory evaluation revealed aspartate aminotransferase 40, alanine aminotransferase 28, alkaline phosphatase 206, total bilirubin 0.1, ammonia 41, total protein 5.2, albumin 3.7, cerebral spinal fluid revealed: glucose 62, protein 22, 0 red blood cells, 0 white blood cells and urine culture revealed: E-coli >100,000. The patient had a renal ultrasound. Subsequently, on 17-AUG-2006, the patient recovered from seizure, and UTI. It was reported the patient had one sibling. Upon internal review, it was considered that seizure was an other important medical event.
Age: 0.35
Sex: F
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC
Symptoms: Blood alkaline phosphatase normal, Blood bicarbonate normal, Blood bilirubin abnormal, Blood chloride increased, Blood creatinine decreased
Clinical narrative: Information has been received from a physician concerning an 16 week old, female, with no pre-existing allergies, birth defects or medical conditions, who reportedly weighted 16 pounds (lbs) and 5 ounces (oz)and whose height was 25 and 3/4 inches (in) who in the "PM" on 15-AUG-2006 was vaccinated intramuscularly in the left thigh with a second dose of Hib conj vaccine (Lot #652867/0084F). On 15-AUG-2006, the patient developed seizure. On 16-AUG-2006, in the "PM" the patient developed seizure and urinary tract infection (UTI). Laboratory evaluation revealed aspartate aminotransferase 40, alanine aminotransferase 28, alkaline phosphatase 206, total bilirubin 0.1, ammonia 41, total protein 5.2, albumin 3.7, cerebral spinal fluid revealed: glucose 62, protein 22, 0 red blood cells, 0 white blood cells and urine culture revealed: E-coli >100,000. The patient had a renal ultrasound. Subsequently, on 17-AUG-2006, the patient recovered from seizure, and UTI. It was reported the patient had one sibling. Upon internal review, it was considered that seizure was an other important medical event.
Age: 0.35
Sex: F
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC
Symptoms: Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea normal, Convulsion
Clinical narrative: Information has been received from a physician concerning an 16 week old, female, with no pre-existing allergies, birth defects or medical conditions, who reportedly weighted 16 pounds (lbs) and 5 ounces (oz)and whose height was 25 and 3/4 inches (in) who in the "PM" on 15-AUG-2006 was vaccinated intramuscularly in the left thigh with a second dose of Hib conj vaccine (Lot #652867/0084F). On 15-AUG-2006, the patient developed seizure. On 16-AUG-2006, in the "PM" the patient developed seizure and urinary tract infection (UTI). Laboratory evaluation revealed aspartate aminotransferase 40, alanine aminotransferase 28, alkaline phosphatase 206, total bilirubin 0.1, ammonia 41, total protein 5.2, albumin 3.7, cerebral spinal fluid revealed: glucose 62, protein 22, 0 red blood cells, 0 white blood cells and urine culture revealed: E-coli >100,000. The patient had a renal ultrasound. Subsequently, on 17-AUG-2006, the patient recovered from seizure, and UTI. It was reported the patient had one sibling. Upon internal review, it was considered that seizure was an other important medical event.
Age: 0.35
Sex: F
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC
Symptoms: Culture urine positive, Electroencephalogram normal, Eosinophil count normal, Escherichia infection, Haematocrit normal
Clinical narrative: Information has been received from a physician concerning an 16 week old, female, with no pre-existing allergies, birth defects or medical conditions, who reportedly weighted 16 pounds (lbs) and 5 ounces (oz)and whose height was 25 and 3/4 inches (in) who in the "PM" on 15-AUG-2006 was vaccinated intramuscularly in the left thigh with a second dose of Hib conj vaccine (Lot #652867/0084F). On 15-AUG-2006, the patient developed seizure. On 16-AUG-2006, in the "PM" the patient developed seizure and urinary tract infection (UTI). Laboratory evaluation revealed aspartate aminotransferase 40, alanine aminotransferase 28, alkaline phosphatase 206, total bilirubin 0.1, ammonia 41, total protein 5.2, albumin 3.7, cerebral spinal fluid revealed: glucose 62, protein 22, 0 red blood cells, 0 white blood cells and urine culture revealed: E-coli >100,000. The patient had a renal ultrasound. Subsequently, on 17-AUG-2006, the patient recovered from seizure, and UTI. It was reported the patient had one sibling. Upon internal review, it was considered that seizure was an other important medical event.
Age: 0.35
Sex: F
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC
Symptoms: Haemoglobin normal, Nuclear magnetic resonance imaging normal, Platelet count increased, Urinary tract infection, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning an 16 week old, female, with no pre-existing allergies, birth defects or medical conditions, who reportedly weighted 16 pounds (lbs) and 5 ounces (oz)and whose height was 25 and 3/4 inches (in) who in the "PM" on 15-AUG-2006 was vaccinated intramuscularly in the left thigh with a second dose of Hib conj vaccine (Lot #652867/0084F). On 15-AUG-2006, the patient developed seizure. On 16-AUG-2006, in the "PM" the patient developed seizure and urinary tract infection (UTI). Laboratory evaluation revealed aspartate aminotransferase 40, alanine aminotransferase 28, alkaline phosphatase 206, total bilirubin 0.1, ammonia 41, total protein 5.2, albumin 3.7, cerebral spinal fluid revealed: glucose 62, protein 22, 0 red blood cells, 0 white blood cells and urine culture revealed: E-coli >100,000. The patient had a renal ultrasound. Subsequently, on 17-AUG-2006, the patient recovered from seizure, and UTI. It was reported the patient had one sibling. Upon internal review, it was considered that seizure was an other important medical event.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site rash
Clinical narrative: Information has been received from a certified medical assistant concerning a 6 month old female with no past medical history and no allergies who on 28-NOV-2006 was vaccinated with PedvaxHIB (lot#653300/0277F) (0.5 ml), IM. Concomitant therapy that day included Prevnar and Pediarix. There was no other concomitant medication. On 30-NOV-2006 the patient experienced red raised papular rash at the injection site. There were no relevant diagnostic tests of laboratory data. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site rash, Urticaria
Clinical narrative: HPV vaccine given 2/15/07. PT called office 2/20/07 with reports of "breaking out from vaccine". States on 2/18 she had hives on waist up, dry and flaky. Only "pain and pimple" at injection site (R arm). Pt denied any other changes in detergents, soap, food, perfume, lotion, etc. Pt told to take Benadryl.
Age: 14.0
Sex: M
Vaccine: FLUN3, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: 1-2 minutes after vaccine patient felt dizzy than blacked out. Lasted 1-2 minutes. No other SX at this time.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Skin lesion, Surgery
Clinical narrative: Bulus lesion then ulcerated the whole size L deltoid and and now pt has to have surgery.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Oxygen saturation decreased, Pain, Respiratory distress, Similar reaction on previous exposure to drug
Clinical narrative: Patient received influenza vaccine on 10-13-06 from unknown site. Approximately 2 days later she developed diarrhea and body aches, these symptoms progressed to respiratory distress and decreased oxygenation and she was subsequently admitted to Hospital on 10-18-06. The patient has suffered similar reactions to vaccines in the past. 3/16/07 Received medical records from hospital which reveal patient experienced difficulty breathing, SOB, fever, cough, malaise/fatigue, diarrhea & wheezing.  Developed diarrhea & myalgia 2 days s/p flu vax w/increased SOB & productive cough on day of admit.  Sats in ER were 40s w/copious secretions.  Admitted on 10/18 & tx w/IV antibiotics, nebs, CPAP & progressed well.  D/C to home on 10/20 on oral antibiotics, nebs & nightime BIPAP. FINAL DX: pneumonia & respiratory distress.
Age: 8.0
Sex: F
Vaccine: FLU3, HPV4, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: The HPV vaccine was given to a 7 yr. old girl.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Stated that injection "felt different".  No immediate pain, burning, numbness, tingling, tenderness or other symptoms upon or immediately after injection.  No symptoms experienced until at least ? 2 days later.  The arm bothers her in the left deltoid area (very localized)upon raising.  No "pain" upon rest or with some types of movement - only with certain types of movement.  Had "rotator cuff" problem in right arm and it may feel something like that but no awareness of injury to left arm.  Is unable to characterize the "pain".  Did not report or seek treatment from her private physician because it "costs too much money".  She stated that she did not try to self-treat with heat, cold or medication.  She states it has gradually improved but was concerned because of the length  of time since receiving.  She may mention to her PMD during her routine checkup in May 2007.
Age: 33.0
Sex: M
Vaccine: TYP
Symptoms: Pyrexia
Clinical narrative: pt noticed that he had a 100 degree fever for 3 days, unsure of timeframe.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Injection site swelling, Pyrexia
Clinical narrative: Left arm swelled at site of injection for 2-3 days then had fever and shortness of breath. This cleared within 24 hours while taking benadryl and tylenol only
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Barium double contrast, Culture stool, Haematochezia, Occult blood positive
Clinical narrative: Rotateq administered 2/15/07. Hematochezia began 2/18/07. Vomiting and abd pain 2/20/07. Air contrast enema negative on 2/21/07. Child better on Alimentum.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Rotateq administered 2/15/07. Hematochezia began 2/18/07. Vomiting and abd pain 2/20/07. Air contrast enema negative on 2/21/07. Child better on Alimentum.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood culture, Bowel movement irregularity, Diarrhoea, Moaning, Vomiting
Clinical narrative: Vomitting x 2 days, Diarrhea x 14 days, bowel movements as of 2/21/07, still not normal, she moans when she has a bowel.  2/26/07 Received medical records from hospital which reveal patient admitted 2/9-2/12/07 after experienced diarrhea, fever, poor oral intake & recurrent UTI.  Patient had been d/c from hospital 48 hours prior to readmission after being admitted for diarrhea & UTI.  Blood c/s at that time was neg.  Returned to PCP 2 days after d/c with Temp 102.6, poor intake & worsened diarrhea.  Admitted for IV hydration, labs & antibiotics.  By d/c, temp had resolved & was tolerating oral fluids.  D/C to home to be f/u by peds uro & VCUG, continued oral antibiotics to complete course & then prophylaxis. FINAL DX: Diarrhea; fever; hyponatremia w/dehydration; diaper rash; & recent UTI.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Gastroenteritis, Hydronephrosis, Rotavirus test negative, Urinary tract infection
Clinical narrative: Vomitting x 2 days, Diarrhea x 14 days, bowel movements as of 2/21/07, still not normal, she moans when she has a bowel.  2/26/07 Received medical records from hospital which reveal patient admitted 2/9-2/12/07 after experienced diarrhea, fever, poor oral intake & recurrent UTI.  Patient had been d/c from hospital 48 hours prior to readmission after being admitted for diarrhea & UTI.  Blood c/s at that time was neg.  Returned to PCP 2 days after d/c with Temp 102.6, poor intake & worsened diarrhea.  Admitted for IV hydration, labs & antibiotics.  By d/c, temp had resolved & was tolerating oral fluids.  D/C to home to be f/u by peds uro & VCUG, continued oral antibiotics to complete course & then prophylaxis. FINAL DX: Diarrhea; fever; hyponatremia w/dehydration; diaper rash; & recent UTI.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Vomitting x 2 days, Diarrhea x 14 days, bowel movements as of 2/21/07, still not normal, she moans when she has a bowel.  2/26/07 Received medical records from hospital which reveal patient admitted 2/9-2/12/07 after experienced diarrhea, fever, poor oral intake & recurrent UTI.  Patient had been d/c from hospital 48 hours prior to readmission after being admitted for diarrhea & UTI.  Blood c/s at that time was neg.  Returned to PCP 2 days after d/c with Temp 102.6, poor intake & worsened diarrhea.  Admitted for IV hydration, labs & antibiotics.  By d/c, temp had resolved & was tolerating oral fluids.  D/C to home to be f/u by peds uro & VCUG, continued oral antibiotics to complete course & then prophylaxis. FINAL DX: Diarrhea; fever; hyponatremia w/dehydration; diaper rash; & recent UTI.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Escherichia infection, Gastroenteritis, Urinary tract infection, Vomiting
Clinical narrative: Vomitting x 2 days, Diarrhea x 14 days, bowel movements as of 2/21/07, still not normal, she moans when she has a bowel.  2/26/07 Received medical records from hospital which reveal patient admitted 2/9-2/12/07 after experienced diarrhea, fever, poor oral intake & recurrent UTI.  Patient had been d/c from hospital 48 hours prior to readmission after being admitted for diarrhea & UTI.  Blood c/s at that time was neg.  Returned to PCP 2 days after d/c with Temp 102.6, poor intake & worsened diarrhea.  Admitted for IV hydration, labs & antibiotics.  By d/c, temp had resolved & was tolerating oral fluids.  D/C to home to be f/u by peds uro & VCUG, continued oral antibiotics to complete course & then prophylaxis. FINAL DX: Diarrhea; fever; hyponatremia w/dehydration; diaper rash; & recent UTI.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Gastroenteritis, Hydronephrosis, Renal disorder, Rotavirus test negative
Clinical narrative: Vomitting x 2 days, Diarrhea x 14 days, bowel movements as of 2/21/07, still not normal, she moans when she has a bowel.  2/26/07 Received medical records from hospital which reveal patient admitted 2/9-2/12/07 after experienced diarrhea, fever, poor oral intake & recurrent UTI.  Patient had been d/c from hospital 48 hours prior to readmission after being admitted for diarrhea & UTI.  Blood c/s at that time was neg.  Returned to PCP 2 days after d/c with Temp 102.6, poor intake & worsened diarrhea.  Admitted for IV hydration, labs & antibiotics.  By d/c, temp had resolved & was tolerating oral fluids.  D/C to home to be f/u by peds uro & VCUG, continued oral antibiotics to complete course & then prophylaxis. FINAL DX: Diarrhea; fever; hyponatremia w/dehydration; diaper rash; & recent UTI.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urinary tract infection, Vomiting
Clinical narrative: Vomitting x 2 days, Diarrhea x 14 days, bowel movements as of 2/21/07, still not normal, she moans when she has a bowel.  2/26/07 Received medical records from hospital which reveal patient admitted 2/9-2/12/07 after experienced diarrhea, fever, poor oral intake & recurrent UTI.  Patient had been d/c from hospital 48 hours prior to readmission after being admitted for diarrhea & UTI.  Blood c/s at that time was neg.  Returned to PCP 2 days after d/c with Temp 102.6, poor intake & worsened diarrhea.  Admitted for IV hydration, labs & antibiotics.  By d/c, temp had resolved & was tolerating oral fluids.  D/C to home to be f/u by peds uro & VCUG, continued oral antibiotics to complete course & then prophylaxis. FINAL DX: Diarrhea; fever; hyponatremia w/dehydration; diaper rash; & recent UTI.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Anorexia, Decreased appetite, Diarrhoea, Feeding disorder of infancy or early childhood, Laboratory test
Clinical narrative: Pt receive the ROT5 (Rotavirus live, pentavalent)  on  12/13/2006 and 02/14/2007. Almost immediately after the 2nd dose, pt's appetite began to decrease, and he stopped feeding completely on 2/16. Had a fever of 99.8 axillary on 2/16. Also had 2 loose stools within 1 hr in the late afternoon of 2/16. No vomiting. Was taken to the ER due to his complete refusal of breast or bottle feeding. Had a negative sepsis screen. Later on that day, resumed breast-feeding and all symptoms resolved.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Pt receive the ROT5 (Rotavirus live, pentavalent)  on  12/13/2006 and 02/14/2007. Almost immediately after the 2nd dose, pt's appetite began to decrease, and he stopped feeding completely on 2/16. Had a fever of 99.8 axillary on 2/16. Also had 2 loose stools within 1 hr in the late afternoon of 2/16. No vomiting. Was taken to the ER due to his complete refusal of breast or bottle feeding. Had a negative sepsis screen. Later on that day, resumed breast-feeding and all symptoms resolved.
Age: 5.0
Sex: M
Vaccine: DTPIPV
Symptoms: Pyrexia
Clinical narrative: Very High Fever 105+
Age: 0.47
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Clinical narrative: Was in apparently vigorous good health and died suddenly within a few hours after leaving clinic visit at which immunizations were administered. 4/13/07 Received autopsy report which reveals COD as SIDS as manner of death as undetermined.
Age: 32.0
Sex: M
Vaccine: FLUX, HEP, TYP
Symptoms: Cough, Headache, Pain, Pharyngolaryngeal pain, Wrong drug administered
Clinical narrative: pt complained of headache, body ache,sore throat, cough. Pt given deconamine,tessalon,and tylenol. Seen by Physician 2/7/07.Pt states immunizations record was falsefied to cover double flu vaccination. documentation show Hep B was given. Pt states he did not receive Hep B. He states he was given a yellow sticky note and sent to Technician for shot. On the note he says it stated Thyphoid and Flu. He stated when he tried to tell the tech that he had receive the flu already he was told that he was gonna have to get what was on the sticky. The pt wasn't given record of vaccination, due to the fact the nurse felt AFCITA verification would slow the process. Vaccine documentation was input at the end of the day.
Age: 19.0
Sex: F
Vaccine: HPVX
Symptoms: Arthralgia, Fatigue, Gait disturbance, Influenza like illness, Muscular weakness
Clinical narrative: 3 weeks after injection, soreness in the left and right wrist, left ankle, and left knee. Pain has worsened and at times is hard to function. E.I- Fingers and wrist get too weak and painful to use, ankle pain increases making it hard to walk. Also, the feeling of having the flu, being constantly run-down and tired. This occured a month after recieving the vaccine.
Age: 0.1
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: CDC contacted and stated that there should be no adverse effects, but these vaccines do not count and 6 weeks should lapse prior to any other vaccines being administered.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction, Angioneurotic oedema, Blood glucose normal, Blood pressure, Dizziness
Clinical narrative: On 11/20/06 this well 13 YO male had Hep BW3 and 1-1 1/2 hours after Hep B # IM the patient felt dizzy, lightheaded and had a tickle in her throat. Her school nurse did BP 100/80 P 98. Her mother took her at me request to urgent care where she had angioedema (throat swollen and lips swollen) and hives. She was treated for anaphylaxis with IV fluids, Epinephrine and Benadryl and IV steroids and released to home care.  04/02/2007 MR received for an ER visit for c/o feeling dizzy with a tickle in her throat 1 hour after 3rd Hep B vax.  While in the ER a rash developed on her back. PMH: none.  Allergies:  none.  Meds:  none. PE:  Slight eyelid edema, initially erythema at the site which resoved with Benadryl. Clinical Impression:  Allergic reaction to hep B shot.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Full blood count normal, Lip swelling, Pharyngeal oedema, Throat irritation, Urine analysis normal
Clinical narrative: On 11/20/06 this well 13 YO male had Hep BW3 and 1-1 1/2 hours after Hep B # IM the patient felt dizzy, lightheaded and had a tickle in her throat. Her school nurse did BP 100/80 P 98. Her mother took her at me request to urgent care where she had angioedema (throat swollen and lips swollen) and hives. She was treated for anaphylaxis with IV fluids, Epinephrine and Benadryl and IV steroids and released to home care.  04/02/2007 MR received for an ER visit for c/o feeling dizzy with a tickle in her throat 1 hour after 3rd Hep B vax.  While in the ER a rash developed on her back. PMH: none.  Allergies:  none.  Meds:  none. PE:  Slight eyelid edema, initially erythema at the site which resoved with Benadryl. Clinical Impression:  Allergic reaction to hep B shot.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: On 11/20/06 this well 13 YO male had Hep BW3 and 1-1 1/2 hours after Hep B # IM the patient felt dizzy, lightheaded and had a tickle in her throat. Her school nurse did BP 100/80 P 98. Her mother took her at me request to urgent care where she had angioedema (throat swollen and lips swollen) and hives. She was treated for anaphylaxis with IV fluids, Epinephrine and Benadryl and IV steroids and released to home care.  04/02/2007 MR received for an ER visit for c/o feeling dizzy with a tickle in her throat 1 hour after 3rd Hep B vax.  While in the ER a rash developed on her back. PMH: none.  Allergies:  none.  Meds:  none. PE:  Slight eyelid edema, initially erythema at the site which resoved with Benadryl. Clinical Impression:  Allergic reaction to hep B shot.
Age: 1.05
Sex: F
Vaccine: DTAP, FLU3, HIBV, MMR, PNC, VARCEL
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Maculopapular erythematous lesions over neck, retro auricular torso, groin and extremities, no adenopathy.