chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Erythema, Swelling
Clinical narrative: Erythema and significant swelling at LLE one day after DTaP given. Bid Benadryl, Tylenol, cool compress and Duricef.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Feeling hot, Injection site induration, Swelling
Clinical narrative: Swelling of right thigh 7.5 inches in diameter indurated, warm to touch. Diagnosed as local reaction to immunization r/o cellulitis. Treated with Benadryl x 2 days and bid x 10 days.  Keflex suspension.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Dyskinesia, Hyperhidrosis, Postictal state, Tremor
Clinical narrative: Per father (who is an EMT) patient did well all day following shots, until approximately 10 pm. Pt was on bed found to be "soaking wet" from sweating, curled in fetal position with arms shaking (jerking, carried downstairs, was "post ictal" around 2 minutes- talked for few minutes, then eyes rolled back and did same thing. Shorter than 1 time. Alert upon arrive to ER around 10 minutes later.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Maculopapular rash started on LUE (wrist and forearm). Rash spread to other arm and both lower extremities. Rash associated with intense itching which was relieved when she took Benadryl. No other body part affected except sparingly on hands and feet. No other symptoms. Rash seems to be resolving. Rash started on 6-9-04 at 1300.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blister, Erythema, Feeling hot, Swelling
Clinical narrative: On 6/15/04: shots given. 6/17/04: pt present with complaint of area LD being red, swollen, blisters, area warm to touch. Rocephine 1cm given. Benadryl 25 mg given. Tolerated well. Pt sent to Medical center on 6/18/04.
Age: 24.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Pt noticed localized reaction left deltoid today. 6/17/04: quarter-sized erythematous, swollen area and increased itchy and warm to touch. No other symptoms noted.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Cellulitis, Contusion, Erythema, Injection site induration
Clinical narrative: Left thigh where 4th DTaP  and 4th DTaP given. Some bruising, induration, some redness. Early cellulitis secondary to above.  Warm compress and antibiotic (Amoxicillin)
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Skin discolouration, Staring
Clinical narrative: Mom states around 7:00 pm: child had blank stare and mild reaction. Legs turned purple. Took child to ER.
Age: 1.26
Sex: M
Vaccine: HIBV
Symptoms: Choking, Cyanosis, Dyspnoea, Vomiting
Clinical narrative: Had SOB and Nebulizer Tx given at home with poor results. Vomited x2 mother states child choked on emesis and turned blue and pulling to right ear x1 week.
Age: 1.5
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Swelling
Clinical narrative: Left leg swelling
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site induration
Clinical narrative: localized erythema and induration
Age: 1.08
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Pt received vaccine on 05/28/2004 came to our clinic on 06/18/04 with c/o 24 hours of rash started on face and up to trunk and leg. No fevers/other complaints. Required Benadryl as needed for itching.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema
Clinical narrative: 6cmx3cm area of erythema surrounding. No significant induration.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Infection, Swelling
Clinical narrative: Large area of swelling on right thigh with redness. No pain to palpation. Did give Keflex to use for infection.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Injection site hypersensitivity, Pruritus, Similar reaction on previous exposure to drug, Swelling
Clinical narrative: Patient is a 29 year old male who developed extensive arm redness and swelling within 48 hrs of receipt of AVA # 8. He reported only minor swelling and redness with previous anthrax immunizations. Patient reports that during the first 24 hrs he had minor redness and swelling and that on the following day the redness and swelling extended form elbow to wrist. He did have itching at the site. Stated his skin felt hot. He denied fever or chills. On 28 May he went to his doctor who then contacted the HC. The physician stated that his arm was red, swollen and hot from shoulder to wrist. There was no fever or lymphadenopathy and nor was there evidence of cellulitis. The vaccine was administered subcutaneously in the tricep area. Management guidelines provided with follow up scheduled. During follow up conservation on 01 June patient reported that the swelling had decreased the following day and is currently doing better. He stated he was treated with rest and Allegra and did not require ibuprofen.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Muscular weakness
Clinical narrative: muscle weakness involving hand, arms, legs following tetanus booster
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Cardiac arrest, Coma, Convulsion, Gastrointestinal disorder, Hypertonia
Clinical narrative: Patient went into full cardiac and respiratory arrest around 3:30 PM on 06/15/2004. He suffered a sub arachnoid hemorhage as well as some retinal hemmorages.  Also there are areas of watershed infarcts due to severe hypoxia.  He is currently in the ICU in a comatose state. Information receive from annually follow up states Seizure disorder, gastrostomy tube dependent , visual impairment, hypertonic, inability to sit or stand at approx. 17 mo old, does not speak, prognosis unknown. These shots nearly killed my son and anyone needing or wanting to contact me about this is more than welcome to these specific shot/lots are dangerous.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Hypoxia, Infarction, Respiratory arrest, Retinal haemorrhage, Speech disorder
Clinical narrative: Patient went into full cardiac and respiratory arrest around 3:30 PM on 06/15/2004. He suffered a sub arachnoid hemorhage as well as some retinal hemmorages.  Also there are areas of watershed infarcts due to severe hypoxia.  He is currently in the ICU in a comatose state. Information receive from annually follow up states Seizure disorder, gastrostomy tube dependent , visual impairment, hypertonic, inability to sit or stand at approx. 17 mo old, does not speak, prognosis unknown. These shots nearly killed my son and anyone needing or wanting to contact me about this is more than welcome to these specific shot/lots are dangerous.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Subarachnoid haemorrhage, Visual acuity reduced
Clinical narrative: Patient went into full cardiac and respiratory arrest around 3:30 PM on 06/15/2004. He suffered a sub arachnoid hemorhage as well as some retinal hemmorages.  Also there are areas of watershed infarcts due to severe hypoxia.  He is currently in the ICU in a comatose state. Information receive from annually follow up states Seizure disorder, gastrostomy tube dependent , visual impairment, hypertonic, inability to sit or stand at approx. 17 mo old, does not speak, prognosis unknown. These shots nearly killed my son and anyone needing or wanting to contact me about this is more than welcome to these specific shot/lots are dangerous.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Apnoea, Child maltreatment syndrome, Fracture, Pulse absent, Retinal haemorrhage
Clinical narrative: Patient went into full cardiac and respiratory arrest around 3:30 PM on 06/15/2004. He suffered a sub arachnoid hemorhage as well as some retinal hemmorages.  Also there are areas of watershed infarcts due to severe hypoxia.  He is currently in the ICU in a comatose state. Information receive from annually follow up states Seizure disorder, gastrostomy tube dependent , visual impairment, hypertonic, inability to sit or stand at approx. 17 mo old, does not speak, prognosis unknown. These shots nearly killed my son and anyone needing or wanting to contact me about this is more than welcome to these specific shot/lots are dangerous.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Subarachnoid haemorrhage, Subdural haematoma
Clinical narrative: Patient went into full cardiac and respiratory arrest around 3:30 PM on 06/15/2004. He suffered a sub arachnoid hemorhage as well as some retinal hemmorages.  Also there are areas of watershed infarcts due to severe hypoxia.  He is currently in the ICU in a comatose state. Information receive from annually follow up states Seizure disorder, gastrostomy tube dependent , visual impairment, hypertonic, inability to sit or stand at approx. 17 mo old, does not speak, prognosis unknown. These shots nearly killed my son and anyone needing or wanting to contact me about this is more than welcome to these specific shot/lots are dangerous.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Cerebral haemorrhage, Child maltreatment syndrome, Coma, Retinal haemorrhage
Clinical narrative: Patient went into full cardiac and respiratory arrest around 3:30 PM on 06/15/2004. He suffered a sub arachnoid hemorhage as well as some retinal hemmorages.  Also there are areas of watershed infarcts due to severe hypoxia.  He is currently in the ICU in a comatose state. Information receive from annually follow up states Seizure disorder, gastrostomy tube dependent , visual impairment, hypertonic, inability to sit or stand at approx. 17 mo old, does not speak, prognosis unknown. These shots nearly killed my son and anyone needing or wanting to contact me about this is more than welcome to these specific shot/lots are dangerous.
Age: 0.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: 2 areas, 4cmX5cm amdm 3cmX4cm.  Both areas red, raised and warm.  Painful.  afebrile
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Pyrexia, Rash, Urticaria
Clinical narrative: Develped headache & low grade fever within 24   hours after receiving #2 Hep. B. This occured in the afternoon for 3 days before it resolved. On day 5 after vaccination developed about 20 small welts scattered through out the body from the neck down.  The welts resolved within 24 hours. The welts were followed with a lacy type rash that was also scatterd through out the body from the next down. This was pretty much resolved within 24 hours. Client states that family members had developed the same type of rash several days prior to her onset of rash and they had not received any vaccinations.
Age: 0.7
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Blood pressure decreased, Hypotonia, Hypoxia, Pallor, Pyrexia
Clinical narrative: PT HAD 9MO IMMUNIZATIONS ON 02/19/2004. TEMP 100.4 IN EVENING. GIVEN TYLENOL AND HAD RESPIRATORY DISTRESS. CLEARED AIRWAY AND SLEPT UNTIL AM 02/20/04 TEMP AGAIN 100.4 GIVEN TYLENOL SUPPOSITORY. PT STARTED TO HAVE RESPIRATORY DISTRESS AND BECAME FLOPPY WITH POOR COLOR. CALLED 911. AT ER PT'S BP DECREASED;RESPIRATION POOR INTUBATED AND AIR FLIGHTED TO ANOTHER HOSPITAL.  REMAINED ON ASSISTED BREATHING FOR 3 DAYS EXTUBATED AND DISCHARGED ON 4TH DAY (02/24/04)  Nurse follow up on 09/02/04 states: "Complete."
Age: 0.7
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Respiratory distress
Clinical narrative: PT HAD 9MO IMMUNIZATIONS ON 02/19/2004. TEMP 100.4 IN EVENING. GIVEN TYLENOL AND HAD RESPIRATORY DISTRESS. CLEARED AIRWAY AND SLEPT UNTIL AM 02/20/04 TEMP AGAIN 100.4 GIVEN TYLENOL SUPPOSITORY. PT STARTED TO HAVE RESPIRATORY DISTRESS AND BECAME FLOPPY WITH POOR COLOR. CALLED 911. AT ER PT'S BP DECREASED;RESPIRATION POOR INTUBATED AND AIR FLIGHTED TO ANOTHER HOSPITAL.  REMAINED ON ASSISTED BREATHING FOR 3 DAYS EXTUBATED AND DISCHARGED ON 4TH DAY (02/24/04)  Nurse follow up on 09/02/04 states: "Complete."
Age: 4.0
Sex: M
Vaccine: DT, MMR
Symptoms: Rash, Vasodilatation
Clinical narrative: 4/8/04: Shots at 9am doctor's clinic. Few small pinhead spots on both lower arms. No redness or itching or trouble breathing. Had waited 15 minutes 3:00pm same day. Mom called states spots red and on both arms and legs with itching. To ER (states viral: no treatment 4/9/04 doctor called / Give Benadryl. 4/12/04 seen per doctor. Do not give fourth DT.
Sex: M
Vaccine: MMR
Symptoms: Hearing impaired
Clinical narrative: Information has been received from a physician concerning a male patient who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). It was reported that the patient's mother felt that the patient became deaf due to vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). The physician reported that the patient wears bilateral hearing aids and that his mother was "terrified" to have her other children receive measles MMR (second generation). It was noted that the reporting physician was not the patient's physician at the time of the MMR live (second generation) vaccination and that he considered the patient's experience to be disabling. The physician had no other information. Unspecified medical attention was sought. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Epistaxis, Platelet count decreased
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old male student who on 01NOV2002 was vaccinated SC in the left arm with the first dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine lie (second generation) (lot #642539/0631M). On 07NOV2002, the patient developed a nosebleed, "which he had never had". Approximately one week later, the patient visited his physician, who reported that the patient's nosebleed "could be related to MMR and decreased platelet". The registered nurse reported that the patient was home schooled, had never been vaccinated and had never been ill. Subsequently, the patient recovered from the nosebleed and possible decreased platelets, "approximately two weeks later". The patient did not receive the second dose of vaccine. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Medication error, Rhinorrhoea, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a consumer concerning her 5 year old son with autism who on 01-Apr-2003 was vaccinated with a second dose of MMR live (second generation) (diluent lot #1221M). It was reported that the patient had been diagnosed with autism in September 2002, and that the physician had agreed to provide the booster vaccination for MMR live (second generation) as monovalents. The patient received a dose of measles virus vaccine, on approximately 04-Jan-2003, and a dose of rubella virus vaccine live, on approximately 04-Feb-2003, and was scheduled to receive a dose of mumps virus vaccine live on approximately 04-Apr-2003. The reporter stated that although the physician's office had mumps virus vaccine live available in the office refrigerator, the patient was "accidently given" the MMR vaccine live (second generation). The next day, on 02-Apr-2003, the patient woke up with a runny nose and a cough. The patient returned to the physician's office on 02-Apr-2003 to have the symptoms checked. It was also reported that the patient had developed autism after vaccination with the first dose of MMR vaccine live (second generation) (WAES #0304USA00462). Additional information received from the physician indicated that the patient had been born at 37 weeks gestation via cesarean section with a birth weight of 3.831 kg. The patient had a dislocation hip secondary to the birth. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 27 year old white female physical therapist with a benign thyroid cyst, benign ovarian cyst, seasonal allergies and a history of situational stress and depression who on 06-Mar-2003 at 11;30 am was vaccinated subcutaneously in the left arm with a dose of MMR live (second generation) (lot 642641/0346M) after an equivocal Rubeola titer of 1.03 on 13 Feb 2003. On 24 Feb 2003, the patient had also received a dose of diphtheria toxoid/ tetanus toxoid (batch U0528AA) intramuscularly in the left deltoid. On 04-Mar-2003, the patient also had a tuberculin purified protein derivative (APLISOL) intradermally in the right arm. The patient was concomitantly taking vitamins. There was no known illness at the time of vaccination. On 16-APR-2003 the patient experienced vaccine failure with an equivocal Rubeola titer of 0.95. Subsequently, the patient recovered. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Agitation, Lymphocyte morphology abnormal, Pyrexia, Rash, White blood cell disorder
Clinical narrative: Information has been received from a physician and follow up information from a nurse concerning a 12 month old female patient with no allergies, no problems with previous immunization, no medical history and who was well at the time of vaccination who on 01-May-2003 at 3:45 PM was vaccinated subcutaneously in the right thigh with a first dose of MMR live (second generation) (lot # 644585/1015M). Secondary suspect therapy included vaccination subcutaneously in the left thigh at 3:45 PM on 01-May-2003 with a first dose of varicella virus vaccine live (lot #641161/0796M). The vaccines were given at different sites. On 12-May-2003 the patient experienced a 103-104 degree fever for 3 days, rash and irritability (onset date of irritability also reported as the PM of 10-May-2003). Follow-up information reported that on 12-May-2003 the patient's parents called the office and reported that the child had a fever which began on 09-May-2003 (also reported as the PM of 10-May-2003) and a rash (also reported as fine rash) which began on 12-May-2003 (also reported as the PM of 10-May-2003). The child was treated with acetaminophen (Tylenol) for the fever. Follow up information reported that the patient was seen by an infectious disease physician and laboratory evaluation which was done on 14-May-2003 revealed a white blood cell count of 4.7 (10E9/L) (normal value 6.0-17.0), platelets of 144 (10E9/L) (normal value 15-35), atypical lymphocytes 17% (normal value 0-8), monocytes 13% (normal value 3-6), eosinophils 4% (normal value 0-3), slight anisocytosis and slight poikilocytosis. On 16-May-2003 the child still had a small rash on her arms, however most of the rash was resolved. On 19-May-2003 the child had broken out in a rash again and was seen in the office on 20-May-2003. The physician diagnosed the rash as a questionable contact rash. The child was started on diphenhydramine hydrochloride (Benadryl). It was reported that by 20-May-2003 the patient had no fever. Additional information has been requested.
Sex: F
Vaccine: IPV, MMR
Symptoms: Injection site erythema, Skin nodule
Clinical narrative: Information has been received from a certified medical assistant and follow up information from a physician concerning a female patient who was vaccinated in the right thigh with a dose of MMR live (second generation) (lot #640790/1378L). Concomitant therapy included vaccination in the same leg with a dose of poliovirus vaccine inactivated (manufacturer unknown). Within seconds after receiving the MMR live (second generation) immunization, the patient developed a red spot about 2 1/2 inches in diameter at the site of injection. Unspecified medical attention was sought. Follow up information per a physician note dated 14-Sep-2003, reported that the patient had no sequelae and the local reaction resolved. The only medication that the patient received was an oral antihistamine (not specified). There were no tests or labs done. No further information is expected.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis
Clinical narrative: Information has been received from a family nurse practitioner concerning a 5 year old male with a seizure disorder who on 30-May-2003 was vaccinated in the right arm with a second dose of MMR live (second generation) (lot #644643/1126M). Concomitant vaccinations, that same day, included a fifth dose of diphtheria toxoid/pertussis vaccine/ teta (Infanrix) (lot #594AZ) given IM in the left arm and a third dose of poliovirus vaccine (IPOL) (lot #W0816) given in the left arm. Other concomitant therapy included divalproex sodium (Depakote). There was no illness at the time of vaccination. On 02-Jun-2003 the patient developed cellulitis of the left upper arm-deltoid to elbow. The patient sought medical attention in the doctor's office. There were no diagnostic/laboratory tests performed. Follow-up information indicated that there was no reaction to the MMR live (second generation) which had been given in the right arm, and that the site of reaction was the left arm, where the diphtheria toxoid/pertussis vaccine/teta (Infanrix) and poliovirus vaccine (IPOL) had been given. It was noted that the patient required two doctors visits and that the cellulitis resolved with antibiotic treatment. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Tenderness
Clinical narrative: Information has been received from a RN concerning a 5 year old female student who on 23Jun03 was vaccinated SC in the left arm with a first dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). On 24Jun03 the pt reported back to the physician's office and had developed redness and tenderness in a 5 inch diameter area around the injection site. The pt was reported to be otherwise healthy and of good demeanor. Medical attention was sought at the pt was treated with amoxicillin (+) clavulanate potassium (Augmentin) 600 mg PO TID. At the time of the report, on 25Jun03, the pt was reported as recovering with sequelae. Follow up information received on 12Aug03 indicated that the pt had not returned to the physician's office since the reaction and was doing fine. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Oedema
Clinical narrative: Information has been received from a health professional concerning a 5 year old female with no medical history or allergies, who on 10-Jun-2003 at 11:15 was vaccinated SC in the left arm with a second dose of MMR vaccine live (second generation) (644155/0945M). There was no illness at the time of vaccination. On 12-Jun-2003 the patient's left arm was red and swollen. Subsequently, the patient recovered. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Erythema
Clinical narrative: Information has been received from a person at a physician's office concerning a 12 month old female patient with no illness at the time of vaccination and with a history of "33 wk-prematurity" who on 02-Jun-2003 at 10:30 am was vaccinated subcutaneously in the left arm with a first dose of MMR live (second generation) (lot #644155/0945M). The vaccine was given at 12 months of age. Several days after the injection, the patient developed "left arm red." No medical attention was sought. It was reported that the patient recovered from the "left arm red". No further information is expected.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Eye pain
Clinical narrative: Information has been received from the mother, a physician's office manager, of an 18 year old male who on 12-Jun-2003 was vaccinated with a dose of MMR vaccine live (second generation) (lot number unavailable). In June 2003 the patient experienced "trouble moving the eyes" and eye weakness. The patient's mother reported that "the physician thought he saw something on optic neuritis due to MMR. In follow-up, the patient's mother reported that the patient "saw an eye doctor and was not diagnosed with optic neuritis". The patient did not receive any treatment for his symptoms, and was "mostly recovered". The patient's mother noted that the patient still had some eye weakness. No additional information is expected.
Age: 4.0
Sex: F
Vaccine: DTP, IPV, MMR
Symptoms: Convulsion
Clinical narrative: Information has been received from a manufacturer. A consumer reported that on an unspecified date in January 2002, her 4 year old daughter was vaccinated with a dose of MMR. On the same day, the patient was also vaccinated with a dose of poliovirus vaccine and a fifth dose of diphtheria toxoid/pertussis vaccine/teta. Later that day in January 2002, the patient experienced four seizures within a 24 hour period. The patient was seen by a physician who prescribed an unspecified anticonvulsant. The mother reported that the patient had no further seizures; however, she continued to take the anticonvulsant as of 7/14/03. The patient reportedly had no adverse experiences following previous immunizations. Upon internal review, the patient's convulsions were considered an other medical event (OMIC). No further information is available.
Age: 1.67
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Erythema, Injection site swelling, Oedema, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 20 month old male with a possible sensitivity to clear adhesive who on 02-Jul-2003 at 1:22 pm was vaccinated SC/ALL with a first dose of MMR live (second generation) (lot 640790/1378L). On 02-Jul-2003, the patient was concomitantly vaccinated IM/LLR with a fourth dose of HIB conjugate vaccine (lot 645615/0144N) (previous 3 doses with HIB conj vaccine (HIBtiter). IM/LUR with a fourth dose of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia) (lot U0852CA) and IM/LL with a third dose of Streptococcus pneumoniae vaccine (Prevnar) (lot 491575). It was reported that the patient had no illness at the time of vaccination. On 02-Jul-2003, within minutes of receiving the vaccinations, the patient developed an approximately 1/2 inch raised hive about the MMR live (second generation) injection site. There was an area of redness enlarged to approximately 1 1/2 to 2 inches. It was reported that the patient also experienced extremity swelling. The patient was undressed and monitored. There was no respiratory distress. A call to emergency medical services was made at 1:27 pm. At 1:36 pm, the patient was given 0.25 ml diphenhydramine HCl IM in LL. At 1:42 pm the ambulance team arrived. No further changes at the injection site were noted. The patient was transported to the emergency room. The patient was evaluated at the emergency room and was given a "steroid liquid." The patient was discharged home, and his mother was instructed to give diphenhydramine HCL every 6 hours X 3 and continue to monitor respirations and for hives. The patient's mother reported that he was doing well. Subsequently, the patient recovered. Additional information is not expected.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cough, Infection, Pyrexia, Rash maculo-papular, Rhinorrhoea
Clinical narrative: Information has been received from a physician's assistant concerning a 14 month old female Hispanic pt with no illness at the time of vaccination, no adverse events following prior vaccinations and with no medical history and no allergies (also reported as an "unremarkable" medical history) who in the PM of 01Jul03 was vaccinated in the left deltoid with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Concomitant medication included vaccination in the left deltoid with a first dose of varicella virus vaccine live in the PM of 01Jul03. Approximately one week later (also reported on follow up as on approximately 10Jul03) the pt developed a low grade fever, runny nose and cough. Upon resolution of the runny nose and fever, a rash developed and it was on the face and trunk. Follow up information reported that the pt was seen on 22Jul03 and it was reported that approximately one week after the fever, runny nose and cough the pt developed a rash which was macular/papular and started at the hairline and spread to the trunk and extremities and it was reported that the rash had been present for about 1 1/2 to 2 weeks. Laboratory evaluation on an unspecified date revealed measles IgM and IgG were positive. Per follow up information, laboratory evaluation on 22Jul03 revealed a Rubeola IgG of 2.8 and IgM of 4.81. It was reported that the pt was recovered on 04Aug03. No further information is expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male who on 6/12/03 was vaccinated with a second dose of MMR. Concomitant vaccination on 6/12/03 included a dose of poliovirus vaccine inactivated and a dose of diphtheria toxoid/pertussis vaccine/tetanus. On 6/12/03 the patient developed a severe anaphylactic reaction. Medical attention was sought and the patient was treated with epinephrine, diphenhydramine hydrochloride, and prednisolone in the physician's office and sent home. Admission was not required. Subsequently, the patient recovered. It was also noted that the reporter did not have a full lot number for the MMR of 0099. Severe anaphylactic reaction was considered to be immediately life-threatening. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Initial information has been received from a registered nurse and follow up information from someone at the physician's office concerning an 11 year old Hispanic female with no illness at the time of vaccination and an allergy to bees who on 06-Aug-2003 at approximately 11:00 AM was vaccinated subcutaneous in the left arm with a second dose of MMR live (second generation) (lot #644579/1039M) (Diluent lot #644953/1224). Two hours post vaccination (also reported as approximately three hours on follow up information) the patient developed a mild rash on her back. The rash resolved within 48 hours. It was reported that unspecified medical attention was sought. Follow up information reported that the patient came to have a tuberculin purified protein derivative (PPD) read and the patient mentioned a rash on her back. She reported that the onset of the rash was approximately 3 hours after she had received the MMR vaccine live (second generation) and the tuberculin purified protein derivative (PPD) placement. There were no other symptoms. It was reported that the rash was resolved when the patient was seen in the clinic on 08-Aug-2003 and the patient had recovered on 07-Aug-2003. There were no diagnostic tests or laboratory data. It was noted that there were no known adverse events following prior vaccinations experienced by the patient or the patient's sibling. No further information is expected.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Hypersensitivity, Rash erythematous, Rash macular, Urticaria
Clinical narrative: Information has been received from a physician concerning a 12 month old Caucasian male with an egg protein allergy (determined on testing after vaccination) and no other past medical history who on 08/22/03 at 10:45AM was vaccinated with a first dose of MMRII (Lot # 645266/0100N), in the right thigh, and a first dose of varicella virus vaccine live (SC, Lot # 641601/0206M), in the left thigh. Concomitant therapy that same day and time included a second dose of Hib conjugated vaccine (tetanus toxoid) (Acthib) (IM, Lot # UA858AA) in the left thigh.  At the time of vaccination the pt had papular acrodermatitis. On 08/22/03 at 12:00PM (also reported as "within two hours of his vaccination"), the pt's mother described the appearance of "welts" on his back, chest and legs. The pt was evaluated in the reporter's office approximately 4 hours after his vaccination. The pt reportedly had "fading erythematous macular." This had spontaneously resolved within 24 hours (also reported as "started to clear up 3 hours post vaccination"). There was no treatment required. On 08/22/03 the pt was considered to be fully recovered. It was also noted that on unspecified dates the pt previously had received two doses of hepatitis B virus vaccine rHBsAg (yeast)(+) Hib conj vaccine (OMPC, MSD). It was also noted that the pt had not had any adverse events following prior vaccinations. No further information is expected.
Age: 1.1
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, PNC
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Information has been received from a RN concerning a 13 month old female with no relevant medical history who on 07/15/03, was vaccinated SC/ALR with a first dose of MMRII (Lot # 643789/0876M).  On 07/15/03, the pt was concomitantly vaccinated IM/LUR with a third dose of DTP, IM/LLL with a 3rd dose of Hib (Lot # 643337/0722M), SC/ALL with a third dose of IPV and IM/LUL with a third dose of Prevnar. On 07/15/03, approximately 15 minutes post vaccination, the pt developed a wheal approximately 2 1/2 cm just above the MMRII injection site with erythema extending 10cm around the area. It was also reported that the pt developed extremity swelling. Ice was applied and 0.25ml of Benadryl was given IM above the site. The wheal subsided within 15 min post Benadryl administration. Erythema also diminished. The pt was evaluated by an emergency medical technician. The pt's mother refused to transport the pt to the ER. The pt was doing well when she left the clinic. It was reported that the pt was crying throughout the experience but there was no respiratory distress noted. Subsequently, the pt recovered. No further information is available.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Feeling hot, Rash erythematous
Clinical narrative: Information has been received from a RN concerning a 4 year old Caucasian female with a history of supraventricular tachycardia at birth, "bypass" at 5 hours of age with blood transfusion - "hepatitis B", who on 09/16/03 at 14:00 was vaccinated SQ in the right arm with a second dose of MMRII (Lot # 644577/1037M).  Concomitant therapy, that same day and at the same time, included a fifth dose of DTAP (Tripedia, Lot # U0987BA) given IM in the left deltoid, a fourth dose of IPV (Lot # W0063-2) given SC in the left arm and a first dose of Prevnar (Lot # 493270) given IM in the right deltoid. There was no illness at the time of vaccination. On 09/16/03 at 14:05 the pt developed a rash - slightly raised, red, blotchy, warm on the face, up and down the extremities and down the front and back of the trunk. There were no diagnostic or lab tests performed. The pt was treated with Benadryl, 0.4mL IM at 14:05 at 1 teaspoon at 19:30 at home. The pt's rash was gone by the evening of 09/16/03.  Additional information is not expected.
Age: 1.5
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 17 month old male with no past medical history reported who on 10/15/03 at 5:00PM was vaccinated with a first dose of MMRII (Lot # 641629/0667N), SC in the right thigh, and a first dose of varicella virus vaccine live (Lot # 646311/0568N), SC in the left thigh. Concomitant therapy that day and time included a fourth dose of Prevnar (Lot # 493475) IM, in the left arm, and a fourth dose of ActHib (Lot # UA865AA), IM in the right arm. There was no illness at the time of vaccination. On 10/15/03 at 5:05PM the pt's mother noticed welts on both thighs at injection sites. The physician gave Benadryl (12.5mg) at 5:10PM. The pt left the office at 5:30PM. The pt recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blood amylase increased, Erythema, Face oedema
Clinical narrative: Information has been received from a woman in a physician's office concerning a 12 month old white female with no allergies or medical conditions who at 5:00PM on 10/07/03 was vaccinated SC with a first dose of MMRII (Lot # 645621/0271N).  Concomitant vaccination on the same day at 5:00PM included a SC first dose of Varicella virus vaccine live (Lot # 646229/0538N). There was no other concomitant medication. Illness at the time of vaccination included cold symptoms for a few days.  The reporter indicated that three weeks after receiving MMRII, on 10/28/03 at 6:30PM, the pt had mild parotitis. The left side of her face was swollen and red. It was also noted that the pt had an elevated amylase level of 388.  The reporter questioned a virus versus a MMRII reaction but with the increased amylase, questioned a reaction to the vaccine. Subsequently, the pt recovered. The reporter also indicated that neither the pt or her siblings had any adverse events following prior vaccinations. No further information is expected.
Age: 1.6
Sex: M
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Erythema, Pyrexia, Urticaria
Clinical narrative: Information has been received from a RN concerning a 17 month old Caucasian male with no past medical history or allergies who on 11/12/03 at 11:00 was vaccinated SC in the right arm with a first dose of MMRII (Lot # 646362/0573N) and IM in the right deltoid with a second dose of hepatitis B virus vaccine rHBsAg (yeast)(+) Hib conj vaccine (Lot # 643887/0739M).  Other concomitant therapy given on the same day and at the same time, included a fourth dose of DTAP (Infanrix, Lot # 610A2) given IM in the left deltoid and a third dose of Prevnar (Lot # 492379) given IM in the right thigh. The pt had a slight runny nose at the time of vaccination. On 11/12/03 the pt ran a low grade fever. On 11/13/03 at approximately 08:00 the pt woke-up with red, slightly raised patches, also described as hives around his eyes and cheek, which spread around his whole face. Unspecified medical attention was sought. No diagnostic or lab tests were performed. At the time of this report the pt was still running a low grade fever and the outcome for the hives was unknown. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Rash erythematous, Skin discolouration
Clinical narrative: Information has been received from a RN concerning a 6 year old male pt with no illness at time of vaccination, no allergies and no medical history who on 08/18/03 was vaccinated SC in the right deltoid with a second dose of MMRII (Lot # 642539/0631M). Concomitant therapy which the pt received on 08/18/03 included vaccination IM in the left deltoid with a fourth dose of DTAP (Infanrix, Lot # 574A2), vaccination SC in the right deltoid with a third dose of IPV (Lot # W0906-2) and administration ID in the left forearm of a "TB test" (Lot # C1600AA). On approximately 08/25/03 the pt experienced slightly raised red rash on his trunk and back. On 09/25/03 it was noted that the rash was resolving on the pt's trunk and back, but appeared to be starting on his legs. Follow up information noted that on 09/23/03 the pt mother reporter to the nurse that the pt developed a rash on his trunk on 08/28/03.  It was reported on 09/23/03 that the rash had extended to the pt's legs and arms the past few days and the rash on chest and back was less reddened. The pt was examined on 09/23/03 and it was noted that the rash was slightly raised, red and scattered on arms, legs and chest and back (1-2mm in size).  It was noted that it appeared like text book pictures of measles. The pt's mother stated the child had not been sick and had not complained of pruritus. It was recommended that the pt see his pediatrician. The pt was seen by a pediatrician and it was reported that lab evaluation revealed that CBC, platelets and urinalysis were all "normal". The pediatrician recommended that the child be seen by a dermatologist. On 09/24/03 the pt was seen by a dermatologist who said it looked like dry skin and recommended petrolatum, white (Vaseline) and triamcinolone ointment daily after bath for 5 days. On 10/16/03 the mother reported to the nurse that the rash on the pt's back and chest was gone, but he still had it on his legs. It was fading. He had a few scabs on waist line and ankle.  The pt's mother did not follow up with the dermatologist, as she did not believe the rash was due to dry skin. The mother reported that the petrolatum, white (Vaseline) and triamcinolone ointment "made no difference in the rash". The pt was seen by the nurse on 11/14/03 who noted that there were some small brownish purple colored spots where some of the red areas were. It was reported that the rash was resolved. No further information is available.
Age: 1.59
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, DTAP, HIBV, MMR
Symptoms: Anorexia, Pyrexia, Rash macular, Rhinorrhoea, Viral infection
Clinical narrative: Information has been received from a RN concerning a 19 month old male pt with no illness at the time of vaccination, no adverse events following prior vaccination and no pre-existing allergies, birth defects or medical conditions. On 07/25/03 at 13:30 the pt was vaccinated SC in the left upper leg with a first dose of MMRII (Lot # 645401/0129N). It was reported that concomitant therapy included vaccination on 07/25/03 at 13:30 with the following vaccinations; IM vaccination in the right upper leg with a fourth dose of Hib conj vaccine (Acthib, Lot # HUA78AA/AVB); IM vaccination in the left upper leg with a third dose of Hib conj vaccine (Acthib, Lot # H492-395/WAI) and IM vaccination in the right upper leg with a fourth dose of alum, potassium (+) DTAP (Tripedia, Lot # HU0855AA.AVB). On 08/06/03 at 12:00AM the pt experienced a runny nose. A fever of 102F for 2 days was also reported. On 08/07/03 the pt developed flat, red marks over the total body for 4 to 5 days. On 08/08/03 the pt experienced no appetite for 4 days. On 08/08/03 the pt went to the ER of hospital and a diagnosis of viral rash was made. No treatment was required. The pt was recovered on 08/12/03.  No further information is available.
Age: 1.59
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, DTAP, HIBV, MMR
Symptoms: Erythema, Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a RN concerning a 19 month old male pt with no illness at the time of vaccination, no adverse events following prior vaccination and no pre-existing allergies, birth defects or medical conditions. On 07/25/03 at 13:30 the pt was vaccinated SC in the left upper leg with a first dose of MMRII (Lot # 645401/0129N). It was reported that concomitant therapy included vaccination on 07/25/03 at 13:30 with the following vaccinations; IM vaccination in the right upper leg with a fourth dose of Hib conj vaccine (Acthib, Lot # HUA78AA/AVB); IM vaccination in the left upper leg with a third dose of Hib conj vaccine (Acthib, Lot # H492-395/WAI) and IM vaccination in the right upper leg with a fourth dose of alum, potassium (+) DTAP (Tripedia, Lot # HU0855AA.AVB). On 08/06/03 at 12:00AM the pt experienced a runny nose. A fever of 102F for 2 days was also reported. On 08/07/03 the pt developed flat, red marks over the total body for 4 to 5 days. On 08/08/03 the pt experienced no appetite for 4 days. On 08/08/03 the pt went to the ER of hospital and a diagnosis of viral rash was made. No treatment was required. The pt was recovered on 08/12/03.  No further information is available.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: Information has been received from Wyeth and was assigned manufacturer report number HQWYE696108AUQ03. Information has been received concerning a 15 month old male patient who on 4/15/03 was vaccinated with a first dose of MMR (lot # 641123/0624M) SC into the left thigh. Concomitant therapy included a first dose of varicella virus vaccine live (lot # 642684/0327M) SC into the right thigh. On 4/15/03 the patient experienced seizure and high fever. It was noted that the patient's mother did not call the office nor was the patient taken to the emergency room. It was reported that the events were considered to be medically important (OMIC). Subsequently, the patient recovered from his experiences. Additional information received on 9/29/03 from a health care professional at the reporting physician's office indicated that on 4/15/03 other concomitant vaccinations included a fourth dose of HIB conjugate vaccine (lot # UA742AA/W0021-2) IM into the left thigh and a third dose of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (lot # 491190) IM into the right thigh. It was reported that the patient had a history of congenital heart disease of ventricular septal defect which was corrected at 9 months of age. Follow up information received from a health professional indicated that the patient received the final dose of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine on 8/4/03. On 8/5/03 the patient developed a fever of 102 degrees F and had 2 seizures. He was taken to the emergency room. Upon internal review, seizure and fever were considered to be important medical events. No further information was expected. The case is considered closed. This was originally reported by a physician. Other business partner numbers include 2003-02051.
Age: 1.0
Sex: F
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Dermatitis bullous, Infection, Irritability, Pruritus, Pyrexia
Clinical narrative: Information has been received from a LPN concerning a 12 month old white female with no medical history and no known allergies who on 04/11/02 was vaccinated in the left arm with a first dose of MMRII (Lot # 640842/1540L).  On 04/11/02 the pt was also vaccinated in the right arm with a first dose of varicella virus vaccine live (Lot # 639901/1152L). There was no illness at the time of vaccination. On 04/19/02 the pt developed a rash, a fever and was "miserable". Subsequently, the pt recovered. It was also reported that subsequent to being vaccinated with the first dose of varicella virus vaccine live, this pt developed breakthrough chickenpox (WAES # 0308USA01109).  It was also reported that an 18 month old male was vaccinated SC in the right arm with a dose of varicella virus vaccine live (Lot # 639901/1152L) and developed breakthrough chickenpox (WAES # 0308USA00828).  No further information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a LPN concerning a 12 month old white female with no medical history and no known allergies who on 04/11/02 was vaccinated in the left arm with a first dose of MMRII (Lot # 640842/1540L).  On 04/11/02 the pt was also vaccinated in the right arm with a first dose of varicella virus vaccine live (Lot # 639901/1152L). There was no illness at the time of vaccination. On 04/19/02 the pt developed a rash, a fever and was "miserable". Subsequently, the pt recovered. It was also reported that subsequent to being vaccinated with the first dose of varicella virus vaccine live, this pt developed breakthrough chickenpox (WAES # 0308USA01109).  It was also reported that an 18 month old male was vaccinated SC in the right arm with a dose of varicella virus vaccine live (Lot # 639901/1152L) and developed breakthrough chickenpox (WAES # 0308USA00828).  No further information is expected.