chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site oedema, Injection site rash, Pruritus, Rash erythematous, Skin ulcer
Clinical narrative: 18 month imm received DTaP, IPV on 06/21/02. On 06/22/02, pt developed an erythematous rash at DTaP injection site approximately 12x8cm with edema. On 06/23/02 he developed more lesions smaller in circumference over trunk and extremities. By 06/24/02 pt developed pruritis, was taken to clinic for evaluation.
Age: 4.25
Sex: F
Vaccine: IPV, MMR
Symptoms: Diarrhoea, Oedema, Pyrexia, Rash
Clinical narrative: High fever. Rash. Severe diarrhea. Swelling of inside of cheeks.
Age: 1.5
Sex: U
Vaccine: DTAP, IPV
Symptoms: Cellulitis
Clinical narrative: 10cm cellulitis-put on Keflex.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Rash
Clinical narrative: Only 5/5: rash (small, red spots) initially seen on left arm. By Fri 06/21, rash had spread to right arm, face, and chest. Rash became confluent. No treatment.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: Large area of redness, warmth, and induration at site of vaccine administration. Began in evening following shot, progressed on 06/27 to overall erythema, more painful and indurated today. Redness extends from Deltoid to just above left elbow. Received ibuprofen, received ice pack and hydrocortisone cream topically to lower itch and erythema.
Age: 4.08
Sex: M
Vaccine: MMR
Symptoms: Discomfort, Face oedema, Parotitis
Clinical narrative: 13 days after vaccine developed right sided parotitis face swelling and discomfort.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Pt came in for 5 year cpx 05/20/02. It was thought at the time he may have chickenpox so vaccine deferred til 06/11/02. On 06/12/02 child was seen in ER presenting with swelling, redness, warmth and pain with ROM. Dx with cellulitis/dose of IV antibiotics and prescribed oral Anti followed up in our office 06/13/02.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site warmth
Clinical narrative: Pt came in for 5 year cpx 05/20/02. It was thought at the time he may have chickenpox so vaccine deferred til 06/11/02. On 06/12/02 child was seen in ER presenting with swelling, redness, warmth and pain with ROM. Dx with cellulitis/dose of IV antibiotics and prescribed oral Anti followed up in our office 06/13/02.
Age: 1.25
Sex: M
Vaccine: IPV, MMR
Symptoms: Decreased appetite, Rash pruritic, Urticaria
Clinical narrative: Had MMR on 24 June 2002. Called 26 June. Seen July 1. Had large whelps, pruritic over trunk and extremities. No fever. Does have low appetite.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Cyanosis, Dyspnoea, Erythema
Clinical narrative: Pt complained of redness of left side of neck 3cmx3cm red area. Pt also complained of difficulty of breathing. Beandryl 50mg IM given in left glutees. Lips cyanotic, nailbeds milder cyanotic. Epinephrine 1:1000, 1mg given with modest improvement. Pt transferred to ER.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 6-7cm left arm erythema, light color, mild swelling.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Lethargy, Pyrexia, Rash
Clinical narrative: Very lethargic temp 103, one red spot with white head on abdomen. Varicella SE vaccination
Age: 1.0
Sex: M
Vaccine: HBHEPB, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Red, hard lump @ shot site . reported to office 3rd day after shot given.
Age: 0.3
Sex: F
Vaccine: DTAP
Symptoms: Screaming
Clinical narrative: Continuous crying for over three hours.
Age: 0.3
Sex: U
Vaccine: DTAP
Symptoms: Agitation, Crying
Clinical narrative: Screaming uncontrollably in pain.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Tennis ball sized area around injection site that is red and warm to touch.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, OPV
Symptoms: Hypokinesia, Injection site induration, Injection site oedema, Pain
Clinical narrative: Mother called 06/19/02. Stated right shoulder swollen; twice normal size. At 5:11pm 06/19/02 mother stated ROM decreased swelling and soreness but ADL's WNL. On 06/20/02,  pt examined by FNP, right arm=2.5inches in diameter with 20x20mm induration to upper right arm.
Age: 6.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Headache, Injection site erythema, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: Localized reaction-right deltoid erythema, warm, slightly raised. 7 cm X 5 cm. slight headaches, fever 99.
Age: 1.0
Sex: M
Vaccine: HEP, IPV, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Administered MMR 6/20/02, 6/27 developed fever 102 rectal and measles like rash 6/30. Possible rubella 7-10 d post vaccine.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Skin ulcer
Clinical narrative: 4-5 papular vesicular lesion -arm, trunk and groin, low grade temperature, malaise.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Local reaction, Treatment-Benadryl, Keflex 500 mg BID x 10 day, cool compresses
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Pelvic pain
Clinical narrative: When I received the first shot I had body and joint aches but did not connect the two and not on the second shot. There was a point where I wondered if maybe it was the shot but after the third shot, there was no doubt in my mind my hip was affected and I felt very sick that night and next day  am still having trouble.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left deltoid red/warm marked local reaction. Treatment -cold compresses, ibuprofen, Cephalexin 375 mg tid x 5-7 d
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Received DTaP on 06/04/02, mother noticed right deltoid red, hot, swollen. Pt complained of pain, slight fever, no diarrhea, vomiting or irritability.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Dermatitis bullous, Injection site erythema, Injection site mass
Clinical narrative: Redness, lump and vesicular lesions at site of varivax.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Syncope
Clinical narrative: Fainting spell lasting for about 1 minute. This happened at about 15 mins after the shot. I examined her at 1 minute was coming out of her spell. Vital signs stable. Child said she was very hungry just before the spell.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Soreness, mild swelling, scattered areas of redness which were hot to touch. Difficulty raising left arm v/x=99.2 po-84/20 120/70.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Soreness, mild swelling, scattered areas of redness which were hot to touch. Difficulty raising left arm v/x=99.2 po-84/20 120/70.
Sex: M
Vaccine: HEP
Symptoms: Viral infection
Clinical narrative: Pt was sick from a nurse spreading rotavirus when first vaccinated at 2 days old with hep b.
Age: 18.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Periorbital oedema, Pruritus, Rash, Urticaria
Clinical narrative: C/O GENERALIZED ITCHING WITHOUT RASH OR WHELPS 6/12/02. BEGINNING 7/6/02 BEGAN RASH, LARGE WHELPS, WITH DIFFICULTY BREATHING, LIPS SWELLING, FEET SWELLING, EYELIDS SWELLING. 7/7/02 WENT TO ER AND WAS TREATED AND RELEASED. 7/8/02 BACK TO ER FOR 5 HOURS.7/10/02 PMD TREATED.RECOVERY PENDING, STILL UNDER TREATMENT.
Age: 1.25
Sex: M
Vaccine: HEP, HIBV, MMR, PNC
Symptoms: Bronchitis, Ecchymosis, Hypertrophy, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from manufacturer for streptococcus pneumoniae vaccine (PREVNAR) and was assigned manufacturer report number HQ4592111DEC2000. This report concerned a 15 month old male who on 17 NOV 2000 was vaccinated with MMR administered SC in the right thigh. Concomitant therapy included the third dose of hepatitis B vaccine recombinant administered IM in the left thigh. Ohter concomitant therapy included the second dose of streptococcus pneumoniae vaccine administered IM in the right thigh and the fourth dose of hib conjugate vaccine administered IM in the left thigh. On 21 NOV 2000 the patient experienced a fever of 102 degrees F, enlarged lymph nodes on the right side of the groin, superficial ecchymosis, and injection site swelling and pain. The patient experienced minimal upper respiratory symptoms. On 24 NOV 2000 a fever of 105 degrees F, clear nasal discharge, moderately unlarged tonsils and a macular reticular rash on face and chest. On 05 DEC 2000, the patient experienced hives. He was treated with diphenhydramine HCl. On 06 DEC 2000 the patient was diagnosed with bronchitis and azithromycin therapy was initiated. Subsequently, the patient recovered from the symptoms. No further information is available. This was originally reported by a registered nurse.
Age: 1.25
Sex: M
Vaccine: HEP, HIBV, MMR, PNC
Symptoms: Lymphadenopathy, Pyrexia, Rash macular, Tonsillitis, Upper respiratory tract infection
Clinical narrative: Information has been received from manufacturer for streptococcus pneumoniae vaccine (PREVNAR) and was assigned manufacturer report number HQ4592111DEC2000. This report concerned a 15 month old male who on 17 NOV 2000 was vaccinated with MMR administered SC in the right thigh. Concomitant therapy included the third dose of hepatitis B vaccine recombinant administered IM in the left thigh. Ohter concomitant therapy included the second dose of streptococcus pneumoniae vaccine administered IM in the right thigh and the fourth dose of hib conjugate vaccine administered IM in the left thigh. On 21 NOV 2000 the patient experienced a fever of 102 degrees F, enlarged lymph nodes on the right side of the groin, superficial ecchymosis, and injection site swelling and pain. The patient experienced minimal upper respiratory symptoms. On 24 NOV 2000 a fever of 105 degrees F, clear nasal discharge, moderately unlarged tonsils and a macular reticular rash on face and chest. On 05 DEC 2000, the patient experienced hives. He was treated with diphenhydramine HCl. On 06 DEC 2000 the patient was diagnosed with bronchitis and azithromycin therapy was initiated. Subsequently, the patient recovered from the symptoms. No further information is available. This was originally reported by a registered nurse.
Age: 1.25
Sex: M
Vaccine: HEP, HIBV, MMR, PNC
Symptoms: Urticaria
Clinical narrative: Information has been received from manufacturer for streptococcus pneumoniae vaccine (PREVNAR) and was assigned manufacturer report number HQ4592111DEC2000. This report concerned a 15 month old male who on 17 NOV 2000 was vaccinated with MMR administered SC in the right thigh. Concomitant therapy included the third dose of hepatitis B vaccine recombinant administered IM in the left thigh. Ohter concomitant therapy included the second dose of streptococcus pneumoniae vaccine administered IM in the right thigh and the fourth dose of hib conjugate vaccine administered IM in the left thigh. On 21 NOV 2000 the patient experienced a fever of 102 degrees F, enlarged lymph nodes on the right side of the groin, superficial ecchymosis, and injection site swelling and pain. The patient experienced minimal upper respiratory symptoms. On 24 NOV 2000 a fever of 105 degrees F, clear nasal discharge, moderately unlarged tonsils and a macular reticular rash on face and chest. On 05 DEC 2000, the patient experienced hives. He was treated with diphenhydramine HCl. On 06 DEC 2000 the patient was diagnosed with bronchitis and azithromycin therapy was initiated. Subsequently, the patient recovered from the symptoms. No further information is available. This was originally reported by a registered nurse.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Information has been received from a pharmacist who reported that an 18 month old female who was vaccinated in March 2001 with a dose of MMR II (lot 636657/1160K). Subsequently 7 to 10 days post vaccination, the pt developed a rash and a fever. The child started with a fever, which was then followed by the "classic measles" rash. She was treated with Tylenol. The pharmacist also reported that her 15 month old daughter (WAES01031049) had a similar experience following exposure to MMR II. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Age: 1.2
Sex: F
Vaccine: DTAP, DTAP, MMR
Symptoms: Mental retardation severity unspecified
Clinical narrative: Information has been received from a health care professional concerning a 14 month old female with cerebral palsy with horrible coordination who on 16 DEC 1996 was vaccinated with MMR. Concomitant therapy the same day included a IM dose of dithpheria toxoid/pertussis vaccine/teta (ACEL-IMUNE)(lot #438622). On 16 DEC 1996, approximately 1-2 hours post-vaccination, the patient developed mental status changes. The event continued for approximatly 7-10 days. Subsequently, the patient recovered. Follow up information has been received from a health care provider that reports the mother stated the patient did not seem as responsive after receiving the (diphtheria toxoid/pertussis vaccine/teta). Attempts to obtain the lot number were unsuccessful. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: DTAP, DTAP, MMR
Symptoms: Mental impairment
Clinical narrative: Information has been received from a health care professional concerning a 14 month old female with cerebral palsy with horrible coordination who on 16 DEC 1996 was vaccinated with MMR. Concomitant therapy the same day included a IM dose of dithpheria toxoid/pertussis vaccine/teta (ACEL-IMUNE)(lot #438622). On 16 DEC 1996, approximately 1-2 hours post-vaccination, the patient developed mental status changes. The event continued for approximatly 7-10 days. Subsequently, the patient recovered. Follow up information has been received from a health care provider that reports the mother stated the patient did not seem as responsive after receiving the (diphtheria toxoid/pertussis vaccine/teta). Attempts to obtain the lot number were unsuccessful. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Swelling and severe pain in left arm where vaccine was administered. T to 102 degrees.
Age: 0.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Dyspnoea, Erythema, Urticaria
Clinical narrative: 2nd day after receiving #2 Prevnar and #3 DTaP (06/18), pt was seen at ER with eryth/hives trunk and arms. Benadryl oral. pt worse following day with SOB and increased erythema and hives but no apparently in pain/distress. prednisone and O2 given in ER.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: Local reaction with erythema, swelling, heat on left deltoid.
Sex: U
Vaccine: ANTH
Symptoms: Dizziness, Fatigue, Headache, Influenza like illness, Injection site erythema
Clinical narrative: After 24hrs, flu-like symptoms, head and neck aches, chills with fever, nausea, large red swelling where shot was given. Fatigue the next day. Light headed.
Sex: U
Vaccine: ANTH
Symptoms: Injection site oedema, Nausea, Neck pain, Pyrexia
Clinical narrative: After 24hrs, flu-like symptoms, head and neck aches, chills with fever, nausea, large red swelling where shot was given. Fatigue the next day. Light headed.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Pt developed induration, redness, swelling and warmth on right deltoid muscle vaccine placed 36 hrs prior.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Chills, Erythema, Feeling hot, Malaise, Nausea
Clinical narrative: Given Td Friday 07/05/02. Evening of 07/06/02 started with nausea, chills, feeling warm and "not right." 07/08/02 AM noticed 2x3" reddened, non-raised, slightly tender area approx 6" below injection site. No tenderness, swelling, etc at injection site.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Tenderness
Clinical narrative: Given Td Friday 07/05/02. Evening of 07/06/02 started with nausea, chills, feeling warm and "not right." 07/08/02 AM noticed 2x3" reddened, non-raised, slightly tender area approx 6" below injection site. No tenderness, swelling, etc at injection site.
Age: 4.08
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: +Warm/swollen/redness at injection site (L upper arm). Tx=Keflex 500mg po bid x 7, warm compresses.
Age: 4.5
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site warmth, Pruritus
Clinical narrative: 3x2inch area of erythema swelling on upper arm at injection site with complaint of warmth, itching.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Maculo papular eruption started head to trunk to extremities 11 days post vaccine administration.
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: This report was received from a manufacturer for HIB-titer vaccine and was assigned manufacturer report number HQ8542119MAR2001. A physician reported that a female patient on 05 JUN 1996 was vaccinated with a dose of MMR. Concomitant therapy the same day included vaccination with varicella virus vaccine live and hib conjugate vaccine (HIBTITER). Two days later, on 07 JUN 1996, the patient developed a fever of 104 degrees F. The patient's outcome was unknown at the time of this report. Additional information has been requested. The physician also reported that the patient's sister experienced an injection site reaction after receiving therapy with MMR. Follow up information from a registered nurse indicated that she is unable to provide additional information because of a lack of patient's identity. No further informaton is available.
Age: 1.25
Sex: F
Vaccine: DTP, MMR, PNC
Symptoms: Erythema, Pallor, Pruritus, Rash
Clinical narrative: Information has been received from a health professional concerning a 15 month old female with no known drug allergies and no significant past medical history who on 23 MAR 2001 was vaccinated with MMR. Concomitant therapy included streptococcus pneumoniae vaccine and diphtheria toxoid, pertussis vaccine, tetanus toxoid. On 02 APR 2001 the patient presented with a rash described as raised, discreet, and erythematous. There were papules at the base and an area of pallor like a halo. The rash was itchy and dispersed all over. Unspecified medical attention was sought. No other information was available. It was reported that another patient (WAES # 01040913) had a similar experience. Additional information has been requested.
Sex: M
Vaccine: DTP, HIBV, IPV, MMR
Symptoms: Pityriasis rosea, Rash
Clinical narrative: Information has been received from a health professional concerning a male patient who 09/21/00 was vaccinated with a dose of MMRII. Concomitant vaccination the same day included a dose of hemophilus b conjugate vaccine, poliovirus vaccine and diptheria toxoid (-) pertussis vaccine (t) tetanus toxoid. On 03/12/01, the patient developed a rash and was seen by his primary care physician and was diagnosed with "pityriasis rosea". The rash persisted and on 03/29/01 he was taken to the emergency room and "measles was suspect" but was not confirmed. No blood work was done and the patient was treated with acetaminophen (Tylenol) and diphenhydramine hydrochloride (Benadryl). It was reported that the patient did not experience a fever associated with this rash. On 03/30/01, that patient was taken to an emergency room and diagnosed with an "ectopic rash". On 04/05/01, the patient's mother reported to the department of Health that the patient had been diagnosed with "actopic dermatitis" by primary care physician. The  patient's mother reported that the patient's rash was not related to therapy with MMRII. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Immunoglobulins decreased, Pyrexia, Rash
Clinical narrative: Information has been received from a health professional concerning a 15 month old female with a history of eczema, fevers, rashes who on approximately 03 MAR 2001, was vaccinated with MMR. Two weeks after vaccination, on approximately 17 MAR 2001, the patient experienced high fever and rash. Unspecified medical attention was sought. Additional information has been received from a health professional who reports the child's rash was concerning and a IgM titer was drawn which was positive. She reported she expected it to be positive because the child was just vaccinated with MMR. It was noted that the child had been seen multiple times for fever and rashes therefore it is unknown if the rash was really an adverse reaction to the vaccine. The child's rash resolved. No further information is expected.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female who on 22 AUG 1995 and 19 MAY 1999 was vaccinated with a first and second dose of MMR. In January 2001, the patient developed a fever and then a rash. It was reported that they are still waiting for lab results to confirm the diagnosis. One week later the patient recovered. It was also reported that the patient's sister had similar events after vaccination with MMR (WAES 01020020). No further information is expected.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning a approximately 13 month old Caucasian female with Hereditary Fructose Intolerance and no association intolerance to fructose, sorbitol, and sucrose, who on 22 SEP 1997 was vaccinated SC in the right leg with a first dose of MMR. There was no concomitant medication. The patient was diagnosed with hereditary fructose intolerance, after her first vaccination with MMR, and it was noted that this condition is not related to the patient's vaccination. Subsequently, due to the patient's intolerance to sorbital, the patient had a titer drawn in the hope that she could avoid a second dose of the vaccine. The patient's titer was negative for measles. The responsible physician planned to obtain blood work. The registered nurse and physician felt the patient's experience was non-serious. Additional information is expected.
Sex: F
Vaccine: MMR
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a doctors office concerning a female who was vaccinated with MMR at a different doctor's office. There was no illness at the time of vaccination. Subsequently the patient experienced a lesion. Subsequently, the patient recovered from lesion with topical steroid use. Unspecified medical attention was sought. The reporter stated that in no way [is she] saying this was a fixed drug reaction nor was it due to MMR. No further information is expected.
Age: 1.25
Sex: F
Vaccine: DTP, MMR, PNC
Symptoms: Pallor, Pruritus, Pyrexia, Rash
Clinical narrative: Information has been received from a health professional concerning a 15 month old female with no known drug allergies and no significant past medical history who on 23 MAR 2001 was vaccinated with MMR. Concomitant therapy included streptococcus pneumoniae vaccine and diphtheria toxoid, pertussis vaccine, tetanus toxoid. On 02 APR 2001 the patient presented with a rash described as raised, discreet and erythematous. There were papules at the base and an area of palor like a halo. The rash was itchy and dispersed all over. It was reported that she also presented with a fever. Unspecified medical attention was sought. No other information was available. Another patient had a similar experience. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Asthma, Condition aggravated, Cough, Pyrexia, Rash
Clinical narrative: Fever, rash,cough, asthma exacerbation
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Bronchiolitis, Condition aggravated, Cough, Dermatitis atopic, Dermatitis bullous
Clinical narrative: Fever, rash,cough, asthma exacerbation
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Heart rate increased, Infection, Pyrexia, Respiratory rate increased, Vomiting
Clinical narrative: Fever, rash,cough, asthma exacerbation
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female who on 05/23/2001 at 9:34 was vaccinated SQ in the left upper arm with a first dose of MMR II. Concomitant vaccination the same day included a first dose of varicella virus vaccine live given SQ in the "RUQ," a third dose of hib/hep b recombinant given IM in the left thigh and a third dos eof Prevnar given IM in the right thigh. There was no other concomitant medication or illness at the time of vaccination. On 05/23/2001 at 9:15, immediately after the injection with MMR II, the pt developed a 3 by 4cm area of pink, blanching rash with central raised urticarial lesion. It was reported that the injection area "became raised the size of a bottle top." Therapy with hydrocortisone cream was prescribed. The pt was observed for 10 minutes and with decreased symptoms. The parents were advised to apply Benadryl and cold compresses. The pt had one diarrhea stool in the evening and subsequently, the pt recovered on 05/23/01. The reporter expressed a concern with the lot MMR II. The records of testing prior to release of this lot have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was reported that two other patients (WAES01060280 and 01061737) had similar experiences following exposure to MMR II. No further info is expected.
Age: 1.08
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Dermatitis atopic, Diarrhoea, Oedema, Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old white male with eczema and atopic dermatitis who on 05/18/01 at 11;05 am, was vaccinated with a first dose of MMRII. Concomitant vaccinations the same day included a first dose of Varivax given SQ in the left upper arm, a third dose of Hemophilus b conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) given IM in the left lateral thigh and fourth dose of Prevnar given IM in the right lateral thigh. At 17:05 on 05/18/02, the patient's mother called the physician's office and reported that the  patient developed a rash on his arm, chest and back which was pink and splotchy. The rash became red and looked like a mild sunburn ant it was noted on his arm and the front and back of his trunk. No hives were noted and he had no swelling and no difficulty swallowing or breathing. He also developed diarrhea. The patient's mother was advised to treat with diphenhydramine, hydrochloride (Benadryl). It was reported that the patient's fever lasted for two days and that his symptoms slowly resolved and no life threatening symptoms were noted. The reporter expressed a concern with the lot for MMRII. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. The patient's twin brother (WAES01061737) and another patient (WAES01061738) had a similar experience following exposure to MMRII. No further information is expected.
Age: 1.08
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old white male with eczema and atopic dermatitis who on 05/18/01 at 11;05 am, was vaccinated with a first dose of MMRII. Concomitant vaccinations the same day included a first dose of Varivax given SQ in the left upper arm, a third dose of Hemophilus b conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) given IM in the left lateral thigh and fourth dose of Prevnar given IM in the right lateral thigh. At 17:05 on 05/18/02, the patient's mother called the physician's office and reported that the  patient developed a rash on his arm, chest and back which was pink and splotchy. The rash became red and looked like a mild sunburn ant it was noted on his arm and the front and back of his trunk. No hives were noted and he had no swelling and no difficulty swallowing or breathing. He also developed diarrhea. The patient's mother was advised to treat with diphenhydramine, hydrochloride (Benadryl). It was reported that the patient's fever lasted for two days and that his symptoms slowly resolved and no life threatening symptoms were noted. The reporter expressed a concern with the lot for MMRII. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. The patient's twin brother (WAES01061737) and another patient (WAES01061738) had a similar experience following exposure to MMRII. No further information is expected.
Age: 1.08
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old male with no past medical history or allergies who on 05/18/2001 at 11:09am was vaccinated with the first dose of MMR II in the right upper arm. Concomitant therapy that same date and time included the first dose of varicella virus vaccine live SC in the left upper arm, the third dose of hib con-hep b vaccine IM lef tlateral thigh and the third dose (also reported as fourth dose) of Prevnar IM in the right lateral thigh. There was no other concomitant medication. There was no illness at the time of vaccination. On 05/18/2001 at 11:13am the pt developed a large hive in the right upper arm where the MMR was given. Therapy with oral Benadryl was given. Within twenty minutes the hives were better. Subsequently, after vaccination with MMR II. The records of testing prior to release of this lot have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info is not expected.
Age: 1.3
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Pyrexia
Clinical narrative: This report was received for Prevnar and Hib conjugate vaccine and was assigned manufacturer report number HQ9618718APR2001. A registered nurse provided info concerning a 16 month old female who on 02/15/2001 was vaccinated with MMR II. Also given that day was Prevnar and Hib conjugate vaccine. Within 24 hrs, the pt developed a fever of 104 degrees F. Additional info has been requested.
Age: 4.5
Sex: U
Vaccine: HIBV, IPV, MMR, PNC, HIBV, IPV, MMR, PNC
Symptoms: Cough, Ear pain, Nasal congestion, Nausea, Pharyngolaryngeal pain
Clinical narrative: On 03/27/2001, a 4 year old child was vacicnated in the thigh with MMR II. Concomitant vaccines on 03/27/01 included one dose in the thigh of hib conjugate vaccine, a first dose IM in the thigh of Prevnar and one dose in the thigh of IPOL. It was noted that the child was administered tuberculin purified protein derivative. There were no illness at the time of vaccination. On 03/27/2001, within one hour of vaccination, the child expeirenced influenza like symptoms described as fever (102-103F), stuffy nose, green drainage, nausea, earache, sore throat and coughing. The child's mother, father and 2 year old sibling (who did not received Prevnar) also developed these symptoms within an hour of the 4 year old's receipt of Prevnar. It was noted that the pt's other sibling had the same experience following vaccination with Prevnar. Additional info has been requested. The child's mother originally reported this experience.
Age: 4.5
Sex: U
Vaccine: HIBV, IPV, MMR, PNC, HIBV, IPV, MMR, PNC
Symptoms: Pyrexia
Clinical narrative: On 03/27/2001, a 4 year old child was vacicnated in the thigh with MMR II. Concomitant vaccines on 03/27/01 included one dose in the thigh of hib conjugate vaccine, a first dose IM in the thigh of Prevnar and one dose in the thigh of IPOL. It was noted that the child was administered tuberculin purified protein derivative. There were no illness at the time of vaccination. On 03/27/2001, within one hour of vaccination, the child expeirenced influenza like symptoms described as fever (102-103F), stuffy nose, green drainage, nausea, earache, sore throat and coughing. The child's mother, father and 2 year old sibling (who did not received Prevnar) also developed these symptoms within an hour of the 4 year old's receipt of Prevnar. It was noted that the pt's other sibling had the same experience following vaccination with Prevnar. Additional info has been requested. The child's mother originally reported this experience.
Age: 4.5
Sex: U
Vaccine: HIBV, IPV, MMR, PNC, HIBV, IPV, MMR, PNC
Symptoms: Cough, Ear pain, Influenza, Influenza like illness, Nasal congestion
Clinical narrative: On 03/27/2001, a 4 year old child was vacicnated in the thigh with MMR II. Concomitant vaccines on 03/27/01 included one dose in the thigh of hib conjugate vaccine, a first dose IM in the thigh of Prevnar and one dose in the thigh of IPOL. It was noted that the child was administered tuberculin purified protein derivative. There were no illness at the time of vaccination. On 03/27/2001, within one hour of vaccination, the child expeirenced influenza like symptoms described as fever (102-103F), stuffy nose, green drainage, nausea, earache, sore throat and coughing. The child's mother, father and 2 year old sibling (who did not received Prevnar) also developed these symptoms within an hour of the 4 year old's receipt of Prevnar. It was noted that the pt's other sibling had the same experience following vaccination with Prevnar. Additional info has been requested. The child's mother originally reported this experience.
Age: 4.5
Sex: U
Vaccine: HIBV, IPV, MMR, PNC, HIBV, IPV, MMR, PNC
Symptoms: Nausea, Pharyngolaryngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: On 03/27/2001, a 4 year old child was vacicnated in the thigh with MMR II. Concomitant vaccines on 03/27/01 included one dose in the thigh of hib conjugate vaccine, a first dose IM in the thigh of Prevnar and one dose in the thigh of IPOL. It was noted that the child was administered tuberculin purified protein derivative. There were no illness at the time of vaccination. On 03/27/2001, within one hour of vaccination, the child expeirenced influenza like symptoms described as fever (102-103F), stuffy nose, green drainage, nausea, earache, sore throat and coughing. The child's mother, father and 2 year old sibling (who did not received Prevnar) also developed these symptoms within an hour of the 4 year old's receipt of Prevnar. It was noted that the pt's other sibling had the same experience following vaccination with Prevnar. Additional info has been requested. The child's mother originally reported this experience.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Information has been received from a physician concerning a 12 month old male patient with an ear infection and upper respiratory infection who on 10/31/01 was vaccinated SC in the right thigh left with a firs t dose of MMRII. concomitant therapy included a first dose of Varivax given IM in the left thigh and amoxicillin for bilateral otitis media. On 11/01/01, at 12:00 pm, 24 hours post vaccination, the patient experienced a febrile seizure. the patient sought medical attention and was hospitalized. It was reported that no prescription drug was required for the patient's experience. The patient experienced another febrile seizure 48 hours post-vaccination. The patients fever was to 102 F. It was reported that the patient was hospitalized for 1 day and recovered on 11/02/01. No further information is available.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC, DTAP, IPV, MMR, PNC, DTP, IPV, MMR, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This report was originally reported by a physician concerning a 4 year old male pt who on 12/17/2001 was vaccinated with a dose (lot 64094/1096L) of MMR II. On 12/18/2001 the pt developed an injection site reaction. It was not reported if the pt sought medical attention. Follow-up info received from a registered nurse indicated that the pt was also vaccinated on 12/17/01 with concomitant doses of Prevnar, diphtheria toxoid/pertussis vaccine/tetanus toxoid (manuf not reported) and poliovirus vaccine. She reported that she did not know the recovery status of the pt. Additional info has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC, DTAP, IPV, MMR, PNC, DTP, IPV, MMR, PNC
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site induration, Ocular hyperaemia
Clinical narrative: This report was originally reported by a physician concerning a 4 year old male pt who on 12/17/2001 was vaccinated with a dose (lot 64094/1096L) of MMR II. On 12/18/2001 the pt developed an injection site reaction. It was not reported if the pt sought medical attention. Follow-up info received from a registered nurse indicated that the pt was also vaccinated on 12/17/01 with concomitant doses of Prevnar, diphtheria toxoid/pertussis vaccine/tetanus toxoid (manuf not reported) and poliovirus vaccine. She reported that she did not know the recovery status of the pt. Additional info has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC, DTAP, IPV, MMR, PNC, DTP, IPV, MMR, PNC
Symptoms: Injection site reaction
Clinical narrative: This report was originally reported by a physician concerning a 4 year old male pt who on 12/17/2001 was vaccinated with a dose (lot 64094/1096L) of MMR II. On 12/18/2001 the pt developed an injection site reaction. It was not reported if the pt sought medical attention. Follow-up info received from a registered nurse indicated that the pt was also vaccinated on 12/17/01 with concomitant doses of Prevnar, diphtheria toxoid/pertussis vaccine/tetanus toxoid (manuf not reported) and poliovirus vaccine. She reported that she did not know the recovery status of the pt. Additional info has been requested.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, PNC, HIBV, MMR, PNC
Symptoms: Eye disorder, Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 15 month old white female with no known allergies and a history of right posterior plagiocephaly at 6 months who on 01/17/2002 was vaccinated with a first dose of MMR II in the right arm. The pt was vaccinated concomitantly with a fourth dose of Prevnar in the left arm and a fourth dose of Hib conjugate vaccine in the left arm. On 01/19/2002, the pt developed redness at the site of injection in the left arm. The pt was treated with amoxicillin for 10 days. On 01/24/2002, the pt had a temperature of 101. On 01/27/2002, the pt developed a total body rash. The pt also began rolling her eyes to the right while eating, with no shaking or jerking motions lasting 1-2 seconds. An EEG was normal and seizure disorder was suled out. On 02/01/2002, the pt's eyes continued a "reaction" to MMR II affecting the neuronal tube with eye and jaw. The pt's mother reported that on 02/14/2002, the pt's eye movements had subsided over the last week, and the pt had returned to normal. The pt subsequently recovered from the fever, rash, and eye deviation to the right side. No additional info is expected.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, PNC, HIBV, MMR, PNC
Symptoms: Injection site erythema, Nervous system disorder, Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 15 month old white female with no known allergies and a history of right posterior plagiocephaly at 6 months who on 01/17/2002 was vaccinated with a first dose of MMR II in the right arm. The pt was vaccinated concomitantly with a fourth dose of Prevnar in the left arm and a fourth dose of Hib conjugate vaccine in the left arm. On 01/19/2002, the pt developed redness at the site of injection in the left arm. The pt was treated with amoxicillin for 10 days. On 01/24/2002, the pt had a temperature of 101. On 01/27/2002, the pt developed a total body rash. The pt also began rolling her eyes to the right while eating, with no shaking or jerking motions lasting 1-2 seconds. An EEG was normal and seizure disorder was suled out. On 02/01/2002, the pt's eyes continued a "reaction" to MMR II affecting the neuronal tube with eye and jaw. The pt's mother reported that on 02/14/2002, the pt's eye movements had subsided over the last week, and the pt had returned to normal. The pt subsequently recovered from the fever, rash, and eye deviation to the right side. No additional info is expected.
Age: 0.2
Sex: F
Vaccine: PNC
Symptoms: Cough, Pyelonephritis, Pyrexia, Urinary tract infection, Vomiting
Clinical narrative: Follow up information received on 08 JUL 2002 provided a change in the final diagnosis from viral syndrome (expected) to pyelonephritis (unexpected). Information was received from an investigator concerning a 2 month old female enrolled in an open label, clinical trial for prophylaxis of diphtheria, tetanus pertussis, hepatitis B, polio, Haemophilus influenzae type B, and Streptococcus pneumoniae. Past medical history included hospitalization for respiratory syncytial virus at two weeks of age. She received dose one of Infanrix penta and Hib-TITER on 29 APR 2002 and her first dose of Prevnar on 16 MAY 2002. On 16 MAY 2002 she developed a fever of 101.6 degrees F. rectally, cough, congestion, and vomiting. She was hospitalized on 17 MAY 2002 for observation and further investigation. She was treated for a urinary tract infection. The fever resolved on 18 MAY 2002; however, she remained hospitalized until cultures were obtained. Blood and urine cultures were negative. WBC was 14,300 cells/mm3 with 54 neutrophils and 30 lymphocytes. A urinalysis was unremarkable. A final diagnosis of pyelonephritis was made. She was discharged on 20 MAY 2002 on amoxicillin/clavulanate. The investigator reported the pyelonephritis to be related to Prevnar. This report was received from manufacturer.
Age: 0.2
Sex: F
Vaccine: PNC
Symptoms: White blood cell count increased
Clinical narrative: Follow up information received on 08 JUL 2002 provided a change in the final diagnosis from viral syndrome (expected) to pyelonephritis (unexpected). Information was received from an investigator concerning a 2 month old female enrolled in an open label, clinical trial for prophylaxis of diphtheria, tetanus pertussis, hepatitis B, polio, Haemophilus influenzae type B, and Streptococcus pneumoniae. Past medical history included hospitalization for respiratory syncytial virus at two weeks of age. She received dose one of Infanrix penta and Hib-TITER on 29 APR 2002 and her first dose of Prevnar on 16 MAY 2002. On 16 MAY 2002 she developed a fever of 101.6 degrees F. rectally, cough, congestion, and vomiting. She was hospitalized on 17 MAY 2002 for observation and further investigation. She was treated for a urinary tract infection. The fever resolved on 18 MAY 2002; however, she remained hospitalized until cultures were obtained. Blood and urine cultures were negative. WBC was 14,300 cells/mm3 with 54 neutrophils and 30 lymphocytes. A urinalysis was unremarkable. A final diagnosis of pyelonephritis was made. She was discharged on 20 MAY 2002 on amoxicillin/clavulanate. The investigator reported the pyelonephritis to be related to Prevnar. This report was received from manufacturer.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Convulsion, Staring, Tremor
Clinical narrative: Seizure. Looked up in space. Was shaking and trembling. On medication for seizure now.
Age: 0.7
Sex: M
Vaccine: PNC
Symptoms: Crying, Diarrhoea, Pyrexia, Screaming, Viral infection
Clinical narrative: Fever, difficult to control x 1. Given Tylenol/Advil. Screaming x 3 hrs. Loose BM x 2. Temp 100.8. Coxsackievirus.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Coma, Hypotonia, Lethargy, Pallor, Vomiting
Clinical narrative: Vomited huge quantity while sleeping@ 10:45 pm. Responsive, but severely lethargic @ 10:05 vomited huge quantity again, then limp and unresponsive, color grey. Taken to ER by ambulance, Responded to 02, but still not alert, Slept between stimulation. Admitted to hospital for tests, released mid-day next day.
Age: 5.4
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Convulsion
Clinical narrative: Vaccines from 05/21/02: DTaP, IPV, MMR, HAV. On 05/25 patient had focal seizure without fever. Normal exam within 10 hours negative work up. The follow up received on 7/18/02 states, "also developed large "bump" and bruise at injection site left deltoid which resolved."
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Decreased appetite, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Vaccine at 11:30 ret home, began to cry inconsolably at 4pm left thigh red, hot, swollen. Refused to feed. Tylenol given , ice applied. To office at 4:45 still crying inconsolably. Left thigh red, hot, swollen and painful 7cm x 7cm. Motrin 100mg given ice applied and leg elevaged. 6pm, physican exam neg except for pain at site DTaP injection. No further redness. Care at home-ice q 2hr 10 mins each time, elevate leg, Motrin. 06/06/02 8am child slept well leg looks fine.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site warmth
Clinical narrative: Vaccine at 11:30 ret home, began to cry inconsolably at 4pm left thigh red, hot, swollen. Refused to feed. Tylenol given , ice applied. To office at 4:45 still crying inconsolably. Left thigh red, hot, swollen and painful 7cm x 7cm. Motrin 100mg given ice applied and leg elevaged. 6pm, physican exam neg except for pain at site DTaP injection. No further redness. Care at home-ice q 2hr 10 mins each time, elevate leg, Motrin. 06/06/02 8am child slept well leg looks fine.
Age: 2.3
Sex: U
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 12cm x 12cm area of redness, and induration at site of Prevnar + 4.
Age: 1.3
Sex: M
Vaccine: DTAPH, PNC
Symptoms: Atelectasis, Hyperventilation, Lung disorder, Obstructive airways disorder
Clinical narrative: Right after immunizations secretion increased; next day mild retractions, nasal flaring, coughing with increase secretions calmer with aerosol tx's secretions the next night also with coughing and discomfort, low grade temp 99.1 F (Tylenol and Motrin) given alternating thru night. 06/27 wheezing, nasal flaring and retracting not relieved by in-line ventilator. Brought to ER. Per ER Xopenex 126mg x 2 given and other ER measures. Tachypnea, atelectasis, pulmonary congestion.
Age: 0.5
Sex: M
Vaccine: HEP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Febrile reaction 104 degrees.
Age: 1.25
Sex: M
Vaccine: DTAPH, PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: June 26, 2002 evening: fever 102 F at 10pm, some redness, swelling, and tenderness left deltoid (prevnar) mild redness, swelling right deltoid (Trihibit). Rx: Ceftnoxone IM and Augmentin 250 mg po bid.