chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, HIBV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intestinal resection, Intussusception, Surgery
Clinical narrative: she had the rotavirus vaccine given to her on  04/04/2007 then the following day she started throwing up and continued to every ten to twenty minutes an could not sleep so i called the doctor and he said she probably had the stomach flu and should last a day or two. Later that night she pooped so i changed her and her diaper was completely filled with blood. so my mom an i rushed her to the emergency room and through x rays found out that she had her bowels clogged so she was transferred in a ambulance to a better hospital were they had to take out some of her intestine and collin. she stayed in the hospital for 5 days. I guess it is called intussusception.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, MMRV
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Fever, pain, limb swelling started within 16 hours of injection. Patient taking ibuprofen for pain and swelling.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Areflexia, Drug administered at inappropriate site, Gait disturbance, Muscular weakness, Pain
Clinical narrative: Information has been received from a physician concerning a 15 year old female with migraines and tension headaches who in January 2007, was vaccinated intramuscularly into the right leg (also reported as "buttocks") with a first dose of GARDASIL. Concomitant therapy included amytripaline (manufacturer unknown and rizatriptan benzoate. In March 2007, a second dose of GARDASIL was administered intramuscularly into the left leg (also reported as "buttocks"). The physician reported that "a few days to a week after each dose the patient developed a sciatic neuropathy". It was further reported that the neuropathy of the right leg had resolved completely over a few weeks (approximately January 2007 or February 2007). The neuropathy of the left leg had improved, but has not resolved. The physician noted that the patient was still having weakness in the left leg and loss of deep tendon reflex at the level of the left ankle. She also had sensory complaints and tingling when touched at the lateral distal lower extremity. The pain was improved however. The patient was reported to still have a limp. It was also reported that the patient was able to attend school but was unable to participate in physical activities due to the sciatic neuropathy. The physician felt that the patient's experiences were disabling. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Sciatic nerve neuropathy, Sensory disturbance, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 15 year old female with migraines and tension headaches who in January 2007, was vaccinated intramuscularly into the right leg (also reported as "buttocks") with a first dose of GARDASIL. Concomitant therapy included amytripaline (manufacturer unknown and rizatriptan benzoate. In March 2007, a second dose of GARDASIL was administered intramuscularly into the left leg (also reported as "buttocks"). The physician reported that "a few days to a week after each dose the patient developed a sciatic neuropathy". It was further reported that the neuropathy of the right leg had resolved completely over a few weeks (approximately January 2007 or February 2007). The neuropathy of the left leg had improved, but has not resolved. The physician noted that the patient was still having weakness in the left leg and loss of deep tendon reflex at the level of the left ankle. She also had sensory complaints and tingling when touched at the lateral distal lower extremity. The pain was improved however. The patient was reported to still have a limp. It was also reported that the patient was able to attend school but was unable to participate in physical activities due to the sciatic neuropathy. The physician felt that the patient's experiences were disabling. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Anorexia, Diarrhoea haemorrhagic, Lethargy
Clinical narrative: Information has been received from a licensed practical nurse concerning a 60-day-old female who on 02-JAN-2007 was vaccinated PO with a 2ml dose of Rotateq (Lot # 655865/1109F). Concomitant therapy that day included a dose of PEDIARIX (Lot # AC218084CA administered IM, a dose of PedvaxHib (Lot # 654401/1015F) administered IM, and a dose of PREVNAR (Lot # B0867CA) administered IM. On 02-JAN-2007 the patient experienced bloody diarrhea, lethargy and anorexia. Subsequently, the patient recovered from bloody diarrhea, lethargy, and anorexia. The patient slept for 10 hours, and "was fine" the next day. The outcome was recovered. Upon internal review, bloody diarrhea was considered to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Developmental delay, Drug exposure during pregnancy
Clinical narrative: A child (demographics not provided) with a reported expected date of birth as 25 May 2003, had received transplacental vaccination with 0.5 milliliter of Fluzone, lot number U0931AA, on 16 December 2002 when his mother was vaccinated with the Fluzone vaccine. The expiration date of the Fluzone vaccine was reported as 30 June 2003. Reportedly, the patient has developmental disabilities. The date of diagnosis, and description of the developmental disabilities was not reported. It is important to note that the mother has a history of hypothyroidism that is treated with Synthroid, and she has scoliosis. No other medical information was provided.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizure
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blister, Cellulitis, Pain, Pruritus, Pyrexia
Clinical narrative: Swelling 3/16/07 pt woke up 3/17/07 with blister, fever and arm warm to the touch. Pt given Tylenol for fever and pain per mom. Pt present today 3/20/07 with cellulitis 8/9 cm and sensitive to the touch. No fever noted. Pt given Keflex 250 PO Q 6 hr #21, Benadryl PRN itching.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Skin warm, Swelling
Clinical narrative: Swelling 3/16/07 pt woke up 3/17/07 with blister, fever and arm warm to the touch. Pt given Tylenol for fever and pain per mom. Pt present today 3/20/07 with cellulitis 8/9 cm and sensitive to the touch. No fever noted. Pt given Keflex 250 PO Q 6 hr #21, Benadryl PRN itching.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Pyrexia, Rash generalised
Clinical narrative: 3/26/07 Dtap, IPV et MMRV given. Ran fever per mother day of vaccine. No fever since. Rash started on hands and spread to rest of body by 3/29/07, TX: Benadryl 12.5mg/5ml Elixir 3/4 tsp Q 4.6 hrs and Prelone 5mg/5ml. Syrup 1 tsp BID x 2 days 1 tsp x 2 days 1/2 tsp x 2 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site papule, Injection site swelling
Clinical narrative: 2/2/07 R upper arm swollen 2 1/2 inches mildly raised with tiny small papules. TX: none
Sex: M
Vaccine: VARCEL
Symptoms: Chest discomfort, Eyelid oedema, Vomiting
Clinical narrative: Vomited within 2 mins of vaccine. Followed by chest tightness/ B eye lid swelling. (no wheeze and no vital signs) - Benadryl/ Orpred administered.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Excoriation, Induration, Pruritus, Skin lesion
Clinical narrative: There is an area of erythema left lateral upper extremity that measures approximately 2 1/2" by 1 1/2 of induration. There is some excoriation surrounding the lesion. The edge is irregular. 0.1% ointment to rash twice a day until clear. Atarax for itching was prescribed.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Parotid gland enlargement, Swelling face
Clinical narrative: Swelling right face. Parotid gland area.
Age: 14.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: PT was administered Dtap instead of Tdap - No adverse effects as of 04/12/2007
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Cellulitis, Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: 3/09/07 noticed lump at injection site the day administered. 3/27/07 injection site became painful to touch and itching noted. Became febrile and upset stomach noted. 4/5/07 seen by employee health 60x40 mm Erythema noted at site with lump noted. T 99.3, P 79, R 16, BP 118/80. States itching at site, + nausea, arm painful to touch, Loratadine 10 mg given. Evaluated by physician 4/5/07 DX cellulitis. RX given for Keflex 500mg + tab Q PO For 10 days.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Pyrexia, Stomach discomfort
Clinical narrative: 3/09/07 noticed lump at injection site the day administered. 3/27/07 injection site became painful to touch and itching noted. Became febrile and upset stomach noted. 4/5/07 seen by employee health 60x40 mm Erythema noted at site with lump noted. T 99.3, P 79, R 16, BP 118/80. States itching at site, + nausea, arm painful to touch, Loratadine 10 mg given. Evaluated by physician 4/5/07 DX cellulitis. RX given for Keflex 500mg + tab Q PO For 10 days.
Age: 4.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash
Clinical narrative: Sister called 3-20-07 stating pt broke out rash 12/ hr after receiving 2nd Hep A and Varicella shot.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Measles antibody, Rash generalised
Clinical narrative: Rash all over body rubs nose excessively
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Local reaction with erythema and induration. No fever
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Family member came  in to clinic with child at 1:13 pm stated Lt arm red, and swollen, notice Lt arm with swelling and redness present in SQ area where Varicella had been administered, ask family member about application of cool compress, stated, no.
Age: 41.0
Sex: F
Vaccine: HEP, TD
Symptoms: Anxiety, Body temperature increased, Feeling jittery, Headache, Musculoskeletal stiffness
Clinical narrative: 30-40 min after vaccine administered pt felt achiness to arms. Pt reports that at 0130 am she had a temp 102.8 and anxiety/jittery. Pt c/o swollen hands headache, and stiff neck. Pt took Motrin and Tylenol for symptoms. Was given Benadryl 25 mg at 1145 on 3/22/07
Age: 41.0
Sex: F
Vaccine: HEP, TD
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: 30-40 min after vaccine administered pt felt achiness to arms. Pt reports that at 0130 am she had a temp 102.8 and anxiety/jittery. Pt c/o swollen hands headache, and stiff neck. Pt took Motrin and Tylenol for symptoms. Was given Benadryl 25 mg at 1145 on 3/22/07
Age: 43.0
Sex: F
Vaccine: TD, UNK
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient received tetanus (Td) 4/4/06. Has experienced increase arm pain (awakening her at night), induration, warmth and swelling at site of injection.
Age: 5.0
Sex: M
Vaccine: DTAP, HIBV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Vaccines given 4/10/07 developed redness, mild erythema and heat at injection site on right deltoid . Slightly tender to palpation. Less common noticed by 4/12/07. No wheezing or other findings or syms.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: RIGHT ARM WITH SWELLING AND REDNESS AROUND INJECTION SITE
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: SMALL AREA TO LEFT ARM RED AND WARM TO TOUCH
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Unevaluable event
Clinical narrative: NONE KNOWN
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site inflammation, Injection site oedema, Injection site pruritus, Injection site warmth, Pruritus
Clinical narrative: 041107 @ 7:30A INJECTION SITES FOR ALL 4 VACCINES INFLAMMED,WARM TO TOUCH,PRUITIC, EDAMATOUS.  TOOK HOT BATH @4PM, SWELLING WENT DOWN. 6P APPLIED NEOSPORIN OINT WHICH HELPED WITH THE INFLAMMATION AND ITCHING. PRESENTS TO CLINIC TODAY (041207) WITH APPRX. 2" CIRCUMFERENCE AREA LOWER LT ARM, 1" CIRC. UPPER LT ARM, 1.5" CIRC UPPER RT. ARM  WITH INFLAM., HOT TO TOUCH, ITCHING, PAINFULAREAS  AND 2" AREA OF INFLAMMATION ONLY RT LOWER ARM.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MER
Symptoms: Erythema, Swelling
Clinical narrative: Patient had localized redness and swelling. Mother advised to apply warm compresses and to notify Dr. of any further selling or pain. Mother has not called us back. Two messages left for Mother to call back with update on status of child.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Erythema, Rash
Clinical narrative: Developlep red lesion on left breast about 1 week after injection then next week developed red raised bumps with white centers all over abdomen progressively spread to back  breasts and neck.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea for 8 days after given immunization.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Cough, Pharyngolaryngeal pain, Pyrexia, Rash
Clinical narrative: 4/5/07 appears in office Had rash from head to toe, started at trunk with macular erythematous lesions with pinpoint vesicles.  Also noted fever, sore throat and cough.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash macular
Clinical narrative: 4/5/07 appears in office Had rash from head to toe, started at trunk with macular erythematous lesions with pinpoint vesicles.  Also noted fever, sore throat and cough.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Blood pressure decreased, Cyanosis, Heart rate decreased, Oxygen supplementation
Clinical narrative: Given DTAP, IPV, MMRV and become cyanotic with decreased HR and BP.  Given oxygen and epinephrine and transported by EMS to hospital.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL, SMALL
Symptoms: Cardiac enzymes increased, Catheterisation cardiac normal, Chest pain, Echocardiogram abnormal, Electrocardiogram ST segment elevation
Clinical narrative: Patient received vaccines:  Anthrax (6th of the series), Typhoid Vi, and small pox all on the 28 th of March 2007.  Vigorous inflammatory response at site of small pox inoculation reported.  On 8 April, the patient developed chest pains with ST elevations.  Cardiac cath on 10 April showed normal coronaries.  Cardiac enzymes mildly positive.  Clinical presentation consistent with acute myopericarditis.  Initial echo showed mild hypokinesis of the distal lateral and inferior walls.  Repeat echo showed normal LV systolic function and wall motion; only trace pericardial effusion noted.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Hypokinesia, Injection site inflammation, Myopericarditis, Pericardial effusion
Clinical narrative: Patient received vaccines:  Anthrax (6th of the series), Typhoid Vi, and small pox all on the 28 th of March 2007.  Vigorous inflammatory response at site of small pox inoculation reported.  On 8 April, the patient developed chest pains with ST elevations.  Cardiac cath on 10 April showed normal coronaries.  Cardiac enzymes mildly positive.  Clinical presentation consistent with acute myopericarditis.  Initial echo showed mild hypokinesis of the distal lateral and inferior walls.  Repeat echo showed normal LV systolic function and wall motion; only trace pericardial effusion noted.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL, SMALL
Symptoms: Ventricular hypokinesia
Clinical narrative: Patient received vaccines:  Anthrax (6th of the series), Typhoid Vi, and small pox all on the 28 th of March 2007.  Vigorous inflammatory response at site of small pox inoculation reported.  On 8 April, the patient developed chest pains with ST elevations.  Cardiac cath on 10 April showed normal coronaries.  Cardiac enzymes mildly positive.  Clinical presentation consistent with acute myopericarditis.  Initial echo showed mild hypokinesis of the distal lateral and inferior walls.  Repeat echo showed normal LV systolic function and wall motion; only trace pericardial effusion noted.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL, SMALL
Symptoms: Blood creatine phosphokinase increased, Chest pain, Electrocardiogram ST segment elevation, Hypokinesia, Troponin increased
Clinical narrative: Patient received vaccines:  Anthrax (6th of the series), Typhoid Vi, and small pox all on the 28 th of March 2007.  Vigorous inflammatory response at site of small pox inoculation reported.  On 8 April, the patient developed chest pains with ST elevations.  Cardiac cath on 10 April showed normal coronaries.  Cardiac enzymes mildly positive.  Clinical presentation consistent with acute myopericarditis.  Initial echo showed mild hypokinesis of the distal lateral and inferior walls.  Repeat echo showed normal LV systolic function and wall motion; only trace pericardial effusion noted.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL, SMALL
Symptoms: Ultrasound scan abnormal
Clinical narrative: Patient received vaccines:  Anthrax (6th of the series), Typhoid Vi, and small pox all on the 28 th of March 2007.  Vigorous inflammatory response at site of small pox inoculation reported.  On 8 April, the patient developed chest pains with ST elevations.  Cardiac cath on 10 April showed normal coronaries.  Cardiac enzymes mildly positive.  Clinical presentation consistent with acute myopericarditis.  Initial echo showed mild hypokinesis of the distal lateral and inferior walls.  Repeat echo showed normal LV systolic function and wall motion; only trace pericardial effusion noted.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL, SMALL
Symptoms: Catheterisation cardiac, Chest pain, Electrocardiogram, Electrocardiogram ST segment elevation
Clinical narrative: Patient received vaccines:  Anthrax (6th of the series), Typhoid Vi, and small pox all on the 28 th of March 2007.  Vigorous inflammatory response at site of small pox inoculation reported.  On 8 April, the patient developed chest pains with ST elevations.  Cardiac cath on 10 April showed normal coronaries.  Cardiac enzymes mildly positive.  Clinical presentation consistent with acute myopericarditis.  Initial echo showed mild hypokinesis of the distal lateral and inferior walls.  Repeat echo showed normal LV systolic function and wall motion; only trace pericardial effusion noted.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: area of erythema and induration at site of second varicella immunization. 9 by 4 cm. no fever
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Irritability
Clinical narrative: RED SWOLLEN "KNOT" @ INJECTION SITE, SIZE OF QUARTER; FUSSY,
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Erythema, Hypoaesthesia, Muscular weakness
Clinical narrative: Evening after shot arm felt sore but within normal expectation.Right arm(the one she had received the vaccine in at 1PM the day before) became tingly around 9AM and her right hand began to go numb and increasingly weak. It became hard to type (she was working). Her  right hand was also colder than her left. Around 10 AM she was becoming increasing dizzy and nauseous, around 10:30 she vomited. Her face was red prior to vomitting and she appeared to be running a fever (of unknown degree) She had at this time very little feeling in all five fingers and slightly more in the center of her hand. Arm was not numb just tingly. Around 11:30 AM called doctor office to see if they thought it could be a reaction to vaccine. Was no longer very nauseous and face was only mildly flush.Family doctor was also consulted still somewhat dizzy. Was told to go to the emgergency room to be checked. After checking her out and speaking to the doctor office where she received the vaccine,  they gave her a steriod shot in the left arm (aroud 1PM). After about an half hour there began to be some improvement in the numbness of her fingers,(arm still "pin and needly feeling). By 3:30 things had improved but could still feel some weakness and numbness.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Paraesthesia, Peripheral coldness, Pyrexia, Vomiting
Clinical narrative: Evening after shot arm felt sore but within normal expectation.Right arm(the one she had received the vaccine in at 1PM the day before) became tingly around 9AM and her right hand began to go numb and increasingly weak. It became hard to type (she was working). Her  right hand was also colder than her left. Around 10 AM she was becoming increasing dizzy and nauseous, around 10:30 she vomited. Her face was red prior to vomitting and she appeared to be running a fever (of unknown degree) She had at this time very little feeling in all five fingers and slightly more in the center of her hand. Arm was not numb just tingly. Around 11:30 AM called doctor office to see if they thought it could be a reaction to vaccine. Was no longer very nauseous and face was only mildly flush.Family doctor was also consulted still somewhat dizzy. Was told to go to the emgergency room to be checked. After checking her out and speaking to the doctor office where she received the vaccine,  they gave her a steriod shot in the left arm (aroud 1PM). After about an half hour there began to be some improvement in the numbness of her fingers,(arm still "pin and needly feeling). By 3:30 things had improved but could still feel some weakness and numbness.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Pain, Pyrexia, Skin warm
Clinical narrative: 5 days after vaccination,and on the day of TB skin testing, approximately 7-8 hours later, developed body aches, feverishness, feeling nauseated, hot. Didn't take temp, didn't seek medical care, no meds.Symptoms resolved spontaneously the next day.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Received 3 immunizations on 4/4/07 around 4:30 PM.  DTaP and IPV in left leg/MMR in right. Reaction started 4/5/07.  Patient was seen on 4/6/07 with a 20cm x 20cm on upper left thigh.  Erthema was present and site was warm to touch.  Parent told to give Benadryl as needed and to call back if site enlarged from markings placed during office visit.   No call back from parent
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Hypoaesthesia oral, Pharyngeal hypoaesthesia, Pruritus, Urticaria
Clinical narrative: 10:15 Tdap given in right arm. 11:30 Student returned to office c/o generalized itching of neck and shoulders. Visualized area to be bright red in color with welps. Called mom. 3tsp. benadryl given PO. 11:40 B/P 100/60 P80 R20. 11:50 c/o throat, mouth, and lips being numb. 911 called. First responder arrived. B/P 110/80 P80 R20. Mom arrived. 12:15 Paramedics arrive.  Pt left in ambulance to hospital for observation. 2:00 mom called school child D/Ced from hospital.  He is to go to PMD tomorrow for follow up.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Familial risk factor, Gastroenteritis, Rotavirus test, Urine analysis
Clinical narrative: Gastroenteritis with sibling testing positive for rotavirus
Age: 0.79
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Agitation, Band neutrophil count increased, C-reactive protein increased, Infection, Intensive care
Clinical narrative: PATIENT DEVELOPED FEVER THE NIGHT AFTER ADMINISTERING 1ST SET (PEDIARIX, HIB, PREVNAR, ROTATEQ). GIVEN DIAGNOSIS OF ACUTE OTITIS MEDIA AND GIVEN PRESCIPTION FOR AMOXICILLIN.  aFTER THE SECOND DOSE OF AMOXICILLIN, THE PATIENT DEVELOPED A RASH, AND WAS EVALUATED IN THE ER AND ADMITTED.  THE PATIENT WAS TREATED WITH AZITHROMYCIN IN THE ER.  ON ADMISSION, THE PATIENT WAS FOUND TO HAVE AN ELEVATED BAND COUND (27%) AND TREATED WITH CEFOTAXIME. BY DAY 3 OF THE ADMISSION, THE PATIENT WAS MUCH MORE FUSSY, AND THE RASH WAS THEN CONFLUENT OVER THE ENTIRE BODY, WITH ONLY SOME FACIAL SPARING.  HIS BAND COUNT ROSE TO 41%, AND HIS CRP ROSE FROM 164 TO 203 MG/L. ON DAY 2 OF ADMISSION THE TOTAL WBC COUNT DROPPED FROM 5.4 TO 3, BUT ROSE TO 9.6 THE FOLLOWING DAY.  INITIAL CHEMISTRIES WERE NORMAL. URINALYSIS AND MONO SCREEN WERE NEGATIVE.  THE PATIENT DEVELOPED PERSISTENT TACHYCARDIA, AND WAS FELT TO BE IN COMPENSATED SHOCK, AND TRANSFERRED TO THE ICU AT THE HOSPITAL, WHERE THE PATIENT IS CURRENTLY IN CRITICAL CONDITION, INTUBATED AND WITH SEVERE GENERALIZED SWELLING.  NONE OF THE WORK-UP DONE TO DATE HAS REVEALED THE CAUSE OF THE PATIENT'S CLINICAL PICTURE.  INFECTION IS CONSIDERED STRONGLY, BUT REACTION TO EITHER THE VACCINES OR ONE OF THE 3 INITIAL ANTIBIOTICS GIVEN IS ALSO CONSIDERED.  5/29/07 Received outlying hospital medical records which reveal on 4/6/08 patient experienced fever & a papule in diaper region.  Dx w/otitis media & tx w/antibiotics.  Developed increased fever, cough & raised macular rash & went to ER on 4/7.  CXR then revealed RLL infiltrate.  Admitted 4/7-4/9/07 w/dx compensated septic shock; possible allergic reaction to antibiotics or vaccines; & clinical sepsis.  Rash continued to develop & became confluent over entire body, sparring face.  Tachycardia to 200 at rest.  Patient was transferred to higher level of care. 6/5/07 Received 2nd hospital medical records which reveal patient experienced intermittent variable rash.  Received vax on 4/5.  On 4/6, seen by PCP & dx w/acute otitis media & started antibiotics.  On 4/7, rash appeared beginning in diaper area & spread over entire body.  Presented to ER on 4/7 w/rash & fever.  CXR at that time revealed RLL infiltrate. Started on additional antibiotics.  Rash worsened & became confluent sparing only face.  Developed shock & was transferred to higher level of care for PICU.  Initially intubated during that admission for resp distress.  Final dx for that admission: respiratory failure; systemic inflammatory response syndrome; thrombocytopenia; probable toxic shock syndrome; rash; fever of unknown origin; and shock.  Rash had resolved by d/c & echocardiogram done 4/23 r/o Kawasaki.  Re-admitted 4/29-5/1/07.  Had been d/c from hospital a few days prior to this admit for possible toxic shock vs SIRS.  Rheumatology consult done.  Rash resolved completely by d/c to home FINAL DX: unknown rash, resolved.
Age: 0.79
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intubation, Otitis media acute, Pyrexia, Rash generalised, Shock
Clinical narrative: PATIENT DEVELOPED FEVER THE NIGHT AFTER ADMINISTERING 1ST SET (PEDIARIX, HIB, PREVNAR, ROTATEQ). GIVEN DIAGNOSIS OF ACUTE OTITIS MEDIA AND GIVEN PRESCIPTION FOR AMOXICILLIN.  aFTER THE SECOND DOSE OF AMOXICILLIN, THE PATIENT DEVELOPED A RASH, AND WAS EVALUATED IN THE ER AND ADMITTED.  THE PATIENT WAS TREATED WITH AZITHROMYCIN IN THE ER.  ON ADMISSION, THE PATIENT WAS FOUND TO HAVE AN ELEVATED BAND COUND (27%) AND TREATED WITH CEFOTAXIME. BY DAY 3 OF THE ADMISSION, THE PATIENT WAS MUCH MORE FUSSY, AND THE RASH WAS THEN CONFLUENT OVER THE ENTIRE BODY, WITH ONLY SOME FACIAL SPARING.  HIS BAND COUNT ROSE TO 41%, AND HIS CRP ROSE FROM 164 TO 203 MG/L. ON DAY 2 OF ADMISSION THE TOTAL WBC COUNT DROPPED FROM 5.4 TO 3, BUT ROSE TO 9.6 THE FOLLOWING DAY.  INITIAL CHEMISTRIES WERE NORMAL. URINALYSIS AND MONO SCREEN WERE NEGATIVE.  THE PATIENT DEVELOPED PERSISTENT TACHYCARDIA, AND WAS FELT TO BE IN COMPENSATED SHOCK, AND TRANSFERRED TO THE ICU AT THE HOSPITAL, WHERE THE PATIENT IS CURRENTLY IN CRITICAL CONDITION, INTUBATED AND WITH SEVERE GENERALIZED SWELLING.  NONE OF THE WORK-UP DONE TO DATE HAS REVEALED THE CAUSE OF THE PATIENT'S CLINICAL PICTURE.  INFECTION IS CONSIDERED STRONGLY, BUT REACTION TO EITHER THE VACCINES OR ONE OF THE 3 INITIAL ANTIBIOTICS GIVEN IS ALSO CONSIDERED.  5/29/07 Received outlying hospital medical records which reveal on 4/6/08 patient experienced fever & a papule in diaper region.  Dx w/otitis media & tx w/antibiotics.  Developed increased fever, cough & raised macular rash & went to ER on 4/7.  CXR then revealed RLL infiltrate.  Admitted 4/7-4/9/07 w/dx compensated septic shock; possible allergic reaction to antibiotics or vaccines; & clinical sepsis.  Rash continued to develop & became confluent over entire body, sparring face.  Tachycardia to 200 at rest.  Patient was transferred to higher level of care. 6/5/07 Received 2nd hospital medical records which reveal patient experienced intermittent variable rash.  Received vax on 4/5.  On 4/6, seen by PCP & dx w/acute otitis media & started antibiotics.  On 4/7, rash appeared beginning in diaper area & spread over entire body.  Presented to ER on 4/7 w/rash & fever.  CXR at that time revealed RLL infiltrate. Started on additional antibiotics.  Rash worsened & became confluent sparing only face.  Developed shock & was transferred to higher level of care for PICU.  Initially intubated during that admission for resp distress.  Final dx for that admission: respiratory failure; systemic inflammatory response syndrome; thrombocytopenia; probable toxic shock syndrome; rash; fever of unknown origin; and shock.  Rash had resolved by d/c & echocardiogram done 4/23 r/o Kawasaki.  Re-admitted 4/29-5/1/07.  Had been d/c from hospital a few days prior to this admit for possible toxic shock vs SIRS.  Rheumatology consult done.  Rash resolved completely by d/c to home FINAL DX: unknown rash, resolved.
Age: 0.79
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Swelling, Tachycardia, Urine analysis, White blood cell count decreased, White blood cell count increased
Clinical narrative: PATIENT DEVELOPED FEVER THE NIGHT AFTER ADMINISTERING 1ST SET (PEDIARIX, HIB, PREVNAR, ROTATEQ). GIVEN DIAGNOSIS OF ACUTE OTITIS MEDIA AND GIVEN PRESCIPTION FOR AMOXICILLIN.  aFTER THE SECOND DOSE OF AMOXICILLIN, THE PATIENT DEVELOPED A RASH, AND WAS EVALUATED IN THE ER AND ADMITTED.  THE PATIENT WAS TREATED WITH AZITHROMYCIN IN THE ER.  ON ADMISSION, THE PATIENT WAS FOUND TO HAVE AN ELEVATED BAND COUND (27%) AND TREATED WITH CEFOTAXIME. BY DAY 3 OF THE ADMISSION, THE PATIENT WAS MUCH MORE FUSSY, AND THE RASH WAS THEN CONFLUENT OVER THE ENTIRE BODY, WITH ONLY SOME FACIAL SPARING.  HIS BAND COUNT ROSE TO 41%, AND HIS CRP ROSE FROM 164 TO 203 MG/L. ON DAY 2 OF ADMISSION THE TOTAL WBC COUNT DROPPED FROM 5.4 TO 3, BUT ROSE TO 9.6 THE FOLLOWING DAY.  INITIAL CHEMISTRIES WERE NORMAL. URINALYSIS AND MONO SCREEN WERE NEGATIVE.  THE PATIENT DEVELOPED PERSISTENT TACHYCARDIA, AND WAS FELT TO BE IN COMPENSATED SHOCK, AND TRANSFERRED TO THE ICU AT THE HOSPITAL, WHERE THE PATIENT IS CURRENTLY IN CRITICAL CONDITION, INTUBATED AND WITH SEVERE GENERALIZED SWELLING.  NONE OF THE WORK-UP DONE TO DATE HAS REVEALED THE CAUSE OF THE PATIENT'S CLINICAL PICTURE.  INFECTION IS CONSIDERED STRONGLY, BUT REACTION TO EITHER THE VACCINES OR ONE OF THE 3 INITIAL ANTIBIOTICS GIVEN IS ALSO CONSIDERED.  5/29/07 Received outlying hospital medical records which reveal on 4/6/08 patient experienced fever & a papule in diaper region.  Dx w/otitis media & tx w/antibiotics.  Developed increased fever, cough & raised macular rash & went to ER on 4/7.  CXR then revealed RLL infiltrate.  Admitted 4/7-4/9/07 w/dx compensated septic shock; possible allergic reaction to antibiotics or vaccines; & clinical sepsis.  Rash continued to develop & became confluent over entire body, sparring face.  Tachycardia to 200 at rest.  Patient was transferred to higher level of care. 6/5/07 Received 2nd hospital medical records which reveal patient experienced intermittent variable rash.  Received vax on 4/5.  On 4/6, seen by PCP & dx w/acute otitis media & started antibiotics.  On 4/7, rash appeared beginning in diaper area & spread over entire body.  Presented to ER on 4/7 w/rash & fever.  CXR at that time revealed RLL infiltrate. Started on additional antibiotics.  Rash worsened & became confluent sparing only face.  Developed shock & was transferred to higher level of care for PICU.  Initially intubated during that admission for resp distress.  Final dx for that admission: respiratory failure; systemic inflammatory response syndrome; thrombocytopenia; probable toxic shock syndrome; rash; fever of unknown origin; and shock.  Rash had resolved by d/c & echocardiogram done 4/23 r/o Kawasaki.  Re-admitted 4/29-5/1/07.  Had been d/c from hospital a few days prior to this admit for possible toxic shock vs SIRS.  Rheumatology consult done.  Rash resolved completely by d/c to home FINAL DX: unknown rash, resolved.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Nodule, Skin warm
Clinical narrative: REDNESS NEAR VACCINATED AREA, NODE ON R LEG, WARM TO TOUCH, OCCURED DAY AFTER VACCINATION, AREA WAS 2 QUARTER SIZES BIG
Age: 13.0
Sex: F
Vaccine: HPVX, MNQ, PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: red raised bumps around injection site, hot to touch, swollen and injection site itself is red was given in the left deltoid
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Biopsy skin normal, Drug exposure during pregnancy, Granulocytes abnormal, Petechiae, Pregnancy test positive
Clinical narrative: Rash started 2 days after vaccination, came to see us 5 days after vaccination (4/2/07).  Sent to derm clinic, with this note from derm: Bilat arms and lower extremities/buttocks wtih papules coalescing into plaques, most prominent on bilat knees.  Petechiae bilat medial knees;  scattered papules on chest and dorsal hands.  She was started on Prednisone 50 mg. po daily, seen in f/u by derm 4/9/07 with improvement noted, Prednisone changed to decreasing doses.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash papular, White blood cell count increased
Clinical narrative: Rash started 2 days after vaccination, came to see us 5 days after vaccination (4/2/07).  Sent to derm clinic, with this note from derm: Bilat arms and lower extremities/buttocks wtih papules coalescing into plaques, most prominent on bilat knees.  Petechiae bilat medial knees;  scattered papules on chest and dorsal hands.  She was started on Prednisone 50 mg. po daily, seen in f/u by derm 4/9/07 with improvement noted, Prednisone changed to decreasing doses.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood test, Crying, Culture stool, Diarrhoea, Haematochezia
Clinical narrative: diarrhea for >15days and still continuing. vomiting, spotty bloody stool, stool is being cultured. irritable crying. unable to sleep. no x ray done yet. blood drawn today 4.12.7 to do further test.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Insomnia, Irritability, Vomiting
Clinical narrative: diarrhea for >15days and still continuing. vomiting, spotty bloody stool, stool is being cultured. irritable crying. unable to sleep. no x ray done yet. blood drawn today 4.12.7 to do further test.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Expired drug administered, Medication error
Clinical narrative: Medication error-child initially received 3  vaccines.  The ProQuad #1131R Merck was noted to be expired (3/13/2007) after administration.  Childs mother was notified of this while still at the clinic.  Informed her dose would not count since expired and she was given the choice to re-immunize her son same day or return in a month.  She requested he receive the 2nd ProQuad the same day and it was given about 2 inches above first vaccine on the same arm.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Hypersensitivity, Induration
Clinical narrative: had a localized allergic type reaction with 3cm induraiton and 8cm erythema. Started 24 hours after vaccine was administered. Expect to improve without any complication.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC
Symptoms: Decreased appetite, Diarrhoea, Irritability, Pyrexia
Clinical narrative: Fever, loss of appetite, diarrhea, irritable
Age: 1.03
Sex: M
Vaccine: MMR, PNC
Symptoms: Dyskinesia, Electroencephalogram abnormal, Injection site erythema, Injection site reaction, Myoclonic epilepsy
Clinical narrative: My son was given his MMR vaccine to his Left thigh  on 10-17-06. Developed a small area at injection site red and raised after the injection with grew to almost his whole thigh in two days. Day 3 back to the doctors office and saw DR the spot starting to go down. Dr advised me that my son had a reaction to the MMR-when it comes time we may think about not giving the second injection. Day 5 my son started having suddle head jerks which have now developed into myoclonic seizures. He now has physical therapy and will have to start speech therapy due to these seizures.  MMR 1 Merk 6/08 Lot 0707F Pub date1/03 Left leg IM, Prevnar Wyeth 1/08 B08649F Pub dat 12/98 Right leg SQ 05/23/07-records received-EEG report 1/24/07-abnormal because of drowsiness and sleep related frontal, central vertex, polyspike and spike wave discharges. No clinical accompaniment was seen with these. This tracing suggestive of the lowered threshold for generalized seizures. 1/4/09 Myclonic, Atoni, Toni-Clonic, seizures multpile daily. 60 day Follow-up Information 07-JUL-2007: Myoclonic seizures.
Age: 1.03
Sex: M
Vaccine: MMR, PNC
Symptoms: Physiotherapy, Somnolence, Speech rehabilitation
Clinical narrative: My son was given his MMR vaccine to his Left thigh  on 10-17-06. Developed a small area at injection site red and raised after the injection with grew to almost his whole thigh in two days. Day 3 back to the doctors office and saw DR the spot starting to go down. Dr advised me that my son had a reaction to the MMR-when it comes time we may think about not giving the second injection. Day 5 my son started having suddle head jerks which have now developed into myoclonic seizures. He now has physical therapy and will have to start speech therapy due to these seizures.  MMR 1 Merk 6/08 Lot 0707F Pub date1/03 Left leg IM, Prevnar Wyeth 1/08 B08649F Pub dat 12/98 Right leg SQ 05/23/07-records received-EEG report 1/24/07-abnormal because of drowsiness and sleep related frontal, central vertex, polyspike and spike wave discharges. No clinical accompaniment was seen with these. This tracing suggestive of the lowered threshold for generalized seizures. 1/4/09 Myclonic, Atoni, Toni-Clonic, seizures multpile daily. 60 day Follow-up Information 07-JUL-2007: Myoclonic seizures.
Age: 13.0
Sex: U
Vaccine: MNQ
Symptoms: Erythema, Injection site swelling, Oedema peripheral, Pruritus
Clinical narrative: arm swelling and significant erythema with marked pruritis. Lasted for 3 days, treated with Benadryl and topical cortisone cream
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Culture stool, Diarrhoea, Rotavirus test negative
Clinical narrative: Severe diarrhea started within 24 hours of vaccination. Watery stools approx 10-12/day lasted about 5 days. Started on pedialyte and soy formula. Resolved with nuetranafer. Stool rota enzyme neg. day 5.
Age: 1.08
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Medication error, Wrong drug administered
Clinical narrative: Pt was inadvertently given ProQuad and Varivax on 4-6-07. Pt has had no adverse event an no treatment required.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site reaction
Clinical narrative: Vaccines (Hib, Prevnar, Pediarix, Rota) were given on 1/30/07. On 4/10/07 patient was consulted due to mom complaining of a dimple like formation on the patient's left leg where vaccine were administered.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, MMRV
Symptoms: Cellulitis
Clinical narrative: L arm cellulitis onset 1 day after vaccine given treated with Bactrim
Age: 1.74
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Gait disturbance, Injection site erythema
Clinical narrative: Reddened area at site of Prevnar inj R deltoid and failure of child to want to walk Hib inj in L thigh IM. Advised warm compress 15 minutes Q 4-5 hours. Tylenol
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site reaction, Plastic surgery
Clinical narrative: Vaccine Hep A was administered on 1/24/07. Mom noticed a dimple like formation on patient's left leg where vaccine, was administered. Patient was consulted 1 month later. No f/u for 3 months on 4/11/07.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Injection site swelling
Clinical narrative: R leg thigh swelling after receiving children immunization.
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm, Urticaria
Clinical narrative: Had C:Pox vaccine 4/10/07, presented today 4/12/07 a large red whelp C shaped with 4-5 cm induration mild erythema and mildly warm to touch.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: R upper arm cellulitis onset 1 day after vaccine given, treated with Bactrim.
Age: 5.0
Sex: F
Vaccine: DTAP, DTPIPV, MMR
Symptoms: Contusion, Pyrexia, Skin warm, Swelling
Clinical narrative: Swelling of Whole right shoulder - soft ball size, swelling down to elbow, blue and red in color from shoulder to elbow, hot to touch, fever
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Mild vaccine reaction - redness around site, advised observe, return to office for antibiotic if worsens (seen by Dr).
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Electrocardiogram, Syncope
Clinical narrative: Syncopal episode within 5 minutes of administering the vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Biopsy skin, Blood test, Body temperature increased, Electroencephalogram, Gait disturbance
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female, with no reported pertinent medical history, drug allergies or reactions, or potentially noxious or environmental factors, who on 19-Dec-2006 was vaccinated with ProQuad (Lot#656165/1387F). Therapy, on that same day, included diphtheria toxoid (+) pertussis acellular vaccine (Lot # 02552AA) (unspecified) (+) tetanus toxoid and Poliovirus vaccine (Lot # Z0306) (unspecified). On 20-DEC-2006 the patient developed a fever, which lasted for 5 days, (recovered 24-DEC-2006). On 27-DEC-2006 the patient experienced leg pain, which was ongoing at the time of reporting. On 19-MAR-2007 the patient experienced a rash, which was ongoing at the time of reporting. Throughout the illness x-rays, labs and biopsy were performed, with no results provided. A diagnosis of Polyarteritis Nodasa was confirmed after "a biopsy" on 23-MAR-2007. The patient is currently being followed by a pediatric rheumatologist. Hospitalization was required. Unspecified prescription drug treatment, as well as medical and/or surgical intervention were required. The patient's status at the time of reporting was considered not recovered. A lot check has been requested. The events were considered to be immediately life-threatening and other medically important events by the reporter. Additional information has been requested
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Myalgia, Nuclear magnetic resonance imaging, Pain in extremity, Polyarteritis nodosa
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female, with no reported pertinent medical history, drug allergies or reactions, or potentially noxious or environmental factors, who on 19-Dec-2006 was vaccinated with ProQuad (Lot#656165/1387F). Therapy, on that same day, included diphtheria toxoid (+) pertussis acellular vaccine (Lot # 02552AA) (unspecified) (+) tetanus toxoid and Poliovirus vaccine (Lot # Z0306) (unspecified). On 20-DEC-2006 the patient developed a fever, which lasted for 5 days, (recovered 24-DEC-2006). On 27-DEC-2006 the patient experienced leg pain, which was ongoing at the time of reporting. On 19-MAR-2007 the patient experienced a rash, which was ongoing at the time of reporting. Throughout the illness x-rays, labs and biopsy were performed, with no results provided. A diagnosis of Polyarteritis Nodasa was confirmed after "a biopsy" on 23-MAR-2007. The patient is currently being followed by a pediatric rheumatologist. Hospitalization was required. Unspecified prescription drug treatment, as well as medical and/or surgical intervention were required. The patient's status at the time of reporting was considered not recovered. A lot check has been requested. The events were considered to be immediately life-threatening and other medically important events by the reporter. Additional information has been requested
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Biopsy, Laboratory test, Pain in extremity, Polyarteritis nodosa, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female, with no reported pertinent medical history, drug allergies or reactions, or potentially noxious or environmental factors, who on 19-Dec-2006 was vaccinated with ProQuad (Lot#656165/1387F). Therapy, on that same day, included diphtheria toxoid (+) pertussis acellular vaccine (Lot # 02552AA) (unspecified) (+) tetanus toxoid and Poliovirus vaccine (Lot # Z0306) (unspecified). On 20-DEC-2006 the patient developed a fever, which lasted for 5 days, (recovered 24-DEC-2006). On 27-DEC-2006 the patient experienced leg pain, which was ongoing at the time of reporting. On 19-MAR-2007 the patient experienced a rash, which was ongoing at the time of reporting. Throughout the illness x-rays, labs and biopsy were performed, with no results provided. A diagnosis of Polyarteritis Nodasa was confirmed after "a biopsy" on 23-MAR-2007. The patient is currently being followed by a pediatric rheumatologist. Hospitalization was required. Unspecified prescription drug treatment, as well as medical and/or surgical intervention were required. The patient's status at the time of reporting was considered not recovered. A lot check has been requested. The events were considered to be immediately life-threatening and other medically important events by the reporter. Additional information has been requested
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Rash, X-ray
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female, with no reported pertinent medical history, drug allergies or reactions, or potentially noxious or environmental factors, who on 19-Dec-2006 was vaccinated with ProQuad (Lot#656165/1387F). Therapy, on that same day, included diphtheria toxoid (+) pertussis acellular vaccine (Lot # 02552AA) (unspecified) (+) tetanus toxoid and Poliovirus vaccine (Lot # Z0306) (unspecified). On 20-DEC-2006 the patient developed a fever, which lasted for 5 days, (recovered 24-DEC-2006). On 27-DEC-2006 the patient experienced leg pain, which was ongoing at the time of reporting. On 19-MAR-2007 the patient experienced a rash, which was ongoing at the time of reporting. Throughout the illness x-rays, labs and biopsy were performed, with no results provided. A diagnosis of Polyarteritis Nodasa was confirmed after "a biopsy" on 23-MAR-2007. The patient is currently being followed by a pediatric rheumatologist. Hospitalization was required. Unspecified prescription drug treatment, as well as medical and/or surgical intervention were required. The patient's status at the time of reporting was considered not recovered. A lot check has been requested. The events were considered to be immediately life-threatening and other medically important events by the reporter. Additional information has been requested
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HPV4, MNQ, HPV4, MNQ
Symptoms: Computerised tomogram abnormal, Fall, Head injury, Headache, Neck pain
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 13 year old female patient with a history or vasovagal response to vaccine who on 02-APR-2007 was vaccinated with a first dose 0.5 mL of Gardasil. Concomitant therapy included Menactra. On 02-APR-2007 the patient felt dizziness and fell on the ground. The patient was hospitalized in intensive care for head injury but did not require any surgery. At the time of this report patient was still in the hospital and had not recovered. Additional information has been requested.