chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.5
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema, Injection site vesicles
Clinical narrative: Swelling of the upper arm and spreads up to the chest and down to the wrist on the left arm where DTaP was given. Also blisters along the upper left arm.
Age: 6.0
Sex: F
Vaccine: HEP, HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Pt broke out with chicken pox.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Pyrexia
Clinical narrative: Fever for seven days. Onset day of immunization 02/21/2002. negative exam that day, after bronchitis and otitis media on 02/11/2002.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Mom noted set redness, swelling at DTaP injection site approximately 48 hrs post injection. Recommended Motrin, Tylenol for discomfort.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt received vaccination at school three days later seen in ER with erythema/induration on the right thigh. Prescribed with Keflex. Follow-up on 10/15/2001. 8.5cm x 4.5cm faint erythema with induration.
Age: 1.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Erythema, Pyrexia, Rhinorrhoea
Clinical narrative: On 04/02/2002 developed fever, runny nose, noted red dots on genitalia.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis of left arm, pt treated with antibiotics.
Age: 82.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema
Clinical narrative: Had Td on 03/22/2002 in LD for inury to leg. No pain, redness, swelling noted until 04/01/2002 when taking shower noted a dime size red mark on left upper arm "where the shot was given."
Age: 1.3
Sex: M
Vaccine: DTAP, IPV
Symptoms: Feeling hot, Injection site erythema, Tenderness
Clinical narrative: 4" x 4" area of erythema, warmth, tenderness. Prescribed with cool compresses and Benadryl.
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: Feeling hot, Pain, Pyrexia, Urticaria
Clinical narrative: Pt received Hep A and B, and TD given on left detoid on 03/22/2002. Arm pain, hot with fever and hives. Seen in ER IM Benadryl given.
Age: 0.6
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Immunizations received on 04/06/2002. The pt seemed fussy that evening. On 04/07/2002, mom gave him a bath and noticed significant swelling in right leg, primarily in the thigh. Swelling extended down to foot, redness around the injection sites. No fever, itching or loss of circulation. Seen in ER and had Motrin at home.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Decreased appetite, Drug ineffective, Herpes zoster, Irritability, Pyrexia
Clinical narrative: Ten days post MMR vaccination, fever, fussiness, rash, decreased appetite lasted 4-5 days. Two days later bad case shingles. Immunization given at 12 months old.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Ten days post MMR vaccination, fever, fussiness, rash, decreased appetite lasted 4-5 days. Two days later bad case shingles. Immunization given at 12 months old.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Cough, Dizziness, Dyspnoea, Injection site pain, Pallor
Clinical narrative: 5-10 mins after injection, the pt developed shortness of breath, pale, dizzy and pain at injection site and down right side. Given Ibuprofen and Benadryl. Then next day, cough, 2 days later fever, rash and increased cough.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Rash
Clinical narrative: 5-10 mins after injection, the pt developed shortness of breath, pale, dizzy and pain at injection site and down right side. Given Ibuprofen and Benadryl. Then next day, cough, 2 days later fever, rash and increased cough.
Age: 3.0
Sex: F
Vaccine: HEP, HIBV, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Erythema progressing in clusters and isolated along right upper back-shoulder, right arm. No systemic symptoms. No current meds No sick contacts.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Purpura, Tenderness
Clinical narrative: Right leg swollen, moderate edema, erythema marked with central purpura, pruritis, tender, very hot, extending from thigh to knee.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Tenderness
Clinical narrative: Left deltoid area swollen, red, tender to touch for 24 hrs. Treated with Motrin and Benadryl.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: Slight redness noticed next am on 03/26/2002 with some swelling by late afternoon. More redness and swelling and itching this am on 03/27/2002. Office visit made to recheck.
Age: 4.0
Sex: M
Vaccine: DTP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Upper arm extremely swollen, red and purple marks all over.
Age: 1.4
Sex: M
Vaccine: PNC
Symptoms: Rash macular
Clinical narrative: Returned to Clinic about 3:40 pm. Mom reported he developed rash about 30-45 mins. post vaccination. Macular rash on neck and shoulder. No acute distress. Referred to MD. See attached.
Age: 0.93
Sex: F
Vaccine: UNK, PNC, PNC
Symptoms: Crying, Feeling hot, Oedema peripheral
Clinical narrative: About 10 minutes after getting Prevnar, infant started to cry and cried for 2 hours-also started to wheeze at that time. Infant developed a flat red rash that she called 'hives" from shoulders down, body to legs. Today child still has "bruising" on buttocks and legs. Received a shot of Benadryl at doctor's office at 12;30 on 2-19-02. 2-28-02 Child is ok now-sent info on NICP and given a phone #.
Age: 0.93
Sex: F
Vaccine: UNK, PNC, PNC
Symptoms: Contusion, Rash, Urticaria, Wheezing
Clinical narrative: About 10 minutes after getting Prevnar, infant started to cry and cried for 2 hours-also started to wheeze at that time. Infant developed a flat red rash that she called 'hives" from shoulders down, body to legs. Today child still has "bruising" on buttocks and legs. Received a shot of Benadryl at doctor's office at 12;30 on 2-19-02. 2-28-02 Child is ok now-sent info on NICP and given a phone #.
Age: 0.93
Sex: F
Vaccine: UNK, PNC, PNC
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema, Injection site reaction
Clinical narrative: About 10 minutes after getting Prevnar, infant started to cry and cried for 2 hours-also started to wheeze at that time. Infant developed a flat red rash that she called 'hives" from shoulders down, body to legs. Today child still has "bruising" on buttocks and legs. Received a shot of Benadryl at doctor's office at 12;30 on 2-19-02. 2-28-02 Child is ok now-sent info on NICP and given a phone #.
Age: 20.0
Sex: M
Vaccine: MEN
Symptoms: Laboratory test abnormal, Meningitis
Clinical narrative: It was reported that a 20 year old male pt received a Menomune A/C/Y/W-135 vaccination administered on 1/16/02. Reportedly, the pt was dx'd with Bacterial Meningitis-Group C on 3/28/02. The pt is recovering. From follow-up it was reported that the patient developed onset symptoms of Meningitis on 3/27/02. From telephone correspondence received at manufacturer on 4/29/02 the lot numbers are either UB0093AA (was determined to be diluent for yellow fever as per regulatory affairs) or UB0095AA. They received Menomune, MMR Tet booster, IPV, YF and Hepatitis A. All three cases are considered recovered.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Coma, Dizziness, Dysphagia, Dyspnoea, Nausea
Clinical narrative: Client received a 3rd Hep-B. She complained of nausea and feeling dizzy around 09:05 to 09:10. She was monitored, vitals stable at 108/60, 72 pulse and RR 20-24. At 09:40, she became unresponsive. She was given .5cc epinephrine SC in left arms. Also reports difficulty breathing and swallowing.
Age: 0.3
Sex: M
Vaccine: DTAP, DTAP, HBHEPB, PNC
Symptoms: Respiratory disorder
Clinical narrative: Infant was receiving his 3rd injection (PCV) in LAT when he started to cry. Infant was crying so, hard he lost his breath. His face  and lips were turning blue. Mother very upset, she began yelling while strking him on back and buttocks she was holding infant in the air shaking him. Infant caught his breatha fter about 1 min of
Age: 45.0
Sex: M
Vaccine: HEP, HEPA, IPV, TYP, YF
Symptoms: Influenza like illness, Malaise, Pain
Clinical narrative: Client made TC to CCHD and stated he received overseas immunizations on last Tuesday 2-26-02 On Friday 3-1-02, he experienced body aches and generalize malaise but no fever or headache. Has taken Ibuprofen off and on, but not today, Temperature not taken today but it has been normal States no egg allergy, is allergy to bakers's yeast. Drug allergies are Erythiomycin and Sulfa. RN    (?thinks) side effects of vaccines given and s/s of possible flu-like symptoms, then to client to MD.
Age: 1.9
Sex: F
Vaccine: HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Hives lower legs bilateral. Began 2 am on 1-15-02
Age: 55.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Dyspnoea, Injection site reaction
Clinical narrative: Onset at 0530 am 4/11/02-irregular breathing, pain in sternum and back with inhalation "deep breath impossible due to pain" to emergency room at 0730 am. No fever vs normal No rash "whelp' at site of YF vaccine. D/C from Emergency at approximately 16:00 pm- provisional diagnosis. Pt saw chiropractor immediately after D/C from Emergency. Had "adjustment".
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Stupor
Clinical narrative: After 1 hr and 45 min. of receiving DTAP #4, Prevnar #3 and HIB #4. Pr became non-coherent X 15 mins. Pt's mom called 911 and pt. stayed @ hospital X 5 hrs. pts. now fine-recovered.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Injection site pain
Clinical narrative: Less than 24 hours right deltoid very sore not red, not swollen, Afebrile. Treated with Tylenol/Benadryl
Age: 1.07
Sex: M
Vaccine: HBHEPB, PNC, VARCEL
Symptoms: Aphasia, Lethargy, Pyrexia
Clinical narrative: Child very ill on day vaccines given. two days later , mom reports child lethargic, ill appearing, moaning. Temperature 102.8. Child had been saying several words at the time vaccines were given. He totally stopped talking and still does not say words Not even "mama" or "dada". They called ER, but did not go in.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Local reactions-swollen, hot to touch, red at all four vaccination sites given, four days ago. Baby is very fussy, cries when upper legs touched. Local reactions seem more intense then what is normally seen-have lasted longer.
Age: 1.25
Sex: F
Vaccine: DTAP, HEP, MMR, PNC
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Redness & "egg-size" knot noted to left upper thigh evening of injections, increase size of knot and area of redness with heat to touch X 2 days, warm baths with relief. Started oral Benadryl 01/16 with change; Keflex started 01/17 am 01/25 mother states much improved
Age: 4.0
Sex: M
Vaccine: HEPA, PNC, VARCEL
Symptoms: Pyrexia, Vomiting, Wheezing
Clinical narrative: Mom phoned me to relate child's recent illness-concerned it could be linked to Prevnar vaccine he received. Approximately twenty days post vaccination, the child developed fever, vomiting and wheezing. Treated with Erythromycin and Albuterol/saline nebulizer. He is now recovering.
Age: 0.2
Sex: F
Vaccine: HEP, HEP, IPV, PNC
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site warmth
Clinical narrative: Hot at site, red, swelling, knot on right leg
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Dyskinesia, Muscle twitching, Stupor, Tremor
Clinical narrative: Mom called office reports baby laying with eyes half open for fifteen minutes.  Upper extremities shaking, not constant, arms twitching and jerking. Casts on feet and legs. No reports will not stop if holds arms can feel them twitching. respiration regular and adequete. No color change, Have been feeding well. Temperature 98.8. Instructed to go  to hospital.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema
Clinical narrative: Pt had immediate swelling erythema at site of Prevnar
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Had shots, was ok. Woke up with fever. Temperature increase that evening 105 F. Next day 103 F then decreased 99-100 F X 3 days. Was given Tylenol for fever. No other symptoms.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever (T max 106
Age: 28.0
Sex: M
Vaccine: TD
Symptoms: Injection site oedema
Clinical narrative: On 3-26-02, pt called concerning TD and soreness of arm. Pt instructed to come for check. No redness and noted no warmth. Area swollen bigger than a fifty cent piece size. Instructed pt to call his family doctor. Pt called on 3-29-02 and stated he spoke to his doctor, who instructed him to use ice pack, Benadryl and Tylenol and not to get another TD. Pt stated that arm had been swollen approximately size of small apple. Now improving and thinks he will not have further problems.
Age: 1.75
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site oedema, Injection site warmth
Clinical narrative: Developed large Hematoma that was red, hot and swollen @ injection site: to RLT the following afternoon after administration. Was given PO antibiotic and is doing well.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Child received DTAP in RA along with MMR & IPV in LA on 3/5/02. returned to clinic on 3-7-2 with mother complaining of Redness approximately 70 mm and firm area approximately 40 mm where DTaP was given. Warm to touch and slight tenderness noted. Afebrile, tylenol was given for discomfort and cool compresses Qid
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: On 3/4/02, child received DTaP in RA along with IPV and MMR in LA. On 3/5/02, mother returned to clinic with child c/p red firm area approximately 22 mm. child febrile Cool compresses and Tylenol have been given. Child continue with daily activities as usual.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Dry throat, Hypoaesthesia, Injection site pain, Pain in jaw
Clinical narrative: Pt c/o numbness @ injection site immediately; somewhat anxious @ time of injection. Within 1 hour c/o discomfort in left jaw and @ injection site at two hours, After two hours, dry throat and discomfort left leg. Pt's grandmother (retired Public Health RN) relates pt dies not require hosp /ER/MD visit as s/s are abating two and a half hours post injection.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Diarrhoea, Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site reaction
Clinical narrative: Swelling of right upper arm, redness, soreness, some breaks in skin noted. Mom stated pt was vomiting on 2nd day and had some low grade fever and some diarrhea. Given Benadryl liquid 1 1/2 tsp.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Swelling of right upper arm, redness, soreness, some breaks in skin noted. Mom stated pt was vomiting on 2nd day and had some low grade fever and some diarrhea. Given Benadryl liquid 1 1/2 tsp.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Injection site oedema, Injection site reaction
Clinical narrative: On 03/08/2002 left upper arm developed swelling from shoulder to mid arm, and shortness of breath. Given Benadryl
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site reaction
Clinical narrative: On 03/08/2002 left upper arm swollen, red, hard from shoulder to elbow. Instructed mom to take child to ER if the arm gets any worse. Told to give Tylenol and cool compress. Parent stated child's arm was better without any swelling and redness on 03/11/2002.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP
Symptoms: Injection site swelling
Clinical narrative: Mom stated child has a raised area where vaccine had been administered. No fever. Mom instructed to apply cool compress and observe for any changes.
Age: 28.0
Sex: M
Vaccine: MMR
Symptoms: Disorientation, Hyperhidrosis, Pruritus, Pyrexia
Clinical narrative: 3/12/02 Started itching this morning and feeling "disoriented". Also feels 'hot and sweaty" Did not take temperature. Advised to go to ER.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Injection site erythema, Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: Left deltoid area with jagged redness, slight swelling and slight warm. Area measures 6" long 5" wide. 1st night pt took Tylenol. Area itches and burns from time to time. On 03/16/2002 first notices small red patch that grew. Pt visited the doctor and was given Zyrtec and hydroxocine and a shot.
Age: 4.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth, Tenderness
Clinical narrative: Swelling, tenderness, hot, and redness.
Age: 29.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Rash maculo-papular, Throat tightness
Clinical narrative: Per client report; went to local ER at 6:30pm with "big splotchy areas on skin and felt like throat was closing up" states was given steroid shot and Benadryl.
Age: 1.75
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Otitis media, Pyrexia, Viral infection
Clinical narrative: Temperature 104 deg. F. Friday at midnight. Diagnosed with bilateral otitis media and respiratory syncytial virus.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling, redness to left arm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: 04/02/02-Pt broke out today in red, raised rash on side of face , both sides of neck and wrist, fever also. Doesn't itch, No indication of per mother child also hoarse 4/3/02 increase breakout of rash, continued fever to doctor. Per Mom, doctor felt not RI shots, but a virus that would run its course.
Age: 0.08
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Eye swelling, Urticaria
Clinical narrative: Six weeks old presented for immunizations on 04/08/2002. Her mother stated that on that same evening the child's eyes started to swell and a rash appeared. Pt was seen on 04/09/2002 at the office and the eyes were no longer swollen but there were still a few hives. She was stated on Benadryl. She was seen by an allergist on 04/10/2002.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis at site of IPV and DTaP on left arm.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Rash
Clinical narrative: Shots given on 03/22/2002; red splotchy rash all over body started on 03/23/2002, less than 24 hrs of immunization.
Age: 18.0
Sex: M
Vaccine: TD
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis at site of injection treated with Augmentin 8.75 mg BID X IOD
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Agitation, Decreased appetite, Irritability, Rash
Clinical narrative: Mother states infant received first immunizations on 01/24/2001. She says infant cried in car on the way home when at home 12 hr after immunization noted rash on trunk on belly. Infant nursed poorly that night, fussier, crying more and rash came and went. On November 2001 referred to dermatologist. Still has rash on trunk and neck.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site urticaria, Tenderness
Clinical narrative: slight tenderness, redness, firm to touch, and urticaria.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema induratum, Urticaria
Clinical narrative: Redness, firm to touch, urticaria
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Swelling
Clinical narrative: Received Kindergarten immunizations and about 24 hours later, noted redness and swelling with no pain or muscle stiffness/tenderness. Measured 4cmx4cm.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Injection site oedema
Clinical narrative: Swelling to three times the normal size of deltoid muscle.
Age: 2.2
Sex: M
Vaccine: VARCEL
Symptoms: Hypersensitivity, Swelling
Clinical narrative: Mother called to let a nurse know that 11 days after receiving varicella, pt had an allergic reaction. Client had also been on "OMNISEF" for an ear infection. Parent took the child to the ER because hands, ears and feet became swollen. MD unsure if it's related to vaccine or antibiotic.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Tremor
Clinical narrative: Child was given dose of Hep B vaccine on 02/08/2002. Child developed left arm soreness when lifting objects, elbow hurts and when straighten arm, hand shakes when drinking. Denies any different activity. may have happened prior to 02/18/2002 but not before shot on 02/08/2002.
Age: 2.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Febrile convulsion
Clinical narrative: After receiving Hepatitis A #2 and Hepatitis B #4, client had a seizure. Mother states it happened about three hours following vaccination States he had a low grade fever at the time of the seizure. Pt had history of febrile seizures which started @ 1 year of age. Parents thought he had outgrown them. Usually set off by a spike fever, unlike the low-grade (fever). he had time. He went to bed after(wards)
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: On 04/04/2002 child awakened at 8:00am with pain and discomfort to right arm. Right arm got red, raise area approx 5cm x 4cm and smaller inside area 4cm x 3 ccm with vesicles, surrounding injection site. Left arm with reddened area approx 6.5cm x 5cm. Pt is afebrile. Referred to private physician for further evaluation.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site vesicles
Clinical narrative: On 04/04/2002 child awakened at 8:00am with pain and discomfort to right arm. Right arm got red, raise area approx 5cm x 4cm and smaller inside area 4cm x 3 ccm with vesicles, surrounding injection site. Left arm with reddened area approx 6.5cm x 5cm. Pt is afebrile. Referred to private physician for further evaluation.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Pt received hep b #3 at school on 04/02/2002. No complaints by client till 04/04/2002 at school. Approx. 4cm hard area around injection site and red area 1 1/2-2" down upper arm. "Red bruised look" per mom. To PMD on 04/04/2002, was recommended symphors with ice and Advil. On 04/05/2002 arm looked much better, still red and swollen but "almost gone."
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal, Swelling, Tenderness
Clinical narrative: Swelling and tenderness of joints of both hands. Onset 1 week after varicella vaccine and lasting 6 to 8 weeks.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Varicella, mild
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site induration
Clinical narrative: Induration centered at DTaP site involved upper arms and all deltoid muscle. Ertyrthema extended from ribs to left ear lobe, approximately 30 hours after immunizations given. Zyrtec 5 mg bid and Prelone 20 mg Im X one given 4/3/2002. Zyrtec continued several days good impprovement.
Age: 4.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Injection site oedema, Tenderness
Clinical narrative: Swelling of left arm from shoulder to elbow, tender to touch and filled with fluid (edema).
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Mild case of varicella (10 lesions) and fever of 99 deg. F.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema multiforme, Joint swelling, Rash
Clinical narrative: The pt developed joint swelling and erythem-multi form lesions. Rash on skin, unable to bare weight.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Three days after administration of varicella vaccine. Pt came back with pruritis, erythematous lesions.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Localized reddened area on right thigh.
Age: 0.7
Sex: M
Vaccine: HEP
Symptoms: Laboratory test abnormal, Pyrexia
Clinical narrative: Less than 6 hrs after hep b vaccination, the pt developed fever of 102-104 deg. F lasting approximately 3 days. Took to docotr, white blood count was 18.6 with no other symptoms. He was given a Rocephin antibiotic shot and then he was fine.
Age: 67.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Nausea, Paraesthesia, Pyrexia
Clinical narrative: On 04/02/2002 telephone call received from client complaining of "tingling sensation arm and shoulder, hands, fever (100 deg. F), nausea, onset developed approximately 1 hour after vaccine administration."
Age: 1.3
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Blister, Rash
Clinical narrative: On 02/11/2002 pt received routine varicella vaccine. Pt was seen in ER on 02/17/2002 for rash . On 02/22/2002 pt was re-evaluated and vesicles were noted on right leg.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Left arm began swelling within 2 hrs of immunization, shortness of breath reported that night. Left arm hot and achy and it's still swollen 04/10/2002.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Skin lesions of chicken pox.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site reaction, Pyrexia
Clinical narrative: large round circle on arm, very red with fever. Two days later still quarter size reaction on arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Tenderness
Clinical narrative: Arm swelling from top of shoulder to bottom of deltoid with redness and tenderness.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site reaction
Clinical narrative: On 06/26/1998 immunization reaction vs. cellulitis on left thigh with large indurated erythematous area injection site. Cold compresses and Duridef given.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Nausea, Pallor, Pharyngitis, Pruritus
Clinical narrative: Rash, fever, nausea, vomiting, itching, pale, pharynx inflammed, small vesicles on trunk, face, and extremities.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Rash, fever, nausea, vomiting, itching, pale, pharynx inflammed, small vesicles on trunk, face, and extremities.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site swelling, Rash macular, Tenderness
Clinical narrative: Small black dot on left thigh, warm, raised area across with blotchy edges, mildly tender approx. 2 1/2"  in diameter. Prescribed Keflex for seven days.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Left thigh generally erythematous, warm, swollen on anterior part, not indurated, no limit of motion on either leg. Able to bear weight on leg.
Age: 1.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: Injection site became red, hot and swollen the next day. On physical exam, area of redness was about 6 x 6cm with a darker area of redness towards the elbow about 3 x 5cm and warm to touch. There was no rash on any other part of the body and no fever. Pt was diagnosed with localized reaction to the immunization DTP and skin infection. She was treated with Augmentin for 10 days and was told to apply ice to the area.
Age: 1.25
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Large 5" area of redness on right arm with 4" induration upper arm.  Lower arm-some redness, no induration with 1" redness.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Laboratory test abnormal
Clinical narrative: Employee received the 2nd dose of Rubeola (measles) vaccine (5 weeks and 3 days after the 1st dose was given without severe reaction) and noted itching and redness at site, approx. 5 1/2 hours, post vax, experienced tiredness and 5 1/2cm by 4 cm area of redness under right upper arm and raised with area pruritic with some tenderness. Denies other adverse reaction or feeling of respiratory alterations. Employee to be seen by FNP today for evaluation. Employee had not taken any antihistamines up the present. Benadryl 25mg every 4-6 hours for itching.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus
Clinical narrative: Employee received the 2nd dose of Rubeola (measles) vaccine (5 weeks and 3 days after the 1st dose was given without severe reaction) and noted itching and redness at site, approx. 5 1/2 hours, post vax, experienced tiredness and 5 1/2cm by 4 cm area of redness under right upper arm and raised with area pruritic with some tenderness. Denies other adverse reaction or feeling of respiratory alterations. Employee to be seen by FNP today for evaluation. Employee had not taken any antihistamines up the present. Benadryl 25mg every 4-6 hours for itching.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Hep-B booster received at 19:30. At 01:00, child awoke yelling "everything hurts" and fever of 102.5F. Fever continued at 101F for 3 days with nausea. Fever came back over 2 weeks. Also had headache and weakness for 3 weeks and sleepiness.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Somnolence
Clinical narrative: Hep-B booster received at 19:30. At 01:00, child awoke yelling "everything hurts" and fever of 102.5F. Fever continued at 101F for 3 days with nausea. Fever came back over 2 weeks. Also had headache and weakness for 3 weeks and sleepiness.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 2 year old with warm, red and indurated area at site of injections (DTAP and Hep-A).
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Cellulitis, Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccines on 3/19/02 and on 3/21/02,  presents with fever, induration, swelling and warmth at the injection site, consistent with cellulitis. Got DTAP and IPV on right arm at injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Pyrexia
Clinical narrative: Pt received vaccines on 3/19/02 and on 3/21/02,  presents with fever, induration, swelling and warmth at the injection site, consistent with cellulitis. Got DTAP and IPV on right arm at injection site.
Age: 4.3
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Pruritus, Rash vesicular
Clinical narrative: Upper arm broke out with vesicles and erythema rash around injection site, the evening (5-6 hours), post vax. Vesicles crusted over and were very itchy.
Age: 23.0
Sex: F
Vaccine: JEV, RAB
Symptoms: Asthenia, Headache, Neck pain, Pain, Pharyngolaryngeal pain
Clinical narrative: Sore throat, legs aching, felt weak, headache, low-grade fever, neck aching and really sore. Seen on 4/1/02 and 4/2/02.
Age: 23.0
Sex: F
Vaccine: JEV, RAB
Symptoms: Pyrexia
Clinical narrative: Sore throat, legs aching, felt weak, headache, low-grade fever, neck aching and really sore. Seen on 4/1/02 and 4/2/02.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Pt developed varicella rash and was seen in the office on 3/15/02 and dx'd as varicella. He was treated with a 5 day course of Zovirax and anti-itch medicine.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Anxiety, Dyspnoea, Hypersensitivity, Tremor
Clinical narrative: Client called to describe shakiness, nervousness and "difficulty breathing-maybe I'm hyperventilating". Able to speak clearly with no apparent dyspnea. Advised ER assessment where she received Ativan 1mgm po and Benadryl 50mgm IV and dx of possible MMR reaction or anxiety.
Age: 6.0
Sex: M
Vaccine: DTAPH, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Pt got chickenpox.
Age: 3.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Pt developed chickenpox.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Softball-sized swelling, redness and hot to touch (tan colored area today).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site warmth, Skin discolouration
Clinical narrative: Softball-sized swelling, redness and hot to touch (tan colored area today).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Tennis ball-sized swelling, redness, hot to touch and itchy.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Tennis ball-sized swelling, redness, hot to touch and itchy.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Pruritus
Clinical narrative: Tennis ball-sized swelling, redness, hot to touch and itchy.
Age: 62.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen right arm, spread with time from shoulder to elbow, redness, hot to touch and painful.
Age: 62.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site inflammation, Injection site pain, Oedema peripheral
Clinical narrative: Swollen right arm, spread with time from shoulder to elbow, redness, hot to touch and painful.
Age: 62.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Pain
Clinical narrative: Swollen right arm, spread with time from shoulder to elbow, redness, hot to touch and painful.
Age: 24.0
Sex: M
Vaccine: TYP
Symptoms: Bronchospasm
Clinical narrative: Bronchospasm/wheezing developed several hours after taking 1st and only dose of oral Typhoid. Didn't seek medication because does not have insurance. Treated with OTC Primatine Mist.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom noted rash on left deltoid this AM. Nurse observed site of DTAP injection in the center of area that was red, raised and almost vesicle-like in appearance. Rash (3" long by 1 1/2" wide area of skin involved). IPV injection site looks fine. Mom was advised to take child to MD.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Rash to bilateral arms, trunk and chest, 3 hours, post vax. Pt was seen by MD, later that day and was given Rx for Zyrtec 10mg 1 qd X 30, Prednisone 40mg 1 qd X 5 days. Per doc 212746, patient is fairly certain she had 3 doses of HebB series in 1989. Facility has closed, no records available.
Age: 28.0
Sex: M
Vaccine: VARCEL
Symptoms: Influenza like illness
Clinical narrative: Chickenpox from VZV and flu-like symptoms.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Cognitive disorder, Dizziness, Heart rate increased, Hyperhidrosis, Pharyngolaryngeal pain
Clinical narrative: Pt complained of dizziness, sweating, rapid heart beat and not thinking clearly about 1 hour, post vax. Pt went to local MD's office. Epi was given and then pt was transported to ER. Pt at work today (3/20/02) and states "I'm better". Complained of sore throat "from swelling".
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Swelling
Clinical narrative: Pt complained of dizziness, sweating, rapid heart beat and not thinking clearly about 1 hour, post vax. Pt went to local MD's office. Epi was given and then pt was transported to ER. Pt at work today (3/20/02) and states "I'm better". Complained of sore throat "from swelling".
Age: 5.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Infection
Clinical narrative: Started to break out with lesions on 3/7/02. "Covered with pox" as stated by mother by 3/9/02. Visit to MD on 3/11/02 and 3/12/02. Lesions dried enough by 3/22/02 to return to pre-school. Sister (DOB 5/12/93) received varicella vaccine on 11/2/95 and broke out with lesions on 3/14/02. Mother felt it was from exposure to her brother.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain
Clinical narrative: Oral Typhoid vaccine was taken at 05:00. Experienced severe abdominal pain and cramping at 07:00. Was taken to the ER at 10:00 and there for 5 hours. Was given a Morphine injection X 3 for pain, IV of normal saline. Stated she was given pain medication (did not know the name) to use at home but did not need to take them.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation
Clinical narrative: Red and inflammed cellulitis, 4 days post vax. Treated with ice, 600mg ibuprofen, Benadryl 25mg 1 q6h X 4 days.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Very large, red area, swollen and hot to the touch, starting 3 days, post vax to 1 week, post vax. Treated with ice, Motrin and Benadryl.
Age: 17.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Very large, red, swollen and hot area with pain, 2 days, post vax. Treated with ice, Benadryl and Motrin.
Age: 3.0
Sex: U
Vaccine: DT
Symptoms: Rash
Clinical narrative: A nurse reported that a 3 year old child received an injection of DT and subsequently developed a localized rash at the injection site. The child recovered.
Sex: U
Vaccine: DT
Symptoms: Pyrexia
Clinical narrative: A purchasing agent reported that an unidentified child received Diphtheria and Tetanus Toxoids Adsorbed, Purogenated (diphtheria and tetanus toxoids, aluminum phosphate-adsorbed) and experienced an "unknown reaction". The reporter states that the mother thinks it may have been due to thimerosal. No additional information was available as of the date of this report. Follow-up information received on 2/20/02 from pediatrician. The adverse event was identified as a "transient fever". The pt recovered.
Age: 21.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash erythematous
Clinical narrative: Nine to ten days after MMR injection developed a rash on lower abdomen and then progressed to chest and back also.  Not very itchy.  Treated with Claritin 10 mg daily for seven days with one refill available
Age: 0.5
Sex: M
Vaccine: HBHEPB
Symptoms: Neurodevelopmental disorder
Clinical narrative: Information has been received from a doctor of veterinary medicine concerning his 6 month old son who on 2/24/00 and 5/11/00 was vaccinated with a 1st and 2nd dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). On 6/12/00, the boy was dx'd with delayed development and hypotonia. Unspecified medical attention was sought. It was noted that the pt received a 3rd dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) on 8/10/00. Upon internal review, delayed development was determined to be an "Other Important Medical Event". Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Autism
Clinical narrative: Information has been received from a physician concerning an approx. 4 year old male child who received the following vaccinations on unspecified dates: 2 dose of MMRII, 1 dose of varicella virus vaccine live and 1 dose of HIB conjugate vaccine. The physician reported that between 2-3 years of age, the child was developing normally. He was made aware of the fact that another physician had since dx'd the child with autism. Upon internal review, autism was determined to be an "Other Important Medical Event". No further information is available. Follow up info from the physician noted, "I am not aware of any adverse reaction to any vaccines this pt recieved." No further info is available.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: CSF test abnormal, Drug ineffective, Feeling hot, Herpes zoster, Infection
Clinical narrative: Information has been received from a physician concerning a 5 year old male pt who on 3/14/00 was vaccinated with varicella virus vaccine live. On 2/17/02, he developed a rash on his shoulder and back in a C2, C3 dermatomal distribution. He presented to the ER on 2/19/02 with a stiff neck and nausea. Other than nuchal rigidity, his neurologic exam was normal. His mother reported him feeling warm to touch at home, however, he was afebrile on admission. Although his mental status was normal and he remained afebrile, he was given a dx of viral meningitis due to VZV and placed on acyclovir. He was immediately placed on respiratory precautions. He improved and WBC returned to normal. He was discharged on 2/26/02. The CDC indicated that this is not a varicella adverse event, but either: shingles and concurrent enteroviral meningitis or possibly enteroviral infection with herpes simplex reactivation. They noted that the skin lesions were never tested and that the physician gave a history compatible with shingles but there was no lab confirmation. PCR analysis was performed at the CDC and the results indicated that the crust of the shingles rash was (+) for Oka strain varicella virus. It was concluded that the child had vaccine-strain shingles and a separate enteroviral meningitis. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection parasitic, Meningitis, Musculoskeletal stiffness, Nausea, Rash
Clinical narrative: Information has been received from a physician concerning a 5 year old male pt who on 3/14/00 was vaccinated with varicella virus vaccine live. On 2/17/02, he developed a rash on his shoulder and back in a C2, C3 dermatomal distribution. He presented to the ER on 2/19/02 with a stiff neck and nausea. Other than nuchal rigidity, his neurologic exam was normal. His mother reported him feeling warm to touch at home, however, he was afebrile on admission. Although his mental status was normal and he remained afebrile, he was given a dx of viral meningitis due to VZV and placed on acyclovir. He was immediately placed on respiratory precautions. He improved and WBC returned to normal. He was discharged on 2/26/02. The CDC indicated that this is not a varicella adverse event, but either: shingles and concurrent enteroviral meningitis or possibly enteroviral infection with herpes simplex reactivation. They noted that the skin lesions were never tested and that the physician gave a history compatible with shingles but there was no lab confirmation. PCR analysis was performed at the CDC and the results indicated that the crust of the shingles rash was (+) for Oka strain varicella virus. It was concluded that the child had vaccine-strain shingles and a separate enteroviral meningitis. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTP, IPV, MMR
Symptoms: Blood glucose increased, Cough, Eye swelling, Glucose urine present, Ketosis
Clinical narrative: Information has been received from a health professional concerning a 5 year old male who on 2/28/02 was vaccinated with a 2nd dose of MMRII (lot 639137/1082L). The 1st dose was given on 3/11/98. Concomitant vaccination on 2/28/02 included a dose of poliovirus vaccine and diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. At the child's well visit, the day of vaccination, it was reported that the pt had been coughing for the past 2 weeks and his mother was treating him with diphenhydramine hydrochloride (Benadryl) and quaifenesin (Robitussin). On this visit, the pt had his urine dipped, which was normal with no ketones or no glucose; he was afebrile and his visit was recorded as a normal exam. On 3/2/02, the pt's mother reported to the physician's office that the pt developed swollen eyes and a pocket of fluid under his left eye and was pale and listless. The physician documented questionable Mono or questionable nephrotic disease. The pt was seen in the office to be evaluated. He had no weight loss but a history of wetting the bed for the past 2-3 weeks. From the office, the pt was admitted to the hospital with the chief complaint of periorbital swelling/early nephrotic syndrome or kidney disease. The plan was to follow his blood sugars every 2 hours and with each void to check his urine for ketones and sugar. The results of blood sugars and urine dips were all normal. The physician's clinical impression was that the child might be on a slope of a normal pancreas or insulin dependent diabetes. The pt was discharged from the hospital on 3/3/02 with instructions for his mother to continue to dip his urine for ketones and sugar at home. The parents requested for him to be seen by a Pediatric Endocrinologist for follow-up. It was reported that the physician did not feel that this adverse event was related to the MMRII. The nurse reported that another pt (WAES0204USA00284) had a similar experience following exposure to MMRII. Additional information has been requested. The follow up states the pt recovered from glycosuria and ketonuria on 3/3/02.
Age: 5.0
Sex: M
Vaccine: DTP, IPV, MMR
Symptoms: Listless, Nephrotic syndrome, Pallor, Urinary incontinence
Clinical narrative: Information has been received from a health professional concerning a 5 year old male who on 2/28/02 was vaccinated with a 2nd dose of MMRII (lot 639137/1082L). The 1st dose was given on 3/11/98. Concomitant vaccination on 2/28/02 included a dose of poliovirus vaccine and diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. At the child's well visit, the day of vaccination, it was reported that the pt had been coughing for the past 2 weeks and his mother was treating him with diphenhydramine hydrochloride (Benadryl) and quaifenesin (Robitussin). On this visit, the pt had his urine dipped, which was normal with no ketones or no glucose; he was afebrile and his visit was recorded as a normal exam. On 3/2/02, the pt's mother reported to the physician's office that the pt developed swollen eyes and a pocket of fluid under his left eye and was pale and listless. The physician documented questionable Mono or questionable nephrotic disease. The pt was seen in the office to be evaluated. He had no weight loss but a history of wetting the bed for the past 2-3 weeks. From the office, the pt was admitted to the hospital with the chief complaint of periorbital swelling/early nephrotic syndrome or kidney disease. The plan was to follow his blood sugars every 2 hours and with each void to check his urine for ketones and sugar. The results of blood sugars and urine dips were all normal. The physician's clinical impression was that the child might be on a slope of a normal pancreas or insulin dependent diabetes. The pt was discharged from the hospital on 3/3/02 with instructions for his mother to continue to dip his urine for ketones and sugar at home. The parents requested for him to be seen by a Pediatric Endocrinologist for follow-up. It was reported that the physician did not feel that this adverse event was related to the MMRII. The nurse reported that another pt (WAES0204USA00284) had a similar experience following exposure to MMRII. Additional information has been requested. The follow up states the pt recovered from glycosuria and ketonuria on 3/3/02.