chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: HEP, PNC
Symptoms: Condition aggravated, Neutropenia, White blood cell count decreased, White blood cell count increased
Clinical narrative: Additional information received from the investigator provided patient medical history, hospitalization details, additional vaccines administered, laboratory results, the additional event of neutropenia and an updated relatedness assessment. Information regarding Prevnar was received from an investigator regarding a 3 month old male. On 5/12/00, at 2 months of age, he received his first dose of Prevnar as part of a study. The participant also received a dose of hepatitis B vaccine on the same day. On 6/9/00, he was hospitalized for complications secondary to prematurity and neutropenia. The patient's concurrent illnesses include anemia and neutropenia (reported as: history of cylic neutropenia) with a past history of Klinefelter's syndrome, premature baby (reported as: 28 weeks gestation), chronic obstructive pulmonary disease (reported as: chronic lung disease), neonatal respiratory distress syndrome (characterized by severe apnea and bradycardia both requiring continuous oxygen treatment), patent ductus arteriosus, ventricular septal defect (reported as: small VSD), clavicle fracture (right), sepsis (reported as: rule out sepsis) hypotension, renal failure (reported as: oliguric renal failure), oliguria (reported as: oliguric renal failure), hyperbilirubinemia, patent ductus arteriosus repair (reported as: PDA ligation), feeding problem in new born (reported as: history of feeding intolerance), hematochezia, and sleep study. Indication for Prevnar was immunization. Product was administered on 5/12/00. Dose regimen was 1 dose 1 time per day. The patient also received a dose of hepatitis B vaccine on the same day. Additional suspect vaccines administered 5/11/00 included Acel-Imune, Hib-Titer Vaccine, and Poliomyelitis vaccine inactivated. Concomitant medications were not reported. On 6/9/00, the participant was hospitalized for complications secondary to prematurity and neutropenia. The reporter observed that the participant's neutropenia was first identified on 5/15/00. The participant partially recovered from the complications of prematurity, but the reporter indicated that the patient's neutropenia was ongoing through end of patient's information on 10/20/03. The investigator considered neutropenia possibly related and non-specific reaction not reported to study product. The medical monitor considered neutropenia related to the child's history of cyclic neutropenia first identified 5/15/00 and not related to the study product. The medical monitor assessment for non-specific reaction was unknown. No additional information was available at the time of this report.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Infantile spasms
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar was received regarding a 3 month old male patient who experienced infantile spasms. The patient received a dose on an unspecified date. The patient previously experienced infantile spasms while taking Rabies Vaccine. The indication for Prevnar was immunization. Product was administered on an unspecified date. The dose regimen was 1 dose 1 time per day. Additional suspect medication included Hib-Titer Vaccine, Pediarix, and Rabies vaccine. Concomitant medications were not reported. Within 24 hours of Prevnar, Hib-Titer, and Pediarix administration, the infant experienced a series of infantile spasms. The episodes occurred over a period of 6 to 8 hours. No additional information was available at the time of this report.
Age: 53.0
Sex: F
Vaccine: TTOX
Symptoms: Pruritus, Rash
Clinical narrative: Donor noticed itching underside of left arm near arm pit 2 days later 5/15/05 at home found red rash. No treatments given.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Swelling to deltoid; redness.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Dyspnoea, Wheezing
Clinical narrative: 1 hour after immunizations, child wheezing and having shortness of breath.
Age: 1.54
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 4/20/05 DTaP right deltoid. 4/22/05 Mom reported redness, swelling to injection site. Advise Motrin and warm compresses. 4/25/05 Spoke with mom; reported no swelling or redness.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, PNC
Symptoms: Swelling
Clinical narrative: 4/14/05 Swelling to left deltoid extending to just above elbow.
Age: 1.4
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Skin ulcer, Viral infection
Clinical narrative: Had varicella vaccine in 1999. Seen on 5/16/05 in our office and diagnosed with varicella by doctor. Exposed to chicken pox at school 3 weeks prior to visit. Had 25 lesions on trunk, arms, some with small central vesicle, a few crusted. No fever.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, OPV
Symptoms: Rash
Clinical narrative: Rash on back and legs.
Age: 11.0
Sex: M
Vaccine: MNQ, TD
Symptoms: Injection site erythema, Injection site warmth, Pyrexia, Tenderness
Clinical narrative: Child presented for 11 year PE on 5/21/05. Menactra administered IM right deltoid. Td administered IM left deltoid. Onset fever Saturday PM; increased to 103.6 oral. No other symptoms. Patient seen in office on 5/23/05. Exam NL with 2" red, warm area right bicep; tender to palp.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Blister, Pyrexia, Rash, Viral infection
Clinical narrative: Mother called on 5/21/05 to report that child had chicken pox. Exposed at school 2-3 weeks ago. Had fever on 5/20/05, T 101 oral for 24 hours. Rash started 5/21/05 on face, trunk, extremities. Many had central vesicle. These were crusted by 5/24/05. Had 40-50 spots. Not seen in office. Siblings had CP in past and mother was sure rash was same.
Age: 1.02
Sex: F
Vaccine: HEP, MMR
Symptoms: Rash
Clinical narrative: Rash all over body- face, neck and extremties.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Bacterial infection, Coma, Convulsion, Depressed level of consciousness, Laboratory test abnormal
Clinical narrative: Brother holding baby while watching TV. Mom took baby, tried to wake baby, unable to wake the baby. Opened up one eye then closed. Lasted 10 minutes until she arrived at the hospital ER.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Sepsis
Clinical narrative: Brother holding baby while watching TV. Mom took baby, tried to wake baby, unable to wake the baby. Opened up one eye then closed. Lasted 10 minutes until she arrived at the hospital ER.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site reaction, Injection site warmth, Pruritus
Clinical narrative: Call from mom 05/13/05 AM-. On 05/12/05 PM child c/o itching to right arm. Mom did not notice any redness or swelling. Now on 05/13/05 AM, child with "grapefruit" sized area of right upper arm with redness, hot, itching. No hardness,no lump, no fever. Appt given but mom cancelled. Gave Benadryl and SS are gone.
Age: 33.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Dizziness, Myalgia
Clinical narrative: Dizziness, and muscle/joint pain.
Age: 1.84
Sex: M
Vaccine: DTAP, MMR, PNC
Symptoms: Injection site inflammation, Injection site oedema, Injection site reaction, Oedema peripheral
Clinical narrative: Left thigh with 4cm x 4cm area of edema and inflammation of upper leg- localized reaction only.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Redness and swelling left arm chest and face.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Had Varivax 4/6/2000; dx with chicken pox on 05/20/2005.
Age: 1.1
Sex: M
Vaccine: HEP, PNC, VARCEL
Symptoms: Blister, Pruritus, Pyrexia, Rash, Rash papular
Clinical narrative: Pt had varicella vaccine on 08/03/2000. Diagnosed with varicella in our office on 5/20/05 by NP. Developed rash and fever of 100 oral on 5/19/05. Had less than 50 lesions on face, trunk, legs and arms. Lesions were mix of papules and vesicles. Mildly itchy. Rash crusted by day 5. Fever lasted 24 hrs.
Age: 1.1
Sex: M
Vaccine: HEP, PNC, VARCEL
Symptoms: Skin ulcer
Clinical narrative: Pt had varicella vaccine on 08/03/2000. Diagnosed with varicella in our office on 5/20/05 by NP. Developed rash and fever of 100 oral on 5/19/05. Had less than 50 lesions on face, trunk, legs and arms. Lesions were mix of papules and vesicles. Mildly itchy. Rash crusted by day 5. Fever lasted 24 hrs.
Age: 52.0
Sex: M
Vaccine: TTOX
Symptoms: Injection site pain
Clinical narrative: Injection given on 4/18/05 pt (donor) reported it to us on 5/16/05 at time he stated his arm was very sore. Appt was scheduled with physician and (donor) did not return 5/18/05.
Age: 23.0
Sex: M
Vaccine: TTOX
Symptoms: Chills, Dizziness, Injection site erythema, Injection site pain, Malaise
Clinical narrative: Soreness and redness of injection site lasted 9 hrs. Muscle aching lasted 24 hrs. Lightheadedness lasted less than 1 hr. Chills off and on 36 hrs. Fever 101 off and on 36 hrs. Nausea off and on 36 hrs. Vomiting 1 episode, paleness lasted 2 hrs. General discomfort lasted 36 hrs. Tetanus shot given 10:27AM 2/2/05. No symptoms started until 10:55AM on 2/2/05. No treatment by doctor, ER, etc, he stayed in bed.
Age: 23.0
Sex: M
Vaccine: TTOX
Symptoms: Myalgia, Nausea, Pallor, Pyrexia, Vomiting
Clinical narrative: Soreness and redness of injection site lasted 9 hrs. Muscle aching lasted 24 hrs. Lightheadedness lasted less than 1 hr. Chills off and on 36 hrs. Fever 101 off and on 36 hrs. Nausea off and on 36 hrs. Vomiting 1 episode, paleness lasted 2 hrs. General discomfort lasted 36 hrs. Tetanus shot given 10:27AM 2/2/05. No symptoms started until 10:55AM on 2/2/05. No treatment by doctor, ER, etc, he stayed in bed.
Age: 78.0
Sex: F
Vaccine: TD
Symptoms: Atrial fibrillation, Chest pain, Fatigue, Heart rate increased, Malaise
Clinical narrative: Client called 4/29/05 reported had Td given at Dr's office 3/24/05. On 3/25/05 stated feeling bad, very tired, chest pain, rapid heart beat. Went to hospital, 3/27/05 for tests. Dx with tachycardia (atrial fib).
Age: 78.0
Sex: F
Vaccine: TD
Symptoms: Tachycardia
Clinical narrative: Client called 4/29/05 reported had Td given at Dr's office 3/24/05. On 3/25/05 stated feeling bad, very tired, chest pain, rapid heart beat. Went to hospital, 3/27/05 for tests. Dx with tachycardia (atrial fib).
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Clumsiness, Encephalopathy, Memory impairment, Psychomotor hyperactivity
Clinical narrative: 4/9/05-Present. Pt is forgetful, hyperactive, and clumsy. Pt was referred to Dr (neurologist). The impression was encephalopathy secondary to MMR vaccination.
Age: 35.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Dizziness, Feeling hot, Injection site mass, Injection site oedema
Clinical narrative: Rt arm (deltoid) swollen, no redness, huge knot approx half dollar in size, pain and warm to touch, shoulder pain, complaints of lightheadedness and nausea started approx 5/21/2005.
Age: 35.0
Sex: M
Vaccine: TD
Symptoms: Injection site pain, Nausea
Clinical narrative: Rt arm (deltoid) swollen, no redness, huge knot approx half dollar in size, pain and warm to touch, shoulder pain, complaints of lightheadedness and nausea started approx 5/21/2005.
Age: 1.5
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash to left lower thigh began 2 days after vaccination on 5/12/05. Mom states slight fever 2 hrs before appt on 5/19/05 T 98.3 at appt time. Observed rash.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Skin ulcer
Clinical narrative: Multiple lesions on back, face, chest and head.
Age: 27.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives both arms. (injection site left deltoid, unremarkable)
Age: 1.42
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Child presents to office 5/23/05 with diagnosis of varicella
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site reaction
Clinical narrative: Erythema and Induration surrounding DTP injection site extending out 6cm from center of left deltoid, started within 24 hrs of shots
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Dx with chicken pox 5/13/05.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Respiratory distress, Urticaria
Clinical narrative: Pt developed severe respiratory distress within 30 mins. He is known to have bronchospasm in the past but no recent events. Pt received Benadryl, Orapred and Xopenex in office with resolution. Also hives.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: L arm red, swollen and warm to the touch.  Swelling increased to elbow two days after shot given.  No fever.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MER
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: L arm swollen, red and with mild tenderness.  Swelling increased to elbow. No fever, no hand swelling.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Approximately 2 days after vaccination, patient developed redness and swelling of left arm.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Viral infection
Clinical narrative: Intermittent Dizziness started within 24 hours.  has continued for 6 days.  Dizziness initially lasted several hours regardless of position (prone, seated, standing) and transition to different positions.  By day 4-5, it was 3-4 hours and worse in the morning.  By day 6, it is getting less severe.
Age: 38.0
Sex: F
Vaccine: TTOX
Symptoms: Anorexia, Dizziness, Fatigue, Hypoaesthesia, Injection site swelling
Clinical narrative: Within two days she noticed under her right arm swollen (has improved somewhat). She had the injection in her right deltoid. She started to feel very tired, lightheaded, dizzy (has spinning when she lies down), no appetite. Has not improved as of 5/26/05. The right side of her face is sometimes numb - mostly around right eye and below. Also noticed this in her ear as well. She has blurred vision in both eyes. She has had days where it lasts all day, and other days where it improves in the evening. She had nightsweats in the beginning.
Age: 38.0
Sex: F
Vaccine: TTOX
Symptoms: Night sweats, Vertigo, Vision blurred
Clinical narrative: Within two days she noticed under her right arm swollen (has improved somewhat). She had the injection in her right deltoid. She started to feel very tired, lightheaded, dizzy (has spinning when she lies down), no appetite. Has not improved as of 5/26/05. The right side of her face is sometimes numb - mostly around right eye and below. Also noticed this in her ear as well. She has blurred vision in both eyes. She has had days where it lasts all day, and other days where it improves in the evening. She had nightsweats in the beginning.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left upper arm with large red area, hard and warm to touch. Given 5/31/2005. Reaction 6/2/2005. Placed on Clindamycin for 10 days.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: PPV. Severe pain in arm and shoulder, fever, muscle aches.  After 26 hours, can still barely lift the arm
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Rash
Clinical narrative: Transient red rash on right arm and most of chest and abdomen, face, well-demarcated, no induration.  Rash started around 4:30 pm, resolved by 6:15 pm.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: After administration of his DaPt booster and mantoux test, upon arrival at his home, less than 30 minutes his father how took him to be inmunized, started to notice welts over his arms and neck. The father contact the office right away and as we did not observe any breathing difficulty dyphenhydramine(Benadryl) in a dose of 5mgr/Kg?day was administer oraly.  I was able to exam him  30 minutes after the Benadryl dose. No  breathing difficulty and no wheezing was present , multiple polyform wealts were present in upper torso and both upper extremities. None in lower extremities. Patient had good capilary refill.  Instructions to continue Benadryl at 25 mgr po every 6 hours, and topical use of calamine lotion. Next morning hives were gone but left arm where DaPT was administered was erythematous, swelling but not warm to touch and did not look like an abcess was been forming in the area of injection. Instructions at that point were to apply warm compresses , continue using Benadryl as needed and any changes or temperature to contact Dr.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Anaemia, Blood urea increased, Convulsion, Crying, Dyskinesia
Clinical narrative: Excessive fussiness and crying followed by leg episodes of jerking/stiffening in the third day after administration of shots. Patient admitted to hospital for observation after NL work up. The suspected seizures were not associated by a fever.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Musculoskeletal stiffness
Clinical narrative: Excessive fussiness and crying followed by leg episodes of jerking/stiffening in the third day after administration of shots. Patient admitted to hospital for observation after NL work up. The suspected seizures were not associated by a fever.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Received Menactra vaccine 5/19/05. Presented in office 5/20/05 injection site red, swollen and hot to touch. Clarinex 2 tsp given in office. Advised to repeat dose tomorrow.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: L thigh swelling with 10x15cm erythema 5x5cm induration and redness.
Age: 1.02
Sex: F
Vaccine: UNK
Symptoms: Headache, Rash
Clinical narrative: Rash on back  this AM. HA last PM. Resolved. No fever. Tx Acyclovir 3tsp QID x 5 days.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Rash, Urticaria
Clinical narrative: 4-5 hrs after receiving Dtap/hib broke out with whelps; spoke with MD via phone, MD suggested giving Benadryl. Today 2 days later still has fine rash noted on back, bottom, face area.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: PN and swelling and redness at site. Treated with Ibuprofen/allergy med.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site oedema, Oedema peripheral
Clinical narrative: Lump. Redness and swelling to left thigh area. Warm to touch. 1) cool packs 2) Benedryl 3) Augmentin for Cellulitis.
Age: 1.05
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Pt presented to current MD office on 06/02/05 with Varicella disease despite having vaccine.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Body temperature increased, Crying, Irritability, Screaming
Clinical narrative: Had shots 05/13/05- went to ER 05/15/05 @ 11:42PM with c/o temperature of 100.3 F , fussy, and crying for 2 days. At ER, stated - immunizations on 05/13 and ss began on 05/14/2005. DC home S/s probably due to immunizations. Saw MD on 05/16/05 in office and pt doing well then.
Age: 16.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Hypersensitivity, Injection site swelling
Clinical narrative: Very sore arm x 2-3 days. Then red, raised area on shoulder increasing in size. After 5 days. Oval shaped. 06/02- Benedryl and ibuprofen given. watching pt as of 05/30/05.
Age: 32.0
Sex: F
Vaccine: HEP, TD
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth, Tenderness
Clinical narrative: Left deltoid swollen, hot to touch. No redness. Localized reaction. Afebrile, tender to touch.
Age: 6.0
Sex: F
Vaccine: IPV, PNC
Symptoms: Erythema, Injection site discolouration
Clinical narrative: Red blanching around injection site.
Age: 1.08
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash, Rash pustular, Rhinorrhoea
Clinical narrative: Red spots on body with pustules, fever, sinus drainage.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Anaphylactic reaction, Pruritus, Urticaria, Wheezing
Clinical narrative: Initial information was received from a health professional and a nurse and follow up information from the nurse and nursing supervisor concerning a 4 year old male pt with no illness at the time of vaccination, no history of allergies (also reported as allergy to morphine) and no history of any problems or reactions to any of his previous vaccinations and with a history of congenital heart problem that has been corrected, noted on follow up to be transposition of great arteries. On 05-MAR-2004 at 1 PM the pt was vaccinated SC with a first dose of MMR II (lot #646898/0950N0. Concomitant therapy included aspirin, Lanoxin and vaccination at 1 PM on 05-MAR-2004 with a first dose of hepatitis A vaccine (lot # 647340/1123N) given IM, with a fourth dose of DTaP (lot # C1679AA) given IM and with a third dose of IPV (lot # X0707) given SC. Subsequently the pt experienced itching, wheezing and hives (also reported as itchy rash and cough developed within one minute of vaccine and wheezing developed soon after). Follow up information reported that the child's reaction was considered to be an anaphylactic reaction with an immediate onset after the vaccination. The child's oxygen saturation went down on the pulse oximetry (value not reported) and then went back up, so oxygen was not required. The pt was not hospitalized. Unspecified medical attention was sought. There was no diagnostic or laboratory testing done. The pt was treated with 2 doses of epinephrine, oral Benadryl and an oral steroid prednisolone and was monitored in the office. The pt recovered on 05-MAR-2004. Follow up information reported that the physician thought that the MMR II was the primary suspect drug. The nurse reported that they were not sure if any of the other vaccinations were suspect because the reaction occurred immediately after the MMR II was given. Upon internal review, anaphylactic reaction was determined to be an other important medical event (OMIC). The nurse also reported that a male pt experienced an anaphylactic reaction following vaccination with MMR II (WAES0403USA02121). Additional information is not expected. Other business partner number included 200401259.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 5 year old female who on 3/26/04 was vaccinated SC in the right thigh with a second dose of MMR (lot # 646556/0813N). Concomitant vaccine therapy included a fifth dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid given IM In the left thigh (lot # U1258DA) and a fourth dose of polio virus vaccine given SC in the left thigh (lot # N0491). On the morning of 3/27/04 the patient developed a red, swollen right leg and went to the emergency room where a complete blood cell count and blood cultures were completed and she was diagnosed with cellulitis. The patient was treated with amoxicillin (+) clavulanate potassium, PO, for 9 days and received a one time dose of ceftriaxone sodium. Subsequently the patient recovered. No further information is expected.
Age: 41.0
Sex: M
Vaccine: MMR
Symptoms: Drug ineffective, Erythema, Rash morbilliform, Rash pruritic, Viral infection
Clinical narrative: Information has been received from a RN concerning a 41 year old male pt with hypertension who on 10-MAR-2004 was vaccinated SC with MMR II (lot#641620/0667N). It was reported that the pt was not ill at the time of vaccination. The pt received a second dose of Twinrix (lot #HAB276A6) on 11-FEB-2004. On 14-MAR-2004 the pt developed a red, itchy measles like rash on the chest. The rash was treated with an unknown topical medication and resolved within 5 days. No other information was available. In follow up information from the RN, it was reported that the rash had spread up to but not on the neck and shoulders. The physician diagnosed measles on 02-APR-2004. The rash resolved and the pt recovered on 13-APR-2004. Previous vaccinations included a dose of measles virus vaccine live (manufacturer unknown) on 15-OCT-1963, a dose of oral typhoid vaccine (unspecified) (manufacturer unknown), yellow fever virus vaccine (YF Vax), and a dose of IPV (unspecified) (manufacturer unknown). Additional information is expected.
Age: 21.0
Sex: F
Vaccine: HEPA, IPV, TYP, YF
Symptoms: Urticaria
Clinical narrative: Info has been received from a health professional concerning a 20 year old female with a history of environmental allergies (but no drug allergies and no egg allergy) who on 4/12/04 was vaccinated with a dose of hepatitis A vaccine inactivated (lot 647701/1165N). Concomitant therapy that day included a dose of yellow fever virus vaccine (lot UB492AA), a dose of Typhim VI (lot W0909), and a dose of IPOL (lot W0450). Two hours after receiving the vaccination, the pt broke out with hives on her face, neck and upper lip. She denied dyspnea or tightness in the chest. She went to the ER where she was given IV Benadryl and Decadron. The hives resolved in minutes after receiving the medication. The pt recovered from the event. It was noted that the pt had received previous doses of every vaccine except for yellow fever virus vaccine. The reporter considered hives to be an other important medical event. No further info is available.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Pruritus, Rash pustular, Skin ulcer
Clinical narrative: Information has been received from a 31 year old postpartum female and LPN who on 30Mar04 was vaccinated with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On approx 09Apr04 the pt developed rash, lesions on arms and legs, red dots throughout the body, and severe itching. The pt stated that she had the vaccination a few days after giving birth to a healthy baby. The pt stated that she was treated with unspecified creams and diphenhydramine hydrochloride (Benadryl). The pt stated that it has been three weeks since the vaccination and she still itches and still has lesions and a rash over her body. The LPN also noted that the pt developed pustules and rashes on extremities one month postpartum and three weeks post measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) vaccination. The pt did not recover from rash pustular, rash, erythema, pruritus and skin lesions. Additional information has been requested.
Age: 1.27
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Local reaction
Clinical narrative: This is in follow up to report(s) previously submitted on 5/28/2004. Information has been receive from a registered nurse concerning an adopted 15 month old Chinese female patient, with no illness at the time of vaccination, who on 10 Feb 2004 was vaccinated subcutaneous in the left leg with a first dose of MMR II (lot# 646740/0822N). The nurse reported that the patient experienced a local site reaction and developed redness at the injection site. It was reported by nurse on follow up that on 10 Feb 2004 the patient experienced redness around area of injection. The patient was observed and no treatment was needed. The reporter has requested a lot check. The records of testing prior to release of this lot (646740/0822N) have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. The nurse reported another child who experienced a similar reaction after therapy with MMR II (WAES # 0402USA01555). The nurse also reported that triplets experienced a similar reaction after therapy with Varivax (WAES# 0402USA01433, 0402USA01540, and 0402USA01541). The nurse reported another child who experience a similar reaction after therapy with Varivax (WAES# 0402USA01546). It was noted that the triplets had the worst reaction.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Erythema, Hypoaesthesia, Lymphadenopathy, Nausea
Clinical narrative: Information has been received from a RN concerning a 57 year old white female with a history of measles and mumps with no known allergies who on 14-JUN-2004 was vaccinated with MMR II (lot # 644420/1010M), SC in the right upper arm. There was no illness at the time of vaccination. On 07-JUL-2004 in the AM the office received a telephone call from pt who had developed a fine red rash over her entire body, and complained of itching and hives. The pt also had swollen glands in her neck. Subsequently, "a day or so after the symptoms began" the pt also developed bilateral joint pain that was noted mostly in her arms, wrists and hands. On 10-JUL-2004 the pt went to the hospital ER with swelling and numbness in both hands and had joint pain. Received oxycodone and went home and had nausea and vomiting. Oxycodone was discontinued. On 11-JUL-2004 the pt returned to the ER to receive "an injection - anti-inflammatory" and reportedly "it helped." On 12-JUL-2004 in the AM the pt had pain, swelling and numbness which "remains now." No product quality complaint involved. On 28-JUL-2004 the pt was considered to be not recovered, but was improved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Oedema, Pruritus, Rash, Urticaria, Vomiting
Clinical narrative: Information has been received from a RN concerning a 57 year old white female with a history of measles and mumps with no known allergies who on 14-JUN-2004 was vaccinated with MMR II (lot # 644420/1010M), SC in the right upper arm. There was no illness at the time of vaccination. On 07-JUL-2004 in the AM the office received a telephone call from pt who had developed a fine red rash over her entire body, and complained of itching and hives. The pt also had swollen glands in her neck. Subsequently, "a day or so after the symptoms began" the pt also developed bilateral joint pain that was noted mostly in her arms, wrists and hands. On 10-JUL-2004 the pt went to the hospital ER with swelling and numbness in both hands and had joint pain. Received oxycodone and went home and had nausea and vomiting. Oxycodone was discontinued. On 11-JUL-2004 the pt returned to the ER to receive "an injection - anti-inflammatory" and reportedly "it helped." On 12-JUL-2004 in the AM the pt had pain, swelling and numbness which "remains now." No product quality complaint involved. On 28-JUL-2004 the pt was considered to be not recovered, but was improved. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash macular, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 month old female with a medical history of allergic rhinitis who on 06 July 2004 was vaccinated with MMR.  There was no illness at teh time of vaccination and no adverse events following prior vaccinations.  On 12 July 2004 reported as post vaccination, the child appeared to have a fine rash (looked like a heat rash) on the face, neck, and some starting on the tummy.  The child was seen on 13 July 2004 and nurse stated she had blotches of hives around swollen eyes and hair/head, described as maculopapular raised circles and dime size smaller, everywhere except soles of feet and palms of hands.  Child was tested for step throat results were negative while blood cell count was slight elevation at 13.2 fever was 101.2.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash, Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female with no past medical history who on 21 June 2001 was vaccinated with a first dose of MMR SC on left thigh.  Concomitant therapy that day included first dose of Varicella SC in right thigh.  There was no illness and no other medications at the time of vaccination.  From 27 June 2004 to 30 June 2004 the patient had a fever (max - 104).  On 01 July 2004 the patient developed a rash.  Reportedly by 06 July 2004 the patient had numerous erythematous papular vesicles and erosions which were appearing secondarily infected.  The patient was treated wth Keflex with improvement.  The patient was seen again for a re-check on 08 July 2004 and on 27 July 2004 and was reported as healing.  It was reported that the patient recovered.  It was noted that there was no known adverse events following prior vaccinations.  There were no relevant test of lab data performed.  No further information is expected.
Age: 1.83
Sex: F
Vaccine: DTAPH, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This report was received from mfr for Havrix. This was originally reported by a physician. On 7/20/04, a 26 month old female (previously reported as a 14 month old male pt), with no relevant medical history was vaccinated IM, in the right deltoid with a 1st dose of Havrix (lot 645054/0011N). Concomitant therapy that day included a 4th IM dose in the left deltoid of Trihibit. It was reported that one day after vaccination, the pt developed a 5 x 7cm induration at the vaccination site and injection site erythema and swelling. The pt was seen at a physician's office. The event was reported to be ongoing at the time of initial reporting. The physician reported the event was possibly related to Havrix. It was noted that the pt recovered and the redness and swelling essentially resolved by 7/22/04. On 8/3/04, the physician reported that the pt did not receive Havrix, but hepatitis A vaccine by another mfr. No further info is expected.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Urticaria
Clinical narrative: Information was received from an office manager concerning a 4 year old female patient who on 01 SEP 2004 was vaccinated with a dose of MMR.  Concomitant vaccine therapy administered on the same day included a dose of DTaP.  The patient experienced generaized hives.  She was prescribed BENADRYL.  The hives improved after the BENADRYL and she recovered on an unknown date.  No other information regarding the patient's event was provided.  There was no product quality complaint reported.  Additional informaton was requested.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Musculoskeletal stiffness
Clinical narrative: Information has been received from a physician concerning a 5 year old male who on 07 September 2004 was vaccinated with a dose of MMR.  Post vaccination on approximately 07 September 2004 the patient developed a stiff neck.  The patient was taken to an emergency room and treated with tylenol with codeine.  The physician indicated the patient still had a stiff neck.  A product quality complaint was not involved.
Age: 1.27
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Agitation, Coma, Crying, Dysphagia, Febrile convulsion
Clinical narrative: Information has been received from a physician and medical records concerning a 15 month  old Asian female with no allergies and no pertinent medial history and a family history of a maternal aunt who had a febrile convulsion as a child who on 03Sep04 was vaccinated SC with a 0.5ml dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 645513/1207N). Concomitant vaccine therapy given SC included a 0.5ml dose of varicella virus vaccine live (lot 647528/1242N). There was no other concomitant medication. On 12Sep04 the pt had a brief febrile convulsion. While drinking milk in her mother's lap, the pt developed a rolling of her eyes, the milk started to dribble from her mouth, she was not swallowing the milk and not responding to her mother. Her lips turned blue, she was unresponsible for about 2-3 minutes and then started to cry. She vomited once after the episode and once earlier in the day. It was noted that the pt had had a fever x 24 hrs but had been playful at the beach that day. Her mother took her to the ER for evaluation. She was alert, in mild distress, irritable but consolable, physical examination was WNL, temp was 101.8. Bloodwork came back normal. During her ER observation, she became progressively more alert. She was treated with acetaminophen (Tylenol) 120mg suppository. No prescription drug treatment was required. She was observed for 4 hrs and was to see her physician the next morning. Her mother received written and verbal instructions regarding her condition. The pt was reported as recovered on 12Sep04. On 13Sep04 she was seen by her physician and seemed to be fine. No product quality complaint was involved. Febrile convulsion was considered life threatening. No further information is expected. This is a consolidation of two reports concerning the same pt.
Age: 1.27
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Gaze palsy, Irritability, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician and medical records concerning a 15 month  old Asian female with no allergies and no pertinent medial history and a family history of a maternal aunt who had a febrile convulsion as a child who on 03Sep04 was vaccinated SC with a 0.5ml dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 645513/1207N). Concomitant vaccine therapy given SC included a 0.5ml dose of varicella virus vaccine live (lot 647528/1242N). There was no other concomitant medication. On 12Sep04 the pt had a brief febrile convulsion. While drinking milk in her mother's lap, the pt developed a rolling of her eyes, the milk started to dribble from her mouth, she was not swallowing the milk and not responding to her mother. Her lips turned blue, she was unresponsible for about 2-3 minutes and then started to cry. She vomited once after the episode and once earlier in the day. It was noted that the pt had had a fever x 24 hrs but had been playful at the beach that day. Her mother took her to the ER for evaluation. She was alert, in mild distress, irritable but consolable, physical examination was WNL, temp was 101.8. Bloodwork came back normal. During her ER observation, she became progressively more alert. She was treated with acetaminophen (Tylenol) 120mg suppository. No prescription drug treatment was required. She was observed for 4 hrs and was to see her physician the next morning. Her mother received written and verbal instructions regarding her condition. The pt was reported as recovered on 12Sep04. On 13Sep04 she was seen by her physician and seemed to be fine. No product quality complaint was involved. Febrile convulsion was considered life threatening. No further information is expected. This is a consolidation of two reports concerning the same pt.
Age: 38.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 38 year old male with no pre-existing allergies or medical conditions who in 09 September 2004 was vaccinated at a student health center in the left upper are with a dose of MMR.  Secondary suspect vaccinations included:  Aplisol gievn 07 SEP 2004 at 13:25 IM in his right deltoid.  At the time of vaccination it was discovered that the patient had a positive TB test, a call was made to a doctor regarding the results.  On 12 SEPT 3 days after administration the patient developed a temperature of 100F and pain, redness and swelling involved all of the right upper arm where a vaccine was given.  Unspecified medical attention was sought, no lab or diagnostic studies were performed at that time.  Subsequently the patient recoverred.  Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 21 month old female with no relevant medical history or illness at the time of vaccination who on 05 APR 2004 was vaccinated SC in the right upper thigh with a first dose of MMR.  On 15 APR 2004 at 17:18 the patient had a seizure and was transported to the hospital by ambulance.  Laboratory evaluations revealed complete blood count, SMA/7, UA/CS, and blood culture were normal.  The patient received unspecified medical attention.  Subsequently the patient recovered.  There was no product quality complaint involved.  Upon internal medical review "experienced seizures" was considered an other important medical event.  No additional information is expected.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cough, Erythema, Pyrexia, Rash papular, Sinus tachycardia
Clinical narrative: Initial and follow up information has been received from an epidemiologist and a registered nurse concerning a 13 month old male with no remarkable medical history who on 11/24/2004 was vaccinated with a dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Concomitant vaccination on the same date included a dose of varicella virus vaccine live.  The patient was seen in the doctor's office on 12/01/2004.  The parents reported that on 11/29/2004 the child developed a fever and that he was sleeping more and pulling his ear.  Upon exam, it was reported that the patient had an associated deep cough and approximately a half dozen 2mm sized reddish blanching papules on his trunk.  TM"s gray and transparent with normal anatomy.  Throat slightly reddened with no exudates.  The patient was assessed as having viral syndrome with exanthem that could possibly be a reaction to measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  The doctor planned to treat with acetaminophen or ibuprofen and diet as tolerated. Upon exam it was also noted that the patient had sinus tachycardia with no murmur.  The epidemiologist wanted to know if the high fever was related to the lot of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Lot check has been requested.  The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory.  The lot complies with the standards of the center for biologics evaluation and research and was released.  This is a consolidation of two reports concerning the same patient.  Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Somnolence, Viral infection
Clinical narrative: Initial and follow up information has been received from an epidemiologist and a registered nurse concerning a 13 month old male with no remarkable medical history who on 11/24/2004 was vaccinated with a dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Concomitant vaccination on the same date included a dose of varicella virus vaccine live.  The patient was seen in the doctor's office on 12/01/2004.  The parents reported that on 11/29/2004 the child developed a fever and that he was sleeping more and pulling his ear.  Upon exam, it was reported that the patient had an associated deep cough and approximately a half dozen 2mm sized reddish blanching papules on his trunk.  TM"s gray and transparent with normal anatomy.  Throat slightly reddened with no exudates.  The patient was assessed as having viral syndrome with exanthem that could possibly be a reaction to measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  The doctor planned to treat with acetaminophen or ibuprofen and diet as tolerated. Upon exam it was also noted that the patient had sinus tachycardia with no murmur.  The epidemiologist wanted to know if the high fever was related to the lot of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Lot check has been requested.  The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory.  The lot complies with the standards of the center for biologics evaluation and research and was released.  This is a consolidation of two reports concerning the same patient.  Additional information is not expected.
Age: 1.18
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Viral infection
Clinical narrative: Initial and follow up information has been received from an epidemiologist and a registered nurse concerning a 14 month old male with no known drug allergies who on approximately 11/18/2004, was vaccinated with a dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Concomitant therapy that day included a dose of HIB conj vaccine, a dose of pneumococcal vaccine (prevnar), and a dose of varicella virus vaccine live.  On 11/26/2004, about 8 days later, the patient presented to the physician with a fever for the past 3-4 days.  No cough or cold symptoms were noted.  There was no rash noted.  He had been otherwise healthy.  His temperature was 103.3.  The assessment was a fever, most likely viral syndrome, or related to measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  A CBC with differential was completed, and the abnormal results included: HCT = 41.1% (high); BAND = 16% (high); MONO = 16% (high); EOS = 0% (high); and C-reactive protein = 3.0mg/dl (high).  A urinalysis was pending at the time of the report.  The epidemiologist wanted to know if the high fever was related to the lot of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Lot check has been requested.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  This is a consolidation of two reports concerning the same patient.  Additional information is not expected.