chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: F
Vaccine: HEP, HEP
Symptoms: Petechiae, Pulmonary congestion, Pulmonary oedema, Somnolence, Sudden infant death syndrome
Clinical narrative: Information has been received regarding a case in litigation concerning a 7-week-old female who on 21-DEC-1994 was vaccinated with a dose of Recombivax HB (manufacturer unspecified). On 21-DEC-1994 the patient experienced sudden infant death syndrome (SIDS). The patient death occurred the same day as her 21-DEC-1994 vaccinated at 7 weeks old, which was reported to be too quickly to have been the result of a catastrophic auto-immune reaction called cytokine storm as pustulated by the petitioner. Cerebral Edema: "Reports of cerebral edema following infection of nervous tissue generally are acommpanied by fever and significant symptom development usually requires several days to occur," reported the petitioner. Although the patient received Recombivax HB (manufacturer unspecified) on the same day of her death, the physician opined that a cytokine-induced cerebral edema would have required days to manifest." The cause of death was ruled SIDS by a forensic pathologist in the coroner's office who noted signs associated with SIDS such as "rare epicardial petechia," pulmonary congestion and edema, the petitioner reporter. And her age was within the accepted temporal window for SIDS. Also the child's mother during her pregnancy took the antipsychotic haloperidol, which was said to have been associated with "sudden and unexpected death." The reporter felt that sudden infant death syndrome was not related to therapy with Recombivax HB (manufacturer unspecified). Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a Registered Nurse (R.N.) and the consumer for the Pregnancy Registry for Gardasil concerning a 28 year old female patient with bacterial infection, sulfonamide allergy and a history of miscarriage few days before Memorial day, and HPV positive who on 08-OCT-2007 was vaccinated IM into left arm whether first dose of Gardasil lot #0530U. Concomitant therapy included "vaginal cream" [therapy unspecified] and YASMIN. The nurse from the physician's office reported that on 09-OCT-2007 the patient notified that her urine pregnancy test was positive on 08-OCT-2007. The patient mentioned that she took a second urine pregnancy test at home on 12-OCT-2007 which was positive. The last menstrual period date was 01-SEP-2007. The patient indicated that she has a follow up visit scheduled with the physician. She confirmed that she was pregnant before but "miscarried at home few days before memorial day." No adverse symptoms and no other information available. The outcome was unknown. Follow up information was received from the registered nurse on 31-MAR-2008. On an unspecified date the patient had an elected termination of the pregnancy. No other information is expected. Upon internal review elective termination of pregnancy was considered to be an other important medical event.
Age: 14.0
Sex: F
Vaccine: BCG, HPV4, MNQ
Symptoms: Hypotension, Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female who on 08-APR-2008 was vaccinated with GARDASIL (lot#659437/1266U) 0.5mL IM. Concomitant therapy included MENACTRA and "TB" vaccine (manufacturer unknown). On 08-APR-28 the patient fainted after receiving GARDASIL. The medical assistant reported that the patient was rushed to the hospital via ambulance due to severe hypotension after receiving the vaccine. At the time of reporting it was unknown if the patient had recovered. The reporter felt that syncope and severe hypotension were considered to be disabling, life threatening and an other medical event. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site irritation, Injection site oedema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from two pharmacists concerning a female inpatient with hypertension, goitre, pneumonia and fever who on 24-MAR-2008 was vaccinated IM into left arm with a dose of 0.5 mL PNEUMOVAX, lot # 659486/1539U.  Concomitant therapy included linezolid (ZYVOX), pantoprazole sodium (PROTONIX), enoxaparin sodium (LOVENOX) and unspecified therapies for hypertension, goiter, and pain.  The patient had not had a PNEUMOVAX vaccine in the past five years.  The patient was admitted to the hospital on 21-MAR-2008 for pneumonia and was treated with ceftriaxone sodium (ROCEPHIN) and azithromycin.  The patient was also treated with ertapenem sodium (MSD) since admission (indication not reported).  On 24-MAR-2008 the patient was administered PNEUMOVAX.  On 25-MAR-2008 therapy with ertapenem sodium (MSD) therapy was discontinued.  No AEs were reported for ertapenem.  On 26-MAR-2008 she developed an injection site reaction consisting of injection site swelling, warmth, tenderness, edema and irritation.  The patient was discharged and the patient's reactions were completely resolved on 01-APR-2008.  There was conflicting information regarding the seriousness of the injection site reactions.  One pharmacist stated that the reactions prolonged the patient's hospitalization and the other pharmacist stated that the patient's reaction did not prolong the patient's hospitalization.  He also reported that the patient did not get any treatment for the reaction (not even topical treatment).  Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Information has been received from two pharmacists concerning a female inpatient with hypertension, goitre, pneumonia and fever who on 24-MAR-2008 was vaccinated IM into left arm with a dose of 0.5 mL PNEUMOVAX, lot # 659486/1539U.  Concomitant therapy included linezolid (ZYVOX), pantoprazole sodium (PROTONIX), enoxaparin sodium (LOVENOX) and unspecified therapies for hypertension, goiter, and pain.  The patient had not had a PNEUMOVAX vaccine in the past five years.  The patient was admitted to the hospital on 21-MAR-2008 for pneumonia and was treated with ceftriaxone sodium (ROCEPHIN) and azithromycin.  The patient was also treated with ertapenem sodium (MSD) since admission (indication not reported).  On 24-MAR-2008 the patient was administered PNEUMOVAX.  On 25-MAR-2008 therapy with ertapenem sodium (MSD) therapy was discontinued.  No AEs were reported for ertapenem.  On 26-MAR-2008 she developed an injection site reaction consisting of injection site swelling, warmth, tenderness, edema and irritation.  The patient was discharged and the patient's reactions were completely resolved on 01-APR-2008.  There was conflicting information regarding the seriousness of the injection site reactions.  One pharmacist stated that the reactions prolonged the patient's hospitalization and the other pharmacist stated that the patient's reaction did not prolong the patient's hospitalization.  He also reported that the patient did not get any treatment for the reaction (not even topical treatment).  Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: DTAP, HBHEPB, HIBV, MMR
Symptoms: Autism, Haematology test
Clinical narrative: Information has been received from a consumer concerning a male with "pediatric asthma as a baby" and no drug reactions/allergies who on 15-APR-2002 was vaccinated with a dose of MMR II (Lot # 640634/1093L). Concomitant therapy that day included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, COMVAX, and PEDVAXHIB. In May 2005, the patient experienced autism. The patient had "blood work". The mother feels her son is autistic due to the "toxicity of the vaccines". The outcome is not recovered. Unspecified medical attention was sought. There was no product quality complaint. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Multiple sclerosis
Clinical narrative: Information has been received via a literature article regarding a case in litigation concerning a 41-year-old female with a history medical leave due to headaches, nausea and depression on November 12, 2002, who on 16-FEB-2003 was vaccinated with a dose of MMR II (manufacturer unknown).  "Within five days of her vaccination," on approximately 21-FEB-2003 the patient displayed symptoms of multiple sclerosis.  A physician hypothesized that "asymptomatic lesions or plaques of the brain stem and spinal cord were exacerbated by the inflammatory response to the vaccine", however, there was no evidence that the patient had lesions prior to her vaccination with MMR II (manufacturer unknown).  The reporter felt that multiple sclerosis was not related to therapy with MMR II.  Upon internal review, multiple sclerosis was determined to be an other important medical event.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood test normal, Pyrexia, Urine analysis normal
Clinical narrative: 4/2/08 mth. called.  Reports pt. began fever of ~101 degrees at approx. 8:30PM.  Took to MGH ER, and temp. by ear thermometer was 99.6 degrees.  Was rechecked with other thermometer and was 103 degrees.  Sent to another ER by PMD.  At other ER, seen by MD and admitted at approx. 1230PM.  Had blood and urine tests per moth.  Stated MD said all normal.  Was kept for observation.  Received Rocephin injection 3/5/08.  Fever went down to low-grade 3/5/08 that night and ran low-grade for a few days.  Was discharged 03/06/08, and mth. states Dr. said possibly vaccine related and vaccine allergy possibly.  Have requested hospitalization notes.5/15/08-records received for DOS 3/5-3/6/08-DC DX: Acute febrile episode status post immunizations. Developed low grade fever within a few hours after vaccine administration. Fever to 103.5 and fussy.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Dizziness, Headache, Hypoaesthesia, Lumbar puncture
Clinical narrative: Dizziness, loss of motor control, headaches - Dec. '07.  Shooting pains, numbness of feet, legs & arms - Jan. '08.  Diagnosed in Jan. 2008 with Transverse Myelitis through spinal MRI's & spinal tap. 5/22/08-records received for DOS 3/18-3/20/08-DC DX: Transverse myelitis with exacerbation. Admitted with history of increasing weakness on both upper and lower extremities with incoordination more on right than on the left. Difficulty holding objects and ambulation. Hiccups. Admitted in January which showed changes suggestive of transverse myelitis in cervical cord. Treated with IV steroids and responded well. PMH: Hypertension and gastroesophageal reflux disease, sinusitis and pulmonary nodule. C/O severe neuropathic pain. Responded well to steroids and was transferred to tertiary care. 6/9/08-records received for DOS 3/20-3/26/08- DC DX:Transverse myelitis. Diabetes type 2 secondary to steroids, hypertension steroid related, C/O strange sensation in throat on 12/07, weakness and clumsiness. Initially treated on 1/08 and in February was walking with complete resolution of numbness of right side. On 3/11/08 nerve pain on left side including face and shoulder and feet. Numbness and tingling followed which progressed to right side and was more profound than previously.  Follow-up: Loss of muscle control. Continued numbness in limbs; neck and head pain, sensitivity to temperature changes. All the various symptoms related to Transverse Myelitis, including urinary sensation and control. Dates of hospitalization since vaccination: 12/18 - 12/23/07. 01/17 - 01/29/08. 03/18 - 03/26/08. 12/15 - 12/18/08. 04/27 - 05/06/09. 05/10 - present. Doctors are considering plasma exchange therapy as a last option of treatment in this rare case. Plasmaphoresis began on May 12, 2009. Doctor ordered treatments for 5/12, 5/14, 5/16 and 5/18/2009.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Motor dysfunction, Myelitis transverse, Nuclear magnetic resonance imaging abnormal, Pain, Plasmapheresis
Clinical narrative: Dizziness, loss of motor control, headaches - Dec. '07.  Shooting pains, numbness of feet, legs & arms - Jan. '08.  Diagnosed in Jan. 2008 with Transverse Myelitis through spinal MRI's & spinal tap. 5/22/08-records received for DOS 3/18-3/20/08-DC DX: Transverse myelitis with exacerbation. Admitted with history of increasing weakness on both upper and lower extremities with incoordination more on right than on the left. Difficulty holding objects and ambulation. Hiccups. Admitted in January which showed changes suggestive of transverse myelitis in cervical cord. Treated with IV steroids and responded well. PMH: Hypertension and gastroesophageal reflux disease, sinusitis and pulmonary nodule. C/O severe neuropathic pain. Responded well to steroids and was transferred to tertiary care. 6/9/08-records received for DOS 3/20-3/26/08- DC DX:Transverse myelitis. Diabetes type 2 secondary to steroids, hypertension steroid related, C/O strange sensation in throat on 12/07, weakness and clumsiness. Initially treated on 1/08 and in February was walking with complete resolution of numbness of right side. On 3/11/08 nerve pain on left side including face and shoulder and feet. Numbness and tingling followed which progressed to right side and was more profound than previously.  Follow-up: Loss of muscle control. Continued numbness in limbs; neck and head pain, sensitivity to temperature changes. All the various symptoms related to Transverse Myelitis, including urinary sensation and control. Dates of hospitalization since vaccination: 12/18 - 12/23/07. 01/17 - 01/29/08. 03/18 - 03/26/08. 12/15 - 12/18/08. 04/27 - 05/06/09. 05/10 - present. Doctors are considering plasma exchange therapy as a last option of treatment in this rare case. Plasmaphoresis began on May 12, 2009. Doctor ordered treatments for 5/12, 5/14, 5/16 and 5/18/2009.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC
Symptoms: Convulsion, Pyrexia, Vomiting
Clinical narrative: Child developed fever >103 then 3-5 min. generalized seizure, emesis x3 after seizure.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: 3/28/08 3:30pm received call from patient.  States nausea, dizziness and weakness developed 1/2 hour after HPV injection.  Symptoms have persisted.  Appt offered to evaluate, patient declined.  Per MD push fluids, Tylenol.  Monitor.
Age: 29.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: HPV vaccine, licensed for age 6-26 given to age 29 female.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Should received age-inappropriate flu vaccine, Fluarix, licensed for age 18 year an older.
Age: 17.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Inappropriate schedule of drug administration, Syncope
Clinical narrative: Syncopal Episode-patient eased to floor with no injury DTaP given instead of Tdap
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Tenderness
Clinical narrative: Erythematous area, ~ 5 cm with 7 cm central redness more pronounced, local tenderness.  No discharge.  No fever.  Treated with clindamycin.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pruritus, Rash erythematous, Skin warm, Swelling
Clinical narrative: Round red and warm rash, itchy 9.5 x 8 cm, and swelling.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen site on LLT.
Age: 0.6
Sex: F
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: None.  Hep A given to 7 mo old by mistaken ID.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Cough, Dizziness, Dyspnoea, Local reaction
Clinical narrative: This case was reported by a physician and described the occurrence of shortness of breath in a 29-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Relevant medical history included a latex allergy and no history of adverse events to previous vaccinations. On 7 April 2008 at 13:05 the subject received 1st dose of BOOSTRIX (.5 ml, single dose vial, left arm). On 7 April 2008, within 20 minutes after vaccination with BOOSTRIX, the subject started to experienced shortness of breath, wheezing, coughing, itching, skin blotches and dizziness. The subject was treated with BENADRYL and Epinephrine in the office. The symptoms improves some and the subject was taken to the emergency room where Solumedrol was administered. The subject was released from the emergency room and was not hospitalized overnight. The subject also experienced a vaccination error as BOOSTRIX is recommended for 10 through 18 years of age. The physician considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were improved. The physician considered the events were probably related to vaccination with BOOSTRIX. Additional information received on 08 April 2008 from a nurse. She reported that the subject had no concurrent medications. She reported that no other vaccinations were given on the same day as BOOSTRIX. She reported that the subject experienced an anaphylactic reaction and BOOSTRIX was mis-administered per the indicated age range. She noted that the subject also had an adverse reaction to the vaccine that was initially local and then became systemic. The nurse reported that the subject received Solumedrol, epinephrine and Pepcid in the healthcare professional's office and then was transported to the hospital by emergency medical services.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash macular, Wheezing, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of shortness of breath in a 29-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Relevant medical history included a latex allergy and no history of adverse events to previous vaccinations. On 7 April 2008 at 13:05 the subject received 1st dose of BOOSTRIX (.5 ml, single dose vial, left arm). On 7 April 2008, within 20 minutes after vaccination with BOOSTRIX, the subject started to experienced shortness of breath, wheezing, coughing, itching, skin blotches and dizziness. The subject was treated with BENADRYL and Epinephrine in the office. The symptoms improves some and the subject was taken to the emergency room where Solumedrol was administered. The subject was released from the emergency room and was not hospitalized overnight. The subject also experienced a vaccination error as BOOSTRIX is recommended for 10 through 18 years of age. The physician considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were improved. The physician considered the events were probably related to vaccination with BOOSTRIX. Additional information received on 08 April 2008 from a nurse. She reported that the subject had no concurrent medications. She reported that no other vaccinations were given on the same day as BOOSTRIX. She reported that the subject experienced an anaphylactic reaction and BOOSTRIX was mis-administered per the indicated age range. She noted that the subject also had an adverse reaction to the vaccine that was initially local and then became systemic. The nurse reported that the subject received Solumedrol, epinephrine and Pepcid in the healthcare professional's office and then was transported to the hospital by emergency medical services.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Pain, Rash pustular
Clinical narrative: DEVELOPED RASH WITH PUSTULES WITH NUMBNESS AND MINIMAL PAIN, ON RT THIGH AND RT BUTTOCKS AREA INTO THE GROIN AREA.  STARTED THE AM OF 4/3/08. DX BY DERMATOLOGY AT THE HOSPITAL ON 4/12/08 AS SHINGLES.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dermatitis contact, Herpes zoster, Hypoaesthesia, Pain, Rash pustular
Clinical narrative: DEVELOPED RASH WITH PUSTULES WITH NUMBNESS AND MINIMAL PAIN, ON RT THIGH AND RT BUTTOCKS AREA INTO THE GROIN AREA.  STARTED THE AM OF 4/3/08. DX BY DERMATOLOGY AT THE HOSPITAL ON 4/12/08 AS SHINGLES.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella
Clinical narrative: developed chickenpox lesions on 4/13/2008
Age: 1.25
Sex: F
Vaccine: DTAP, FLU3, MMR, VARCEL
Symptoms: Rash morbilliform, Rash vesicular
Clinical narrative: 2 days after MMR/varicella/Dtap/flu vaccines, developed a measles-like rash that lasted about 2 weeks. 1 week after same, developed a varicella rash lasting a few days.
Age: 0.35
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: Mom first called for swelling at Rt thigh on 04-08-2008. It was non tender, non erythmatous swelling without any fever or irritability. On 04-14-2008 Mom reported that swelling is getting red and tender without any fever. On examination local infection with possibility of developing abscess. With parents agreement patient is placed in Augmentin 600 mg/5 ml, 3 ml po bid. Will follow in 48 hr / earlier if patient gets worse. Today patient is still afebrile. Parents were explained about possible need for hospital admission and drainage if get worse and report if any fever or patient getting worse.  This batch number is very close that of recalled batch of Comvax 0376 and 0387U. Was there is any contamination of this batch with same bacteria?
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, pain and warmth at injection site.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Hypersensitivity, Local reaction, Swelling, Urticaria
Clinical narrative: Local and allergic reaction to Tdap. Patient had a 7 x 5 cm. area of swelling and erythema on left deltoid area. Furthermore, she had hives on her trunk. Patient was treated with prednisone: 40mg. daily x 2 days, 30 mg. daily x 2 days, 20 mg. daily x 2 days and then 10 mg. daily x 2 days (8 total days of therapy).
Age: 56.0
Sex: F
Vaccine: TTOX
Symptoms: Activities of daily living impaired, Headache, Insomnia, Musculoskeletal pain, Neck pain
Clinical narrative: Went to minor ER clinic for a sinus infection.  Because summer is upon us, I requested a tetanus shot since I hadn't had one for years.  I was given a shot and sent home and told not to lay on that arm for a day or so.  This was April 3, 2008.  My arm, shoulder and neck are still sore including causing headaches, unable to sleep, difficulty typing, dressing, picking anything up including sometimes even my coffee cup.
Age: 56.0
Sex: F
Vaccine: TTOX
Symptoms: Sinusitis
Clinical narrative: Went to minor ER clinic for a sinus infection.  Because summer is upon us, I requested a tetanus shot since I hadn't had one for years.  I was given a shot and sent home and told not to lay on that arm for a day or so.  This was April 3, 2008.  My arm, shoulder and neck are still sore including causing headaches, unable to sleep, difficulty typing, dressing, picking anything up including sometimes even my coffee cup.
Age: 25.0
Sex: F
Vaccine: ANTH, HPV4, TYP
Symptoms: Injection site rash
Clinical narrative: Rash near the site of injection, Dr. had stated that the reason for this reaction is indefinite that it was anthrax vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, MMRV, VARCEL
Symptoms: Blister, Injection site discharge, Pyrexia, Skin swelling
Clinical narrative: On 4/11/08, four (4) Vaccines were administered approximately 11:15 a.m. to outside thighs on both legs. Fever of 101 - 104 began by 6 p.m.  Skin Swelling overnight to @ 1/4 inch high, and circular 4-5 inches wide/long.   Approximately 2 p.m. a small bump, ie., blister-like appeared where shot was given with continual emitting and oozing of pus/blood, and liquid drainage occurred, and continued to grow.  E/R admistered Benadryl and Motrin, and prescribed Bactrim @ 10 p.m. Condition continued to grow until Sun., 4/13/08 9 a.m.  Blister  continues to emit drainage.  Returned to hospital on Mon., 4/14/08 at 2:15 p.m.   Chief of Pediatrics checked out affected right leg and indicated that it looked like the flesh-eating disease, but symptoms were not as severe and ruled it out and he suggested to continue medication; Bactrim for 10 days; Motrin and Benadryl, as needed.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Injection site erythema
Clinical narrative: Site red about the size of baseball - pt instructed to take Benadryl and use hydrocortisone on the site.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, PNC
Symptoms: Pyrexia, Urticaria, Vaccination complication
Clinical narrative: Immunization given in right thigh as patient moved his hip away from the injection.  The syringe came out approximately 1/2 inch as the Dtap was being injected and therefore gave the immunization as SQ instead of IM.  Patient came back on Monday and a large red wheal approximately 3 1/2 by 4 cm was noted.  The patient had a fever over the weekend and the redness spread from dime size to the above stated size.  Mother had taken patient into see another physician then came back to the clinic.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site mass
Clinical narrative: LUMP AT VACCINATION SITE, LASTING APPROX. 1 MONTH, WAS APPROX 4 INCHES ACROSS AT IT'S PEAK.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Both of my children recieved the chicken Pox vaccine.  They both had identical reactions. At the site of injection that got a SQUARE rash, larger than a half dollar. It was hot to the touch and extremely itchy.  It lasted 3 weeks.
Age: 28.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Abdominal pain, Alanine aminotransferase normal, Antibody test negative, Antinuclear antibody negative, Aspartate aminotransferase normal
Clinical narrative: Pt was in good health until he reported to the Clinic on 06 Feb 08 for evaluation of abdominal pain.  His pain started approx 01 Feb and persisted for a total of 6-7 days.  Lab review at that time noted elevated eosinophils.  He subsequently underwent a thorough evaluation by Infectious Disease on 25 Feb, Cardiology on 27 Feb, Hematology on 29 Feb, and Allergy on 28 Mar.  These evaluations and subsequent diagnostics did not identify an etiology for the eosinophilia.  F/U with ID on 31 Mar noted that other than occas headaches, he has returned to his normal health.  DX: Eosinophilia  Symptom: Abdominal Pain Start: 02/01/2008 End: 02/06/2008
Age: 28.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Blood immunoglobulin A, C-reactive protein normal, Complement factor C3, Complement factor C4 decreased, Complement factor decreased
Clinical narrative: Pt was in good health until he reported to the Clinic on 06 Feb 08 for evaluation of abdominal pain.  His pain started approx 01 Feb and persisted for a total of 6-7 days.  Lab review at that time noted elevated eosinophils.  He subsequently underwent a thorough evaluation by Infectious Disease on 25 Feb, Cardiology on 27 Feb, Hematology on 29 Feb, and Allergy on 28 Mar.  These evaluations and subsequent diagnostics did not identify an etiology for the eosinophilia.  F/U with ID on 31 Mar noted that other than occas headaches, he has returned to his normal health.  DX: Eosinophilia  Symptom: Abdominal Pain Start: 02/01/2008 End: 02/06/2008
Age: 28.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Electrocardiogram normal, Eosinophil count increased, Eosinophilia, Fungus serology test negative, Headache
Clinical narrative: Pt was in good health until he reported to the Clinic on 06 Feb 08 for evaluation of abdominal pain.  His pain started approx 01 Feb and persisted for a total of 6-7 days.  Lab review at that time noted elevated eosinophils.  He subsequently underwent a thorough evaluation by Infectious Disease on 25 Feb, Cardiology on 27 Feb, Hematology on 29 Feb, and Allergy on 28 Mar.  These evaluations and subsequent diagnostics did not identify an etiology for the eosinophilia.  F/U with ID on 31 Mar noted that other than occas headaches, he has returned to his normal health.  DX: Eosinophilia  Symptom: Abdominal Pain Start: 02/01/2008 End: 02/06/2008
Age: 28.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Helicobacter pylori identification test negative, Hepatitis viral test, Nuclear magnetic resonance imaging normal, Parasite stool test negative, Red blood cell sedimentation rate normal
Clinical narrative: Pt was in good health until he reported to the Clinic on 06 Feb 08 for evaluation of abdominal pain.  His pain started approx 01 Feb and persisted for a total of 6-7 days.  Lab review at that time noted elevated eosinophils.  He subsequently underwent a thorough evaluation by Infectious Disease on 25 Feb, Cardiology on 27 Feb, Hematology on 29 Feb, and Allergy on 28 Mar.  These evaluations and subsequent diagnostics did not identify an etiology for the eosinophilia.  F/U with ID on 31 Mar noted that other than occas headaches, he has returned to his normal health.  DX: Eosinophilia  Symptom: Abdominal Pain Start: 02/01/2008 End: 02/06/2008
Age: 28.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Rheumatoid factor negative
Clinical narrative: Pt was in good health until he reported to the Clinic on 06 Feb 08 for evaluation of abdominal pain.  His pain started approx 01 Feb and persisted for a total of 6-7 days.  Lab review at that time noted elevated eosinophils.  He subsequently underwent a thorough evaluation by Infectious Disease on 25 Feb, Cardiology on 27 Feb, Hematology on 29 Feb, and Allergy on 28 Mar.  These evaluations and subsequent diagnostics did not identify an etiology for the eosinophilia.  F/U with ID on 31 Mar noted that other than occas headaches, he has returned to his normal health.  DX: Eosinophilia  Symptom: Abdominal Pain Start: 02/01/2008 End: 02/06/2008
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Culture wound negative, Incisional drainage, Injection site abscess
Clinical narrative: Sterile abscess at site of injection.  Began few days after shot.  Wound cultures x2 both negative.  Had I&D.  Given Bactrim.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Pruritus
Clinical narrative: Erythema from elbow up to shoulder - pruritic - went to E.R. - also up to another hospital.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Balance disorder, Chills, Dyspnoea, Headache, Muscle fatigue
Clinical narrative: Got Tdap yesterday at office.  By last night, 8 hours later, began to feel right arm pain, then head pounding, balance issues, nausea, chills, shortness of breath.  Now his hips feel pressure, his head feels squished, and R arm hurts like it has been hit by a baseball bat.  Now it is 24 hrs later and he looks ill, face and head & neck are pink and were not yesterday.  Got shot in right arm, left arm just feels fatigue.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pain in extremity, Pallor, Sensation of pressure, Skin discolouration
Clinical narrative: Got Tdap yesterday at office.  By last night, 8 hours later, began to feel right arm pain, then head pounding, balance issues, nausea, chills, shortness of breath.  Now his hips feel pressure, his head feels squished, and R arm hurts like it has been hit by a baseball bat.  Now it is 24 hrs later and he looks ill, face and head & neck are pink and were not yesterday.  Got shot in right arm, left arm just feels fatigue.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria - itching all limbs.  Rx - cyproheptadine 4mg, hydrocort cream 1%, ranitidine 150mg.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash, Viral test
Clinical narrative: Rash, fever.  Tx: Benadryl, Aveeno bath.
Age: 0.5
Sex: F
Vaccine: HIBV, PNC
Symptoms: Face oedema, Vomiting
Clinical narrative: Swelling to face; Vomiting
Age: 4.0
Sex: U
Vaccine: DTAP, MMR
Symptoms: Erythema, Induration
Clinical narrative: Right arm 5x6 cm erythema and 1.5 cm induration; #5 DTAP, #2 MMR on right arm. Treated with warm compress and Rocephin and PO Augmentin.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A nonserious report of expired dose of vaccine administered has been received from a nurse concerning a child above two-years old. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. No relevant medical or drug history information was reported. The patient was given FluMist on 29-Feb-2008. The FluMist had expired on 26-Feb-2008. No adverse events were reported from this error. Rechallenge is not applicable. Causality assessment is not applicable. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning a 27-month-old female.  This case is submitted in accordance with an article on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 11-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the vaccines clinic on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  The patient had no adverse events at the time the report was received, neither as of 18-April-2008 when the office was contacted for follow-up information. The event has resolved.  It was not reported whether or not FluMist was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Follow-up information received 18-Apr-2008 and incorporated into he narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning a four year old male. The case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 11-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the vaccines for the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continue to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006659; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667;MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning a four-year-old male.  This case is submitted in accordance with an article on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 11-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  No adverse events were reported.  The event has resolved.  It was not reported whether or not FluMist was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning a 29-month-old male. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient recovered FluMist on 12-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she recovered 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received. Neither as of 18-Apr-2008 when the office was contacted for follow-up information. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006659; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672;MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684. The patietn received FLUMIST on 12-Mar-2008.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse in concerning four-year old female. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 12-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported. The event has resolved.  It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006659; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning a 38-month-old female.  This case is submitted in accordance with an article on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 12-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  No adverse events were reported.  The event has resolved.  It was not reported whether or not FluMist was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006659; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684. Follow up information received 18-Apr-2008 and incorporatedinto the narrative: no adverse event occurred.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning a 36-month old male. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 12-Mar-2008. The FluMist had expired on 10-Jan-2008. The reporter stated that she received 100 doses of FluMist from the vaccines program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinical did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006659; MEDI-0006669; MEDI-0006670; MEDI-0006671 MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning a four-year-old female.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 12-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccines expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  No adverse events were reported.  The event has resolved.  It was not reported whether or not FluMist was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006659; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning a 44-month-old female. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 13-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continues to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006659; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.